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April 2016

Conventional Units
Worldwide Report
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017

Acetaminophen Chemiluminescence µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 13.99 14.55 −− −− 133.4 137.3
SD 1 1.23 1.01 2 −− −− 3 9.08 8.75
CV 8.8 7.0 −− −− 6.8 6.4
# Points 82 516 −− −− 83 543
# Labs 3 3 3 3

Beckman Coulter UniCel DxC Series
Mean 16.75 16.75 −− −− 160.7 160.7
SD 1 0.408 0.387 2 −− −− 3 1.22 0.949
CV 2.4 2.3 −− −− 0.8 0.6
# Points 4 6 −− −− 4 6
# Labs 1 1 1 1

Method Group • Chemiluminescence
Mean 14.12 14.57 −− −− 134.6 137.6
SD 1 1.34 1.04 2 −− −− 3 10.57 9.03
CV 9.5 7.1 −− −− 7.8 6.6
# Points 86 522 −− −− 87 549
# Labs 4 4 4 4

Acetaminophen Colorimetric µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models) • Sekisui Diagnostics
Mean 14.37 14.37 44.95 44.95 141.7 141.7
SD 1 0.340 0.340 2 0.994 0.994 3 1.15 1.15
CV 2.4 2.4 2.2 2.2 0.8 0.8
# Points 23 23 19 19 13 13
# Labs 1 1 1 1 1 1

Siemens Dimension Series
Mean −− −− 47.98 46.74 −− 138.2
SD 1 −− −− 2 1.28 1.26 3 −− 1.50
CV −− −− 2.7 2.7 −− 1.1
# Points −− −− 9 53 −− 11
# Labs 1 2 1

Method Group • Colorimetric
Mean 14.37 14.37 45.93 46.27 141.7 140.1
SD 1 0.340 0.340 2 1.79 1.43 3 1.15 2.23
CV 2.4 2.4 3.9 3.1 0.8 1.6
# Points 23 23 28 72 13 24
# Labs 1 1 2 3 1 2

Acetaminophen EIA µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 14.64 14.41 45.73 44.87 138.7 137.8
SD 1 1.25 1.15 2 4.15 3.46 3 11.22 10.00
CV 8.6 8.0 9.1 7.7 8.1 7.3
# Points 347 2171 268 1645 367 2201
# Labs 7 8 4 4 7 8

Roche cobas 6000/8000/c 311
Mean 14.47 14.54 44.98 44.98 −− −−
SD 1 0.390 0.511 2 1.31 1.31 3 −− −−
CV 2.7 3.5 2.9 2.9 −− −−
# Points 30 87 24 24 −− −−
# Labs 1 1 1 1

The statistics in this report are derived from user−supplied data and are provided by Bio−Rad Laboratories as a service to its customers. Such action does not imply support of reported analytes and test methods. Refer to the package
insert for specific analyte claims and stability information. Qualitative percentages may not add up to 100 due to rounding. Peer group statistics contained in this report may not be used without the expressed written consent of Bio−Rad
Laboratories.

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 1

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Acetaminophen EIA µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Method Group • EIA
Mean 14.63 14.41 45.67 44.87 138.7 137.8
SD 1 1.21 1.14 2 4.00 3.43 3 11.22 10.00
CV 8.3 7.9 8.8 7.7 8.1 7.3
# Points 377 2258 292 1669 367 2201
# Labs 8 9 5 5 7 8

Acetaminophen Enzymatic µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean −− 15.44 44.90 44.24 132.7 131.7
SD 1 −− 0.256 2 0.000 0.523 3 0.000 0.789
CV −− 1.7 0.0 1.2 0.0 0.6
# Points −− 14 1 14 1 10
# Labs 1 1 1 1 1

Siemens ADVIA Chemistry Systems
Mean 14.20 14.38 47.80 45.53 134.8 136.6
SD 1 0.783 0.795 2 4.17 1.74 3 3.11 3.67
CV 5.5 5.5 8.7 3.8 2.3 2.7
# Points 440 4259 19 1114 414 4225
# Labs 13 19 3 7 10 17

Siemens ADVIA Chemistry Systems • Siemens ADVIA Acetaminophen, Cal Lot 9520521+
Mean 13.40 13.51 42.60 42.68 124.1 127.3
SD 1 0.740 7.76 2 2.07 2.07 3 8.87 9.84
CV 5.5 57.4 4.9 4.8 7.1 7.7
# Points 26 169 28 157 27 157
# Labs 1 1 1 1 1 1

Siemens ADVIA Chemistry Systems • Siemens ADVIA Acetaminophen, Cal Lots pre 9520521
Mean −− 14.43 −− −− −− 152.6
SD 1 −− 0.372 2 −− −− 3 −− 14.60
CV −− 2.6 −− −− −− 9.6
# Points −− 434 −− −− −− 428
# Labs 1 1

Siemens Dimension Series
Mean −− 22.85 −− −− −− 137.8
SD 1 −− 0.754 2 −− −− 3 −− 3.07
CV −− 3.3 −− −− −− 2.2
# Points −− 56 −− −− −− 56
# Labs 1 1

Method Group • Enzymatic
Mean 14.15 14.45 44.71 45.17 134.2 137.7
SD 1 0.802 1.73 2 3.95 2.00 3 4.51 7.58
CV 5.7 11.9 8.8 4.4 3.4 5.5
# Points 466 4932 48 1285 442 4876
# Labs 14 23 5 9 12 21

Acetaminophen Enzymatic, colorimetric µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models)
Mean 14.49 14.32 44.77 44.69 141.1 139.5
SD 1 0.498 0.717 2 1.41 1.40 3 4.57 6.10
CV 3.4 5.0 3.1 3.1 3.2 4.4
# Points 103 1059 65 429 77 989
# Labs 7 16 5 8 5 12

Abbott AEROSET/ARCHITECT (c, i, ci models) • Alternate Formulation/Standardization
Mean −− 13.86 −− 45.18 −− 141.5
SD 1 −− 0.653 2 −− 2.24 3 −− 2.33
CV −− 4.7 −− 5.0 −− 1.6
# Points −− 83 −− 96 −− 81
# Labs 1 1 1

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 2

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Acetaminophen Enzymatic, colorimetric µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models) • Sekisui Diagnostics
Mean 14.44 14.30 45.27 45.55 142.2 142.9
SD 1 0.473 0.653 2 1.65 1.75 3 2.64 3.21
CV 3.3 4.6 3.6 3.8 1.9 2.2
# Points 96 540 124 401 125 638
# Labs 5 6 4 4 5 6

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 15.70 15.50 45.20 44.78 134.2 134.3
SD 1 0.140 0.535 2 0.420 0.633 3 0.710 2.58
CV 0.9 3.5 0.9 1.4 0.5 1.9
# Points 2 19 2 19 2 18
# Labs 1 1 1 1 1 1

Roche cobas 6000/8000/c 311
Mean 10.85 10.93 −− 42.92 129.7 129.3
SD 1 0.830 0.752 2 −− 1.25 3 5.84 5.64
CV 7.6 6.9 −− 2.9 4.5 4.4
# Points 311 1943 −− 60 310 1944
# Labs 9 13 4 9 11

Roche cobas 6000/8000/c 311 • Roche Acetaminophen, No Correction
Mean 10.49 10.53 −− −− 128.1 128.3
SD 1 0.859 0.858 2 −− −− 3 6.74 10.15
CV 8.2 8.1 −− −− 5.3 7.9
# Points 65 183 −− −− 64 185
# Labs 2 2 2 2

Roche cobas 6000/8000/c 311 • Roche Acetaminophen, Offset Correction
Mean −− 10.80 −− −− −− 126.6
SD 1 −− 1.25 2 −− −− 3 −− 5.44
CV −− 11.6 −− −− −− 4.3
# Points −− 328 −− −− −− 338
# Labs 1 1

Roche cobas INTEGRA
Mean 11.00 11.28 40.50 41.19 129.2 130.8
SD 1 0.400 0.405 2 1.20 1.32 3 3.60 3.42
CV 3.6 3.6 3.0 3.2 2.8 2.6
# Points 59 495 59 495 59 494
# Labs 1 1 1 1 1 1

Siemens Dimension Series
Mean 23.46 23.45 46.99 47.05 137.0 137.2
SD 1 1.04 1.11 2 0.915 1.12 3 1.73 2.26
CV 4.4 4.7 1.9 2.4 1.3 1.6
# Points 409 3288 110 987 360 3175
# Labs 20 31 5 6 16 29

Siemens Dimension Vista
Mean 23.34 23.28 47.34 47.48 136.6 136.7
SD 1 0.922 0.943 2 1.01 1.17 3 2.20 2.69
CV 4.0 4.1 2.1 2.5 1.6 2.0
# Points 1218 14906 287 3497 1318 14778
# Labs 42 58 10 15 42 57

VITROS Microslide Series • Slide generation #00
Mean 17.19 17.26 53.40 53.50 151.9 152.2
SD 1 0.242 0.234 2 0.378 0.453 3 1.24 1.27
CV 1.4 1.4 0.7 0.8 0.8 0.8
# Points 31 162 31 163 31 162
# Labs 1 1 1 1 1 1

VITROS Microslide Series • Slide generation #01
Mean −− 17.69 −− −− −− 150.5
SD 1 −− 0.480 2 −− −− 3 −− 1.20
CV −− 2.7 −− −− −− 0.8
# Points −− 13 −− −− −− 13
# Labs 1 1

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 3

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Acetaminophen Enzymatic, colorimetric µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
VITROS Microslide Series • Slide generation #12
Mean 17.74 17.35 54.54 53.46 153.7 151.6
SD 1 0.432 0.313 2 0.637 0.908 3 1.17 2.52
CV 2.4 1.8 1.2 1.7 0.8 1.7
# Points 22 350 20 325 19 339
# Labs 1 2 1 2 1 2

VITROS Microslide Series • Slide generation #13
Mean 17.70 17.47 54.18 53.90 151.9 151.9
SD 1 0.214 0.342 2 0.560 0.636 3 1.65 1.77
CV 1.2 2.0 1.0 1.2 1.1 1.2
# Points 60 542 60 544 63 553
# Labs 1 1 1 1 1 1

VITROS Microslide Series • Slide generation #14
Mean 17.42 17.42 54.09 53.78 152.4 151.8
SD 1 0.476 0.609 2 0.699 0.711 3 2.63 2.57
CV 2.7 3.5 1.3 1.3 1.7 1.7
# Points 301 2026 85 613 274 1986
# Labs 13 21 4 6 12 23

Method Group • Enzymatic, colorimetric
Mean 19.75 20.63 47.87 48.07 138.2 138.0
SD 1 4.95 4.50 2 3.98 3.60 3 7.28 6.67
CV 25.1 21.8 8.3 7.5 5.3 4.8
# Points 2677 25854 843 7533 2702 25612
# Labs 103 155 33 49 96 148

Acetaminophen Immunoturbidimetric µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 14.10 13.68 −− −− 133.5 132.1
SD 1 0.740 0.634 2 −− −− 3 5.74 5.54
CV 5.2 4.6 −− −− 4.3 4.2
# Points 27 175 −− −− 28 180
# Labs 1 1 1 1

Beckman Coulter UniCel DxC Series
Mean 16.22 15.92 53.11 52.50 164.8 162.5
SD 1 1.20 1.48 2 1.89 2.83 3 5.73 6.00
CV 7.4 9.3 3.6 5.4 3.5 3.7
# Points 233 1645 67 774 203 1516
# Labs 8 10 4 6 6 8

Method Group • Immunoturbidimetric
Mean 16.00 15.70 53.11 52.50 161.0 159.3
SD 1 1.33 1.57 2 1.89 2.83 3 11.74 11.11
CV 8.3 10.0 3.6 5.4 7.3 7.0
# Points 260 1820 67 774 231 1696
# Labs 9 11 4 6 7 9

Acid Phosphatase, Prostatic (Temperature Dependent) a−naphthyl phosphate, end point U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Siemens ADVIA Chemistry Systems
Mean 8.07 7.74 −− −− 51.51 50.43
SD 1 0.460 0.752 2 −− −− 3 1.70 2.78
CV 5.7 9.7 −− −− 3.3 5.5
# Points 24 118 −− −− 24 118
# Labs 1 1 1 1

Method Group • a−naphthyl phosphate, end point
Mean 8.07 7.74 −− −− 51.51 50.43
SD 1 0.460 0.752 2 −− −− 3 1.70 2.78
CV 5.7 9.7 −− −− 3.3 5.5
# Points 24 118 −− −− 24 118
# Labs 1 1 1 1

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 4

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Acid Phosphatase, Prostatic (Temperature Dependent) a−naphthyl phosphate, kinetic U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
ILab Taurus
Mean −− 3.17 −− 8.35 −− −−
SD 1 −− 0.484 2 −− 0.568 3 −− −−
CV −− 15.3 −− 6.8 −− −−
# Points −− 6 −− 6 −− −−
# Labs 1 1

Method Group • a−naphthyl phosphate, kinetic
Mean −− 3.17 −− 8.35 −− −−
SD 1 −− 0.484 2 −− 0.568 3 −− −−
CV −− 15.3 −− 6.8 −− −−
# Points −− 6 −− 6 −− −−
# Labs 1 1

Acid Phosphatase, Prostatic (Temperature Dependent) a−naphthyl phosphate, tartrate U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Roche MODULAR (ISE, D, P, E170)
Mean 7.59 8.13 17.31 17.90 −− −−
SD 1 0.235 0.689 2 0.530 0.624 3 −− −−
CV 3.1 8.5 3.1 3.5 −− −−
# Points 12 147 21 161 −− −−
# Labs 2 3 3 3

Method Group • a−naphthyl phosphate, tartrate
Mean 7.59 8.13 17.31 17.90 −− −−
SD 1 0.235 0.689 2 0.530 0.624 3 −− −−
CV 3.1 8.5 3.1 3.5 −− −−
# Points 12 147 21 161 −− −−
# Labs 2 3 3 3

Acid Phosphatase, Total a−naphthyl phosphate, end point U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models)
Mean 5.98 8.01 14.07 15.68 −− 46.80
SD 1 2.11 2.15 2 4.68 5.38 3 −− 0.000
CV 35.3 26.8 33.3 34.3 −− 0.0
# Points 10 30 9 19 −− 2
# Labs 1 1 1 1 1

Siemens ADVIA Chemistry Systems
Mean 10.57 10.58 −− −− 50.73 50.35
SD 1 0.170 0.339 2 −− −− 3 1.64 2.80
CV 1.6 3.2 −− −− 3.2 5.6
# Points 24 121 −− −− 24 121
# Labs 1 1 1 1

Method Group • a−naphthyl phosphate, end point
Mean 9.22 10.07 14.07 15.68 50.73 50.29
SD 1 2.40 1.43 2 4.68 5.38 3 1.64 2.81
CV 26.0 14.2 33.3 34.3 3.2 5.6
# Points 34 151 9 19 24 123
# Labs 2 2 1 1 1 2

Acid Phosphatase, Total a−naphthyl phosphate, kinetic U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
ILab Taurus
Mean −− 5.07 −− 10.27 −− −−
SD 1 −− 0.336 2 −− 0.416 3 −− −−
CV −− 6.6 −− 4.0 −− −−
# Points −− 31 −− 31 −− −−
# Labs 1 1

Siemens ADVIA Chemistry Systems
Mean −− 9.43 −− 13.27 −− −−
SD 1 −− 0.851 2 −− 1.18 3 −− −−
CV −− 9.0 −− 8.9 −− −−
# Points −− 44 −− 43 −− −−
# Labs 1 1

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 5

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Acid Phosphatase, Total a−naphthyl phosphate, kinetic U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Method Group • a−naphthyl phosphate, kinetic
Mean −− 5.07 −− 10.27 −− −−
SD 1 −− 0.336 2 −− 0.416 3 −− −−
CV −− 6.6 −− 4.0 −− −−
# Points −− 31 −− 31 −− −−
# Labs 1 1

Albumin Bromcresol Green (BCG) %
Level Mon Cum Level Mon Cum Level Mon Cum
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 2.39 2.42 3.32 3.35 4.21 4.23
SD 1 0.042 0.049 2 0.066 0.061 3 0.076 0.073
CV 1.8 2.0 2.0 1.8 1.8 1.7
# Points 78 584 57 423 78 584
# Labs 3 3 2 2 3 3

Horiba ABX Pentra 400
Mean −− 2.58 −− −− −− 4.25
SD 1 −− 0.067 2 −− −− 3 −− 0.087
CV −− 2.6 −− −− −− 2.0
# Points −− 45 −− −− −− 45
# Labs 1 1

Method Group • Bromcresol Green (BCG)
Mean 2.39 2.43 3.32 3.35 4.21 4.23
SD 1 0.042 0.065 2 0.066 0.061 3 0.076 0.075
CV 1.8 2.7 2.0 1.8 1.8 1.8
# Points 78 629 57 423 78 629
# Labs 3 4 2 2 3 4

Albumin Bromcresol Green (BCG) g/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models)
Mean 2.51 2.49 3.45 3.42 4.32 4.28
SD 1 0.053 0.061 2 0.060 0.071 3 0.065 0.095
CV 2.1 2.5 1.8 2.1 1.5 2.2
# Points 2060 10632 1230 6550 1692 8864
# Labs 71 79 45 50 60 68

Abbott AEROSET/ARCHITECT (c, i, ci models) • PROLABS
Mean −− 2.54 −− 3.38 −− 4.07
SD 1 −− 0.031 2 −− 0.024 3 −− 0.221
CV −− 1.2 −− 0.7 −− 5.4
# Points −− 57 −− 55 −− 56
# Labs 1 1 1

Abbott AEROSET/ARCHITECT (c, i, ci models) • Shanghai Chang Zheng
Mean −− −− 3.46 3.44 4.35 4.24
SD 1 −− −− 2 0.045 0.036 3 0.041 0.109
CV −− −− 1.3 1.1 0.9 2.6
# Points −− −− 9 28 10 29
# Labs 1 1 1 1

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 2.41 2.42 3.36 3.37 4.24 4.25
SD 1 0.070 0.071 2 0.087 0.092 3 0.108 0.116
CV 2.9 2.9 2.6 2.7 2.6 2.7
# Points 2659 15575 1869 10324 2381 13204
# Labs 88 113 63 80 83 108

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Alternate Formulation/Standardization
Mean −− −− 3.43 3.40 4.32 4.28
SD 1 −− −− 2 0.054 0.098 3 0.067 0.116
CV −− −− 1.6 2.9 1.5 2.7
# Points −− −− 52 232 53 232
# Labs 2 2 2 2

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 6

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Albumin Bromcresol Green (BCG) g/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • BC AU Urine/CSF Albumin, OSR6X67
Mean 2.39 2.42 3.37 3.40 4.27 4.27
SD 1 0.027 0.047 2 0.047 0.058 3 0.045 0.073
CV 1.1 1.9 1.4 1.7 1.1 1.7
# Points 53 176 20 114 53 174
# Labs 2 2 1 1 2 2

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Zhong Sheng
Mean −− −− 3.43 3.49 4.04 4.08
SD 1 −− −− 2 0.102 0.148 3 0.092 0.135
CV −− −− 3.0 4.2 2.3 3.3
# Points −− −− 45 217 45 216
# Labs 2 2 2 2

Beckman Coulter LX20, LXi725 Chemistry Systems • LEADMAN
Mean −− −− 3.12 3.12 4.16 4.16
SD 1 −− −− 2 0.055 0.055 3 0.066 0.066
CV −− −− 1.8 1.8 1.6 1.6
# Points −− −− 4 4 4 4
# Labs 1 1 1 1

Beckman Coulter UniCel DxC Series
Mean −− 2.48 3.39 3.39 4.28 4.29
SD 1 −− 0.042 2 0.056 0.041 3 0.066 0.050
CV −− 1.7 1.6 1.2 1.6 1.2
# Points −− 15 4 165 4 152
# Labs 1 3 4 3 3

Dirui CS Series
Mean −− 2.49 3.75 3.69 −− 5.14
SD 1 −− 0.179 2 0.390 0.380 3 −− 0.491
CV −− 7.2 10.4 10.3 −− 9.6
# Points −− 316 15 373 −− 58
# Labs 8 1 7 1

DIRUI−CS−240
Mean −− −− −− 3.66 −− 4.47
SD 1 −− −− 2 −− 0.085 3 −− 0.088
CV −− −− −− 2.3 −− 2.0
# Points −− −− −− 117 −− 105
# Labs 1 1

Hitachi Chemistry Series
Mean 2.56 2.59 3.53 3.52 4.50 4.49
SD 1 0.047 0.097 2 0.105 0.110 3 0.056 0.112
CV 1.8 3.7 3.0 3.1 1.2 2.5
# Points 11 129 34 322 22 192
# Labs 1 1 2 2 1 1

Hitachi Chemistry Series • MAKER
Mean −− −− −− 3.41 −− 4.20
SD 1 −− −− 2 −− 0.076 3 −− 0.063
CV −− −− −− 2.2 −− 1.5
# Points −− −− −− 40 −− 49
# Labs 1 1

Horiba ABX Pentra 400
Mean −− 2.53 3.42 3.42 −− 4.00
SD 1 −− 0.094 2 0.040 0.040 3 −− 0.178
CV −− 3.7 1.2 1.2 −− 4.5
# Points −− 188 6 6 −− 174
# Labs 1 1 1 1

ILab 600
Mean 2.58 2.56 3.45 3.44 −− −−
SD 1 0.048 0.053 2 0.062 0.066 3 −− −−
CV 1.8 2.1 1.8 1.9 −− −−
# Points 114 631 113 631 −− −−
# Labs 3 3 3 3

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 7

1 3.089 0.56 3.9 2.54 SD 1 0.63 −− −− SD 1 −− −− 2 0.040 0.62 3.49 4.052 3 −− 0.9 2.8 2.6 1.52 3.084 0.101 CV −− −− 2. P.39 SD 1 0. Worldwide Report April 2016 Multiqual 1.4 −− 1.54 4.072 0.59 SD 1 0.9 1.114 2 0.022 0.3 3.2 2.51 4.120 0.046 3 −− −− CV −− −− 1.2 # Points −− −− 54 229 29 153 # Labs 2 2 1 1 JEOL BioMajesty JCA−BM Series • Zhong Sheng Mean −− −− −− 3.9 −− −− 1.64 2.071 0.113 0.8 # Points 30 122 195 1261 155 950 # Labs 1 1 10 13 8 9 Roche Hitachi Systems (International) • BIODEVICE Srl Mean −− −− 3. D.6 2.2 3.108 0.061 3 −− 0.074 2 0.094 CV −− 2.3 3.2. E170) Mean 2.089 2 0.075 0.134 CV 3.043 0.35 4.41 4.9 3.4 # Points 2891 17435 1460 6106 2472 16426 # Labs 83 103 51 57 64 84 Roche cobas c 111 Mean 2.58 4.061 2 −− 0.092 3 0.105 3 0.7 −− 2.65 3.139 0.135 CV 4.62 −− 4.4 −− 1.38 SD 1 0.59 SD 1 −− −− 2 0.55 2. Inc.5 3.38 SD 1 −− −− 2 −− 0.40 4.6 2.063 0.0 2.086 2 0.64 3.55 4.54 3.112 0.0 2.109 CV 3.0 3.36 SD 1 0.4 # Points 50 269 42 676 50 701 # Labs 3 4 6 7 7 8 Mindray BS 200E/380/400/480/800/2000 • Alternate Formulation/Standardization Mean −− 2.70 2.36 SD 1 −− 0.046 2 −− −− 3 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Albumin Bromcresol Green (BCG) g/dL Level Mon Cum Level Mon Cum Level Mon Cum JEOL BioMajesty JCA−BM Series Mean −− −− 3.077 CV 2.106 0.49 SD 1 0.099 0.50 −− −− 4.095 0.58 2.7 3.1 # Points 441 3499 251 1982 458 3370 # Labs 21 27 13 16 18 20 Roche Hitachi Systems (International) Mean 2.3 2.53 2.076 2 0.9 1.57 3.7 3.5 # Points −− −− −− 44 −− 35 # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean 2.2 3.68 3.068 CV −− −− −− 1.50 2.0 2.119 0.56 4.48 −− 4.57 4.103 3 0.063 CV 0.156 CV 2.60 3.129 3 0.55 3.59 3.56 3.52 −− 3.8 3.66 4.051 0.1 1.0 # Points 123 847 124 838 69 521 # Labs 6 9 6 9 3 3 Copyright © 2015 Bio−Rad Laboratories.4 # Points 21 177 −− −− 21 177 # Labs 1 1 1 1 Roche cobas INTEGRA Mean 2.151 0.2 # Points −− 21 −− 19 −− 20 # Labs 1 1 1 Roche cobas 6000/8000/c 311 Mean 2.3 4.115 3 0.48 4.114 3 0.3 −− −− # Points −− −− 20 83 −− −− # Labs 1 1 Roche MODULAR (ISE.1 3.2 1.5 3.60 4.4 2.6 1. Generated 22−May−2016 17:45:01 Page 8 .

8 −− 1.39 4.5 2.036 2 −− −− 3 −− 0.075 0.55 2.55 3.2 2.5 # Points 100 302 −− −− −− 308 # Labs 2 2 2 Siemens ADVIA Chemistry Systems • LEADMAN Mean −− −− 3.096 CV 2.4 −− −− −− 1.47 3.066 3 −− 0.71 −− 3.9 2.04 3.029 3 −− −− CV −− −− −− 0.37 4.091 3 0.40 3.046 0.33 4.5 # Points −− 21 −− 10 −− 16 # Labs 1 1 1 Toshiba TBA−120FR Mean −− −− 3.48 4.070 0.046 2 −− 0.050 CV −− −− 1.115 0.097 CV 1.02 4.083 3 0.044 0.3 # Points 3656 21712 2529 16466 3195 19207 # Labs 102 134 80 110 89 114 Siemens ADVIA Chemistry Systems • DiaSys Diagnostic Systems Mean 2.8 2.6 # Points −− 104 −− −− −− 104 # Labs 1 1 Tokyo Boeki BIOLIS 50i Mean −− 2.36 SD 1 −− −− 2 0.101 0.3 2.10 SD 1 0.048 2 0.101 0.40 −− −− −− 4.02 SD 1 −− −− 2 0.046 3 0.4 # Points 140 1047 65 437 155 1122 # Labs 4 6 2 4 5 7 Siemens Dimension Series • Alternate Formulation/Standardization Mean 2.054 3 −− 0.053 0.7 0.52 −− −− −− 4.5 2.7 2.064 CV 1.60 4.029 CV −− −− 0.38 3.1 # Points −− −− 30 262 31 295 # Labs 1 1 1 1 Toshiba TBA−40FR (Accute) Mean −− −− −− 3.50 SD 1 −− 0.4 3.028 0.36 SD 1 0.5 2.2 2.8 1.8 −− −− # Points −− −− −− 26 −− −− # Labs 1 Copyright © 2015 Bio−Rad Laboratories.058 0.065 CV −− 1.022 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Albumin Bromcresol Green (BCG) g/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens ADVIA Chemistry Systems Mean 2.52 2.1 1.063 0.068 CV −− 1.1 2.45 2.7 # Points −− −− 4 4 6 6 # Labs 1 1 1 1 Siemens Dimension Series Mean 2.5 2.7 0.043 CV −− −− −− 1.3 1. Generated 22−May−2016 17:45:01 Page 9 .2 # Points 53 193 47 188 47 180 # Labs 2 2 2 2 2 2 Siemens Dimension Vista Mean −− 2.098 CV 2.057 2 0.59 −− 4.72 −− −− SD 1 −− −− 2 −− 0.28 3.04 4.45 3.116 0.10 4.029 0.0 2.5 −− −− −− 1.2 1.26 4.7 0.07 SD 1 −− 0.37 2.058 2 0.62 3.036 2 −− −− 3 −− 0.7 −− 1.13 SD 1 −− −− 2 −− 0.31 4.2. Inc.022 3 0.074 3 0.4 2.3 1.5 −− 1.26 SD 1 0.26 SD 1 0.0 # Points −− −− −− 134 −− 182 # Labs 2 2 Toshiba−TBA Mean −− −− −− 3. Worldwide Report April 2016 Multiqual 1.63 −− 4.

21 3.093 0. Worldwide Report April 2016 Multiqual 1.2 1.7 3.6 # Points 12382 73384 8155 47474 10884 66800 # Labs 389 499 297 379 352 446 Albumin Bromcresol Green (BCG) − Vitros % Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #05 Mean 2.062 2 0.126 CV 2.054 2 −− −− 3 0.22 4.19 2.125 3 0.04 SD 1 0.4 2.33 4.4 3.15 3.3 3.6 2.4 3.15 4.16 SD 1 0.2.4 2.031 0.110 0.060 0.147 0.12 3.031 0.96 4.048 2 −− −− 3 0.145 0.5 2.2 −− −− 1.9 2.22 −− −− −− 4.6 3.034 2 −− −− 3 −− 0.1 # Points 30 253 −− −− 62 316 # Labs 1 1 2 2 VITROS Microslide Series • Slide generation #12 Mean −− 2.15 2.33 SD 1 0.1 # Points 25 119 −− −− 25 121 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #00 Mean 2.44 3.5 −− −− −− 1.03 4.19 4.04 SD 1 0.96 4.050 0.1 2.18 4.048 2 −− −− 3 0.118 0.6 # Points −− 15 −− −− −− 3 # Labs 1 1 Method Group • Bromcresol Green (BCG) − Vitros Mean 2.49 3.9 2.070 2 0.6 3.2 −− −− 7.5 # Points 1387 13241 324 3615 1363 12874 # Labs 52 91 17 39 51 92 Copyright © 2015 Bio−Rad Laboratories.2 −− −− 7.3 2. Inc.066 0.5 1.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Albumin Bromcresol Green (BCG) g/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #05 Mean 2.03 4.071 3 0.08 SD 1 0.16 3.205 CV 1.22 2.48 2.7 3.13 2.30 SD 1 0.02 SD 1 0.093 2 0.09 SD 1 −− 0.0 # Points 33 130 32 130 32 132 # Labs 1 1 1 1 1 1 Method Group • Bromcresol Green (BCG) Mean 2.8 # Points 20 74 −− −− 53 274 # Labs 1 1 2 3 VITROS Microslide Series • Slide generation #01 Mean 2.142 CV 3.088 CV 1.109 3 0.20 −− −− 3.36 4.099 0.074 2 0.3 −− −− 2.0 # Points 30 268 −− −− 62 319 # Labs 1 2 2 3 Albumin Bromcresol Green (BCG) − Vitros g/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens ADVIA Chemistry Systems Mean 2.19 −− −− 3.204 CV 1.040 0.5 5.5 1.156 CV 3.296 0.093 3 0.8 3.075 0.3 3.19 2.14 −− −− 4.5 5.43 −− −− 4.6 2.22 4.029 0. Generated 22−May−2016 17:45:01 Page 10 .032 0.3 # Points 23 292 23 196 23 397 # Labs 1 4 1 3 1 5 VITROS Microslide Series • Slide generation #05 Mean 2.04 SD 1 0.134 CV 1.085 0.4 2.6 3.028 2 −− −− 3 0.068 0.296 0.4 3.21 3.114 CV 1.052 0.3 2.44 4.28 3.16 2.7 3.48 2.065 CV −− 1.

040 3 −− 0.1 4.12 −− 3.91 −− 7.058 3 0.079 2 0.05 4.127 3 0.7 3.3 3.03 SD 1 0.5 2.1 4.99 4.14 2.94 3.9 5.040 0.5 2.133 0.2 4.133 3 0. Generated 22−May−2016 17:45:01 Page 11 .020 0.803 1.1 3.5 2.41 3.14 2.92 SD 1 0.6 6.9 2.92 1.2 1.073 2 0.2.7 3.24 3.96 SD 1 0.07 4.15 3.02 SD 1 0.16 3.149 CV 1.22 4.7 −− 3.860 −− 1.041 0.0 # Points 21 323 30 312 22 317 # Labs 1 2 1 2 1 2 VITROS Microslide Series • Slide generation #40 Mean −− 2.032 0.1 1.22 3.7 # Points −− 161 −− 162 −− 163 # Labs 1 1 1 VITROS Microslide Series • Slide generation #46 Mean 2.13 3.0 −− 3.242 0.3 −− 2.0 # Points 314 868 112 273 247 658 # Labs 16 21 7 9 11 19 Method Group • Bromcresol Green (BCG) − Vitros Mean 2.147 0.174 0.114 3 0.5 3.27 4.075 0.27 SD 1 −− 0.126 CV 2.3 4.4 7.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Albumin Bromcresol Green (BCG) − Vitros g/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #06 Mean 2.182 CV 2.063 2 −− 0.1 # Points 484 2629 184 1053 544 2738 # Labs 22 37 9 20 23 35 VITROS Microslide Series • Slide generation #39 Mean 2.20 3.9 3.093 CV 2.20 2.166 CV 4.93 6.110 CV −− 2.14 3.7 # Points 60 646 60 783 60 787 # Labs 1 1 1 2 1 2 VITROS Microslide Series • Slide generation #90 Mean −− 0.110 0.1 −− 1.13 −− 2.5 2.99 4.076 0.150 3 0.124 2 0.140 0.0 2.16 4.016 2 0.3 # Points 24 112 24 111 24 110 # Labs 1 1 1 1 1 1 VITROS Microslide Series • Slide generation #99 Mean 2.075 2 0.080 0.13 3.15 4.04 SD 1 0.8 4.308 0.19 4.6 1.94 SD 1 −− 0.1 3.7 4.4 4.082 0.057 2 −− 0.7 2.145 CV −− 2.123 0.083 2 0.13 2.90 6.032 3 0.8 7.5 # Points −− 13 −− 14 −− 13 # Labs 1 1 1 VITROS Microslide Series • Slide generation #93 Mean 0.01 SD 1 0.6 6.120 CV 3.149 0. Worldwide Report April 2016 Multiqual 1.8 3.0 3.060 0.059 2 0.269 CV 6.15 3.7 # Points 2616 20558 808 7165 2634 20454 # Labs 112 197 46 92 107 196 Copyright © 2015 Bio−Rad Laboratories.020 2 −− 0.0 −− 1.075 0.12 SD 1 0.152 CV 1.15 3.8 # Points 109 946 −− 64 100 911 # Labs 3 6 2 3 6 VITROS Microslide Series • Slide generation #12 Mean 2.800 0.096 0.8 2.053 0.4 3.01 SD 1 0.112 3 0.1 4.094 0.19 3.05 4.06 4.14 −− 3.202 3 0. Inc.068 0.095 3 −− 0.6 2.6 3.23 2.15 3.0 3.5 # Points 149 1134 51 582 173 1091 # Labs 13 30 9 12 12 28 VITROS Microslide Series • Slide generation #13 Mean 2.3 3.13 2.16 2.20 3.

9 1.123 3 0.24 3.083 0.46 2.157 CV 3.8 2.51 4. Worldwide Report April 2016 Multiqual 1.064 CV 1.141 CV 1.49 2.051 0.031 0.5 # Points 5443 43968 2270 17721 4331 37373 # Labs 172 229 65 90 146 199 Copyright © 2015 Bio−Rad Laboratories.38 −− 3.5 1.5 3.23 3.2 # Points −− 166 −− 165 −− 166 # Labs 1 1 1 Method Group • Bromcresol Purple (BCP) Mean −− 2.040 2 0.207 CV 4.073 0.095 3 0.3 2.27 3.3 −− −− # Points −− 37 −− 37 −− −− # Labs 1 1 Siemens ADVIA Chemistry Systems Mean 2.07 SD 1 −− 0.31 4.26 4.46 3.02 SD 1 0.2 4.3 1.1 2.3 2.043 3 0.048 0.3 3. LXi725 Chemistry Systems Mean 2.9 2.38 −− 3.06 SD 1 0.3 2.103 CV 2.2 3.152 3 −− −− CV −− 4.25 SD 1 0.8 3.36 2.40 3.7 2.25 −− 4.0 # Points 316 1311 365 1544 40 406 # Labs 6 7 8 8 1 3 Siemens Dimension Series Mean 2.050 CV −− 2.3 2.21 SD 1 0.7 3.2 1.4 −− 4.40 4. i.2 1.4 −− 1.087 2 0.0 2.07 4.050 CV −− 2.057 2 −− 0. Generated 22−May−2016 17:45:01 Page 12 .43 2.101 0. ci models) Mean 2.2 2.5 2.076 0.115 2 −− −− 3 0.39 2.32 4.23 4.037 0. Inc.074 2 0.01 4.043 2 0.045 0.2 1.094 0.083 CV 3.39 3.097 3 0.1 3.073 0.7 1.056 3 −− 0.21 4.7 −− 1.35 3.07 SD 1 −− 0.40 SD 1 0.095 3 0.44 4.25 −− 4.076 0.9 2.054 0.43 −− −− 4.7 −− 1.057 0.8 2.113 0.50 3.092 CV 2.29 SD 1 0.1 2.030 0.7 −− −− 5.112 2 −− 0.21 SD 1 0.6 4.48 3.45 2.4 −− 1.40 2.218 0.2 # Points 32 89 19 155 49 226 # Labs 1 1 1 1 2 2 Beckman Coulter UniCel DxC Series Mean 2.22 4.7 # Points 154 732 90 780 63 309 # Labs 3 3 2 3 1 2 Beckman Coulter LX20.088 0.6 # Points 1479 7910 1319 5947 1397 7775 # Labs 42 52 29 36 40 48 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 2.2 # Points −− 166 −− 165 −− 166 # Labs 1 1 1 Albumin Bromcresol Purple (BCP) g/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.078 0.2 # Points 1016 7301 411 2956 857 6373 # Labs 32 39 18 26 24 28 Roche cobas 6000/8000/c 311 Mean 2.056 3 −− 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Albumin Bromcresol Purple (BCP) % Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Series Mean −− 2.071 2 0.9 # Points 167 858 −− −− 166 815 # Labs 4 4 4 4 Roche Hitachi Systems (International) Mean −− 2.2.37 3.064 0.081 3 0.42 3.27 4.24 4.8 1.3 1.35 3.49 −− −− SD 1 −− 0.091 2 0.57 −− 3.7 1.057 2 −− 0.

58 −− −− SD 1 0.32 1.05 59.13 SD 1 0.9 3.06 SD 1 −− 0.23 59.186 0.088 0.8 1.9 # Points 65 843 1 18 66 833 # Labs 2 2 1 2 2 2 Method Group • Immunonephelometric.0 −− −− # Points 11 49 11 37 −− −− # Labs 1 1 1 1 Siemens BN Series Nephelometers • DiaSorin.71 59.7 # Points 14708 124K 6392 49458 12858 114K # Labs 435 570 173 237 388 513 Albumin Capillary Electrophoresis % Level Mon Cum Level Mon Cum Level Mon Cum Sebia CAPILLARYS Mean 56.06 4.36 4.9 1.4 5.23 4.2 2.817 3 −− −− CV 0.9 0.060 2 0.6 2.108 0.89 1.25 4.44 2 1.080 3 0. Mean −− 2.555 2 1.089 3 0.1 2.43 3.069 0.42 59.25 −− −− SD 1 0.069 2 0.4 2.69 2.120 CV 2.032 0.20 3.25 3.5 2.2 2. fixed time.024 0.84 3 0.31 4.95 5.07 59.6 5.91 3.812 3 −− −− CV 2.3 2.001 3 −− −− CV 3.2 0.457 0.001 0.245 CV −− 3.0 23.16 2 1.13 0.0 2.0 1.032 −− −− SD 1 0.9 111.4 2.001 0.8 4.7 # Points 76 926 20 98 74 875 # Labs 3 4 3 4 3 3 Copyright © 2015 Bio−Rad Laboratories.6 2.95 59.071 0.96 4.000 1.17 SD 1 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Albumin Bromcresol Purple (BCP) g/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Vista Mean 2.001 2 0.39 2.1 3.24 4.5 1.088 CV 2.109 2 0.061 0.8 # Points −− 34 8 43 8 42 # Labs 1 1 1 1 1 Siemens Dimension Vista Mean 2.701 2 0.271 0.088 0.000 0.203 3 0. Worldwide Report April 2016 Multiqual 1.39 3. Inc.64 59. kinetic g/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens BN Series Nephelometers Mean 0.7 2.075 3 0. fixed time.2 −− −− # Points 8 16 8 16 −− −− # Labs 1 1 1 1 Method Group • Capillary Electrophoresis Mean 59.8 4.174 0.28 −− −− SD 1 1.053 0.0 2.7 78.70 59.108 CV 2.15 4.45 2.2 2.88 59.1 6.6 3.083 0.4 −− −− # Points 10 35 29 167 −− −− # Labs 2 2 2 2 Albumin Immunonephelometric.2 # Points 6101 62193 1918 20318 5955 60754 # Labs 175 234 50 72 170 227 Method Group • Bromcresol Purple (BCP) Mean 2.2 1.78 3.859 0.2.5 2. Generated 22−May−2016 17:45:01 Page 13 .275 0.9 2.1 2.39 2.10 2.2 2.25 3.06 SD 1 0. kinetic Mean 2.32 0.024 0.30 1.4 −− −− # Points 2 19 21 151 −− −− # Labs 1 1 1 1 Sebia MINICAP Mean 59.38 3.4 2.717 3 −− −− CV 0. Inc.08 4.05 SD 1 0.073 2 0.237 CV 41.

3 2.32 3.1 92.16 SD 1 0. Generated 22−May−2016 17:45:01 Page 14 .065 0.3 2.81 2 1.0 268.65 2 231.30 3.7 6.3 5.840 1.97 SD 1 0.08 3 −− −− CV 2.5 4.156 3 −− −− CV 3.8 # Points −− −− 24 557 24 495 # Labs 5 5 5 5 Method Group • 4−aminoantipyrine Mean −− −− 131.36 4.178 CV 3.073 2 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Albumin Immunoturbidimetric g/dL Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/8000/c 311 Mean 2.7 3.193 3 0.4 329.2 4. ci models) Mean 33.120 2 0.4 1.35 4.053 CV 2.0 3.5 129.01 SD 1 0.0 5.20 77.112 3 0.58 7.07 4.044 0. Inc.1 2.1 CV 3.89 3 5.3 1150 2 2961 3653 3 477.094 0.2 SD 1 −− −− 2 3.7 3.155 0.0 1.5 3.5 126.2 SD 1 −− −− 2 3.092 2 0.8 # Points −− −− 24 557 24 495 # Labs 5 5 5 5 Copyright © 2015 Bio−Rad Laboratories.080 0.33 2.177 CV 4.6 4.8 4.1 3.7 6.64 10.52 2.8 3.87 4.0 3.58 7.5 −− −− # Points 87 461 88 456 −− −− # Labs 6 6 6 6 Siemens Dimension Series Mean 2.1 3 477.067 3 0.073 0.3 3.1 CV 48.3 # Points 26 192 24 182 22 183 # Labs 1 1 1 1 1 1 Method Group • 4−aminoantipyrine Mean 1930 1242 5935 3772 14370 14416 SD 1 928.8 3.4 # Points 487 1979 232 957 270 1048 # Labs 16 16 11 11 6 6 Alkaline Phosphatase 4−aminoantipyrine U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.2.2 2.0 268. E170) Mean 2.2 −− −− # Points 6 173 6 182 −− −− # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #48 Mean 2368 2331 7388 7417 14370 14416 SD 1 78.5 5.5 # Points 255 1074 92 260 180 859 # Labs 7 7 3 3 5 5 Roche MODULAR (ISE.0 2.45 126.181 0.1 1.28 3.111 0.2 6.14 3.49 −− −− SD 1 0.9 3.141 2 0. P.04 3.5 −− −− SD 1 0.89 3 5. i.174 0.4 272.37 3.50 33.12 4.3 # Points 145 444 52 241 90 189 # Labs 3 3 2 2 1 1 Method Group • Immunoturbidimetric Mean 2.53 3.39 2.3 # Points 32 365 30 364 22 183 # Labs 2 2 2 2 1 1 Alkaline Phosphatase 4−aminoantipyrine U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Mindray BS 200E/380/400/480/800/2000 Mean −− −− 131.1 4.1 2.4 329.38 CV −− −− 2.6 49. Worldwide Report April 2016 Multiqual 1.1 3.2 4.100 0.38 CV −− −− 2.072 0.9 96.5 129.43 3.47 3.14 4.4 272.64 10.3 3.40 2. D.6 206.1 2.

7 5.8 2.89 2 5.0 235.6 SD 1 0.02 30.04 3 4.48 2.81 1.1 # Points 4263 22891 3085 15493 3696 21088 # Labs 129 142 85 95 113 128 Copyright © 2015 Bio−Rad Laboratories.11 2.20 CV −− 3. AMP Buffer Mean 30.3 −− −− −− 3.89 2 5.9 SD 1 2.2 119.4 4.7 4.9 243.08 11.6 3. Worldwide Report April 2016 Multiqual 1. AMP Buffer U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.1 7.3 11.46 4.61 3 −− −− CV −− 5. AMP Buffer U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.46 33.87 33.02 CV 7.49 2 4.61 3 −− −− CV −− 5.06 CV 2.17 CV 5.44 −− −− −− 268. ci models) Mean 33.1 # Points −− 31 −− −− −− 31 # Labs 1 1 Roche cobas INTEGRA Mean 31.5 2.50 2 5.7 SD 1 1.56 2 −− −− 3 −− 8.4 −− −− SD 1 −− 1.66 128.3 27.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Alkaline Phosphatase PNPP. AMP Buffer Mean −− 33.39 −− −− −− 267.4 4.09 −− −− 256.8 267.23 5.01 CV 7.9 SD 1 3.2 4. Generated 22−May−2016 17:45:01 Page 15 .6 7. ci models) Mean −− 34.7 4.7 254.7 4.2 2.15 128.2.2 # Points 45 290 45 290 45 290 # Labs 2 2 2 2 2 2 Siemens Dimension Series Mean 36.30 17.3 127.3 127.83 3.1 # Points 133 1065 57 419 145 1158 # Labs 6 8 3 4 7 9 Alkaline Phosphatase PNPP.3 −− −− 1.2 4.20 2 8.77 6.15 128.35 2 −− −− 3 −− 5.5 4.00 3 10.8 7.33 5.4 −− −− # Points −− 46 16 45 −− −− # Labs 1 1 1 Method Group • PNPP.4 −− −− SD 1 −− 1.4 −− −− # Points −− 46 16 45 −− −− # Labs 1 1 1 Alkaline Phosphatase PNPP.54 19. AMP Buffer U/L @ 35° C Level Mon Cum Level Mon Cum Level Mon Cum ILab 600 Mean −− 33. i.01 110.8 4.2 5.0 SD 1 2.4 234.33 5.0 SD 1 −− 1.9 −− −− −− 1.02 3 12.70 113.36 2 2.1 44.41 CV −− 5.09 113.6 # Points 22 69 −− −− 22 69 # Labs 1 1 1 1 Method Group • PNPP. Inc.58 2 −− −− 3 2.81 3 13.7 1.40 32.8 251.9 114. i.91 28.50 37.980 1.0 1.2 243.6 130.9 # Points −− 158 −− −− −− 157 # Labs 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 26.82 CV 13.1 129.3 SD 1 −− 1.9 8.92 57.99 3.4 267.6 # Points 66 517 12 129 78 611 # Labs 3 3 1 2 4 4 Beckman Coulter UniCel DxC Series Mean −− 29.4 7.8 4.2 249.

3 SD 1 2.15 2 −− 21. ci models) • PROLABS Mean −− 31.00 3.5 249.50 29.80 3 11.4 5.2 3.1 SD 1 2.3 SD 1 −− −− 2 −− 5.94 CV −− 0.2 120.4 2.958 2 −− 3.3 8.2 10.2 5.5 253.4 212.37 125.34 CV −− 4.7 6.42 6.5 4.9 9.7 1.25 12.0 2.96 2 3.1 8.44 1.17 CV 9.5 −− 16.5 −− 5.0 134.33 CV 10.0 132.9 SD 1 2.01 2 8.6 −− 261.96 16.7 271.2 # Points −− 1 45 207 45 208 # Labs 1 2 2 2 2 Beckman Coulter LX20.1 SD 1 −− 1. i.57 29.9 286.8 315.94 3 8.68 3 4.1 4.02 155.61 2.83 7.1 10.6 2.77 3 13.00 2 10.15 CV 7.1 5.49 4.28 −− 127.60 11.9 14.7 5.0 5.16 7.8 SD 1 3.5 6.06 12.000 2 2.4 # Points 1580 11267 1095 7345 1394 10391 # Labs 53 74 35 46 45 65 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU International Calibrator OE 66300 Mean 34.76 CV −− 3.47 3.5 # Points 10 338 −− 331 11 51 # Labs 1 8 7 1 1 DIRUI−CS−240 Mean −− −− −− 102.03 3.9 SD 1 −− 0.7 271. Worldwide Report April 2016 Multiqual 1.1 5.5 4.2 280. i.8 253.49 35.63 3 16.17 122.30 36.3 SD 1 1.8 SD 1 −− 0.67 −− 124.4 3.07 CV 3.1 2.2 # Points −− 320 10 363 11 254 # Labs 2 1 3 1 3 Abbott AEROSET/ARCHITECT (c.6 −− 2.6 138.9 123.1 # Points 131 598 125 555 123 416 # Labs 2 2 2 2 2 2 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Zhong Sheng Mean −− 136.2 4.92 25.67 13.1 −− 2.96 CV −− −− −− 5.2.3 145.2 4.9 312.5 6.41 144.95 132.11 122. Inc.3 252.5 # Points 916 6454 454 3454 712 5453 # Labs 31 39 22 32 25 29 Dirui CS Series Mean 28.1 2.81 2.61 2 3.3 2.86 6.59 29.6 19.0 SD 1 3.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Alkaline Phosphatase PNPP.23 38.7 8.51 CV 10.0 # Points 884 3860 610 2794 501 2145 # Labs 26 30 19 23 16 21 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • IFCC 2002 (Enzymes) Mean 39.4 5.5 269.04 3 12.73 2 3.1 # Points −− −− −− 122 −− 111 # Labs 1 1 Copyright © 2015 Bio−Rad Laboratories.6 # Points −− 56 −− 54 −− 54 # Labs 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 29.26 3 −− 6.9 5.62 9. LXi725 Chemistry Systems Mean 25.1 152.68 2 7.65 3 −− 10.2 119. AMP Buffer U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.45 6.10 13.61 CV 10. ci models) • Alternate Formulation/Standardization Mean −− 36.4 # Points 26 80 19 136 45 200 # Labs 1 1 1 1 2 2 Beckman Coulter UniCel DxC Series Mean 28. Generated 22−May−2016 17:45:01 Page 16 .2 6.4 328.1 322.5 4.8 3.9 −− 215.71 3 8.86 3 17.3 283.2 200.91 5.

13 149.68 CV −− −− 5.9 3.5 −− 6. AMP Buffer U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Hitachi Chemistry Series Mean 33.91 2 −− 8. Worldwide Report April 2016 Multiqual 1.7 # Points −− −− 49 253 20 174 # Labs 2 2 1 1 JEOL BioMajesty JCA−BM Series • Zhong Sheng Mean −− −− −− 92.99 3 −− 29.73 31.630 1.33 CV 6.5 240.2 # Points −− 17 −− 45 −− 46 # Labs 1 1 1 Copyright © 2015 Bio−Rad Laboratories.9 # Points −− −− −− 44 −− 35 # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean 34.8 # Points 29 157 −− −− 29 157 # Labs 2 2 2 2 Mindray BS 200E/380/400/480/800/2000 • Alternate Formulation/Standardization Mean −− 31.26 CV 1.2 149.6 124.5 SD 1 −− 2.2 5.66 33.2.4 128.92 6.40 CV −− −− −− 1.2 −− 279.9 5.2 SD 1 −− 1.8 −− 5.6 −− 10.71 2 −− −− 3 11.44 CV 6.87 2 −− 10.3 14.8 136.01 −− 127.57 129.1 300.41 8.1 −− 5.8 5.5 SD 1 −− −− 2 −− 1.9 # Points 19 89 −− −− 4 4 # Labs 2 2 1 1 JEOL BioMajesty JCA−BM Series Mean −− −− 131.2 12.49 34.4 # Points −− 204 6 6 −− 156 # Labs 1 1 1 1 ILab 600 Mean 32.4 −− −− 3.65 3 −− 3.1 −− 264.2 SD 1 1.2 −− 5.4 SD 1 −− 4.5 12.2 5.6 −− −− SD 1 2.7 # Points 10 134 34 334 23 197 # Labs 1 1 2 2 1 1 Hitachi Chemistry Series • MAKER Mean −− −− −− 127.49 3 3.84 126.35 1.2 SD 1 0.9 2.63 3 2.6 −− 272.6 −− −− 4.89 2 18.2 2.12 3 −− 15.41 −− −− 294.42 3 −− −− CV 6.0 −− −− # Points 116 651 114 649 −− −− # Labs 3 3 3 3 ILab 650 Mean 30.80 35.9 7.58 6.97 2 −− −− 3 14.70 CV −− 15.6 # Points −− 20 −− 20 −− 19 # Labs 1 1 1 Mindray BS 200E/380/400/480/800/2000 • Daiichi Mean −− 25. Generated 22−May−2016 17:45:01 Page 17 .44 11. Inc.2 # Points −− −− −− 41 −− 49 # Labs 1 1 Horiba ABX Pentra 400 Mean −− 35.82 −− 223.14 CV −− 8.3 1.04 1.0 1.94 2 7.69 CV −− 7.80 8.2 294.91 1.50 19.0 295.59 −− 130.2 253.7 −− 8.3 −− 1.8 5.82 3 −− 13.35 2 5.8 4.72 38.99 −− −− 294.9 SD 1 −− −− 2 7.12 CV −− −− −− 18.9 3.1 12.7 248.9 SD 1 −− −− 2 −− 16.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Alkaline Phosphatase PNPP.2 −− 279.12 18.0 SD 1 2.94 3 −− 13.

AMP Buffer U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/c 311 Mean 31.7 114.0 SD 1 1.4 263.8 SD 1 1.37 4.50 128.96 2 12.1 9.62 2 9.19 9.3 4.99 28.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Alkaline Phosphatase PNPP.7 233.94 −− −− 229.44 20.68 3.8 218.6 3.42 1.4 3.4 5.5 3.2 285.76 1.6 5.58 CV 7.71 2 −− −− 3 −− 12.0 # Points 1569 15073 414 2590 1513 12301 # Labs 54 74 22 27 49 69 Roche cobas 8000 Mean 31.48 10. E170) Mean 31.8 133. Inc.90 112.85 3 7.1 3.2 2.08 1.42 CV 3.4 257.6 108.4 252.9 294.29 111.89 3 30.5 225.1 −− −− 1.25 112. P.9 4.3 SD 1 2.56 5.28 3 6.03 121.7 SD 1 2.9 230.1 2.97 CV 3.5 5.8 # Points 2318 18419 1570 13591 1705 14738 # Labs 65 106 46 83 48 79 Copyright © 2015 Bio−Rad Laboratories.5 5.0 4.1 1.81 2 4.1 228.9 SD 1 3.53 3 14.57 32.9 3.40 3.6 4.29 2 4.7 3.79 3 8.89 CV 4.5 1.8 220.09 CV 5.1 3.19 −− −− −− 269.2 4.15 76.0 4.53 2.7 SD 1 −− 1.42 2.71 32.59 12.7 # Points 171 1242 59 380 158 1045 # Labs 4 4 2 2 3 3 Siemens ADVIA Chemistry Systems Mean 34.9 225.6 10.76 8.8 231.2 3.88 2 4.44 3 6.9 3.1 3.5 SD 1 1.0 134. D.5 277.1 # Points 138 947 136 937 69 522 # Labs 9 13 9 13 3 3 Roche Reflotron Mean −− 43.24 1.2 5.08 109.3 532.2 227.32 2 2.5 4.6 # Points 21 177 −− −− 21 177 # Labs 1 1 1 1 Roche cobas INTEGRA Mean 31.5 4.29 2 6.6 4.62 3 3.51 32.0 −− −− −− 4.5 122.4 # Points 1391 6546 948 3768 1083 5763 # Labs 35 36 26 28 23 24 Roche cobas 8000 • 2nd Generation Mean 75.73 32.3 530.01 1. Worldwide Report April 2016 Multiqual 1.62 6.38 5.35 262.00 CV 5.74 4.03 139.2 3.3 112.9 2.2 4.63 2 3.18 10.0 271.65 CV 6.8 # Points 30 145 88 1002 54 705 # Labs 1 2 8 10 6 6 Roche MODULAR (ISE.21 7.5 9.7 SD 1 1.58 CV 4.61 4.44 1.77 CV 4.77 3 18.9 4.9 # Points 111 473 108 446 115 466 # Labs 4 5 4 5 4 5 Roche cobas c 111 Mean 32.2 3.5 114.0 3.69 2. Generated 22−May−2016 17:45:01 Page 18 .1 SD 1 1.0 9.20 CV −− 4.0 6.48 30.50 32.6 2.27 2 −− −− 3 4.93 31.2 9.5 # Points −− 11 −− −− −− 12 # Labs 1 1 Siemens ADVIA 1200 Mean 31.7 # Points 348 2593 184 1285 300 2385 # Labs 17 20 10 12 14 16 Roche Hitachi Systems (International) Mean 30.38 34.3 4.2.66 5.8 SD 1 1.

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Alkaline Phosphatase PNPP, AMP Buffer U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Siemens ADVIA Chemistry Systems • DiaSys Diagnostic Systems
Mean 36.77 36.65 −− −− −− 240.9
SD 1 2.01 1.79 2 −− −− 3 −− 10.23
CV 5.5 4.9 −− −− −− 4.2
# Points 114 316 −− −− −− 308
# Labs 2 2 2

Siemens Dimension Series
Mean 34.93 35.32 122.5 122.8 250.3 249.5
SD 1 2.50 2.82 2 5.28 7.98 3 7.63 7.90
CV 7.2 8.0 4.3 6.5 3.0 3.2
# Points 990 7618 700 4398 669 6619
# Labs 35 54 20 24 27 47

Siemens Dimension Series • Factored, IFCC Correlated
Mean −− 35.39 −− −− −− 243.0
SD 1 −− 2.56 2 −− −− 3 −− 4.63
CV −− 7.2 −− −− −− 1.9
# Points −− 283 −− −− −− 282
# Labs 1 1

Siemens Dimension Vista
Mean 33.71 35.11 122.4 124.9 249.2 255.5
SD 1 1.98 1.97 2 3.70 5.01 3 7.17 9.19
CV 5.9 5.6 3.0 4.0 2.9 3.6
# Points 1559 15837 154 2233 1530 15936
# Labs 42 60 5 10 41 61

Siemens Dimension Vista • Alternate Formulation/Standardization
Mean 31.22 33.85 116.3 123.0 243.9 253.0
SD 1 1.33 1.72 2 2.75 4.75 3 6.30 7.56
CV 4.3 5.1 2.4 3.9 2.6 3.0
# Points 72 637 66 620 67 629
# Labs 2 2 2 2 2 2

Toshiba TBA−120FR
Mean −− −− 157.8 163.3 327.1 340.6
SD 1 −− −− 2 5.27 6.96 3 8.80 12.29
CV −− −− 3.3 4.3 2.7 3.6
# Points −− −− 35 252 34 287
# Labs 1 1 1 1

Toshiba TBA−40FR (Accute)
Mean −− −− −− 141.9 −− 313.7
SD 1 −− −− 2 −− 7.10 3 −− 5.90
CV −− −− −− 5.0 −− 1.9
# Points −− −− −− 110 −− 158
# Labs 2 2

Toshiba−TBA
Mean −− −− −− 126.5 −− −−
SD 1 −− −− 2 −− 6.20 3 −− −−
CV −− −− −− 4.9 −− −−
# Points −− −− −− 26 −− −−
# Labs 1

VITROS Microslide Series • Slide generation #10
Mean 39.55 40.40 125.0 126.5 239.5 241.7
SD 1 1.31 1.59 2 6.09 5.39 3 12.85 10.22
CV 3.3 3.9 4.9 4.3 5.4 4.2
# Points 34 125 34 128 34 123
# Labs 1 1 1 1 1 1

Method Group • PNPP, AMP Buffer
Mean 33.08 33.31 127.0 127.8 259.4 258.8
SD 1 4.62 4.20 2 17.93 16.00 3 34.41 29.46
CV 14.0 12.6 14.1 12.5 13.3 11.4
# Points 16778 116K 10066 62873 13888 102K
# Labs 521 686 328 437 432 580

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 19

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Alkaline Phosphatase PNPP, AMP Buffer U/L
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models)
Mean −− 31.57 −− 120.8 −− 265.5
SD 1 −− 0.882 2 −− 1.84 3 −− 12.22
CV −− 2.8 −− 1.5 −− 4.6
# Points −− 35 −− 35 −− 35
# Labs 1 1 1

Roche cobas 6000/c 311
Mean −− 33.02 −− −− −− 229.5
SD 1 −− 1.08 2 −− −− 3 −− 4.74
CV −− 3.3 −− −− −− 2.1
# Points −− 81 −− −− −− 81
# Labs 1 1

Method Group • PNPP, AMP Buffer
Mean −− 32.58 −− 120.8 −− 240.4
SD 1 −− 1.22 2 −− 1.84 3 −− 18.32
CV −− 3.7 −− 1.5 −− 7.6
# Points −− 116 −− 35 −− 116
# Labs 2 1 2

Alkaline Phosphatase PNPP, AMP Buffer − IFCC Ref. Proc.,Calibrated U/L @ 25° C
Level Mon Cum Level Mon Cum Level Mon Cum
Roche cobas 6000/c 311
Mean 34.36 32.90 −− −− 240.0 243.2
SD 1 1.44 1.43 2 −− −− 3 1.56 6.99
CV 4.2 4.4 −− −− 0.7 2.9
# Points 33 261 −− −− 33 261
# Labs 1 1 1 1

Roche cobas INTEGRA
Mean 31.00 29.88 110.0 107.5 225.0 222.5
SD 1 1.00 1.41 2 2.00 3.04 3 3.00 4.72
CV 3.2 4.7 1.8 2.8 1.3 2.1
# Points 60 486 60 486 60 486
# Labs 1 1 1 1 1 1

Siemens Dimension Series
Mean 36.60 36.39 −− 123.9 242.8 245.0
SD 1 1.47 4.32 2 −− 5.45 3 4.09 10.01
CV 4.0 11.9 −− 4.4 1.7 4.1
# Points 21 291 −− 35 21 274
# Labs 1 2 1 1 2

Siemens Dimension Vista
Mean 32.63 34.63 −− −− 247.0 255.1
SD 1 1.31 1.57 2 −− −− 3 4.39 5.51
CV 4.0 4.5 −− −− 1.8 2.2
# Points 35 372 −− −− 35 371
# Labs 1 2 1 2

Method Group • PNPP, AMP Buffer − IFCC Ref. Proc.,Calibrated
Mean 32.92 33.03 110.0 108.6 236.0 239.5
SD 1 2.33 3.46 2 2.00 5.24 3 9.93 14.78
CV 7.1 10.5 1.8 4.8 4.2 6.2
# Points 149 1410 60 521 149 1392
# Labs 4 6 1 2 4 6

Alkaline Phosphatase PNPP, AMP Buffer − IFCC Ref. Proc.,Calibrated U/L @ 35° C
Level Mon Cum Level Mon Cum Level Mon Cum
Mindray BS 200E/380/400/480/800/2000
Mean 29.34 29.51 128.0 124.9 −− −−
SD 1 2.25 1.82 2 10.40 6.76 3 −− −−
CV 7.7 6.2 8.1 5.4 −− −−
# Points 25 120 26 121 −− −−
# Labs 1 1 1 1

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 20

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Alkaline Phosphatase PNPP, AMP Buffer − IFCC Ref. Proc.,Calibrated U/L @ 35° C
Level Mon Cum Level Mon Cum Level Mon Cum
Method Group • PNPP, AMP Buffer − IFCC Ref. Proc.,Calibrated
Mean 29.34 29.51 128.0 124.9 −− −−
SD 1 2.25 1.82 2 10.40 6.76 3 −− −−
CV 7.7 6.2 8.1 5.4 −− −−
# Points 25 120 26 121 −− −−
# Labs 1 1 1 1

Alkaline Phosphatase PNPP, AMP Buffer − IFCC Ref. Proc.,Calibrated U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models) • Factored, IFCC Correlated
Mean 36.73 36.67 140.0 138.9 −− 282.8
SD 1 1.21 1.38 2 2.65 2.79 3 −− 4.73
CV 3.3 3.8 1.9 2.0 −− 1.7
# Points 83 480 84 483 −− 402
# Labs 2 4 2 4 2

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 36.08 35.44 152.9 152.4 262.8 257.7
SD 1 2.75 4.00 2 6.89 7.11 3 5.78 12.50
CV 7.6 11.3 4.5 4.7 2.2 4.8
# Points 463 2275 595 2806 46 508
# Labs 16 20 16 17 2 4

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Alternate Formulation/Standardization
Mean −− −− 137.4 141.1 292.4 294.3
SD 1 −− −− 2 3.73 10.34 3 6.77 22.29
CV −− −− 2.7 7.3 2.3 7.6
# Points −− −− 54 227 54 228
# Labs 2 2 2 2

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU International Calibrator OE 66300
Mean 31.75 35.98 123.8 121.3 287.7 273.6
SD 1 2.49 4.99 2 9.70 6.89 3 19.69 22.28
CV 7.9 13.9 7.8 5.7 6.8 8.1
# Points 60 328 18 75 61 130
# Labs 2 3 1 1 2 2

Beckman Coulter LX20, LXi725 Chemistry Systems • LEADMAN
Mean −− −− 150.0 150.0 301.8 301.8
SD 1 −− −− 2 4.97 4.97 3 7.59 7.59
CV −− −− 3.3 3.3 2.5 2.5
# Points −− −− 4 4 4 4
# Labs 1 1 1 1

Mindray BS 200E/380/400/480/800/2000
Mean 41.13 41.26 187.5 176.4 −− −−
SD 1 2.95 3.89 2 7.84 18.26 3 −− −−
CV 7.2 9.4 4.2 10.4 −− −−
# Points 15 60 13 44 −− −−
# Labs 1 2 1 2

Roche cobas 6000/c 311
Mean 30.64 31.15 114.4 114.3 228.3 232.2
SD 1 1.14 1.10 2 2.30 2.26 3 3.72 4.18
CV 3.7 3.5 2.0 2.0 1.6 1.8
# Points 136 577 42 60 82 539
# Labs 6 6 2 2 5 6

Roche cobas 8000
Mean 30.60 30.42 108.4 108.4 −− 223.8
SD 1 1.20 1.24 2 3.20 3.20 3 −− 2.74
CV 3.9 4.1 2.9 2.9 −− 1.2
# Points 93 251 58 58 −− 98
# Labs 2 2 2 2 1

Roche Hitachi Systems (International)
Mean −− −− 134.7 135.3 280.1 276.1
SD 1 −− −− 2 3.49 3.51 3 5.73 21.07
CV −− −− 2.6 2.6 2.0 7.6
# Points −− −− 96 235 97 264
# Labs 3 3 3 4

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 21

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Alkaline Phosphatase PNPP, AMP Buffer − IFCC Ref. Proc.,Calibrated U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Roche Hitachi Systems (International) • DiaSys Diagnostic Systems
Mean −− −− 96.10 98.71 −− −−
SD 1 −− −− 2 8.57 9.91 3 −− −−
CV −− −− 8.9 10.0 −− −−
# Points −− −− 20 83 −− −−
# Labs 1 1

Siemens ADVIA 1200
Mean 34.33 33.63 120.2 120.2 245.1 245.1
SD 1 0.617 1.52 2 1.29 1.29 3 2.92 2.92
CV 1.8 4.5 1.1 1.1 1.2 1.2
# Points 15 35 18 18 16 16
# Labs 1 2 1 1 1 1

Siemens ADVIA Chemistry Systems
Mean 33.33 34.00 120.4 124.3 245.9 255.5
SD 1 1.58 2.07 2 5.35 8.03 3 11.86 16.43
CV 4.7 6.1 4.4 6.5 4.8 6.4
# Points 1713 3687 1220 2482 1177 2256
# Labs 40 43 29 35 30 31

Siemens Dimension Series
Mean 34.54 35.47 121.6 122.6 248.7 249.0
SD 1 2.57 2.73 2 4.46 4.39 3 7.32 7.65
CV 7.4 7.7 3.7 3.6 2.9 3.1
# Points 5131 37259 2156 16806 4378 33053
# Labs 151 198 61 86 136 177

Siemens Dimension Vista
Mean 33.21 34.52 117.3 121.4 248.2 253.3
SD 1 1.99 2.11 2 4.74 5.23 3 8.26 9.30
CV 6.0 6.1 4.0 4.3 3.3 3.7
# Points 5422 55668 2421 24532 5476 53852
# Labs 147 208 59 88 146 204

Siemens Dimension Vista • IFCC 2002 (Enzymes)
Mean 30.69 32.19 −− −− 241.1 246.5
SD 1 0.990 2.03 2 −− −− 3 6.17 8.19
CV 3.2 6.3 −− −− 2.6 3.3
# Points 64 403 −− −− 64 401
# Labs 2 2 2 2

Method Group • PNPP, AMP Buffer − IFCC Ref. Proc.,Calibrated
Mean 33.80 34.85 122.7 123.9 248.5 251.7
SD 1 2.40 2.50 2 11.56 9.21 3 9.66 9.63
CV 7.1 7.2 9.4 7.4 3.9 3.8
# Points 13112 101K 6661 47203 11401 91121
# Labs 368 486 177 239 328 433

Alkaline Phosphatase PNPP, AMP Buffer − IFCC Ref. Proc.,Calibrated U/L
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models) • Factored, IFCC Correlated
Mean −− 26.77 −− 106.7 −− 233.2
SD 1 −− 4.08 2 −− 12.97 3 −− 25.40
CV −− 15.2 −− 12.2 −− 10.9
# Points −− 101 −− 100 −− 99
# Labs 1 1 1

Method Group • PNPP, AMP Buffer − IFCC Ref. Proc.,Calibrated
Mean −− −− −− −− −− −−
SD 1 −− −− 2 −− −− 3 −− −−
CV −− −− −− −− −− −−
# Points −− −− −− −− −− −−
# Labs

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 22

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Alkaline Phosphatase PNPP, AMP Buffer−VITROS U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
VITROS Microslide Series • Slide generation #00
Mean 38.00 40.09 −− −− 225.7 228.2
SD 1 1.10 2.37 2 −− −− 3 8.59 8.44
CV 2.9 5.9 −− −− 3.8 3.7
# Points 20 74 −− −− 53 284
# Labs 1 1 2 3

VITROS Microslide Series • Slide generation #01
Mean −− 37.54 −− 122.7 −− 233.8
SD 1 −− 1.85 2 −− 4.12 3 −− 6.99
CV −− 4.9 −− 3.4 −− 3.0
# Points −− 105 −− 105 −− 101
# Labs 2 2 2

VITROS Microslide Series • Slide generation #06
Mean −− 40.47 −− −− −− 231.1
SD 1 −− 1.17 2 −− −− 3 −− 4.34
CV −− 2.9 −− −− −− 1.9
# Points −− 55 −− −− −− 57
# Labs 1 1

VITROS Microslide Series • Slide generation #07
Mean −− 38.15 −− −− −− 241.6
SD 1 −− 1.45 2 −− −− 3 −− 11.01
CV −− 3.8 −− −− −− 4.6
# Points −− 471 −− −− −− 471
# Labs 2 2

VITROS Microslide Series • Slide generation #08
Mean 37.92 36.98 −− −− 243.2 239.1
SD 1 1.98 2.27 2 −− −− 3 4.55 10.87
CV 5.2 6.1 −− −− 1.9 4.5
# Points 129 720 −− −− 116 646
# Labs 3 4 3 4

VITROS Microslide Series • Slide generation #09
Mean 37.49 38.45 118.4 119.7 227.4 229.9
SD 1 2.20 1.91 2 5.31 5.83 3 9.32 10.44
CV 5.9 5.0 4.5 4.9 4.1 4.5
# Points 141 7780 193 2240 194 5318
# Labs 8 63 10 33 9 62

VITROS Microslide Series • Slide generation #10
Mean 38.33 37.89 122.1 120.7 233.2 232.0
SD 1 2.00 2.03 2 4.60 4.96 3 7.92 9.15
CV 5.2 5.4 3.8 4.1 3.4 3.9
# Points 1845 11470 614 4643 1965 11337
# Labs 71 85 28 39 70 83

VITROS Microslide Series • Slide generation #27
Mean 40.00 40.67 −− −− 237.5 238.5
SD 1 0.863 1.33 2 −− −− 3 3.54 5.94
CV 2.2 3.3 −− −− 1.5 2.5
# Points 24 142 −− −− 25 143
# Labs 1 1 1 1

VITROS Microslide Series • Slide generation #38
Mean 40.00 40.00 124.0 124.0 235.0 235.0
SD 1 1.00 1.00 2 2.30 2.30 3 5.70 5.70
CV 2.5 2.5 1.9 1.9 2.4 2.4
# Points 32 32 32 32 32 32
# Labs 1 1 1 1 1 1

VITROS Microslide Series • Slide generation #47
Mean −− 37.53 −− 115.9 −− 230.5
SD 1 −− 1.36 2 −− 4.34 3 −− 8.23
CV −− 3.6 −− 3.7 −− 3.6
# Points −− 194 −− 206 −− 212
# Labs 1 1 1

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 23

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Alkaline Phosphatase PNPP, AMP Buffer−VITROS U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
VITROS Microslide Series • Slide generation #48
Mean 37.80 38.20 122.3 122.4 237.1 237.2
SD 1 1.88 1.71 2 4.76 3.95 3 5.39 5.17
CV 5.0 4.5 3.9 3.2 2.3 2.2
# Points 20 196 23 175 21 195
# Labs 1 1 1 1 1 1

VITROS Microslide Series • Slide generation #49
Mean 37.15 37.89 114.7 115.5 232.2 230.2
SD 1 0.883 1.58 2 2.62 4.87 3 3.65 7.91
CV 2.4 4.2 2.3 4.2 1.6 3.4
# Points 61 547 67 589 72 571
# Labs 1 1 1 1 1 1

VITROS Microslide Series • Slide generation #99
Mean 38.47 38.61 118.9 120.1 239.9 238.0
SD 1 2.16 2.03 2 6.02 5.10 3 13.74 12.96
CV 5.6 5.2 5.1 4.2 5.7 5.4
# Points 391 1071 90 314 349 916
# Labs 17 20 7 9 15 17

Method Group • PNPP, AMP Buffer−VITROS
Mean 38.28 38.13 120.7 120.0 234.0 232.2
SD 1 2.03 2.01 2 5.24 5.39 3 9.42 10.06
CV 5.3 5.3 4.3 4.5 4.0 4.3
# Points 2663 22857 1019 8304 2827 20283
# Labs 104 183 48 87 103 179

Alkaline Phosphatase PNPP, DEA Buffer U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 29.12 29.11 140.3 138.1 263.4 254.3
SD 1 1.55 1.86 2 3.65 3.65 3 21.09 18.22
CV 5.3 6.4 2.6 2.6 8.0 7.2
# Points 165 899 25 51 195 997
# Labs 5 6 1 1 6 6

Beckman Coulter UniCel DxC Series
Mean −− 29.75 −− 126.8 −− −−
SD 1 −− 2.30 2 −− 7.22 3 −− −−
CV −− 7.7 −− 5.7 −− −−
# Points −− 155 −− 156 −− −−
# Labs 3 3

Roche Hitachi Systems (International) • BIODEVICE Srl
Mean −− −− −− 164.0 −− −−
SD 1 −− −− 2 −− 12.67 3 −− −−
CV −− −− −− 7.7 −− −−
# Points −− −− −− 22 −− −−
# Labs 1

Roche MODULAR (ISE, D, P, E170)
Mean 32.17 32.33 110.2 108.1 −− −−
SD 1 1.41 1.74 2 4.51 4.88 3 −− −−
CV 4.4 5.4 4.1 4.5 −− −−
# Points 40 222 41 216 −− −−
# Labs 2 2 2 2

Siemens ADVIA 1200
Mean 60.00 68.92 190.5 183.8 428.0 428.0
SD 1 0.000 7.53 2 27.58 10.30 3 0.000 0.000
CV 0.0 10.9 14.5 5.6 0.0 0.0
# Points 4 13 2 13 1 1
# Labs 1 2 2 2 1 1

Siemens ADVIA Chemistry Systems
Mean 76.02 77.11 201.9 202.2 368.0 373.8
SD 1 4.64 4.33 2 9.17 11.97 3 13.84 16.26
CV 6.1 5.6 4.5 5.9 3.8 4.4
# Points 672 4939 704 5063 577 3792
# Labs 22 31 26 36 22 29

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 24

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Alkaline Phosphatase PNPP, DEA Buffer U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Method Group • PNPP, DEA Buffer
Mean 65.18 67.39 195.0 195.6 341.7 348.9
SD 1 20.00 19.52 2 24.54 25.37 3 48.28 51.34
CV 30.7 29.0 12.6 13.0 14.1 14.7
# Points 881 6228 772 5521 773 4790
# Labs 30 44 31 45 29 36

Alkaline Phosphatase PNPP, Tris Buffer U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Roche cobas 6000/c 311
Mean −− −− 112.5 112.8 221.3 227.8
SD 1 −− −− 2 3.27 4.83 3 6.46 9.97
CV −− −− 2.9 4.3 2.9 4.4
# Points −− −− 19 77 19 78
# Labs 1 1 1 1

Method Group • PNPP, Tris Buffer
Mean −− −− 112.5 112.8 221.3 227.8
SD 1 −− −− 2 3.27 4.83 3 6.46 9.97
CV −− −− 2.9 4.3 2.9 4.4
# Points −− −− 19 77 19 78
# Labs 1 1 1 1

Alpha−1−Globulin Capillary Electrophoresis %
Level Mon Cum Level Mon Cum Level Mon Cum
Sebia CAPILLARYS
Mean 8.90 7.16 7.19 7.87 −− −−
SD 1 0.000 1.72 2 0.390 0.557 3 −− −−
CV 0.0 24.0 5.4 7.1 −− −−
# Points 2 19 20 148 −− −−
# Labs 1 1 1 1

Sebia MINICAP
Mean 5.11 5.22 4.33 4.39 −− −−
SD 1 0.113 0.235 2 0.116 0.247 3 −− −−
CV 2.2 4.5 2.7 5.6 −− −−
# Points 8 16 8 16 −− −−
# Labs 1 1 1 1

Method Group • Capillary Electrophoresis
Mean 5.87 6.28 6.37 7.53 −− −−
SD 1 1.60 1.60 2 1.36 1.17 3 −− −−
CV 27.3 25.4 21.3 15.5 −− −−
# Points 10 35 28 164 −− −−
# Labs 2 2 2 2

Alpha−2−Globulin Capillary Electrophoresis %
Level Mon Cum Level Mon Cum Level Mon Cum
Sebia CAPILLARYS
Mean 6.10 5.69 9.09 8.85 −− −−
SD 1 0.000 0.752 2 0.260 0.748 3 −− −−
CV 0.0 13.2 2.9 8.5 −− −−
# Points 2 9 21 149 −− −−
# Labs 1 1 1 1

Sebia MINICAP
Mean 3.12 3.12 3.38 3.49 −− −−
SD 1 0.175 0.173 2 0.139 0.213 3 −− −−
CV 5.6 5.5 4.1 6.1 −− −−
# Points 8 16 8 16 −− −−
# Labs 1 1 1 1

Method Group • Capillary Electrophoresis
Mean 3.72 4.05 7.51 8.33 −− −−
SD 1 1.26 1.34 2 2.61 1.74 3 −− −−
CV 34.0 33.0 34.7 20.9 −− −−
# Points 10 25 29 165 −− −−
# Labs 2 2 2 2

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 25

63 CV 4.6 3.2 184.8 5.20 4.7 2.0 2789 1014 11496 11701 SD 1 872.2 2 2572 2020 3 304.79 6.5 351.6 3.1 3.3 # Points −− −− 16 495 20 500 # Labs 4 5 4 5 ALT (ALAT/GPT) Enzymatic.09 CV 4.56 3 3.2 184.7 2.56 3 3.6 SD 1 −− −− 2 0.46 22.9 −− −− 1.2 1.75 79.69 5.80 −− −− 178.8 2 175.3 202.5 351.28 −− −− SD 1 1.00 4.2 12.2 CV 82.1 7.1 238.4 5.52 3 −− −− CV 6.5 198.17 CV −− −− 1.1 2.2 3 304.6 SD 1 −− −− 2 0.7 3.86 180.6 3.5 2.0 # Points 31 56 24 47 25 50 # Labs 1 1 1 1 1 1 Method Group • Dinitrophenyl hydrazine Mean 1058 407.673 1. Generated 22−May−2016 17:45:01 Page 26 .3 179.8 # Points 28 239 −− −− 35 243 # Labs 1 1 1 1 Siemens Dimension Series Mean 26.12 2 −− −− 3 2.89 2.3 −− −− # Points 21 217 21 217 −− −− # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #15 Mean 1763 1907 5165 5341 11496 11701 SD 1 144.65 2 −− −− 3 2.5 # Points 88 568 −− −− 88 575 # Labs 3 3 3 3 Siemens ADVIA Chemistry Systems Mean 20.48 77.6 3. Inc.5 92.28 2 −− −− 3 3.86 180.6 3.4 4. Worldwide Report April 2016 Multiqual 1.28 6.5 5.838 1.1 3.1 8.07 1. i.25 1.5 4.3 SD 1 0.7 5.0 # Points 52 273 45 264 25 50 # Labs 2 2 2 2 1 1 ALT (ALAT/GPT) Dinitrophenyl hydrazine U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Mindray BS 200E/380/400/480/800/2000 Mean −− −− 75.20 2 4.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) Dinitrophenyl hydrazine U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.4 −− −− 1.4 2. colorimetric U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Fuji Dri−Chem NX500/i Mean 21.859 2.60 26.1 2.2 CV 8.21 1.30 CV 3.0 # Points 29 235 −− −− 24 224 # Labs 1 1 1 1 Copyright © 2015 Bio−Rad Laboratories.9 SD 1 0.95 78.00 4.52 19.07 18.0 771.12 80.2 1.17 CV −− −− 1.70 21.3 # Points −− −− 16 495 20 500 # Labs 4 5 4 5 Method Group • Dinitrophenyl hydrazine Mean −− −− 75.75 −− −− SD 1 1.6 −− −− # Points 10 76 17 73 −− −− # Labs 1 1 1 1 Roche cobas 6000/8000/c 311 Mean 18.28 −− −− 189. ci models) Mean 17.75 79.2.90 73.2 199.859 2.4 SD 1 1.52 3 −− −− CV 5.11 −− −− 206.9 −− −− 1.2 241.4 189.61 2 1.

Generated 22−May−2016 17:45:01 Page 27 .45 1.2 SD 1 1.2 −− −− −− 1.00 −− −− −− −− SD 1 −− 0.7 2.2 1.12 2.0 −− −− 2.1 −− 1. colorimetric Mean 20.5 −− −− 1.12 1.73 2 −− 121.89 18.12 80.2 SD 1 1.1 −− 3.44 11. Inc.41 CV 6.67 3 −− −− CV −− 4.3 # Points 33 261 −− −− 33 261 # Labs 1 1 1 1 Method Group • Other NADH depletion Mean 20.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) Enzymatic.46 CV 7.52 3 10.78 74.4 SD 1 1.33 21.05 2 −− −− 3 2.20 19.50 1.20 4.4 5.7 # Points 110 541 −− −− 116 551 # Labs 4 6 4 6 ILab 600 Mean −− 18.6 5. colorimetric U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Method Group • Enzymatic.20 2.35 3.786 2 1.69 CV −− 9. i.93 164.0 # Points 110 749 17 46 116 707 # Labs 4 9 1 1 4 7 ALT (ALAT/GPT) UV with P5P U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean −− 944.46 CV 7.3 # Points 33 261 −− −− 33 261 # Labs 1 1 1 1 ALT (ALAT/GPT) Other NADH depletion U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.1 186.2 −− −− # Points −− 46 17 46 −− −− # Labs 1 1 1 Siemens Dimension Series Mean −− 29.91 CV 6.29 78.0 SD 1 3.15 −− −− 187. ci models) Mean −− 21.3 11.4 163.3 # Points 155 1118 17 73 147 1042 # Labs 6 6 1 1 5 5 ALT (ALAT/GPT) Other NADH depletion U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/8000/c 311 Mean 20.9 −− 3945 −− 9372 SD 1 −− 85.5 −− −− 1.77 −− −− 164.07 2 1.0 2.0 2.93 −− −− SD 1 −− 0.44 4.4 SD 1 −− 2.4 SD 1 1.89 17.1 2.75 185.4 CV −− 9.5 14.00 2 −− −− 3 −− 2.9 # Points −− 41 −− 41 −− 41 # Labs 1 1 1 Copyright © 2015 Bio−Rad Laboratories.70 11.7 7.67 74.2 1.07 2 −− −− 3 4.67 3 4.4 5.05 2 −− −− 3 2.60 −− −− −− 190.2 2. Worldwide Report April 2016 Multiqual 1.4 5.2 3 −− 178.8 6.45 1.12 74.90 CV 16.8 5.000 2 −− −− 3 −− −− CV −− 0.4 # Points −− 161 −− −− −− 156 # Labs 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 17.5 189.0 −− −− −− −− # Points −− 1 −− −− −− −− # Labs 1 Method Group • Other NADH depletion Mean 17.3 6.2.20 2.1 186.20 19.15 2 4.4 169.12 74.15 −− −− 187.50 1.2 2.

26 79.1 2. IFCC Correlated Mean −− 14.6 −− −− −− 1.92 77.58 78.43 −− −− SD 1 0.8 −− 1.03 3.18 −− −− −− 163.14 3 6. Inc.7 5.0 −− −− −− 1.26 2 4.6 −− −− # Points 92 439 91 439 −− −− # Labs 2 2 2 2 Copyright © 2015 Bio−Rad Laboratories. LXi725 Chemistry Systems Mean 22.19 3 12.78 CV 6.82 19.7 −− −− 2.32 2.65 2. i.0 11.4 # Points −− 5 −− 5 −− 5 # Labs 1 1 1 Abbott AEROSET/ARCHITECT (c.30 187.0 # Points −− 77 −− −− −− 76 # Labs 2 2 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Zhong Sheng Mean −− 90.81 6.04 3 7.1 # Points 26 81 −− −− 26 64 # Labs 1 1 1 1 Beckman Coulter UniCel DxC Series Mean 23.73 2 −− 121.0 SD 1 2.04 −− 191.835 CV −− 0.000 2 −− 0.48 23.63 13.623 2 −− −− 3 −− 1.80 −− 198.0 SD 1 1.0 3.0 6.2 3 −− 178.45 3 −− 3.3 181.2 SD 1 −− 0.10 CV −− 5.00 −− −− −− 209. i.5 5. ci models) • Abbott ALT (REF 8L92) Mean −− 15.90 2 4.18 2 3.6 # Points 557 2953 383 1979 401 1704 # Labs 14 18 11 14 11 12 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • IFCC 2002 (Enzymes) Mean −− 17.69 CV 8.000 2 −− −− 3 −− 2. ci models) • Factored.6 # Points −− 438 −− 438 −− 438 # Labs 2 2 2 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 19.9 # Points −− 41 −− 41 −− 41 # Labs 1 1 1 ALT (ALAT/GPT) UV with P5P U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.9 −− 3945 −− 9372 SD 1 −− 85.2 3.2 # Points −− 1 −− −− −− 15 # Labs 1 1 Beckman Coulter LX20.00 −− 80.35 77. ci models) Mean 19.4 SD 1 1.0 171.3 3.45 −− −− 171.29 20.0 179.9 7.9 4.1 SD 1 1.50 1.52 1. Worldwide Report April 2016 Multiqual 1.41 19.28 2 −− −− 3 3.03 3 −− −− CV 3.3 6.2 8.9 SD 1 −− 0.59 78.7 2.0 −− 0.5 3.59 3.6 −− 0.93 3.448 3 −− 0.959 2 1.1 2.5 6.1 SD 1 −− 0.6 −− 1.9 4. i.8 4.5 # Points 822 3933 546 2489 436 2215 # Labs 26 28 17 18 14 16 Abbott AEROSET/ARCHITECT (c.66 79.18 6.33 183.85 −− 80.44 77. Generated 22−May−2016 17:45:01 Page 28 .1 SD 1 −− 0.50 22.1 −− 3.88 5.792 0.830 2 −− 1.2 3.60 CV 12.64 CV 6.67 CV −− 3.2 # Points 67 818 47 1084 72 1019 # Labs 4 6 7 11 6 9 ILab 600 Mean 20.5 9.59 CV −− 0.2.4 CV −− 9.67 1.08 177.6 188.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) UV with P5P U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Method Group • UV with P5P Mean −− 944.1 −− 1.84 79.

8 195.07 CV 6.5 2.7 5.0 SD 1 −− 3.48 9.20 4.7 SD 1 1.5 5.9 SD 1 3. Calibrated U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Series Mean 26.43 3 6.52 87.09 24.70 206.4 3.6 197.44 2 −− −− 3 3.7 # Points 361 2691 228 1317 340 2721 # Labs 13 14 9 10 11 12 Roche MODULAR (ISE.35 3.96 2.0 209.8 202.6 4.12 2.13 2 2. E170) Mean 19.4 2.66 84.5 167.1 # Points 428 1641 295 1125 402 1778 # Labs 11 12 9 9 10 10 Siemens Dimension Series Mean 25.69 −− −− SD 1 1.4 3.8 5.73 1.8 194.47 3 −− −− CV 7.79 194.8 SD 1 1.40 83.87 6.6 1.62 84.12 2.09 1.36 76.50 80.2 SD 1 2.1 181.31 CV 6.5 SD 1 0.9 6.45 2 2.91 25.44 77.0 198.1 3.3 206.04 198.476 0.72 3 6.70 24.55 23.5 3.3 3.7 SD 1 1.59 2.20 6.000 0.2 −− −− # Points 77 355 75 332 −− −− # Labs 3 5 3 5 Siemens ADVIA 1200 Mean −− 21.93 3 5.8 2.79 24.0 # Points −− 5 2 20 1 1 # Labs 1 2 2 1 1 Siemens ADVIA Chemistry Systems Mean 23.66 2 1.5 # Points 1040 6310 651 4386 714 5934 # Labs 30 50 20 24 23 44 Siemens Dimension Series • Alternate Formulation/Standardization Mean 25.2.84 −− −− 167.5 0.70 88.45 18.63 212.27 8.5 3. Worldwide Report April 2016 Multiqual 1.22 19.05 81.0 0.08 2 2.28 2.6 7.12 3.80 24.5 # Points 21 100 −− −− 4 4 # Labs 2 2 1 1 Roche cobas 6000/8000/c 311 Mean 19.8 5.03 2 6.3 6.8 6.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) UV with P5P U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum ILab 650 Mean 18.6 1.1 7.9 # Points 23 110 21 135 21 128 # Labs 1 1 1 1 1 1 Siemens Dimension Vista Mean 23.03 2 2.6 2.1 3.35 5.5 2.84 −− −− 203..2 SD 1 1.93 CV 7.000 CV −− 14.50 2. Inc.51 2.06 3 0.75 82.69 CV 13.76 3.20 85. P.52 1.85 209.1 6.5 # Points 5017 33741 2552 16127 3864 29439 # Labs 144 194 86 111 116 162 ALT (ALAT/GPT) UV with P5P − IFCC Ref.69 19.89 CV 5.3 4.8 −− −− 2.11 CV 6.1 2.3 8.78 4.0 3.6 4.35 10.7 SD 1 1.1 3.64 3 3.29 77.30 2 5.9 2.03 91.83 1.76 88.2 # Points 1526 14333 234 2951 1468 13918 # Labs 38 52 6 15 38 53 Method Group • UV with P5P Mean 22.7 7.68 2 1.6 2.12 CV 8.59 198. Generated 22−May−2016 17:45:01 Page 29 . D. Proc.519 2 −− −− 3 4.1 # Points 21 185 −− −− 21 167 # Labs 1 1 1 1 Copyright © 2015 Bio−Rad Laboratories.8 −− −− 1.2 8.52 76.6 2.3 3.20 87.05 6.20 CV 2.9 1.8 13.31 3 3.61 1.05 180.46 3 11.

i.48 1.9 2.. i.8 5.5 3.0 # Points 618 3133 573 2779 463 2701 # Labs 12 12 10 10 8 8 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 20.8 5.95 3 3.4 SD 1 1.68 9.42 4.2 9.0 0.02 6. Calibrated U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Method Group • UV with P5P − IFCC Ref.0 # Points 202 333 202 341 185 322 # Labs 6 6 6 6 6 6 Abbott AEROSET/ARCHITECT (c.3 2.9 0.1 196.2 SD 1 1.77 1.7 189. ci models) • Factored.31 CV 7.2 188.72 10. Worldwide Report April 2016 Multiqual 1.15 2 1.7 SD 1 0.46 3.29 77.6 SD 1 0.4 SD 1 1.00 196.27 8.8 −− −− 1.0 2.6 2.2.2 2.53 189.7 4.04 CV 6.08 20.34 197.80 CV 6.4 2.76 78. Generated 22−May−2016 17:45:01 Page 30 .1 2.01 2 −− 1.08 3 7.81 CV 8.5 1. Calibrated U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c..3 3.0 0.00 84.8 2.63 3.22 1.7 SD 1 1.04 14.44 2 −− −− 3 3.5 # Points 270 915 317 945 368 1240 # Labs 10 12 13 14 15 16 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU International Calibrator OE 66300 Mean 21.1 5.47 1.6 # Points −− −− 96 218 97 250 # Labs 3 3 3 4 Siemens ADVIA 1200 Mean −− 22.12 2 0.44 85.000 3 0.1 2. Proc.3 SD 1 −− −− 2 2.18 195.26 3 4.14 189.20 81.03 CV −− −− 2.10 CV 7. ci models) • Abbott ALT (REF 8L92) Mean 13.9 190.1 # Points 21 185 −− −− 21 167 # Labs 1 1 1 1 ALT (ALAT/GPT) UV with P5P − IFCC Ref. IFCC Correlated Mean 14.41 3 4.9 9.944 1.28 77.73 1.61 79.3 0.8 195.11 CV 6..18 82.3 7.1 # Points 148 516 257 817 138 493 # Labs 4 4 4 4 4 4 Abbott AEROSET/ARCHITECT (c.04 3 4. Calibrated Mean 26.6 4.96 3 3.59 3 −− −− CV −− 4.40 3.28 84. Proc.6 # Points −− −− 25 53 25 53 # Labs 1 1 1 1 Roche Hitachi Systems (International) Mean −− −− 84.577 CV 9.5 −− 2.3 # Points 2 2 3 3 3 3 # Labs 1 1 1 1 1 1 Beckman Coulter UniCel DxC Series Mean 19.4 4.000 0.1 3.9 8.65 14.3 SD 1 2.53 20.6 2.577 0.23 3 −− 3.34 −− 180.14 2 1.30 −− −− SD 1 −− 1.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) UV with P5P − IFCC Ref.84 −− −− 203. i.0 −− −− # Points −− 20 −− 20 −− −− # Labs 1 1 Copyright © 2015 Bio−Rad Laboratories.12 79.12 2.7 2.17 2.84 79. Inc.96 CV −− −− 2.3 196.5 2.7 2.4 195.838 0.82 80.20 −− 81.73 1. Proc.04 83.74 4.80 24.17 2.62 14.5 2.0 192.12 2 2. ci models) Mean 14.37 2.50 84.0 6.22 187.89 2 2.5 5.5 SD 1 −− −− 2 2.10 187.2 3.50 21.6 2.927 2 2.7 # Points 37 354 69 260 −− 300 # Labs 1 3 2 3 1 JEOL BioMajesty JCA−BM Series Mean −− −− 82.3 −− 1.

5 3.8 3.53 CV −− 7. Proc.53 −− 193.07 1.83 87.2 6.3 1.7 SD 1 1.09 23.22 1.93 3.70 85.3 2.15 2 3.64 2 −− −− 3 3.48 2 −− −− 3 1.75 86.56 3.9 1.88 197.1 # Points 34 127 34 127 34 120 # Labs 1 1 1 1 1 1 VITROS Microslide Series • Slide generation #27 Mean 33.7 4.2 SD 1 3.2 7. Calibrated Mean 24.40 25.59 2.85 5.71 1. Proc.1 # Points 11817 102K 5669 44886 11411 97336 # Labs 347 463 154 209 335 443 ALT (ALAT/GPT) UV with P5P−VITROS U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #16 Mean −− −− −− 92.8 SD 1 −− −− 2 −− 2.4 3.76 91.38 199.97 89.4 3.9 SD 1 −− 2.8 # Points −− 63 −− −− −− 62 # Labs 1 1 Method Group • UV with P5P − IFCC Ref.3 4.49 CV 4.2 3.95 3 5.6 194.5 4.5 SD 1 −− 1.7 # Points −− −− −− 13 −− 13 # Labs 1 1 Copyright © 2015 Bio−Rad Laboratories.27 3 5.17 −− −− 193.2 4.60 2 −− −− 3 −− 3.11 CV 11.96 3 7.3 199.51 87.74 3 4.91 −− −− −− 194.59 7..82 24.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) UV with P5P − IFCC Ref.28 205.1 # Points 5419 40060 2187 16626 4815 36852 # Labs 166 210 63 86 147 188 Siemens Dimension Series • IFCC 2002 (Enzymes) Mean −− 23.8 SD 1 1.38 8.39 CV −− 4. Generated 22−May−2016 17:45:01 Page 31 .0 5.82 2.7 2..7 −− −− 1.76 3.20 24.48 86.4 −− −− −− 1.2.03 2 2.96 3 −− 3.8 3.16 2.05 2 −− −− 3 −− 2.73 3 6.94 CV 6.7 −− −− −− 1.16 CV 9.80 −− −− 187.6 3.6 197.24 86.93 −− −− −− 191.4 5.2 −− 1. Inc.36 23.8 1.85 34.29 2 4. Calibrated U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Siemens ADVIA Chemistry Systems Mean 23.3 7.27 CV 7.77 2 2. Worldwide Report April 2016 Multiqual 1.1 14.6 7.0 SD 1 1.2 2.8 8.66 5.6 # Points 25 120 −− −− 25 122 # Labs 1 1 1 1 Siemens Dimension Series Mean 25.14 89.14 CV 7.2 −− −− 0.56 3.26 CV −− −− −− 3.9 SD 1 1.1 202.70 201.47 191.99 2.5 3.6 # Points 5582 58729 2439 25135 5584 56668 # Labs 154 218 59 88 152 214 Siemens Dimension Vista • IFCC 2002 (Enzymes) Mean 23.6 188.13 3.7 193.8 # Points 67 667 40 341 106 758 # Labs 2 3 1 1 3 3 VITROS Microslide Series • Slide generation #22 Mean 30.08 CV 5.3 3.7 SD 1 1.39 34.9 SD 1 2.61 8.7 9.8 198.92 87.66 4.49 5.0 3.2 # Points −− 30 −− −− −− 31 # Labs 1 1 Siemens Dimension Vista Mean 23.6 # Points 31 62 −− −− 31 62 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #45 Mean −− 33.74 2 1.

8 12.71 CV 11.6 SD 1 3.6 3.4 # Points −− −− −− −− 33 64 # Labs 1 1 Method Group • UV with P5P−VITROS Mean −− −− 87.4 SD 1 3.1 59.52 3 3.49 193.6 1.85 −− −− 189.7 194.3 188.9 5.56 31.8 9.61 −− −− −− 186.87 3.00 35.43 9169 8451 SD 1 −− −− 2 1.37 3 −− 9.50 31.77 3 3.66 −− −− 186.16 4.54 11.7 496.5 # Points 20 74 −− −− 64 283 # Labs 1 1 3 3 VITROS Microslide Series • Slide generation #01 Mean 31.3 15.4 −− 2. Inc.2 # Points −− 486 −− 163 −− 478 # Labs 3 1 3 VITROS Microslide Series • Slide generation #05 Mean 32.7 2.1 3.8 5.11 89.8 −− 5.1 # Points −− −− 8 23 41 87 # Labs 1 1 2 2 ALT (ALAT/GPT) UV with P5P−VITROS U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #00 Mean 30.2 −− −− −− 2.38 90.8 2.6 4.52 2 −− −− 3 3.99 CV −− 12.40 3.83 −− 190.5 −− −− 1.8 SD 1 2.3 # Points −− 33 −− −− −− 33 # Labs 1 1 VITROS Microslide Series • Slide generation #08 Mean 31.4 192.08 3.55 3.4 −− 3.2 189.3 −− −− 2.5 SD 1 −− 4.99 2 3.38 90.43 189.84 3.39 3 −− 2.21 2 −− −− 3 5.29 4.8 SD 1 −− 1.72 CV 5.2.6 SD 1 1.89 32.15 2 −− 3.73 −− −− 185.01 −− 194. Generated 22−May−2016 17:45:01 Page 32 .27 2 −− −− 3 5. Worldwide Report April 2016 Multiqual 1.68 87.49 2 −− −− 3 −− 4.9 49.80 CV −− 5.9 # Points 18 149 18 214 18 209 # Labs 1 3 1 4 1 4 VITROS Microslide Series • Slide generation #02 Mean −− 32.62 CV −− −− 2.41 5.9 CV −− −− −− −− 4.9 # Points 79 480 −− −− 67 421 # Labs 2 2 2 2 Copyright © 2015 Bio−Rad Laboratories.66 −− 88.1 3.59 CV 10.5 # Points 59 262 −− −− 61 264 # Labs 2 2 2 2 VITROS Microslide Series • Slide generation #06 Mean −− 34.60 −− 87.9 # Points −− −− 8 23 8 23 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #27 Mean −− −− −− −− 11346 11419 SD 1 −− −− 2 −− −− 3 516.52 3 4500 4998 CV −− −− 2.9 1.7 −− 1.11 4.28 CV −− 7.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) UV with P5P−VITROS U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #19 Mean −− −− 87.26 CV 8.4 # Points −− 113 −− 112 −− 113 # Labs 1 1 1 VITROS Microslide Series • Slide generation #04 Mean −− 33.5 SD 1 −− 2.8 −− −− 2.4 187.1 10.8 2.1 SD 1 −− −− 2 1.84 3.60 5.3 1.78 2 −− 2.

9 # Points −− 651 −− 610 −− 803 # Labs 8 4 10 VITROS Microslide Series • Slide generation #19 Mean 31.2 # Points 33 301 33 265 33 293 # Labs 2 3 2 2 2 3 VITROS Microslide Series • Slide generation #14 Mean −− 38.45 3 −− 8.85 CV 10.3 SD 1 4.4 9.56 85.08 2 4.3 3.63 −− 193.10 −− 85.64 CV 6.2 −− 3.34 −− 194.5 1.94 4.75 3 4.1 # Points 52 165 −− −− 48 145 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #10 Mean −− 34.2.50 2 −− 3.2 194.76 84.41 CV −− 7.94 3.71 −− −− 191.1 11.82 3.6 2.86 CV −− 10.6 # Points 24 962 −− 113 24 1010 # Labs 1 12 2 1 12 VITROS Microslide Series • Slide generation #20 Mean 33.98 CV 6.72 CV 12.47 88.48 85.0 # Points 32 1515 35 1334 11 1554 # Labs 3 14 4 13 2 15 VITROS Microslide Series • Slide generation #21 Mean 33.9 −− 4.2 −− 2.3 SD 1 −− 2.63 2 3.96 2.8 −− −− 2.8 9.03 2.0 6.6 2.96 32.0 193.2 4.4 # Points 25 623 22 468 20 559 # Labs 1 10 1 5 1 9 VITROS Microslide Series • Slide generation #16 Mean 27.10 31.61 3.07 3 3.52 87.3 2.3 192.8 195.9 1.01 3.29 3.97 4.7 −− 5.77 193.50 2 −− 3.09 2 −− 3.75 4.68 6.28 2 1.9 SD 1 1.2 −− 3.66 3 3.5 2.38 33.92 3 −− 7.1 2.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) UV with P5P−VITROS U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #09 Mean 34.9 6.9 2.22 −− 87.64 CV 10.44 34.8 10.83 34.44 −− 85.0 9.49 −− 87.31 2 −− −− 3 3.5 5.5 # Points 432 3981 264 1644 485 4158 # Labs 19 42 13 22 21 44 Copyright © 2015 Bio−Rad Laboratories.68 3.78 3 6.9 5.03 90.5 −− 3.1 SD 1 1.5 1.1 3.1 2.9 # Points 21 1072 −− 174 21 1033 # Labs 1 15 7 1 15 VITROS Microslide Series • Slide generation #17 Mean −− 33.73 88. Generated 22−May−2016 17:45:01 Page 33 .98 CV 5.39 191.1 2.4 SD 1 2.6 189.66 4. Worldwide Report April 2016 Multiqual 1.4 SD 1 2.26 −− 88. Inc.7 2.1 188.09 −− 190.07 4.3 3.98 191.91 3 −− 3.12 5.37 186.58 34.12 CV 6.7 8.5 −− 4.08 3 3.8 192.9 SD 1 3.9 SD 1 2.6 −− 2.6 # Points −− 994 −− 330 −− 755 # Labs 16 9 13 VITROS Microslide Series • Slide generation #11 Mean 33.42 3.6 4.5 3.75 2 5.0 # Points −− 50 −− 98 −− 54 # Labs 3 1 3 VITROS Microslide Series • Slide generation #15 Mean 27.02 2 −− 4.26 89.40 5.91 187.9 SD 1 −− 3.54 3 2.8 SD 1 −− 2.99 CV −− 7.00 33.81 192.86 3.92 2 −− 1.

74 4.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) UV with P5P−VITROS U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #22 Mean 35.4 SD 1 3.9 7.0 3.46 2 3.62 191.56 CV 11.2 5.54 CV 11.4 # Points −− 92 −− −− −− 96 # Labs 1 1 Copyright © 2015 Bio−Rad Laboratories.4 SD 1 2.33 89.24 192.16 2 −− 3.1 −− −− −− 3.4 192.0 0.84 5.18 193.17 2 3.3 0.5 3.1 3.92 189.73 7.82 CV 9.50 6.9 12.3 195.2 184. Generated 22−May−2016 17:45:01 Page 34 .5 194.80 −− −− −− 189.11 79.5 3.3 # Points 225 1034 132 495 158 683 # Labs 8 9 5 8 5 7 VITROS Microslide Series • Slide generation #25 Mean 34.39 2 3.8 2.12 −− 89.9 3.17 2.79 7.60 2 −− −− 3 −− 4.75 2.61 2 −− −− 3 −− 6.1 9.4 SD 1 −− 2.9 193. Inc.85 −− −− −− 186.4 3.40 186.42 89.47 35.07 CV 11.82 3 0.56 89.04 3 4.7 7. Worldwide Report April 2016 Multiqual 1.25 31.82 6.9 10.75 2 0.5 5.2.5 3.1 3.1 −− −− −− 2.29 89.30 92.36 86.9 3.11 30.8 2.4 # Points 526 1648 304 821 613 1724 # Labs 19 20 9 9 21 23 VITROS Microslide Series • Slide generation #28 Mean 30.82 35.3 9.64 83.8 195.89 3.4 SD 1 3.12 CV 8.6 # Points 355 1767 108 786 369 1774 # Labs 14 22 7 12 15 23 VITROS Microslide Series • Slide generation #27 Mean 32.92 79.8 3.7 19.98 2 2.9 8.73 195.5 4.1 2.13 4.18 3.7 2.43 3 8.4 189.9 # Points 34 190 34 183 30 148 # Labs 6 7 4 5 4 4 VITROS Microslide Series • Slide generation #36 Mean 32.65 31.8 3.6 10.2 # Points −− 79 −− −− −− 79 # Labs 1 1 VITROS Microslide Series • Slide generation #47 Mean −− 36.5 SD 1 2.05 CV 8.3 4.919 6.48 196.71 3 7.41 7.44 2 4.00 3 7.7 # Points 225 2211 57 634 221 2345 # Labs 11 26 2 8 11 27 VITROS Microslide Series • Slide generation #24 Mean 34.28 6.3 SD 1 2.04 3.8 SD 1 −− 2.84 3.50 3 6.25 86.1 192.36 4.06 CV −− 7.3 SD 1 4.50 32.90 86.2 # Points 2 1241 −− 670 2 1124 # Labs 1 15 10 1 15 VITROS Microslide Series • Slide generation #23 Mean 31.67 90.10 6.4 3.8 # Points 60 502 64 565 62 560 # Labs 1 1 1 1 1 1 VITROS Microslide Series • Slide generation #42 Mean −− 36.33 CV 6.6 9.60 3 4.000 0.000 3 6.31 32.48 3.6 # Points 190 190 1 1 185 185 # Labs 9 9 1 1 9 9 VITROS Microslide Series • Slide generation #29 Mean 31.8 3.0 SD 1 2.30 CV 7.39 CV −− 7.1 0.77 3.46 2 6.4 3.1 3.2 −− 4.79 86.34 184.55 84.40 7.6 3.7 5.03 3.8 SD 1 3.84 32.

4 SD 1 3.3 8.0 −− 1.4 # Points 44 364 −− 20 67 492 # Labs 2 3 1 3 3 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • IFCC 2002 (Enzymes) Mean −− 16.8 2.7 5.05 75.52 17.7 3.8 6. ci models) Mean 19.2 4.53 75.9 11. Inc.8 SD 1 −− 0.3 SD 1 1.3 4.97 20.46 −− 70.56 CV 9.35 3.8 4.90 CV −− 3.0 3.886 1.45 3 4.2 SD 1 −− 0.7 # Points 124 1239 80 795 147 1387 # Labs 4 9 2 5 5 9 ALT (ALAT/GPT) UV without P5P U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.2 −− 1.4 5.7 3.19 78.0 SD 1 3.4 5.5 −− 1.13 185.9 10.21 4.75 1.5 # Points 80 626 80 612 80 623 # Labs 2 2 2 2 2 2 Method Group • UV without P5P Mean 18.07 3 −− 2.53 3 8.76 75.86 34.4 3.77 2 3.86 177.31 18.08 4.78 −− 182.8 # Points −− 91 −− 113 −− 113 # Labs 1 1 1 Beckman Coulter UniCel DxC Series Mean −− 25.20 2 2.03 15.3 3.71 1.09 7.5 SD 1 1.20 5.6 SD 1 0.2.7 # Points −− 127 −− 50 −− 128 # Labs 2 1 2 Roche cobas INTEGRA Mean 18.1 # Points 3425 19498 2161 12109 3101 18719 # Labs 98 115 58 72 92 110 Copyright © 2015 Bio−Rad Laboratories.59 88.03 CV 11.44 CV 4.1 6.98 33.50 3 7.73 CV −− 2.7 165.7 20.4 2.2 SD 1 −− 1.26 5. i.16 −− 164.790 3 −− 3.4 3.08 CV 11.2 # Points 421 1144 124 378 371 938 # Labs 19 22 9 11 16 19 Method Group • UV with P5P−VITROS Mean 32.91 19.2 3.19 3 6.55 3 6.4 193.90 3.6 188.27 1.25 2 −− 2.17 89.87 186.5 10.31 −− 76.2 3.622 2 −− 2.6 186.9 −− 1.92 3.1 2.84 CV 8.5 # Points −− 31 −− −− −− 31 # Labs 1 1 Roche cobas 6000/8000/c 311 Mean −− 20.72 79.03 2.41 89.07 CV −− 5.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) UV with P5P−VITROS U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #99 Mean 33.14 88.8 −− 2.3 2. Worldwide Report April 2016 Multiqual 1.06 2 −− 0.0 163.5 4.617 2 −− −− 3 −− 2.96 171.20 −− 171.4 −− −− −− 1.4 SD 1 1.20 5.05 73.15 191.6 # Points 2833 21913 1196 9869 2863 21732 # Labs 122 269 59 134 120 270 ALT (ALAT/GPT) UV without P5P U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 17.1 176.10 CV 6. Generated 22−May−2016 17:45:01 Page 35 .88 2 2.84 8.23 −− −− −− 187.66 3 7.8 8.33 6.0 172.81 2 5.5 6.51 2 7.

47 82.75 3 7.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) UV without P5P U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.0 0.6 193.6 2.09 −− 85.0 SD 1 −− −− 2 1.1 6.90 73.7 SD 1 1.06 3 10.0 # Points −− −− 3 3 3 3 # Labs 1 1 1 1 Beckman Coulter UniCel DxC Series Mean 24.93 191.2 191.6 −− 4.0 SD 1 −− −− 2 4.57 6.29 6.1 3.74 8.77 1.7 5.00 3 0.89 81.3 # Points −− 55 −− 54 −− 54 # Labs 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 18.1 4.4 5.98 3.0 SD 1 1.59 2.00 1.41 72.1 0.26 −− 194. Generated 22−May−2016 17:45:01 Page 36 .8 # Points −− −− 8 27 9 28 # Labs 1 1 1 1 Abbott AEROSET/ARCHITECT (c.8 6.91 82.8 # Points −− −− 19 136 19 136 # Labs 1 1 1 1 Beckman Coulter LX20.88 6.65 3 −− 7.8 165.00 75.16 CV 9.70 78.47 CV 7.04 1.2 −− 2. Inc.6 2.9 5. ci models) • Alternate Formulation/Standardization Mean −− −− 78.2 8.33 CV −− −− 2.20 23.6 8.15 192.93 82.58 178.16 1.57 20.9 SD 1 −− −− 2 2.30 185.6 8.23 CV 5.0 # Points 783 5473 368 2582 664 4382 # Labs 25 35 16 27 19 22 Dirui CS Series Mean 21.0 189.9 3.2.9 4.74 2 −− 5.05 2 2.68 1.93 CV 7.91 80.79 4.6 −− 6.1 1.1 3. LXi725 Chemistry Systems • LEADMAN Mean −− −− 89.90 5.44 3 4.40 CV −− −− −− 3.77 4.00 189. i.53 −− 177.7 185.71 9.1 SD 1 1. i.71 3 3.53 2 6.7 # Points 1563 8066 1241 6981 686 2928 # Labs 30 34 24 28 18 23 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Zhong Sheng Mean −− −− 80.6 4.3 196.000 CV −− −− 1.6 # Points 10 311 −− 350 11 70 # Labs 1 7 7 1 1 DIRUI−CS−240 Mean −− −− −− 74.37 3 10.0 SD 1 −− −− 2 −− 2.0 2. LXi725 Chemistry Systems Mean −− −− 79.0 4.4 4.0 3.0 2.2 SD 1 1.7 # Points −− −− 45 215 45 215 # Labs 2 2 2 2 Beckman Coulter LX20.13 CV −− −− 5.2 # Points −− −− −− 125 −− 114 # Labs 1 1 Copyright © 2015 Bio−Rad Laboratories.5 3. ci models) • PROLABS Mean −− 20.85 24.36 5.3 11.58 191.89 3 −− 4.48 CV −− 9.40 3 5.55 2.19 17.2 −− 2.000 0.2 2.28 9.8 4.55 CV −− −− 3.1 SD 1 −− 1.00 89.4 175.8 172.1 3.66 −− 86.67 184.7 5. Worldwide Report April 2016 Multiqual 1.51 2 3.03 3 5.5 # Points 1553 10390 1124 7066 1531 10057 # Labs 48 61 32 43 47 64 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU International Calibrator OE 66300 Mean 20.41 167.85 2 −− 1.4 SD 1 −− −− 2 2.

20 21.36 2.72 6.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) UV without P5P U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Hitachi Chemistry Series Mean 21.8 −− 3.5 −− 2.50 81.44 −− 186.90 197.9 6.66 3 −− 3.70 −− 201.35 3 −− −− CV −− −− 2.6 SD 1 1.41 14.9 3.08 80.53 7.9 0.76 CV 2.85 CV 3.97 75.97 −− 190.6 192.2 # Points −− 195 6 6 −− 172 # Labs 1 1 1 1 ILab 600 Mean 21. Generated 22−May−2016 17:45:01 Page 37 .53 3 −− 6.9 1.856 2 1.42 75.2 6.784 0.03 77.41 −− −− SD 1 0.1 3.03 CV −− 12.41 19.5 SD 1 −− 2.963 0.616 2 1.3 # Points 66 359 39 211 27 205 # Labs 4 5 2 3 2 3 Mindray BS 200E/380/400/480/800/2000 • Alternate Formulation/Standardization Mean −− 20.9 −− 3.1 SD 1 −− −− 2 −− 0.5 182.88 78.7 SD 1 −− 0.0 # Points −− 21 −− 19 −− 19 # Labs 1 1 1 Roche cobas 6000/8000/c 311 Mean 19.4 9.4 −− 1.34 2 2.6 4.9 4.33 80.3 187.7 2.30 3 0.34 −− −− 175.29 19.53 77. Inc.9 2.04 CV 7.5 # Points 10 121 32 321 22 197 # Labs 1 1 2 2 1 1 Hitachi Chemistry Series • MAKER Mean −− −− −− 84.64 CV −− 3.4 −− −− 1.61 −− 196.0 1.2 7.3 3.75 2.05 CV 6.2.709 2 −− 2.00 3.9 # Points −− −− −− 40 −− 49 # Labs 1 1 Horiba ABX Pentra 400 Mean −− 22.1 SD 1 0.2 4.4 SD 1 1.0 2. Worldwide Report April 2016 Multiqual 1.73 CV −− −− −− 0.564 3 −− 1.8 3.1 −− −− # Points 24 163 24 163 −− −− # Labs 1 1 1 1 JEOL BioMajesty JCA−BM Series Mean −− −− 81.3 # Points 3168 18060 1562 6070 2564 16711 # Labs 95 118 53 60 70 95 Roche cobas c 111 Mean 20.7 −− 0.6 # Points 21 177 −− −− 21 177 # Labs 1 1 1 1 Copyright © 2015 Bio−Rad Laboratories.07 2.17 20.43 −− −− SD 1 −− −− 2 2.852 2 −− −− 3 1.76 181.66 CV −− −− −− 5.80 3 4.19 −− 79.0 SD 1 −− −− 2 −− 4.79 2 7.75 80.33 22.50 2.47 1.39 1.63 184.2 2.1 6.9 −− −− # Points −− −− 28 77 −− −− # Labs 1 1 JEOL BioMajesty JCA−BM Series • Zhong Sheng Mean −− −− −− 86.46 75.4 2.9 9.24 3 −− 5.840 2.94 1.35 2 5.9 # Points −− −− −− 44 −− 35 # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean 21.4 2.18 80.8 176.9 SD 1 0.5 1.420 0.72 3 −− −− CV 4.96 3 5.

01 84.91 3 4.51 2 2.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) UV without P5P U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas INTEGRA Mean 18.5 SD 1 1.1 SD 1 1.80 20.8 6.4 203.50 1.86 78.85 2 3.85 86.0 3.39 19.70 3.50 24.4 8.8 −− −− 1.0 163.60 76.7 # Points 179 1252 63 415 154 1069 # Labs 5 5 2 2 3 3 Siemens ADVIA Chemistry Systems Mean 22.18 2 6.48 6.56 2 −− −− 3 −− 7.41 203.9 3.4 SD 1 0.35 3 −− 3.7 # Points 33 395 −− −− 33 401 # Labs 1 2 1 2 Tokyo Boeki BIOLIS 50i Mean −− 23.4 SD 1 0.16 −− −− 202.9 6.4 3.3 3.8 SD 1 1.39 3.3 2.34 −− 84.8 8.24 3 6.1 181.03 188.7 −− −− 4. Worldwide Report April 2016 Multiqual 1.77 23. Generated 22−May−2016 17:45:01 Page 38 .9 1.21 23.16 −− −− 161.30 21.93 1.3 6.3 7.4 3.790 1.17 CV 6.22 5.71 82.71 1.95 75.53 3 4.6 4.3 # Points 160 1067 162 1069 68 522 # Labs 9 10 9 10 3 3 Roche Reflotron Mean 19.75 83. D.5 # Points −− −− 33 266 32 297 # Labs 1 1 1 1 Copyright © 2015 Bio−Rad Laboratories.549 2 −− −− 3 6.4 6.44 81. P.67 CV 8.2 201.87 CV 8.33 −− 192.39 2 −− 2.65 2 −− −− 3 2.24 CV 8.74 7.48 3 13.81 4.0 SD 1 1.50 2 3.15 3.37 CV 6.50 18.41 3 6.09 177.09 CV 3.11 5.71 2 3.8 2.62 CV −− 5.2 3.9 3.2 SD 1 1.91 2.4 SD 1 1.2 # Points 498 3590 314 2048 358 3034 # Labs 25 32 17 20 16 19 Roche Hitachi Systems (International) Mean 22.8 3.9 # Points −− 21 −− 22 −− 22 # Labs 1 1 1 Toshiba TBA−120FR Mean −− −− 84.7 179.1 2.7 # Points 4 16 −− −− 4 16 # Labs 1 1 1 1 Siemens ADVIA 1200 Mean 23.31 84.9 # Points 30 152 128 1137 62 714 # Labs 1 2 9 11 6 6 Roche MODULAR (ISE.50 9.79 CV 3.9 SD 1 −− 1.09 3 2.6 3.7 −− −− −− 3.0 4.2.61 1.0 # Points 4672 26580 3523 20807 3073 17865 # Labs 114 147 92 129 85 114 Siemens ADVIA Chemistry Systems • DiaSys Diagnostic Systems Mean 21.7 3.70 5.7 4.8 2.9 191.06 CV −− −− 3.82 3.6 6.22 2.5 5.750 0.14 5.3 3.70 CV 4.1 198.12 181.97 23.54 1.5 1.0 3.9 4.5 SD 1 −− −− 2 3. Inc.67 77.19 −− −− −− 206.14 82.72 194.6 2.05 1.97 204.0 194.7 # Points 97 296 −− −− −− 307 # Labs 2 2 2 Siemens Dimension Vista Mean 23.8 −− 1.4 7.9 −− 2. E170) Mean 19.

21 5.2 1.40 27.4 2.634 CV 6.71 −− −− −− 322.520 0.2 1.0 0.60 185.0 184.849 2 −− −− 3 −− −− CV −− 1.377 3 0.00 34.89 20. Generated 22−May−2016 17:45:01 Page 39 .20 −− −− 191.1 # Points 35 143 −− −− 34 149 # Labs 1 1 1 1 Method Group • UV without P5P Mean 20.12 −− 203.62 2.0 0.60 3 −− 7.9 2.7 6.24 17.420 0.98 SD 1 0.21 CV 12.000 0.48 3 10.9 SD 1 2.9 2.37 17.99 80.07 CV 8.13 3.000 0.8 10.0 −− −− 3.34 −− −− SD 1 −− −− 2 −− 6.5 195.24 17.06 6.0 # Points 1 1 −− −− 1 1 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #25 Mean 35.340 0.9 −− −− −− 0.8 SD 1 −− 0. ci models) Mean 5.420 0.000 2 −− −− 3 0.98 SD 1 0.7 −− −− # Points −− −− −− 27 −− −− # Labs 1 VITROS Microslide Series • Slide generation #22 Mean 34. i.849 2 −− −− 3 −− 2.37 17.63 2 5.0 190.0 SD 1 0.5 12.1 # Points 16332 96381 10875 62317 12513 78621 # Labs 464 584 324 427 373 483 Amikacin Immunoturbidimetric µg/mL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.82 CV −− −− −− 4.9 −− −− −− −− # Points −− 17 −− −− −− −− # Labs 1 Copyright © 2015 Bio−Rad Laboratories.00 −− −− 190.0 2.62 11. Inc.6 # Points −− 17 −− −− −− 17 # Labs 1 1 Method Group • 2−chloro−PNP−maltoheptaose Mean −− 45.365 2 0.68 3 −− −− CV −− −− −− 7.000 CV 0.3 −− 3.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units ALT (ALAT/GPT) UV without P5P U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Toshiba TBA−40FR (Accute) Mean −− −− −− 84.4 7.40 27.02 CV −− 1.5 6.8 # Points −− −− −− 148 −− 200 # Labs 2 2 Toshiba−TBA Mean −− −− −− 86.86 27.2.71 −− −− −− −− SD 1 −− 0.4 2.86 27.5 6.25 80.3 # Points 26 68 29 76 25 57 # Labs 1 1 1 1 1 1 Method Group • Immunoturbidimetric Mean 5.8 5.4 SD 1 −− −− 2 −− 3.340 0.4 7.68 37. Worldwide Report April 2016 Multiqual 1.520 0.0 2.634 CV 6.0 −− −− 0.365 2 0.3 # Points 26 68 29 76 25 57 # Labs 1 1 1 1 1 1 Amylase 2−chloro−PNP−maltoheptaose U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Series Mean −− 45.8 SD 1 3.73 2 −− −− 3 6.28 5.377 3 0.28 5.2 3.

00 89.99 3 −− −− CV −− −− 3.4 296.2 −− −− 2.2.1 5.10 3.5 −− −− # Points −− −− 19 54 −− −− # Labs 1 1 VITROS Microslide Series • Slide generation #33 Mean −− −− 89.3 −− −− # Points 11 74 17 76 −− −− # Labs 1 1 1 1 Method Group • Amylopectin.1 251.1 3.03 2 1.9 3.2 1.5 3.10 3 1.00 46.07 −− −− SD 1 −− −− 2 3.30 2 4.09 −− −− SD 1 −− −− 2 3. colorimetric−VITROS Mean −− −− 89. ci models) Mean 45.850 1.2 −− −− # Points −− −− 38 73 −− −− # Labs 2 2 Copyright © 2015 Bio−Rad Laboratories.10 3 −− −− CV −− −− 3.5 126.00 124.23 CV 0.72 15.8 −− −− SD 1 2.10 3.73 15.0 2.1 6. Worldwide Report April 2016 Multiqual 1.2 3.00 −− −− SD 1 −− −− 2 3.5 −− −− # Points −− −− 19 19 −− −− # Labs 1 1 Method Group • Amylopectin.8 251.1 5.70 46. i.27 128.0 # Points 38 146 −− −− 37 149 # Labs 1 2 1 2 Mindray BS 200E/380/400/480/800/2000 Mean −− −− 124.12 3 −− −− CV 4.54 CV 1.00 89. colorimetric Mean 51.3 271.53 4.6 # Points 1 179 26 296 26 296 # Labs 1 1 2 2 2 2 Fuji Dri−Chem NX500/i Mean 51.34 7.5 127.1 SD 1 0.7 # Points −− −− 22 491 22 461 # Labs 5 5 5 5 Method Group • 2−chloro−PNP−maltoheptaose Mean 45.1 SD 1 0.38 2.7 3.56 7.3 314.35 6.22 3 7.6 4.2 5.53 4.10 3 18.4 # Points 38 146 22 491 59 610 # Labs 1 2 5 5 6 7 Amylase Amylopectin.78 4.00 −− −− 310.36 47.4 273.40 CV 1.000 0.6 # Points 12 253 43 372 26 296 # Labs 2 2 3 3 2 2 Amylase Amylopectin.80 3 7.23 CV 5.5 290.8 2.6 131.1 0.6 2.06 3.1 5.827 2 3.00 46. Generated 22−May−2016 17:45:01 Page 40 .4 282.03 2 −− −− 3 6.00 89.73 15.1 3.3 5.850 1.3 271.5 125.9 2.9 2.59 1.8 SD 1 0.20 118.5 4.76 3 −− −− CV −− −− 3.6 131.66 CV −− −− 1.31 7.70 46.50 2 6.51 122.0 1. colorimetric−VITROS U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #27 Mean −− −− 89.7 3.3 SD 1 −− −− 2 1.2 3. Inc.4 4. colorimetric U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 47.8 6.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase 2−chloro−PNP−maltoheptaose U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.8 SD 1 2.

0 6.96 84.89 1.07 5.8 3.28 CV −− −− −− 7.4 170.0 7.491 2 4.20 31.4 2.000 1.30 3 6.86 162.2 3.88 6.9 4.2 # Points −− −− 63 563 73 637 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #20 Mean −− −− −− 85.5 3.6 −− 2.9 7.1 8.9 −− 3.6 # Points 39 483 83 807 81 822 # Labs 3 3 5 7 5 6 VITROS Microslide Series • Slide generation #12 Mean −− −− −− 79. colorimetric−VITROS U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #00 Mean −− −− −− −− 169.3 SD 1 −− 0.2 SD 1 1.88 3 7.78 84.95 84.02 CV −− −− −− 3.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase Amylopectin.2 2.0 4.0 SD 1 −− −− 2 −− 6.39 −− 81.41 5.0 4.30 6.64 3 7.61 CV 0.06 168.00 76.9 # Points 2 21 −− 72 31 142 # Labs 1 1 1 1 2 VITROS Microslide Series • Slide generation #26 Mean −− 30.16 175.0 5.6 6.36 3 5. Inc.2.4 169.0 6.02 3 4.08 80.59 2 7.0 3. Worldwide Report April 2016 Multiqual 1.8 # Points −− 293 103 1991 101 1881 # Labs 7 5 23 5 22 VITROS Microslide Series • Slide generation #27 Mean 30.35 3 −− 6.50 CV −− 1.36 −− 164.33 CV 2.6 SD 1 0.02 5.6 166.9 # Points −− −− −− 324 −− 324 # Labs 2 2 VITROS Microslide Series • Slide generation #23 Mean 32.82 3 −− 4.84 83.84 7.22 CV −− −− −− 3.21 2 5.60 168.3 SD 1 −− 0.0 6.9 163.5 # Points −− 1 48 341 69 405 # Labs 1 1 3 2 4 Copyright © 2015 Bio−Rad Laboratories.47 6.08 CV −− 0.29 172.14 2 −− 4.86 83.86 CV 6.5 # Points −− −− −− 136 −− 136 # Labs 1 1 VITROS Microslide Series • Slide generation #14 Mean −− −− 76.31 −− 158.01 −− 159.4 # Points 9 589 342 2999 364 3955 # Labs 2 8 15 24 16 37 VITROS Microslide Series • Slide generation #28 Mean −− 30.9 163.70 CV −− −− −− −− 2.52 5.47 80.0 SD 1 −− −− 2 −− 2.08 6.27 CV −− −− 4.51 168.99 79.43 3 4.6 5.0 SD 1 −− −− 2 −− 3.2 3.9 SD 1 −− −− 2 −− −− 3 4.6 173.7 SD 1 −− −− 2 3.8 7.69 30.4 3.6 −− 5.00 29.64 5.5 3.9 SD 1 0.4 # Points −− −− −− 244 −− 242 # Labs 2 2 VITROS Microslide Series • Slide generation #22 Mean −− −− −− 85.8 −− 4.0 4.9 # Points −− −− −− −− 30 209 # Labs 1 2 VITROS Microslide Series • Slide generation #01 Mean 31. Generated 22−May−2016 17:45:01 Page 41 .3 3.25 5.80 6.7 3.000 2 4.710 1.62 3 −− 7.9 173.

89 −− 161.3 2.1 # Points −− −− −− 203 −− 212 # Labs 1 1 VITROS Microslide Series • Slide generation #99 Mean 33.51 3 5.6 SD 1 2.35 2 5.4 3.8 # Points −− −− 29 111 28 112 # Labs 2 2 2 2 VITROS Microslide Series • Slide generation #46 Mean −− −− −− 82.1 3.22 7.53 3 6.3 # Points 130 441 172 521 347 907 # Labs 11 13 11 13 15 16 Method Group • Amylopectin.32 84.2.29 6.5 282.71 9.9 133.34 2 5.0 167.3 3.10 46.94 7.760 0.28 CV 0.2 286.3 6.2 3.32 3 −− 5.88 84.05 165.75 5.48 4.6 1.94 2 4.32 81.9 3.9 3. colorimetric−VITROS U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #29 Mean 30.28 33.88 2 5.1 4.4 # Points 4 26 −− 13 4 18 # Labs 1 2 1 1 1 Copyright © 2015 Bio−Rad Laboratories.8 5.36 CV −− −− −− 6.8 SD 1 25.7 6.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase Amylopectin.3 # Points 668 4094 1521 13728 2280 17163 # Labs 41 75 74 146 96 190 Amylase CNP−maltoheptaoside U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/8000/c 311 Mean 46.66 83.48 3 0.01 31.9 3.9 52.5 4.0 3.61 6.778 2 1.13 82.97 3 5.81 6.2 1.19 5.8 # Points 16 69 10 58 9 56 # Labs 1 1 1 1 1 1 Roche Reflotron Mean 56.000 1.45 173.36 CV 1.33 3 2.4 4.05 4.81 −− 172.19 83.3 5.8 −− 5.12 3 7.3 6.8 7. Generated 22−May−2016 17:45:01 Page 42 .0 6.0 285.5 6.8 # Points 3 31 111 1451 146 1723 # Labs 2 3 5 13 6 18 VITROS Microslide Series • Slide generation #30 Mean 30.06 3 5.0 3.37 84.3 5.98 19.92 85.7 165.56 83.44 3 6.8 167.72 5.64 1.34 4.46 84.51 CV 7.43 CV −− −− 4.952 2.8 SD 1 −− −− 2 −− 5.078 0.75 6.12 CV 34. Worldwide Report April 2016 Multiqual 1.92 CV 0.44 1. Inc.85 167.3 SD 1 0.79 5.61 5.1 0.61 166.7 1.688 2 4.59 167.64 CV 7.1 SD 1 0.18 164.01 CV 56.3 165.08 84.1 # Points 40 1208 120 2367 139 2812 # Labs 2 14 6 19 5 26 VITROS Microslide Series • Slide generation #31 Mean 31. colorimetric−VITROS Mean 34.1 0.0 # Points 338 815 336 1016 602 1700 # Labs 15 18 16 17 23 24 VITROS Microslide Series • Slide generation #33 Mean 45.4 SD 1 11.52 2 −− 8.3 4.50 31.61 169.8 5.53 131.4 −− 3.69 CV 2.2 4.00 29.0 # Points 107 212 114 582 269 944 # Labs 5 7 7 17 14 24 VITROS Microslide Series • Slide generation #34 Mean −− −− 83.44 2.6 4.6 174.08 2 3.00 3 6.1 6.54 6.9 6.02 30.0 14.8 4.8 165.7 SD 1 0.44 83.3 0.8 298.6 17.17 54.7 7.91 5.6 2.2 SD 1 1.64 38.9 167.3 SD 1 −− −− 2 4.5 SD 1 2.7 4.12 84.

64 11.4 4.9 317.9 138.8 11.36 11.80 44. Inc.875 2 −− −− 3 2.4 0.60 47. i.7 # Points 16 180 −− −− 16 122 # Labs 1 1 1 1 Method Group • CNP−triose/CNPG3 Mean 39.190 0. i.7 SD 1 −− 1.55 34.0 275.45 4. ci models) • Alternate Formulation/Standardization Mean −− 50.53 −− 152.29 3 14.88 2 1.9 5.4 2.0 1.3 1.8 SD 1 1.95 CV 11.76 14. Generated 22−May−2016 17:45:01 Page 43 .56 1.5 241.00 35.8 314.55 CV 1.23 3 −− 6.68 CV 5.5 # Points 5 7 −− −− 5 7 # Labs 1 1 1 1 Amylase CNP−triose/CNPG3 U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.22 3.9 317.00 3 3.3 −− −− 0.3 112.23 CV 4.1 −− 2.3 # Points 24 127 −− 20 24 135 # Labs 1 1 1 1 1 Siemens Dimension Series Mean 44. Worldwide Report April 2016 Multiqual 1.5 SD 1 0.2 8.9 SD 1 4.2 1.65 6.5 SD 1 0.7 4.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase CNP−maltoheptaoside U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Method Group • CNP−maltoheptaoside Mean 48.8 8.9 12.67 CV 0.12 CV 8.1 285.00 1.7 287.5 5.51 −− 249.7 1.9 −− −− 0.06 −− 249.0 # Points 40 307 −− 20 40 257 # Labs 2 2 1 2 2 Amylase CNP−triose/CNPG3 U/L @ 35° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.2 316.99 1.05 2 −− 2.0 249.8 4.8 # Points 20 95 10 71 13 74 # Labs 2 3 1 2 2 2 Amylase CNP−triose/CNPG3 U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 36. ci models) Mean 47.00 3 32.160 2 −− −− 3 1.8 5.0 250.0 # Points −− 183 −− 192 −− 167 # Labs 2 2 2 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 34.82 131.6 243.5 # Points 5 7 −− −− 5 7 # Labs 1 1 1 1 Method Group • CNP−triose/CNPG3 Mean 47.61 −− −− 313.1 SD 1 4.4 0.2.60 47.67 CV 0.6 −− 0.91 141.56 2 −− 3.5 # Points 2803 15823 2148 10648 2481 14996 # Labs 87 100 58 68 79 94 Abbott AEROSET/ARCHITECT (c.8 # Points 961 6790 513 3762 1034 7137 # Labs 32 41 18 21 34 44 Copyright © 2015 Bio−Rad Laboratories.00 3.82 33.76 2 −− 2.51 3 12.8 4.74 5.65 3 7.4 282. ci models) Mean 46.63 6.25 2 6.90 2 6.7 4.8 314.84 CV −− 3.12 48.8 1.79 5.5 0.2 SD 1 1.89 46.9 −− 346.1 −− 2. i.580 0.56 1.97 −− −− 314.0 −− 0.160 2 −− −− 3 1.4 SD 1 0.1 4.9 1.37 CV 2.8 3.40 113.190 0.3 −− −− 0.7 141.3 11.52 41.5 0.6 SD 1 2.8 5.24 2.61 −− −− 313.

61 145.58 44.60 −− −− −− −− SD 1 0.9 −− −− # Points 114 690 131 691 −− −− # Labs 3 4 4 4 ILab 650 Mean 42.46 6.7 326.1 2.7 321.110 1.4 145.2 4.4 148.61 CV −− −− 1.19 2 3.7 SD 1 1.7 2.5 # Points −− −− −− −− −− 38 # Labs 1 Siemens ADVIA Chemistry Systems Mean −− −− 125.2.69 3 3.8 SD 1 0.68 3 3.99 3.1 # Points 6622 66598 2345 24067 6656 65201 # Labs 184 256 58 90 181 248 Toshiba−TBA Mean −− −− −− 140.66 45.2 1.7 274.41 3.53 2.12 119.7 # Points −− 50 22 248 22 195 # Labs 1 1 2 1 1 ILab 600 Mean 43.4 2.45 6.66 129.3 3.02 42. Worldwide Report April 2016 Multiqual 1.1 −− 4.7 130.000 2 −− −− 3 −− −− CV −− 0.96 CV 2.2 −− −− SD 1 1.37 3 −− −− CV 3.04 43.7 124. Generated 22−May−2016 17:45:01 Page 44 .6 3.53 CV −− −− −− −− −− 4.3 1.6 −− −− −− −− # Points 5 50 −− −− −− −− # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean −− −− −− −− −− 278.9 1.39 −− 139.46 2.4 5.4 2.91 4.3 SD 1 −− 2.4 321.8 1.59 3 6.35 4.0 −− −− −− −− SD 1 −− 0.1 SD 1 −− −− 2 1.7 1.1 SD 1 −− −− 2 −− −− 3 −− 12.0 2.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase CNP−triose/CNPG3 U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Shanghai Kehua Bio−engineering (KHB) Mean −− 133.64 3 −− −− CV −− 5.883 0.93 1.6 271.8 −− −− # Points −− 170 −− 172 −− −− # Labs 4 4 Hitachi Chemistry Series Mean −− 47.1 # Points 4616 35630 1949 15370 4325 35079 # Labs 154 202 62 86 139 186 Siemens Dimension Vista Mean 44.11 1.20 3 −− −− CV −− −− −− 3.77 CV 2.9 327.0 −− −− −− −− # Points −− 1 −− −− −− −− # Labs 1 Beckman Coulter UniCel DxC Series Mean −− 48. Inc.3 259.53 2 −− −− 3 −− −− CV 0.20 2 5.48 2 −− 6.0 4.51 CV −− 6.6 2.81 148.3 # Points −− −− 44 302 44 308 # Labs 1 1 1 1 Siemens Dimension Series Mean 45.5 1.3 2.971 2 2.9 126.3 1.79 3 5.89 6.1 −− −− SD 1 −− −− 2 −− 5.93 2 1.2 1.5 1.7 −− −− SD 1 −− 2.7 −− −− # Points −− −− −− 25 −− −− # Labs 1 Copyright © 2015 Bio−Rad Laboratories.2 264.

55 2 −− −− 3 5.7 # Points −− −− −− 82 −− 130 # Labs 2 2 Copyright © 2015 Bio−Rad Laboratories.5 −− −− SD 1 −− −− 2 1.992 2 −− 3.0 −− −− # Points −− −− 29 79 −− −− # Labs 1 1 JEOL BioMajesty JCA−BM Series • Shinotest Mean −− −− −− −− 284.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase CNP−triose/CNPG3 U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Method Group • CNP−triose/CNPG3 Mean 44.80 3 −− −− CV −− −− 1.1 1.7 # Points 15121 126K 7152 55088 14562 123K # Labs 461 605 202 272 435 574 Amylase G7 PNP U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.0 SD 1 3.2 −− −− # Points −− −− 20 117 −− −− # Labs 1 1 Siemens ADVIA Chemistry Systems Mean 45.09 9.78 2.0 6.1 6.3 # Points 25 152 −− 33 25 151 # Labs 1 1 3 1 1 Roche Hitachi Systems (International) • BIODEVICE Srl Mean −− −− 125.93 3.26 CV 7.65 3 −− −− CV −− −− 0.11 −− 142.7 290.2 −− −− SD 1 −− −− 2 2.0 −− 2.2 289.9 −− 6.6 −− 284.75 CV 2. i.2 −− −− SD 1 −− 4.5 7.8 −− −− # Points −− 8 −− 15 −− −− # Labs 1 1 JEOL BioMajesty JCA−BM Series Mean −− −− 136.7 1.1 SD 1 −− −− 2 −− 3.1 # Points −− −− −− −− 25 120 # Labs 2 2 Mindray BS 200E/380/400/480/800/2000 Mean 47.69 44.2 281.33 4.1 2.10 47.3 3.2 287.63 CV −− −− −− 3.4 # Points −− −− 9 28 10 29 # Labs 1 1 1 1 Beckman Coulter UniCel DxC Series Mean −− 35.4 −− −− SD 1 −− −− 2 1.0 SD 1 0.17 1.05 CV −− −− 0.4 291.84 5.1 316. ci models) Mean −− −− 140.2 1. i.1 −− 2.3 143.89 5.2 SD 1 −− −− 2 0.57 2 −− 7.7 132.33 CV 2.05 −− −− 289.36 −− 112.91 2 10.11 2. Generated 22−May−2016 17:45:01 Page 45 .87 46.76 9. Inc.94 3 22.8 1.4 141.2 −− −− # Points −− −− 26 83 −− −− # Labs 1 1 Abbott AEROSET/ARCHITECT (c.970 1.38 3 2.1 292.1 4.68 142.56 21.0 3.9 SD 1 −− −− 2 −− −− 3 5.90 CV −− −− −− −− 2. ci models) • Alternate Formulation/Standardization Mean −− −− 131.54 3 −− −− CV −− −− 2.2.0 125.4 2.9 7.4 1.62 3 −− −− CV −− 12.3 SD 1 1.984 0.2 # Points 113 414 −− −− 117 421 # Labs 3 3 3 3 Toshiba TBA−40FR (Accute) Mean −− −− −− 127. Worldwide Report April 2016 Multiqual 1.1 6.86 3 −− 7.03 1.0 1.1 2.6 318.4 −− −− 2.4 137.59 3 3.

24 3 2.2 4.64 9.8 0.4 1.01 3 −− 8.00 2.3 274.9 133.7 272.4 2.6 # Points 59 486 59 487 59 485 # Labs 1 1 1 1 1 1 Method Group • G7 PNP.7 132.1 270.65 3 0.13 2.30 CV 3. Generated 22−May−2016 17:45:01 Page 46 .81 CV −− 3.5 125.03 2 6.29 44.9 271. LXi725 Chemistry Systems • LEADMAN Mean −− −− 146.8 3.07 1.8 −− −− # Points −− 85 −− 86 −− −− # Labs 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Zhong Sheng Mean −− −− 122.580 CV −− −− 1.8 6.6 −− 296.2. Blocked U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/8000/c 311 Mean 45.985 2 1.4 SD 1 1.2 265.2 2.00 4.0 2.0 # Points −− 3154 −− 1367 −− 2979 # Labs 22 15 18 Copyright © 2015 Bio−Rad Laboratories.0 # Points 138 574 75 294 167 692 # Labs 4 5 3 4 6 6 Amylase G7 PNP.20 3 5.28 2 −− 2.05 3 8. Blocked U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 47.91 11.38 6.1 6.65 CV 2.27 24.25 46.70 2 −− 8. Worldwide Report April 2016 Multiqual 1.48 2.65 133.0 127.8 0.0 302.75 126.8 127.8 SD 1 1.92 123.78 125.0 0.0 271.0 −− 1.18 134.2 0.35 4.5 −− 6.74 8.5 2.2 # Points −− −− 45 205 45 202 # Labs 2 2 2 2 Beckman Coulter LX20.16 5.7 SD 1 0.09 46.0 3.4 2.65 2.83 5.580 0.898 2 1.000 0.4 3.9 2.0 146.1 3.2 # Points −− −− 3 3 3 3 # Labs 1 1 1 1 Beckman Coulter UniCel DxC Series Mean −− 48.8 1.21 3 21.6 288.3 # Points 14 104 4 10 14 99 # Labs 2 4 1 3 2 3 Roche cobas INTEGRA Mean 44.25 44.4 270.5 274.7 1.27 −− 132.8 SD 1 −− 1.8 1.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase G7 PNP U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Method Group • G7 PNP Mean 46.4 3.60 −− 135.81 2.51 9.5 SD 1 0.9 5.03 3 6.8 1.29 CV 0.6 125.2 1.5 288.1 3.1 270.4 4.43 CV −− −− 5. Blocked Mean 44.0 # Points 73 590 63 497 73 584 # Labs 3 5 2 4 3 4 Amylase G7 PNP.00 CV 2.44 3 −− −− CV −− 9.3 302.00 44.32 2 6.3 SD 1 −− −− 2 2. Inc.0 −− 3.9 SD 1 1.6 8.4 SD 1 −− −− 2 6.4 4.6 −− −− SD 1 −− 4.40 CV 1.9 7.9 # Points 1232 6222 1226 5428 946 4207 # Labs 32 44 34 43 28 37 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • 2nd Generation Mean −− 47.3 279.683 0.30 3 3.99 2 4.4 4.

0 0.2 SD 1 0.9 4.19 CV 2.94 3 11.5 # Points 101 302 −− −− −− 307 # Labs 2 2 2 Copyright © 2015 Bio−Rad Laboratories.7 128.54 127.21 2 3.7 128.9 3.54 19.9 SD 1 1.47 3 2.1 2.11 9.4 −− −− 0.6 2.2 2.5 1.3 4.2.604 2 1. P.6 2.7 2.32 1.65 3 6.9 274.2 SD 1 0.9 7.2 2.5 288.47 CV 3.2 3.05 127.994 1.0 275.58 CV 1.97 4.08 2 2.6 3.6 # Points 2805 16239 1307 4580 2332 14953 # Labs 87 106 45 48 69 87 Roche cobas 6000/8000/c 311 • 2nd Generation Mean 44.5 146.2 287.94 8.13 CV 2.21 2 3.96 45.16 1.1 # Points 30 134 203 1218 162 976 # Labs 1 2 11 14 9 10 Roche MODULAR (ISE.0 7.82 39.50 133.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase G7 PNP.0 125.8 276.1 # Points 3441 20042 2816 15732 2097 13250 # Labs 90 118 76 103 64 90 Siemens ADVIA Chemistry Systems • DiaSys Diagnostic Systems Mean 39.92 121.9 # Points 74 377 68 361 75 376 # Labs 3 4 3 4 3 4 Roche cobas INTEGRA Mean 45.44 1.49 131.8 SD 1 1.9 SD 1 1.73 −− −− −− 256.60 43.1 −− −− # Points −− −− 6 6 −− −− # Labs 1 1 ILab 650 Mean 39.2 288.7 128.74 2 8.97 10.1 1.31 45.548 2 −− −− 3 2. D.9 2.1 2. Generated 22−May−2016 17:45:01 Page 47 .3 1.3 −− −− −− 2.5 SD 1 1.535 0.6 # Points 143 1075 23 195 118 879 # Labs 4 5 3 3 3 3 Siemens ADVIA Chemistry Systems Mean 45.548 0.7 2.2 130.82 3.07 126.68 45.0 1.4 2.3 3.5 −− −− SD 1 −− −− 2 1.2 2.1 275.06 2.1 1.6 272.63 2.1 1.4 # Points 284 1998 172 1113 185 1320 # Labs 14 19 9 11 8 9 Roche Hitachi Systems (International) Mean 43.6 259. Inc.9 # Points 190 944 190 936 42 318 # Labs 9 10 9 10 2 2 Siemens ADVIA 1200 Mean 43.2 269.07 3 20.60 39.89 1.91 7.28 2.57 3 −− −− CV −− −− 1.4 1.08 45. E170) Mean 45.1 9.54 45.00 1.6 SD 1 1.13 127.7 255.60 −− −− 287.26 1.5 2.61 CV 2.64 2 4.9 2.3 6.0 275.8 SD 1 0.06 CV 1.7 # Points 5 5 −− −− 4 4 # Labs 1 1 1 1 Roche cobas 6000/8000/c 311 Mean 45.7 258.45 3 25.2 275.32 3 6.6 3.6 2.9 1.91 3 6.826 2 1.3 7. Worldwide Report April 2016 Multiqual 1.8 133.30 2 −− −− 3 −− 6.910 0.7 3.57 1.9 127.12 CV 3.6 SD 1 0.78 2.43 1.72 CV 2.34 CV 2.3 271.7 0. Blocked U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Horiba ABX Pentra 400 Mean −− −− 146.2 1.12 43.5 2.99 6.20 6.

0 1.72 131.8 SD 1 0.62 46.40 4.85 8..3 SD 1 −− −− 2 2.1 281.0 280.4 SD 1 1.26 2 3.1 2. Calibrated Mean −− −− −− −− −− −− SD 1 −− −− 2 −− −− 3 −− −− CV −− −− −− −− −− −− # Points −− −− −− −− −− −− # Labs Amylase G7 PNP.2 163.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase G7 PNP.17 40.1 1.7 4.4 2.92 152.8 1.6 257.3 284. Blocked Mean 45.1 # Points 18 73 −− −− 19 72 # Labs 1 1 1 1 Abbott AEROSET/ARCHITECT (c.45 49.45 2.7 −− 340.17 40.25 −− −− 260.1 # Points −− 31 −− −− −− 31 # Labs 1 1 Method Group • G7 PNP.3 SD 1 −− 0.1 SD 1 1.70 13..6 6.9 2.95 3 13.2.4 −− −− 1. Calibrated U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter UniCel DxC Series • Factored.6 2.7 132. Blocked U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Siemens ADVIA Chemistry Systems • LEADMAN Mean −− −− 163.60 −− −− 260.3 330.0 −− −− 1.48 2.15 CV −− −− 1.0 1.10 3 6.4 SD 1 −− −− 2 2.48 3 −− 4.44 CV 3. i.9 SD 1 0.96 2. Generated 22−May−2016 17:45:01 Page 48 .26 1.04 7.8 1.82 3 5.3 309.3 4.0 1. Blocked − IFCC Ref.0 −− −− −− 2. Calibrated U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.0 309. Proc..58 45.75 CV 2.56 4.17 4. Inc. IFCC Correlated Mean −− 47.990 0.5 133.05 CV 2.6 286. IFCC Correlated Mean 50. Blocked − IFCC Ref.68 −− −− −− 289.15 4.91 2.80 CV −− −− 2.4 2.9 258.0 2.81 2 5.3 # Points −− −− 4 4 6 6 # Labs 1 1 1 1 Toshiba TBA−120FR Mean −− −− 142. ci models) • Factored.96 3 4.7 2.9 4. Blocked − IFCC Ref.8 # Points 218 768 212 755 211 770 # Labs 6 6 6 6 6 6 Copyright © 2015 Bio−Rad Laboratories. Worldwide Report April 2016 Multiqual 1.21 CV −− 2.945 2 −− −− 3 −− 6.53 1.25 CV 2.7 # Points 30 151 −− −− 28 148 # Labs 1 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 46.8 144. ci models) • Roche Mean 41. Proc.2 330.6 1.3 1.8 SD 1 1. ci models) Mean 41.8 # Points 8305 50372 6094 31489 6047 39860 # Labs 243 333 196 258 192 267 Amylase G7 PNP.7 2.5 # Points −− −− 31 255 32 296 # Labs 1 1 1 1 Method Group • G7 PNP.9 3.0 3. i.980 1. Proc.91 132.81 CV 1.970 2 −− −− 3 2.03 2 2.9 151. i.43 2 −− −− 3 2.4 # Points 66 362 69 364 −− 299 # Labs 2 3 2 3 1 Abbott AEROSET/ARCHITECT (c.09 2.6 3.6 −− 1.

35 CV 5.2 SD 1 −− −− 2 −− 6.7 SD 1 0.24 11.6 # Points 17 90 16 73 18 86 # Labs 1 1 1 1 1 1 Beckman Coulter LX20.574 0.56 7. Worldwide Report April 2016 Multiqual 1.0 SD 1 1.32 130.5 3.000 CV 2.9 2. Proc.41 2. Blocked.8 SD 1 −− 1.6 291.88 46.15 3 −− 8.1 −− −− SD 1 −− 1.58 3 9.9 −− 2.6 −− 1. Calibrated U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU International Calibrator OE 66300 Mean 46.14 2 −− 1.3 SD 1 1.02 47.04 45.54 3 0. Calibrated Mean 45.95 2 7.66 4.547 2 1.0 # Points 787 2669 322 1525 604 1788 # Labs 26 33 13 20 19 21 Mindray BS 200E/380/400/480/800/2000 Mean 45.22 47.76 CV −− −− −− 8.0 1..2 125.7 2.36 1. Inc.64 1.0 1.34 19.17 2 2.3 1.95 4.5 6.1 0. Factored U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.1 271.8 0.5 2.5 2.1 5.19 8.03 130.7 130.7 133.43 3 2.4 3.4 4. ci models) • Factored.7 7.2 2. i.2. Blocked − IFCC Ref.55 CV 3.1 4.4 131.11 −− 157.85 2 4.16 1.2 276.0 1.79 134.19 2.9 1.000 0.9 2.7 SD 1 2.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase G7 PNP.7 136.9 0.38 2 2.63 125. Blocked.4 291.27 CV 4.4 −− 4.0 # Points 398 1525 324 1231 366 1390 # Labs 13 14 10 12 12 13 Amylase G7 PNP.2 282.8 # Points 88 289 71 231 88 288 # Labs 2 2 2 2 2 2 VITROS Microslide Series • Slide generation #01 Mean −− −− −− 79. IFCC Correlated Mean 47.40 −− 130. LXi725 Chemistry Systems • Factored.3 3. IFCC Correlated Mean −− 52. Generated 22−May−2016 17:45:01 Page 49 .1 1.66 131.0 295.4 # Points −− 145 −− 142 −− 140 # Labs 1 1 1 Method Group • G7 PNP.2 136.2 270.0 1.64 2.8 292. Proc.1 −− −− # Points −− 20 −− 20 −− −− # Labs 1 1 Siemens ADVIA Chemistry Systems Mean 42.0 # Points 27 134 25 129 2 2 # Labs 2 2 1 1 1 1 Siemens ADVIA 1200 Mean −− 44.2 6.0 SD 1 2.0 0.8 284.14 3.55 CV −− 2. Blocked − IFCC Ref. IFCC Correlated Mean 48.53 2 −− 4.5 # Points 27 84 19 132 46 198 # Labs 1 1 1 1 2 2 Beckman Coulter UniCel DxC Series • Factored.56 CV 3..66 3 −− 7.1 292.6 3.70 1.3 6.57 2.53 3 10. Factored Mean −− −− −− −− −− −− SD 1 −− −− 2 −− −− 3 −− −− CV −− −− −− −− −− −− # Points −− −− −− −− −− −− # Labs Copyright © 2015 Bio−Rad Laboratories.8 −− 349.8 SD 1 1.13 CV 1.59 3 5.6 # Points −− −− −− 23 −− 24 # Labs 1 1 Method Group • G7 PNP.3 1.73 137.5 278.3 5.70 42.05 7.15 −− 167.30 2 1.6 −− 2.0 291.41 46.08 3 3.45 3 −− −− CV −− 2.

1 2.74 3 3.1 1.5 SD 1 3.45 13.9 4.6 101.04 24.6 # Points 4 16 −− −− 4 16 # Labs 1 1 1 1 Method Group • CNP−maltoheptaoside Mean 25.2 3.15 3 −− 5.5 2.832 2 −− −− 3 −− 3.6 235.4 −− −− # Points 15 56 15 40 −− −− # Labs 1 1 1 1 Roche Reflotron Mean 34.4 −− 1.27 −− −− 260. Inc.07 −− 141.8 2.852 2.65 5.5 −− 1.5 5.2 245.31 101.3 # Points 24 131 14 42 12 82 # Labs 1 1 1 1 1 1 Mindray BS 200E/380/400/480/800/2000 Mean 24.1 −− 302.0 −− −− 2.8 1.5 1.5 −− 2.1 # Points −− 55 −− −− −− 60 # Labs 1 1 Method Group • Maltotetraose Mean −− 48.1 SD 1 1.34 −− −− SD 1 0.22 86.6 SD 1 −− 2.29 2.550 0.7 240. Generated 22−May−2016 17:45:01 Page 50 .93 103.7 # Points −− 242 −− 196 −− 252 # Labs 2 1 2 Amylase.2.591 2 1.1 # Points 43 203 29 82 16 98 # Labs 3 3 2 2 2 2 Amylase.48 3 −− −− CV 2.48 2.54 CV −− 1.2 2.54 CV 12.75 CV 3.857 0.7 2. Pancreatic CNP−maltoheptaoside U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.99 102.735 2 2.15 3 −− 8.4 100.92 34.22 22.17 99.47 CV 2.722 2 0.6 101.6 # Points 32 33 33 34 30 31 # Labs 1 1 1 1 1 1 Beckman Coulter UniCel DxC Series Mean 22.7 SD 1 −− 0.7 # Points −− 187 −− 196 −− 192 # Labs 1 1 1 Siemens Dimension Vista Mean −− 44.05 2.9 −− −− SD 1 0.5 −− −− # Points 68 92 60 83 −− −− # Labs 2 2 2 2 Copyright © 2015 Bio−Rad Laboratories.8 SD 1 −− 1.83 CV 2. i.03 2 −− 2. ci models) Mean 24.67 23.34 3 10.68 1.1 −− 306.5 2.10 24.6 1.14 2 −− 2.3 4.1 −− 1.8 245.4 241.0 2.951 2 1.600 0.1 3.12 1.8 SD 1 0.25 CV −− 4.25 86.75 3.27 24.07 3 3.488 0.06 CV −− 2. Worldwide Report April 2016 Multiqual 1.58 −− −− −− 318.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase Maltotetraose U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter UniCel DxC Series Mean −− 49.3 2.3 1.7 1.3 3.9 −− −− −− 1.09 −− 141.6 11.2 240.19 2.26 235.13 3 −− −− CV 3.11 7.0 0.7 SD 1 0. Pancreatic G7 PNP immunoinhibition U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • DiaSys Diagnostic Systems Mean 24.0 3.83 2 2.03 2 −− −− 3 6.10 99.

0 0.868 3 −− −− CV −− 1. Generated 22−May−2016 17:45:01 Page 51 .9 2.25 3 9.90 2 2.4 −− 8.13 99. D.3 SD 1 1.9 # Points 306 1873 165 882 283 1657 # Labs 13 16 10 13 9 12 Roche cobas INTEGRA Mean −− 25.9 −− −− SD 1 −− 0.2 1.560 2 1.9 −− −− SD 1 0.80 3 −− −− CV −− 15.88 102.606 0.79 1.8 −− −− # Points −− 57 −− 57 −− −− # Labs 1 1 Roche MODULAR (ISE.0 −− −− −− −− # Points 5 5 −− −− −− −− # Labs 1 1 Siemens Dimension Vista Mean −− 26.87 3 5.90 2 5. ci models) Mean 25. E170) Mean 25.1 # Points −− 111 −− −− −− 92 # Labs 1 1 Copyright © 2015 Bio−Rad Laboratories.07 3 7. Worldwide Report April 2016 Multiqual 1.9 2. Pancreatic G7 PNP.392 2 −− 0.2.3 241.0 102.40 102.7 5.23 1.2 246.7 240.02 9. Blocked U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.745 1.0 4.3 1.000 0.62 2 −− −− 3 −− 10.61 4.46 99.57 CV 2.1 3.58 11.26 7.00 24.5 2.0 7.0 1.25 3 −− −− CV 0.2 −− −− # Points −− 113 −− 102 −− −− # Labs 1 1 Method Group • G7 PNP immunoinhibition Mean 24.4 SD 1 −− −− 2 −− −− 3 4.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase. Pancreatic G7 PNP immunoinhibition U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum ILab 600 Mean 25.72 −− 102.5 SD 1 0.52 3 −− −− CV 7.4 SD 1 −− 3.8 # Points 195 938 172 1207 110 525 # Labs 5 8 5 8 3 5 Siemens Dimension Series • Sentinel Mean −− 32.39 −− 107.5 −− 0.5 5.000 0.1 4.75 CV −− −− −− −− 1.14 24.8 1.91 1.0 0.9 −− −− SD 1 −− 4.1 7.00 25.2 7.75 101.01 25.78 CV 2.000 2 −− −− 3 −− −− CV 0.7 2.8 247.6 99.000 1.15 CV −− 13.8 3.9 SD 1 0.9 # Points 644 3284 474 2535 449 2334 # Labs 25 35 22 32 15 20 Amylase.38 CV 5.4 105.2 −− −− # Points 1 8 1 8 −− −− # Labs 1 1 1 1 JEOL BioMajesty JCA−BM Series • Shinotest Mean −− −− −− −− 261.05 −− −− −− 246.98 2 −− 8.9 3.32 4.80 25.4 237.00 −− −− −− −− SD 1 0.71 5.991 2 0.51 100.6 262.98 −− −− SD 1 1.4 2. Inc.76 103.9 3.7 236.9 1.00 2 2.5 −− −− # Points 42 170 43 162 −− −− # Labs 3 5 3 5 Siemens ADVIA Chemistry Systems Mean 25.8 # Points −− −− −− −− 26 121 # Labs 2 2 Roche cobas 6000/8000/c 311 Mean 25. i. P.9 −− −− −− 4.41 25.57 3.

4 5.4 # Points 728 2557 370 1599 346 827 # Labs 21 21 12 12 9 9 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 23.99 3 3.4 7.6 2.5 SD 1 0.6 105.27 CV 2.64 24.93 3 −− −− CV 3.958 0.2 5.7 −− −− # Points 4 125 4 126 −− −− # Labs 2 2 2 2 Copyright © 2015 Bio−Rad Laboratories.70 3 4. Blocked U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c. Generated 22−May−2016 17:45:01 Page 52 .04 CV 3.6 # Points 65 204 375 1943 353 1814 # Labs 3 3 6 6 5 5 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Roche Mean −− −− 101.0 SD 1 1.6 239.23 9.45 101.43 10. E170) Mean 25.628 2 1. i.90 CV 5.00 26.5 100.654 2 2. Blocked Mean 25.06 3. P.77 CV −− −− 5.11 103.0 3.8 1.3 244.000 0.08 92.41 6. Pancreatic G7 PNP.0 13. Worldwide Report April 2016 Multiqual 1.00 −− −− −− 246.5 # Points 329 560 277 574 223 573 # Labs 6 6 6 6 6 6 Roche cobas INTEGRA Mean 26.0 2. ci models) Mean 24. Inc.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase.5 2.000 3.4 240.6 4.37 4.63 86.61 CV 2.57 3 6.2 4.82 24.00 26.8 5. Blocked U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Method Group • G7 PNP.2 SD 1 −− −− 2 5.572 0.57 2 2.0 2.26 96.50 80.4 SD 1 0.21 2.13 1.9 6.9 3.4 −− −− SD 1 0.3 241. Pancreatic G7 PNP.775 2 2.0 100.01 23.36 4.34 97.15 CV 0.16 1.4 247.3 −− 1.0 −− −− # Points 22 100 17 101 −− −− # Labs 1 1 1 1 Roche cobas 6000/8000/c 311 Mean 24.26 103.8 2.0 2.17 3.62 3 −− 2.2 SD 1 0.7 4.51 3 −− −− CV 0.51 3.917 3.6 1.8 2.5 235.9 −− −− # Points −− −− 22 107 −− −− # Labs 1 1 Roche MODULAR (ISE.6 −− −− −− 4.97 100.850 1.75 25.2 0.84 1.577 2 0.65 −− 214.54 2 −− −− 3 −− 10.4 # Points 25 201 24 212 −− 34 # Labs 2 3 2 3 1 Mindray BS 200E/380/400/480/800/2000 Mean 21.7 3.2 2.5 4.644 2 1.87 3 13.6 101.0 1.88 22.1 235.7 1.61 2 3.1 # Points 5 116 −− −− −− 92 # Labs 1 2 1 Amylase.7 −− −− SD 1 0.74 3 −− −− CV 3.46 6.0 102.81 104.729 0.2.3 104.1 2.73 3 −− −− CV −− −− 3.451 0.3 SD 1 0.3 −− −− # Points 8 62 8 63 −− −− # Labs 2 2 2 2 Roche Hitachi Systems (International) • DiaSys Diagnostic Systems Mean −− −− 93.09 −− −− SD 1 0. D.8 2.4 3.64 −− −− SD 1 −− −− 2 3.1 1.5 1.1 # Points −− −− 44 212 44 211 # Labs 2 2 2 2 Beckman Coulter UniCel DxC Series Mean 20.0 236.63 23.3 2.

62 26.2 SD 1 1.4 SD 1 0.2 # Points 149 765 148 783 59 192 # Labs 5 7 5 7 2 2 Apolipoprotein A Immunonephelometric.3 # Points −− −− 10 29 11 30 # Labs 1 1 1 1 Method Group • Immunonephelometric.82 102.988 2.0 115. i.1 # Points −− 192 −− −− −− 192 # Labs 1 1 Method Group • G7 PNP.00 3. Inc.0 2.6 4.50 CV 0.74 4.00 3.2 0.70 3 2.4 1.54 3 2.8 −− −− # Points 91 577 90 595 −− −− # Labs 3 5 3 5 Method Group • G7 PNP. Blocked.3 245.4 SD 1 0.4 106.7 3.46 4.9 2.0 2.64 CV −− 2.14 5.943 0.9 2.64 3 5.7 2. Factored Mean 24.745 0.6 6. Pancreatic G7 PNP. ci models) Mean 24.5 102.49 3.7 2.1 −− −− −− 2.0 101.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Amylase.57 CV 2.43 CV −− −− 2.00 23.759 2 1.0 148.01 25.30 107.36 −− −− −− 319.91 101.72 2 6.15 80.1 3.2 # Points 1575 6075 1399 6583 1289 4780 # Labs 48 51 43 47 31 33 Amylase.70 CV 5.54 101.25 3 2.66 115.9 1.4 255.581 2 0.7 SD 1 −− −− 2 3. Generated 22−May−2016 17:45:01 Page 53 . end point Mean −− −− 113.5 SD 1 2.6 239.1 150.4 4.5 2.9 2.3 # Points −− −− 10 29 11 30 # Labs 1 1 1 1 Apolipoprotein A Immunoturbidimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 85. Worldwide Report April 2016 Multiqual 1.2. Blocked.910 2 −− −− 3 −− 6.0 254.34 3.00 3. Pancreatic G7 PNP. i.0 148.0 2.7 3.6 0.80 3 9.8 239. Factored U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.88 2.3 247.0 8.50 CV 3.1 150.4 13.8 2.3 245. Blocked U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Siemens ADVIA Chemistry Systems Mean 26.7 101.732 0.99 6.43 CV −− −− 2. ci models) • Zhong Sheng Mean −− −− 113.8 4.2 142.2 −− −− SD 1 0.98 23.87 3 −− −− CV 3.7 2.8 2.7 3.7 3.7 7.39 CV 2.762 2 2.2 # Points 41 218 44 283 40 221 # Labs 2 2 3 3 2 2 Copyright © 2015 Bio−Rad Laboratories.0 SD 1 0.7 244.1 148.4 113.7 SD 1 −− −− 2 3. end point mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.4 1.0 115. Blocked Mean 25.5 3.51 3 4.03 24.2 1.00 3.6 3.90 9.692 2 1.2 # Points 58 188 58 188 59 192 # Labs 2 2 2 2 2 2 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 23.56 2 4.9 2.66 3.04 17.3 SD 1 −− 0.14 5.2 103.4 2.5 # Points 394 2074 258 1646 323 1129 # Labs 11 12 9 12 9 9 Siemens Dimension Vista Mean −− 44.07 3.187 0.70 102.51 3 4.

24 CV −− 1.5 SD 1 4.3 3.81 2.83 2 6.77 131.0 155.0 −− −− −− −− # Points −− 1 −− −− −− −− # Labs 1 Copyright © 2015 Bio−Rad Laboratories.0 142.24 CV −− 1.4 3.97 CV 3.89 99.92 117.6 149.27 −− −− 137.4 28.2 SD 1 2.75 2 4.3 155.2.4 # Points −− 18 −− 37 −− 38 # Labs 1 1 1 Apolipoprotein A−I Immunonephelometric.9 # Points 22 169 −− −− 24 166 # Labs 1 1 1 1 Method Group • Immunoturbidimetric Mean 82.92 115.34 97.3 3.26 5.26 5.0 # Points 63 387 44 283 64 387 # Labs 3 3 3 3 3 3 Apolipoprotein A−I Immunonephelometric.3 SD 1 14.4 3.0 124.0 4.1 SD 1 −− 1.1 7.5 22. end point Mean −− 90.6 20. kinetic mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Vista Mean 81.4 4.3 3.35 22.4 3.00 83.92 3 −− 11.4 113. Worldwide Report April 2016 Multiqual 1.5 3.70 2 3.0 155.4 3.90 9.5 −− 152.5 # Points 56 199 43 298 67 390 # Labs 2 2 3 3 4 4 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 75.92 3 −− 11.00 −− 120.0 4.81 2.70 2 −− 3.59 9.4 SD 1 2.7 117.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Apolipoprotein A Immunoturbidimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/8000/c 311 Mean 77.5 21.72 CV 5.21 CV 19.1 4. end point mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Mindray BS 200E/380/400/480/800/2000 Mean −− 90.000 2 −− −− 3 −− −− CV −− 0.95 3.67 20.47 CV 3.97 2 −− −− 3 2.31 5.97 5. fixed time. i.70 2 3.55 3.59 81.84 3 5.42 5.74 81.1 SD 1 −− 1.4 3. fixed time.0 −− −− −− −− SD 1 −− 0.1 4.6 17.4 # Points −− 18 −− 37 −− 38 # Labs 1 1 1 Method Group • Immunonephelometric.3 155.0 8. Inc.70 2 −− 3.84 3 5.87 109.51 80. kinetic Mean 81.47 CV 3.1 6.62 71.0 6.9 5.93 6.5 # Points 210 1550 124 1113 319 1400 # Labs 6 7 2 3 6 7 Apolipoprotein A−I Immunoturbidimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.74 81.69 3 6.1 # Points 153 473 143 803 224 821 # Labs 4 8 5 10 6 9 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Shanghai Chang Zheng Mean −− 117.92 117. ci models) Mean 86.4 113.5 # Points 210 1550 124 1113 319 1400 # Labs 6 7 2 3 6 7 Method Group • Immunonephelometric.13 3 22.2 SD 1 2.5 6.95 3.1 144.5 −− 152.3 −− 7.4 3.74 CV 3.00 −− 120.9 −− 3.2 SD 1 2.3 −− −− 2.9 −− 3.24 4.7 117.96 26. Generated 22−May−2016 17:45:01 Page 54 .2 142.3 3.4 147.59 2 20.3 −− 7.54 3 5.

1 3.67 2 5.4 # Points −− −− 22 169 22 167 # Labs 1 1 1 1 Hitachi Chemistry Series • MAKER Mean −− −− −− 102.00 3 5.8 −− −− SD 1 −− −− 2 2.77 CV −− −− −− 1.9 SD 1 −− −− 2 −− 8. Inc.1 −− 148.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Apolipoprotein A−I Immunoturbidimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter LX20.6 −− 1.0 128.7 133.3 # Points −− −− −− 37 −− 46 # Labs 1 1 JEOL BioMajesty JCA−BM Series Mean −− −− 104. LXi725 Chemistry Systems Mean −− −− 95.28 CV −− −− −− −− 3.40 CV 4.9 2.0 106.9 8.70 76.5 −− 155.1 # Points 86 321 141 809 88 599 # Labs 3 5 5 11 3 8 Hitachi Chemistry Series Mean −− −− 104.00 30.75 CV −− −− −− 6.00 10.0 193.24 11. Worldwide Report April 2016 Multiqual 1.9 3.0 193.8 −− 1.37 3 4.98 121.00 15. LXi725 Chemistry Systems • LEADMAN Mean −− −− 128.7 −− 131.5 SD 1 −− −− 2 11.8 21.6 # Points −− −− 19 128 19 125 # Labs 1 1 1 1 Beckman Coulter LX20.4 8.6 2.6 SD 1 −− −− 2 2.0 SD 1 −− −− 2 5.30 105.6 # Points −− −− 3 3 3 3 # Labs 1 1 1 1 Beckman Coulter UniCel DxC Series Mean 73.5 −− −− SD 1 −− −− 2 3.24 6.0 SD 1 −− −− 2 −− −− 3 4.25 3 −− 1.8 12.9 2.00 92.14 3 −− −− CV −− −− 1.9 5.5 SD 1 −− −− 2 −− 2.7 5.9 2.00 6.00 2.00 CV −− −− 3.2.48 CV −− −− 1.0 −− −− # Points −− −− 19 58 −− −− # Labs 1 1 JEOL BioMajesty JCA−BM Series • MAKER Mean −− −− −− 121.7 139.76 12.10 CV −− −− 11.9 SD 1 −− −− 2 −− 1.60 3 26.92 CV −− −− −− 1.62 3 −− 1.00 5.4 140.0 105.2 # Points −− −− −− 44 −− 35 # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean −− −− −− 119.9 7.00 5.5 # Points −− −− −− 108 −− 69 # Labs 4 3 Roche cobas 6000/8000/c 311 Mean −− −− −− −− 132.5 SD 1 3.6 16.0 141.0 108.82 3 5.9 −− 4. Generated 22−May−2016 17:45:01 Page 55 .0 117.6 −− −− # Points −− −− 11 216 −− −− # Labs 1 2 Copyright © 2015 Bio−Rad Laboratories.0 3.9 # Points −− −− −− −− 31 156 # Labs 1 1 Roche Hitachi Systems (International) Mean −− −− 105.9 3.0 136.63 99.79 3 −− −− CV −− −− 2.5 25.20 3 −− 6.00 3.00 5.

7 104.9 1.5 1.00 3.5 7.2 # Points 41 141 61 292 20 155 # Labs 1 1 2 2 1 1 Siemens ADVIA Chemistry Systems • LEADMAN Mean −− −− 109.6 SD 1 −− −− 2 4.05 59.8 135.00 6. Inc.00 70.0 109. i.44 76.19 20.0 SD 1 −− −− 2 1.1 20.67 48.37 3 −− 7.00 59.21 CV −− −− −− −− 4.3 SD 1 −− −− 2 −− 4.1 # Points −− −− −− −− 24 64 # Labs 1 1 Toshiba TBA−40FR (Accute) Mean −− −− −− 116.08 3 17.9 0.1 1.2 # Points −− 18 −− 34 −− 35 # Labs 1 1 1 Method Group • Immunonephelometric.46 105.89 CV −− −− −− 3.43 2 5. ci models) • Zhong Sheng Mean −− −− 48.00 1.2 # Points −− −− −− 120 −− 172 # Labs 2 2 Toshiba−TBA Mean −− −− −− 114.49 3 5.56 CV −− −− 2.08 3 1.9 # Points −− −− 94 235 93 232 # Labs 3 4 3 4 Siemens ADVIA Chemistry Systems Mean 80.2.00 1.6 101.2 # Points −− −− 10 29 11 30 # Labs 1 1 1 1 Mindray BS 200E/380/400/480/800/2000 Mean −− 47.70 3. end point mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.96 14.0 136.3 5.8 # Points 336 1134 560 3096 597 2799 # Labs 10 16 24 39 23 34 Apolipoprotein B Immunonephelometric.8 SD 1 1. Generated 22−May−2016 17:45:01 Page 56 .3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Apolipoprotein A−I Immunoturbidimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Roche Hitachi Systems (International) • Zhong Sheng Mean −− −− 101.9 108.4 # Points −− 18 10 63 11 65 # Labs 1 1 2 1 2 Copyright © 2015 Bio−Rad Laboratories.00 12.00 46.1 4.95 SD 1 −− 3.8 8.98 10.40 101.8 131.00 1.1 −− −− SD 1 −− −− 2 −− 3.59 −− 79.9 0.000 10.7 14.0 151.8 2.9 131.02 CV 2.45 CV −− −− 4.3 −− 150.41 5.00 60.00 3 1.87 8.1 4.0 150.7 14.000 2.90 SD 1 −− −− 2 1.0 4.3 4.7 # Points −− −− 4 4 6 6 # Labs 1 1 1 1 Siemens Dimension Series Mean −− −− −− −− 149.0 SD 1 −− −− 2 −− −− 3 6.1 136.61 2 11.8 −− 6.37 80.8 −− 5.7 0.57 SD 1 −− 3.73 2 1.67 −− 69.32 3 2.7 4.5 12.2 134.8 −− 6.90 CV −− 7.43 3 −− −− CV −− −− −− 3.1 11.03 CV 14.0 −− −− # Points −− −− −− 26 −− −− # Labs 1 Method Group • Immunoturbidimetric Mean 77.2 SD 1 10.2 19.0 151. end point Mean −− 47.92 3 1.73 3 −− 4.00 CV −− −− 0.73 2 −− 4.92 15.1 4. Worldwide Report April 2016 Multiqual 1.69 59.5 2.8 14.19 CV −− 7.

96 SD 1 3.00 3. ci models) Mean 37.1 5.65 3 1.48 CV −− −− 1.25 71.67 2 2.86 61.1 3.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Apolipoprotein B Immunonephelometric.38 1.68 74.22 2.06 73.00 12.32 2.36 69.85 SD 1 −− −− 2 1.1 3.58 2 2.9 15.00 2.2 8.86 61.85 77.00 110.1 2.47 2.45 3 2.83 42.15 −− 90.28 SD 1 −− −− 2 7.45 CV 9. fixed time.60 60.2 3.81 SD 1 −− 0.8 # Points 86 340 139 744 86 536 # Labs 3 5 5 11 3 8 Hitachi Chemistry Series Mean −− −− 56.2 3.68 74.4 6. LXi725 Chemistry Systems Mean −− −− 59.47 2.4 # Points −− 1 −− 116 −− 116 # Labs 1 1 1 Beckman Coulter LX20.834 3 −− 1.32 2.00 −− 66.2 11. fixed time.20 SD 1 1.7 1.000 3.2.66 CV −− −− 11.8 4.0 4.02 SD 1 1.39 SD 1 −− −− 2 −− 0.68 CV 5.38 1.1 6. kinetic mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Vista Mean 42.00 69.03 62.00 59.000 2 −− 3.0 3. kinetic Mean 42.9 6. Worldwide Report April 2016 Multiqual 1.68 61.7 # Points −− −− 3 3 3 3 # Labs 1 1 1 1 Beckman Coulter UniCel DxC Series Mean 44.89 2 4.47 4.28 4.00 64.89 CV 4.3 16.0 # Points −− −− 19 151 19 151 # Labs 1 1 1 1 Beckman Coulter LX20. LXi725 Chemistry Systems • LEADMAN Mean −− −− 59.20 SD 1 1.83 42.24 3 2.7 4.85 3.0 3.1 13.99 71.0 4. i.4 5.00 56.68 61.17 3 6. Inc.89 CV 3.7 4.7 2.98 75.7 7.94 3 9.5 # Points 58 294 41 288 69 479 # Labs 2 2 3 3 4 4 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 42.00 CV −− −− 5.6 19.64 60.85 −− 71.89 CV 3.0 110.5 # Points −− −− −− 40 −− 49 # Labs 1 1 Copyright © 2015 Bio−Rad Laboratories.8 # Points 236 1836 161 1426 346 1694 # Labs 7 8 3 4 7 8 Method Group • Immunonephelometric.4 −− 2.45 3 2.5 11.00 79.79 CV −− −− −− 1.0 −− 4.52 2 6.39 SD 1 2.01 71.1 3.7 11.58 2 2.87 5.0 SD 1 −− −− 2 3.9 13.9 −− 4.0 # Points −− −− 22 195 22 193 # Labs 1 1 1 1 Hitachi Chemistry Series • MAKER Mean −− −− −− 58.69 8.69 14.04 7.97 59.9 11. Generated 22−May−2016 17:45:01 Page 57 .00 3 3.3 13.66 8.97 36.29 44.00 9.22 75.98 72.98 75.8 # Points 236 1836 161 1426 346 1694 # Labs 7 8 3 4 7 8 Apolipoprotein B Immunoturbidimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.98 CV −− 0.4 # Points 122 387 110 773 181 725 # Labs 5 8 7 11 7 9 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Shanghai Chang Zheng Mean −− 70.50 45.93 64.71 3 8.48 58.8 8.2 3.00 3.26 3 −− 3.

1 −− 14.88 3 2.01 3.11 CV −− −− −− 5.53 4.3 3.2 # Points 28 167 −− −− 62 329 # Labs 1 1 2 2 Roche Hitachi Systems (International) Mean −− −− 51. Inc.60 SD 1 2.15 2.95 −− −− 69.7 6.00 66.3 −− −− # Points −− −− 11 206 −− −− # Labs 1 2 Roche Hitachi Systems (International) • Zhong Sheng Mean −− −− 48.55 −− 69.00 94.18 3 −− −− CV −− −− −− 6.91 58.15 2 −− −− 3 4.00 CV −− −− 2.9 −− −− 6.2 # Points 43 143 64 275 21 136 # Labs 1 1 2 2 1 1 Siemens ADVIA Chemistry Systems • LEADMAN Mean −− −− 44.56 4.20 CV 4.00 66.5 # Points −− −− −− 120 −− 170 # Labs 2 2 Toshiba−TBA Mean −− −− −− 84.6 6.00 5.7 # Points −− −− −− 112 −− 69 # Labs 4 3 Roche cobas 6000/8000/c 311 Mean 45.58 3 −− −− CV −− −− 2.53 98.4 −− 2.56 67.58 4.00 2.7 −− 4.00 6.00 58.1 7.0 6.88 49.00 1.8 4.0 3.37 12.25 43.89 64. Generated 22−May−2016 17:45:01 Page 58 .31 −− −− SD 1 −− −− 2 5.0 11.2 −− −− # Points −− −− 29 78 −− −− # Labs 1 1 JEOL BioMajesty JCA−BM Series • MAKER Mean −− −− −− 64.20 −− −− SD 1 −− −− 2 −− 5.03 CV −− −− 4.62 3 −− 23.00 SD 1 −− −− 2 1.10 58.41 −− 81.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Apolipoprotein B Immunoturbidimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum JEOL BioMajesty JCA−BM Series Mean −− −− 61.0 SD 1 −− −− 2 −− 31.3 2.89 SD 1 −− −− 2 −− 0.70 37.9 24.57 CV −− −− −− 29.8 # Points −− −− −− 44 −− 35 # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean −− −− −− 108.77 3 −− 3.8 2.49 2 14.2 10.6 −− 160.3 11.000 6.2 −− −− # Points −− −− −− 25 −− −− # Labs 1 Copyright © 2015 Bio−Rad Laboratories.0 # Points −− −− 4 4 6 6 # Labs 1 1 1 1 Toshiba TBA−40FR (Accute) Mean −− −− −− 48.56 3 −− −− CV −− −− 8.2.30 CV −− −− −− 1. Worldwide Report April 2016 Multiqual 1.00 64.97 SD 1 2.9 # Points −− −− 90 231 90 229 # Labs 3 4 3 4 Siemens ADVIA Chemistry Systems Mean 34.85 3 1.42 −− −− SD 1 −− −− 2 1.00 3 2.00 44.94 SD 1 −− −− 2 −− 2.4 20.27 SD 1 −− −− 2 2.871 3 −− 2.36 58.0 2.85 CV 7.

2 250.4 2.9 105.9 107.0 257.9 # Points 32 227 32 223 26 50 # Labs 2 2 2 2 1 1 AST (ASAT/GOT) Dinitrophenyl hydrazine U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Mindray BS 200E/380/400/480/800/2000 Mean −− −− 105.62 3 4.0 2.77 −− 110.4 254.5 1.0 62.21 72.49 2 169.97 CV −− −− 1.7 1.61 4.2 13.03 CV 10.6 2.5 −− 1.1 # Points 337 1331 532 3032 559 2871 # Labs 12 17 26 40 24 34 AST (ASAT/GOT) Dinitrophenyl hydrazine U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.6 1.4 SD 1 −− 0.56 43.77 CV −− −− 1.0 256.63 88.730 1. colorimetric Mean −− −− 106.4 181.6 159.6 2.72 2.9 # Points −− −− 12 109 12 109 # Labs 1 1 1 1 Copyright © 2015 Bio−Rad Laboratories.1 SD 1 −− −− 2 1. Generated 22−May−2016 17:45:01 Page 59 .5 1.57 2 7.4 254. Inc.9 # Points −− −− 24 554 29 519 # Labs 5 5 5 5 Roche cobas 6000/8000/c 311 Mean −− 46.75 103.2 250.23 60.0 −− −− SD 1 0.62 3 4.2 # Points −− 47 24 604 29 567 # Labs 1 5 6 5 6 AST (ASAT/GOT) Enzymatic.9 # Points −− −− 12 109 12 109 # Labs 1 1 1 1 Method Group • Enzymatic.1 0.6 523.30 11.0 1.2 # Points −− 47 −− 50 −− 48 # Labs 1 1 1 Method Group • Dinitrophenyl hydrazine Mean −− 46.3 15.2 3.3 179.2.77 105.5 14.77 CV −− 1.530 0.10 3 10. colorimetric U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean −− −− 106.3 −− 267.7 3.04 5.61 4.46 5.77 8.96 3 −− −− CV 1.9 −− −− # Points 9 178 9 176 −− −− # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #16 Mean 3063 3042 7351 7310 18392 18240 SD 1 75.77 CV −− −− 1.5 2.9 1.41 42.04 4.1 SD 1 −− 0.9 105.5 SD 1 −− −− 2 1.4 3 543.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Apolipoprotein B Immunoturbidimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Method Group • Immunoturbidimetric Mean 41.00 72.17 3 4.698 2 −− 1.3 CV 2.5 1.2 2. i.8 1.14 58.8 256.9 # Points 23 49 23 47 26 50 # Labs 1 1 1 1 1 1 Method Group • Dinitrophenyl hydrazine Mean 2214 690.0 2.9 2.3 2.95 SD 1 4.15 CV −− 1.5 SD 1 −− −− 2 1.51 2.4 2.9 107.2 −− 1.6 523. ci models) Mean 44.09 3 4.51 2.6 256.8 13.4 103.8 1.698 2 1.6 1.72 2.3 13.9 5313 1622 18392 18240 SD 1 1380 1237 2 3314 2947 3 543.937 2 0.3 CV 62. Worldwide Report April 2016 Multiqual 1.32 3 −− 3.

16 2 2.00 2 −− −− 3 4.86 2.8 2.4 2.6 290.86 2.9 −− −− SD 1 0.0 285.3 # Points 26 233 −− −− 26 230 # Labs 1 1 1 1 Method Group • Enzymatic.6 257.9 4.6 −− −− 3.800 2.0 SD 1 2.36 112.06 2.39 45.1 2. colorimetric Mean 46.2 −− −− 1.1 110.0 116.6 3.0 −− 3.49 2.8 −− 308.30 3 8399 8325 CV −− −− 2.30 3 2.1 110.55 47.2.739 1.0 1.4 5.91 −− 124.48 2 −− −− 3 3.58 CV −− −− 2.2 1.0 74.79 3 −− 10.11 2 −− −− 3 4.80 8.4 71.49 2. colorimetric U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Fuji Dri−Chem NX500/i Mean 48.17 112. Generated 22−May−2016 17:45:01 Page 60 .0 2 −− −− 3 620.0 # Points 125 908 17 75 113 829 # Labs 5 5 1 1 4 4 AST (ASAT/GOT) Enzymatic.5 3.3 SD 1 −− −− 2 2. colorimetric−VITROS U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #00 Mean 49.65 CV 2.53 3 −− −− CV 1.9 2.14 1.931 1.9 −− −− 1.9 −− 3.1 2.53 3 7.0 # Points 20 74 −− −− 20 110 # Labs 1 1 1 2 VITROS Microslide Series • Slide generation #01 Mean −− 50.4 277.5 # Points −− −− 20 35 55 101 # Labs 1 1 2 2 AST (ASAT/GOT) Enzymatic.66 CV −− 3.6 109.5 # Points 87 600 −− −− 87 599 # Labs 3 3 3 3 Siemens ADVIA Chemistry Systems Mean 49.63 CV 1.5 # Points −− 74 −− 119 −− 116 # Labs 2 3 3 Copyright © 2015 Bio−Rad Laboratories.4 −− −− 1.6 # Points 32 61 −− −− 35 66 # Labs 1 1 1 1 Method Group • Enzymatic.89 3.0 116.48 CV 4.6 2.77 51.2 # Points −− −− 20 35 20 35 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #23 Mean 3006 3026 −− −− 17562 17666 SD 1 109.73 −− −− 256.9 CV 3.00 47.3 2.81 2 2.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units AST (ASAT/GOT) Enzymatic.3 2.15 3.7 3.9 260. colorimetric−VITROS Mean −− −− 117.54 6.6 4.00 47. Worldwide Report April 2016 Multiqual 1.5 2.61 −− −− 271.2 SD 1 0.20 −− −− 286.49 CV 2. Inc.8 SD 1 −− 1.3 −− −− # Points 12 75 17 75 −− −− # Labs 1 1 1 1 Roche cobas 6000/8000/c 311 Mean 45.1 2.6 11282 11645 SD 1 −− −− 2 2.0 1.6 2.1 SD 1 1.6 291.0 263.0 630. colorimetric−VITROS U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #21 Mean −− −− 117.7 SD 1 0.98 2 −− 3.57 10.

14 4.3 9.9 # Points 79 467 −− −− 68 496 # Labs 2 2 2 2 VITROS Microslide Series • Slide generation #19 Mean 50.80 2 −− −− 3 9.36 118.49 −− −− 296.05 2 −− 2.7 3.3 SD 1 −− 1.1 −− 307.6 # Points −− −− −− 136 −− 136 # Labs 1 1 VITROS Microslide Series • Slide generation #18 Mean 49.99 8.21 CV 2.2 2.5 # Points 1 173 1 175 1 175 # Labs 1 1 1 1 1 1 VITROS Microslide Series • Slide generation #15 Mean −− 50.0 120.54 49.5 1.78 1.820 0.000 7.9 119.7 −− −− 3.99 3 7.1 −− 2. Inc.04 3 0.0 # Points 1022 10013 436 4429 1043 9447 # Labs 39 69 20 35 39 67 VITROS Microslide Series • Slide generation #22 Mean 49.5 SD 1 −− −− 2 −− 1.3 2.79 1.000 3.72 3 −− 4.8 −− 3.48 48.85 3 8.7 294.77 CV −− 3. Worldwide Report April 2016 Multiqual 1.0 2.88 3 −− 6.2 1.3 SD 1 1.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units AST (ASAT/GOT) Enzymatic.67 3.31 CV 3.6 −− 304. colorimetric−VITROS U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #02 Mean 48.69 −− 120.5 SD 1 1.96 CV 3.4 −− 1.75 CV −− −− −− 1.0 296.10 −− 121.3 2.78 2.7 299.50 −− −− 294.37 46.0 # Points −− 145 −− 139 −− 157 # Labs 1 1 1 VITROS Microslide Series • Slide generation #17 Mean −− −− −− 121.67 119.45 3.2.14 −− 122.8 294.7 3.000 1.63 7.30 CV 0.6 # Points −− 195 −− 212 −− 223 # Labs 1 1 1 VITROS Microslide Series • Slide generation #16 Mean −− 51.23 3 −− 7.6 −− 3.7 1.35 1.4 −− 2.49 2 0.76 3 7.45 12.60 2 2.6 3.4 # Points 60 879 61 481 71 955 # Labs 1 3 1 2 1 2 VITROS Microslide Series • Slide generation #21 Mean 49. Generated 22−May−2016 17:45:01 Page 61 .6 296.2 # Points 16 16 −− −− 16 16 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #23 Mean 49.5 −− 2.65 118.2 3.0 0.4 294.9 SD 1 −− 1.94 120.6 3.7 −− 2.6 2.7 SD 1 1.67 CV 1.3 3.1 3.89 11.00 49.9 SD 1 −− 1.40 3 −− 9.9 5.0 # Points −− 78 −− 79 −− 78 # Labs 1 1 1 Copyright © 2015 Bio−Rad Laboratories.3 284.79 2 4.86 CV 2.8 2.4 SD 1 0.7 −− −− 1.36 2 −− 3.14 CV −− 2.0 2.6 −− 297.4 −− 314.5 4.85 2 −− 4.6 3.8 289.5 117.22 CV −− 2.5 SD 1 1.820 2 −− −− 3 3.5 # Points 297 566 162 330 255 421 # Labs 17 18 10 11 14 15 VITROS Microslide Series • Slide generation #25 Mean −− 51.1 119.72 49.0 3.3 288.27 6.5 0.2 SD 1 0.50 49.46 2 2.8 294.

27 6.8 119.00 43.32 104.50 CV −− 1.4 3.6 # Points −− 151 −− −− −− 149 # Labs 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 39.58 CV 4. ci models) Mean −− 45.9 5.8 # Points −− 21 −− −− −− 17 # Labs 1 1 VITROS Microslide Series • Slide generation #99 Mean 50.2 SD 1 0.2.4 3.5 296.8 245.3 −− −− # Points −− 46 17 46 −− −− # Labs 1 1 1 Roche cobas 6000/8000/c 311 Mean 44.4 SD 1 1.92 4.0 # Points 88 427 −− −− 88 420 # Labs 4 4 4 4 ILab 600 Mean −− 44.3 117.72 2. colorimetric−VITROS Mean 49.7 251.1 0.640 1.7 104. Generated 22−May−2016 17:45:01 Page 62 .17 13.892 2 1.18 2 4. i.63 1.7 # Points 19 70 19 68 19 68 # Labs 1 1 1 1 1 1 Method Group • Other NADH depletion Mean 40.49 CV 3.8 1.74 41.08 3 6.49 118.5 −− −− 1.4 3.929 1.8 299.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units AST (ASAT/GOT) Enzymatic.01 −− −− −− 250.712 2 −− −− 3 −− 1.5 2.2 # Points 359 1044 84 283 301 857 # Labs 15 15 7 7 13 14 Method Group • Enzymatic.3 2.56 9.7 3.0 2.8 295.78 4.1 2.0 1.5 104.12 3 1.8 2.76 104.3 # Points 21 185 −− −− 21 167 # Labs 1 1 1 1 Copyright © 2015 Bio−Rad Laboratories.9 SD 1 −− 0.64 CV 3.7 2.67 1.5 0.726 2 −− −− 3 −− 2.7 6.2 4.00 4.75 49.60 CV −− 1.9 3.436 1.52 2 0.1 1. Inc.5 4.7 251.63 −− −− 246.96 2 −− −− 3 4.5 −− −− 1.3 3.04 50.44 5.0 SD 1 1.5 2.94 39.38 3 −− −− CV −− 2.11 2 0.21 3 8.8 4.44 44.82 CV 3.0 −− −− SD 1 −− 0.92 −− −− 224.9 SD 1 1.92 2.86 −− −− −− 304.988 2 −− −− 3 3. colorimetric−VITROS U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #31 Mean −− 50.8 SD 1 1. Worldwide Report April 2016 Multiqual 1.22 104.6 SD 1 0.3 # Points 1854 13745 744 6383 1775 13204 # Labs 77 116 39 63 72 112 AST (ASAT/GOT) Other NADH depletion U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.9 SD 1 −− 0.21 CV 1.02 118.18 1.906 0.9 1.27 3 11.4 229.4 −− −− −− 0.1 223.34 4.45 CV 2.8 104.0 299.6 1.6 −− −− −− 0.69 2 4.0 0.8 # Points 107 694 36 114 107 637 # Labs 5 7 2 2 5 6 AST (ASAT/GOT) UV with P5P U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Series Mean 44.0 232.

7 2.7 SD 1 −− 0.92 42.8 1.1 2.69 CV 8.44 5. LXi725 Chemistry Systems Mean 44.9 105.7 2.64 CV 3.9 −− 1.840 0.16 2 1. Inc.8 1.883 2 −− −− 3 1.71 106.7 # Points −− 77 −− −− −− 76 # Labs 2 2 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Zhong Sheng Mean −− 118.56 CV −− 1.0 100.4 241.8 245.5 243.47 CV 2.0 # Points −− 1 −− −− −− 15 # Labs 1 1 Beckman Coulter LX20.8 4.64 −− −− −− 215.29 1.8 SD 1 −− 0.8 SD 1 1.6 SD 1 1.65 44.00 43.3 # Points 21 185 −− −− 21 167 # Labs 1 1 1 1 AST (ASAT/GOT) UV with P5P U/L @ 35° C Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Vista Mean 41.7 SD 1 1.2.61 3 25.0 −− −− −− 284.6 252.87 CV −− 0.78 3 6.0 1.96 5.3 9.31 44.0 # Points 26 81 −− −− 26 64 # Labs 1 1 1 1 Copyright © 2015 Bio−Rad Laboratories.92 42.0 100.67 1.8 −− 261.72 CV 3.22 2 2.9 2.0 −− −− 0.86 2.44 2.10 24.13 3.77 3 2.8 1.1 9.7 −− −− −− 0.7 9.8 1.69 105.8 2. i.5 # Points −− 5 −− 5 −− 5 # Labs 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 46.60 45.82 2 9.4 241.72 CV 3.77 3 2. Worldwide Report April 2016 Multiqual 1.8 2.9 252.7 −− 0.0 −− −− −− 1.7 SD 1 0. ci models) • Abbott AST (REF 8L91) Mean −− 47.9 258.8 1.5 −− −− 1.1 # Points 48 266 58 276 26 140 # Labs 1 1 1 1 1 1 AST (ASAT/GOT) UV with P5P U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.2 250.8 1.7 2.11 100.6 SD 1 −− 0.7 SD 1 1.78 1.7 SD 1 4.29 1.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units AST (ASAT/GOT) UV with P5P U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Method Group • UV with P5P Mean 44.96 2 −− −− 3 4.5 243.30 CV −− 1.1 2.63 −− −− 246.00 −− −− 236.44 2.78 1.90 9.16 2 1.8 2. Generated 22−May−2016 17:45:01 Page 63 .60 −− 111. ci models) Mean 44.93 3 −− 1.0 1.87 2.000 2 −− −− 3 −− 2.43 CV 1.893 2 −− 1.8 # Points 514 2840 347 1888 362 1627 # Labs 15 19 11 14 11 12 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • IFCC 2002 (Enzymes) Mean −− 38.8 1.2 # Points 801 3920 560 2622 399 2137 # Labs 25 27 17 18 13 15 Abbott AEROSET/ARCHITECT (c.25 1.647 2 −− −− 3 −− 1.4 235.4 9.11 100.2 104.9 8. i.1 # Points 48 266 58 276 26 140 # Labs 1 1 1 1 1 1 Method Group • UV with P5P Mean 41.

8 2.7 5.5 SD 1 2. IFCC Correlated Mean −− 42.2 0.60 42.58 2 −− 2.000 0.60 25.4 −− 1.21 105.44 3 8.50 113.0 −− 249.0 −− 1. E170) Mean 42.4 2.60 3 7.0 −− −− # Points 67 331 71 328 −− −− # Labs 3 5 3 5 Siemens ADVIA 1200 Mean −− 47.7 5.57 1.30 2.96 2 0.5 243.9 106.89 99.45 −− −− 243.0 # Points 6227 45844 2854 21064 5208 41884 # Labs 192 253 82 111 166 223 Siemens Dimension Series • Factored. P.3 1.2 103.7 269.56 3.5 # Points −− 89 −− 56 −− 52 # Labs 1 1 1 Siemens Dimension Vista Mean 42.30 CV −− 1.4 256.577 CV 4.38 −− 100.0 107.0 3.9 3.62 7.50 CV 3.1 252. Generated 22−May−2016 17:45:01 Page 64 .1 241.87 103.4 4.8 # Points 6580 65104 2184 22610 6560 63434 # Labs 183 250 52 86 178 242 Copyright © 2015 Bio−Rad Laboratories.7 # Points 386 1351 215 937 365 1620 # Labs 10 11 7 7 9 9 Siemens Dimension Series Mean 43.7 3.07 2.0 # Points 372 2263 136 861 342 2299 # Labs 14 15 6 8 11 13 Roche MODULAR (ISE.3 252.40 44.01 2.5 SD 1 1.97 102.5 2.94 43.50 2 2.87 1. Inc.90 2 2.35 45.33 3 4.4 2.35 1.03 3 −− 3.63 CV 3.87 7.3 0.0 4.00 −− 108.53 CV 4.54 7.82 4. Worldwide Report April 2016 Multiqual 1.0 # Points −− 4 2 19 1 1 # Labs 1 2 2 1 1 Siemens ADVIA Chemistry Systems Mean 50.8 2.6 103.60 103.1 3.2.6 3.4 248.38 CV 4.2 2.90 1.000 CV −− 2.0 0.17 2 2.9 # Points 105 1010 17 878 102 1124 # Labs 4 7 3 7 6 9 Beckman Coulter UniCel DxI Series Mean −− 48.0 SD 1 −− 1.1 107.11 50.84 3.64 2 2.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units AST (ASAT/GOT) UV with P5P U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter UniCel DxC Series Mean 45.5 269.57 2.82 1.577 0.75 2.7 3.1 251.29 2 5.5 276.0 4.8 0.0 276.01 3 0.1 3.5 3.4 −− 241.51 42.02 3 −− −− CV 4.63 3 6.3 252.6 9.7 −− 2.8 108.7 3.9 1.5 248.48 CV 4.5 2.3 # Points −− 34 −− 32 −− 33 # Labs 1 1 1 ILab 650 Mean 40. D.3 SD 1 1.4 SD 1 2.3 −− 1.1 SD 1 −− 1.0 2.23 2 3.876 8.68 CV −− 3.5 2.8 SD 1 1.58 41.7 SD 1 1.0 SD 1 −− 0.38 3 7.9 7.36 −− −− SD 1 1.0 −− −− 0.2 2.89 108.2 # Points 22 109 −− −− 4 4 # Labs 2 2 1 1 Roche cobas 6000/8000/c 311 Mean 44.26 2 −− −− 3 0.7 3.3 2.36 99.66 3.50 3 −− 3.600 2 −− 1.

52 42.64 3.52 2.1 SD 1 0.739 0.00 2 1.62 45.702 2 1.2 SD 1 0.1 SD 1 0.91 3. i.81 CV 3.48 3 2.7 2.9 # Points 124 1169 124 1158 123 1165 # Labs 4 4 4 4 4 4 AST (ASAT/GOT) UV with P5P − IFCC Ref.2 3.50 CV 2.45 104.0 # Points 33 269 −− −− 33 293 # Labs 1 1 1 1 Method Group • UV with P5P − IFCC Ref.4 SD 1 2. Proc.4 3.74 2 2.8 3.1 109.7 251.9 2.67 2 3. Calibrated Mean 45.52 42..5 # Points 633 3681 587 3315 453 3083 # Labs 12 14 10 12 8 10 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 46.0 260.8 251. Proc.70 2.66 43.0 2.45 3 3. ci models) • Abbott AST (REF 8L91) Mean 46.1 2.26 2 4.10 3.34 112.1 109.58 2.5 5.8 258.5 −− −− 0.7 SD 1 1. Calibrated U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/8000/c 311 Mean 45..4 5.9 3.5 253. ci models) Mean 45. IFCC Correlated Mean 45.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units AST (ASAT/GOT) UV with P5P U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Method Group • UV with P5P Mean 43.1 SD 1 0.4 262.9 260.86 46.5 253.7 4.8 261. i.96 4.20 2 1.00 110.0 2.7 262.400 1.6 1.1 109..5 −− −− 0.5 1.4 266..20 46.4 1.4 1.7 261.9 3. Proc.6 1.81 CV 3.70 CV 5.77 3 8.0 103.1 # Points 15100 123K 6386 51244 13369 114K # Labs 449 595 183 260 397 530 AST (ASAT/GOT) UV with P5P − IFCC Ref.3 5.59 45.. Calibrated U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.6 SD 1 1.44 CV 1.5 1.9 # Points 188 319 191 328 177 308 # Labs 6 6 6 6 6 6 Abbott AEROSET/ARCHITECT (c.44 15.57 109. Calibrated U/L @ 35° C Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Vista Mean 42.5 1.00 3 3.16 CV 5.4 1.2 251.61 2 −− −− 3 1.0 103.6 1.0 103.7 251.56 1.56 1.4 1.9 # Points 316 1013 318 933 373 1219 # Labs 12 13 12 13 14 15 Copyright © 2015 Bio−Rad Laboratories.000 7.7 4. Worldwide Report April 2016 Multiqual 1. Generated 22−May−2016 17:45:01 Page 65 .4 3.07 −− −− 258.6 1.96 4.20 46.400 1.10 2.45 104. Proc.6 SD 1 1.74 2 2.14 4. ci models) • Factored. Calibrated Mean 42.81 CV 0.04 109.10 2.2 261.81 CV 0.0 # Points 33 269 −− −− 33 293 # Labs 1 1 1 1 AST (ASAT/GOT) UV with P5P − IFCC Ref.05 3 11.4 1.000 7.68 1.7 4.6 1.45 3 3.939 1. Inc.4 3.39 2.90 CV 2.0 0.0 2.6 3.4 110.6 1. Proc.9 # Points 124 1169 124 1158 123 1165 # Labs 4 4 4 4 4 4 Method Group • UV with P5P − IFCC Ref.3 # Points 144 521 249 809 130 488 # Labs 4 4 4 4 4 4 Abbott AEROSET/ARCHITECT (c.17 46.51 1.8 1.45 7.61 2 −− −− 3 1.1 2.78 3 3.07 −− −− 258.36 104.7 262.2.2 1. i.9 3.23 1.1 SD 1 2.

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

AST (ASAT/GOT) UV with P5P − IFCC Ref. Proc., Calibrated U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU International Calibrator OE 66300
Mean 50.00 50.00 120.7 120.7 284.3 284.3
SD 1 0.000 0.000 2 1.53 1.53 3 4.73 4.73
CV 0.0 0.0 1.3 1.3 1.7 1.7
# Points 2 2 3 3 3 3
# Labs 1 1 1 1 1 1

Beckman Coulter UniCel DxC Series
Mean 48.04 48.35 121.6 122.0 −− −−
SD 1 1.60 1.61 2 2.21 3.33 3 −− −−
CV 3.3 3.3 1.8 2.7 −− −−
# Points 48 64 47 63 −− −−
# Labs 2 2 2 2

JEOL BioMajesty JCA−BM Series
Mean −− −− 108.8 108.6 240.3 239.8
SD 1 −− −− 2 1.20 1.30 3 1.88 1.80
CV −− −− 1.1 1.2 0.8 0.8
# Points −− −− 27 54 27 54
# Labs 1 1 1 1

Roche Hitachi Systems (International)
Mean −− −− 107.3 107.6 256.5 257.8
SD 1 −− −− 2 5.73 5.42 3 12.62 11.93
CV −− −− 5.3 5.0 4.9 4.6
# Points −− −− 97 232 97 231
# Labs 3 3 3 3

Siemens ADVIA 1200
Mean −− 45.40 −− 105.1 −− −−
SD 1 −− 1.39 2 −− 1.68 3 −− −−
CV −− 3.1 −− 1.6 −− −−
# Points −− 20 −− 20 −− −−
# Labs 1 1

Siemens ADVIA Chemistry Systems
Mean 48.40 48.55 −− −− 258.3 258.0
SD 1 1.04 1.30 2 −− −− 3 1.75 3.14
CV 2.1 2.7 −− −− 0.7 1.2
# Points 25 121 −− −− 25 123
# Labs 1 1 1 1

Siemens Dimension Series
Mean 42.71 42.84 103.0 102.7 239.7 240.8
SD 1 1.63 1.45 2 2.97 2.61 3 7.52 6.66
CV 3.8 3.4 2.9 2.5 3.1 2.8
# Points 360 1101 65 142 434 1439
# Labs 8 8 2 2 8 8

Siemens Dimension Vista
Mean 43.07 43.00 99.48 100.7 246.2 248.6
SD 1 1.53 1.52 2 2.56 2.44 3 6.78 6.39
CV 3.5 3.5 2.6 2.4 2.8 2.6
# Points 399 3480 182 1282 359 3458
# Labs 9 15 6 9 8 15

Siemens Dimension Vista • Alternate Formulation/Standardization
Mean −− 41.67 −− 98.00 −− 238.5
SD 1 −− 1.53 2 −− 1.00 3 −− 2.12
CV −− 3.7 −− 1.0 −− 0.9
# Points −− 3 −− 3 −− 2
# Labs 1 1 1

Siemens Dimension Vista • Factored, IFCC Correlated
Mean 42.54 42.47 100.9 100.7 243.0 242.6
SD 1 1.79 1.64 2 2.22 2.35 3 3.64 3.84
CV 4.2 3.9 2.2 2.3 1.5 1.6
# Points 174 2945 176 2154 105 2344
# Labs 7 10 7 8 5 8

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 66

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

AST (ASAT/GOT) UV with P5P − IFCC Ref. Proc., Calibrated U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
VITROS Microslide Series • Slide generation #21
Mean 50.39 50.50 118.9 119.8 299.6 299.7
SD 1 1.14 1.13 2 3.76 3.04 3 7.94 6.87
CV 2.3 2.2 3.2 2.5 2.6 2.3
# Points 66 256 35 132 66 253
# Labs 2 2 1 1 2 2

Method Group • UV with P5P − IFCC Ref. Proc., Calibrated
Mean 44.87 44.09 109.0 107.1 254.6 252.1
SD 1 2.73 2.51 2 6.04 6.03 3 16.22 13.96
CV 6.1 5.7 5.5 5.6 6.4 5.5
# Points 1548 6897 1214 3998 1691 7576
# Labs 45 53 38 43 48 56

AST (ASAT/GOT) UV with P5P−VITROS U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
VITROS Microslide Series • Slide generation #00
Mean −− −− −− −− 289.4 298.1
SD 1 −− −− 2 −− −− 3 5.12 9.45
CV −− −− −− −− 1.8 3.2
# Points −− −− −− −− 33 177
# Labs 1 1

VITROS Microslide Series • Slide generation #01
Mean 50.29 49.68 121.4 120.7 302.1 304.1
SD 1 1.27 1.04 2 2.31 2.06 3 6.50 6.02
CV 2.5 2.1 1.9 1.7 2.2 2.0
# Points 14 71 14 72 14 71
# Labs 1 1 1 1 1 1

VITROS Microslide Series • Slide generation #16
Mean 51.05 51.60 124.0 121.9 306.8 304.5
SD 1 1.03 2.92 2 2.65 3.15 3 6.93 8.43
CV 2.0 5.7 2.1 2.6 2.3 2.8
# Points 19 198 21 173 18 196
# Labs 1 1 1 1 1 1

VITROS Microslide Series • Slide generation #18
Mean 50.73 51.13 −− −− 303.1 305.8
SD 1 1.26 1.44 2 −− −− 3 6.03 6.44
CV 2.5 2.8 −− −− 2.0 2.1
# Points 30 68 −− −− 31 70
# Labs 1 1 1 1

VITROS Microslide Series • Slide generation #19
Mean 48.74 46.36 118.9 119.5 298.4 293.1
SD 1 0.995 2.76 2 2.04 2.47 3 5.12 8.14
CV 2.0 5.9 1.7 2.1 1.7 2.8
# Points 33 584 33 267 33 598
# Labs 2 3 2 2 2 3

VITROS Microslide Series • Slide generation #21
Mean 50.71 50.08 119.7 120.3 298.3 297.9
SD 1 1.24 1.58 2 2.53 5.45 3 7.04 7.82
CV 2.4 3.2 2.1 4.5 2.4 2.6
# Points 456 5936 188 2200 522 6446
# Labs 19 30 9 13 21 32

VITROS Microslide Series • Slide generation #22
Mean 49.35 49.35 −− −− 292.9 292.9
SD 1 1.04 1.04 2 −− −− 3 7.10 7.10
CV 2.1 2.1 −− −− 2.4 2.4
# Points 2 2 −− −− 2 2
# Labs 2 2 2 2

VITROS Microslide Series • Slide generation #23
Mean 49.51 49.48 120.4 120.5 296.0 296.0
SD 1 1.69 1.69 2 2.26 2.75 3 7.56 7.50
CV 3.4 3.4 1.9 2.3 2.6 2.5
# Points 316 572 62 118 315 565
# Labs 11 11 3 3 11 11

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 67

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

AST (ASAT/GOT) UV with P5P−VITROS U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
VITROS Microslide Series • Slide generation #99
Mean 49.59 50.04 117.3 120.2 286.1 290.1
SD 1 1.49 1.45 2 3.42 4.26 3 6.07 9.90
CV 3.0 2.9 2.9 3.5 2.1 3.4
# Points 45 80 38 92 36 46
# Labs 4 7 2 4 2 5

Method Group • UV with P5P−VITROS
Mean 50.17 49.79 119.8 120.4 297.2 297.6
SD 1 1.55 2.04 2 2.89 4.97 3 7.73 8.12
CV 3.1 4.1 2.4 4.1 2.6 2.7
# Points 915 7511 356 2922 1004 8171
# Labs 41 56 18 24 42 57

AST (ASAT/GOT) UV without P5P U/L @ 25° C
Level Mon Cum Level Mon Cum Level Mon Cum
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 39.43 38.78 −− 233.0 219.5 219.3
SD 1 2.08 2.63 2 −− 1.50 3 9.97 8.97
CV 5.3 6.8 −− 0.6 4.5 4.1
# Points 65 494 −− 20 66 504
# Labs 3 3 1 3 3

Roche cobas 6000/8000/c 311
Mean −− 45.65 −− −− −− 257.3
SD 1 −− 1.55 2 −− −− 3 −− 4.25
CV −− 3.4 −− −− −− 1.7
# Points −− 79 −− −− −− 79
# Labs 1 1

Roche cobas INTEGRA
Mean 43.74 43.02 102.7 101.5 246.5 243.2
SD 1 1.09 1.14 2 1.09 1.94 3 2.90 4.10
CV 2.5 2.6 1.1 1.9 1.2 1.7
# Points 80 621 80 621 80 621
# Labs 2 2 2 2 2 2

Method Group • UV without P5P
Mean 41.81 41.44 102.7 105.6 234.3 234.1
SD 1 2.68 3.02 2 1.09 22.96 3 15.21 14.60
CV 6.4 7.3 1.1 21.7 6.5 6.2
# Points 145 1194 80 641 146 1204
# Labs 5 6 2 3 5 6

AST (ASAT/GOT) UV without P5P U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models)
Mean 44.68 44.56 104.8 104.9 250.6 250.4
SD 1 1.23 1.25 2 2.24 2.38 3 5.22 4.91
CV 2.8 2.8 2.1 2.3 2.1 2.0
# Points 3371 19203 2095 12629 2967 18399
# Labs 97 112 58 70 90 108

Abbott AEROSET/ARCHITECT (c, i, ci models) • Alternate Formulation/Standardization
Mean −− −− 103.3 103.4 249.7 235.6
SD 1 −− −− 2 0.870 0.748 3 1.30 12.62
CV −− −− 0.8 0.7 0.5 5.4
# Points −− −− 9 28 10 29
# Labs 1 1 1 1

Abbott AEROSET/ARCHITECT (c, i, ci models) • PROLABS
Mean −− 46.50 −− 110.8 −− 263.1
SD 1 −− 3.52 2 −− 3.66 3 −− 3.65
CV −− 7.6 −− 3.3 −− 1.4
# Points −− 55 −− 54 −− 54
# Labs 1 1 1

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 68

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

AST (ASAT/GOT) UV without P5P U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 38.64 38.81 90.95 90.83 217.7 218.0
SD 1 1.59 1.57 2 4.63 3.82 3 9.80 9.19
CV 4.1 4.0 5.1 4.2 4.5 4.2
# Points 1139 9070 566 4362 1151 9105
# Labs 37 53 17 26 37 55

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU International Calibrator OE 66300
Mean 48.84 48.68 114.6 114.2 271.6 270.3
SD 1 1.30 1.34 2 2.65 2.68 3 6.42 6.72
CV 2.7 2.8 2.3 2.4 2.4 2.5
# Points 1386 6989 1132 6092 633 2485
# Labs 32 36 25 29 18 23

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Zhong Sheng
Mean −− −− 108.2 110.0 257.8 262.4
SD 1 −− −− 2 4.18 4.74 3 9.22 10.43
CV −− −− 3.9 4.3 3.6 4.0
# Points −− −− 41 202 41 202
# Labs 2 2 2 2

Beckman Coulter LX20, LXi725 Chemistry Systems
Mean −− −− 116.1 113.1 274.6 267.5
SD 1 −− −− 2 2.14 3.98 3 5.06 7.91
CV −− −− 1.8 3.5 1.8 3.0
# Points −− −− 19 140 20 140
# Labs 1 1 1 1

Beckman Coulter LX20, LXi725 Chemistry Systems • LEADMAN
Mean −− −− 103.3 103.3 235.7 235.7
SD 1 −− −− 2 2.08 2.08 3 0.580 0.580
CV −− −− 2.0 2.0 0.2 0.2
# Points −− −− 3 3 3 3
# Labs 1 1 1 1

Beckman Coulter UniCel DxC Series
Mean 45.77 45.87 103.1 104.4 244.3 245.4
SD 1 1.11 1.30 2 2.31 4.31 3 3.47 6.18
CV 2.4 2.8 2.2 4.1 1.4 2.5
# Points 933 6157 409 3059 785 4939
# Labs 30 40 17 30 23 27

Dirui CS Series
Mean 44.90 42.76 −− 101.1 249.1 248.4
SD 1 1.37 3.17 2 −− 6.89 3 4.39 24.86
CV 3.1 7.4 −− 6.8 1.8 10.0
# Points 10 363 −− 370 11 71
# Labs 1 7 7 1 2

DIRUI−CS−240
Mean −− −− −− 104.9 −− 241.5
SD 1 −− −− 2 −− 3.80 3 −− 11.98
CV −− −− −− 3.6 −− 5.0
# Points −− −− −− 115 −− 104
# Labs 1 1

Hitachi Chemistry Series
Mean 47.73 49.25 107.3 111.0 257.9 262.0
SD 1 0.650 2.07 2 2.16 4.40 3 3.18 4.35
CV 1.4 4.2 2.0 4.0 1.2 1.7
# Points 11 122 33 321 22 196
# Labs 1 1 2 2 1 1

Hitachi Chemistry Series • MAKER
Mean −− −− −− 108.4 −− 255.8
SD 1 −− −− 2 −− 0.921 3 −− 2.06
CV −− −− −− 0.9 −− 0.8
# Points −− −− −− 40 −− 49
# Labs 1 1

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 69

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

AST (ASAT/GOT) UV without P5P U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Horiba ABX Pentra 400
Mean −− 44.64 114.4 114.4 −− 255.8
SD 1 −− 2.24 2 1.98 1.98 3 −− 9.02
CV −− 5.0 1.7 1.7 −− 3.5
# Points −− 196 6 6 −− 190
# Labs 1 1 1 1

ILab 600
Mean 45.47 45.63 107.0 107.2 −− −−
SD 1 0.864 0.929 2 1.60 1.65 3 −− −−
CV 1.9 2.0 1.5 1.5 −− −−
# Points 114 640 113 641 −− −−
# Labs 3 3 3 3

JEOL BioMajesty JCA−BM Series
Mean −− −− 106.5 106.0 −− −−
SD 1 −− −− 2 2.10 2.25 3 −− −−
CV −− −− 2.0 2.1 −− −−
# Points −− −− 29 79 −− −−
# Labs 1 1

JEOL BioMajesty JCA−BM Series • Zhong Sheng
Mean −− −− −− 112.5 −− 268.3
SD 1 −− −− 2 −− 3.10 3 −− 2.44
CV −− −− −− 2.8 −− 0.9
# Points −− −− −− 46 −− 35
# Labs 1 1

Mindray BS 200E/380/400/480/800/2000
Mean 48.08 47.27 112.2 107.4 272.4 261.3
SD 1 2.09 2.66 2 5.21 6.00 3 4.89 20.94
CV 4.3 5.6 4.6 5.6 1.8 8.0
# Points 66 354 40 210 29 205
# Labs 4 5 2 3 2 3

Mindray BS 200E/380/400/480/800/2000 • Alternate Formulation/Standardization
Mean −− 47.34 −− 111.0 −− 268.3
SD 1 −− 1.85 2 −− 3.39 3 −− 8.14
CV −− 3.9 −− 3.1 −− 3.0
# Points −− 20 −− 20 −− 19
# Labs 1 1 1

Roche cobas 6000/8000/c 311
Mean 44.85 44.98 105.4 106.0 253.2 254.8
SD 1 1.44 1.38 2 3.00 2.96 3 6.35 6.33
CV 3.2 3.1 2.8 2.8 2.5 2.5
# Points 3264 18501 1618 6291 2722 16652
# Labs 94 116 54 62 73 95

Roche cobas c 111
Mean 43.67 44.02 −− −− 243.6 245.9
SD 1 0.577 0.829 2 −− −− 3 3.57 3.78
CV 1.3 1.9 −− −− 1.5 1.5
# Points 21 177 −− −− 21 177
# Labs 1 1 1 1

Roche cobas INTEGRA
Mean 44.38 44.65 104.4 105.4 247.6 251.0
SD 1 1.63 1.54 2 2.74 3.04 3 7.54 7.82
CV 3.7 3.4 2.6 2.9 3.0 3.1
# Points 463 3293 290 2098 300 2464
# Labs 24 30 16 20 14 17

Roche Hitachi Systems (International)
Mean 49.90 48.64 109.4 108.0 256.7 253.5
SD 1 0.920 2.21 2 4.56 4.09 3 5.45 6.98
CV 1.8 4.5 4.2 3.8 2.1 2.8
# Points 30 146 128 1133 67 717
# Labs 1 2 9 12 6 6

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 70

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

AST (ASAT/GOT) UV without P5P U/L @ 37° C
Level Mon Cum Level Mon Cum Level Mon Cum
Roche MODULAR (ISE, D, P, E170)
Mean 44.01 43.99 103.4 103.8 247.5 246.7
SD 1 1.79 1.69 2 2.84 3.00 3 3.50 4.80
CV 4.1 3.8 2.7 2.9 1.4 1.9
# Points 165 1068 165 1070 66 521
# Labs 9 10 9 10 3 3

Roche Reflotron
Mean −− 60.62 −− −− −− 308.6
SD 1 −− 1.24 2 −− −− 3 −− 15.53
CV −− 2.0 −− −− −− 5.0
# Points −− 12 −− −− −− 8
# Labs 1 1

Siemens ADVIA 1200
Mean 48.99 48.82 108.3 109.1 256.9 257.7
SD 1 1.40 1.62 2 1.73 2.76 3 7.04 4.18
CV 2.9 3.3 1.6 2.5 2.7 1.6
# Points 174 1229 65 410 145 1035
# Labs 5 5 2 2 3 3

Siemens ADVIA Chemistry Systems
Mean 49.45 49.56 112.9 113.3 266.7 267.8
SD 1 2.19 2.19 2 3.19 3.22 3 5.89 6.40
CV 4.4 4.4 2.8 2.8 2.2 2.4
# Points 4696 26597 3575 20833 3168 18092
# Labs 114 147 91 128 88 115

Siemens ADVIA Chemistry Systems • DiaSys Diagnostic Systems
Mean 48.64 48.50 −− −− −− 273.2
SD 1 1.96 1.68 2 −− −− 3 −− 8.14
CV 4.0 3.5 −− −− −− 3.0
# Points 101 302 −− −− −− 308
# Labs 2 2 2

Tokyo Boeki BIOLIS 50i
Mean −− 45.52 −− 106.5 −− 256.1
SD 1 −− 0.875 2 −− 3.86 3 −− 4.75
CV −− 1.9 −− 3.6 −− 1.9
# Points −− 16 −− 23 −− 21
# Labs 1 1 1

Toshiba TBA−120FR
Mean −− −− 106.8 110.1 250.3 256.5
SD 1 −− −− 2 4.37 8.95 3 8.53 21.04
CV −− −− 4.1 8.1 3.4 8.2
# Points −− −− 39 265 38 287
# Labs 1 1 1 1

Toshiba TBA−40FR (Accute)
Mean −− −− −− 119.1 −− 262.7
SD 1 −− −− 2 −− 7.89 3 −− 15.98
CV −− −− −− 6.6 −− 6.1
# Points −− −− −− 168 −− 243
# Labs 3 3

Toshiba−TBA
Mean −− −− −− 112.8 −− −−
SD 1 −− −− 2 −− 1.29 3 −− −−
CV −− −− −− 1.1 −− −−
# Points −− −− −− 26 −− −−
# Labs 1

Method Group • UV without P5P
Mean 46.20 45.98 108.1 108.0 253.1 252.3
SD 1 3.42 3.58 2 6.55 7.00 3 15.28 16.22
CV 7.4 7.8 6.1 6.5 6.0 6.4
# Points 15944 94490 10366 60492 12189 76459
# Labs 455 574 312 416 365 473

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 71

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Beta Globulin Capillary Electrophoresis %
Level Mon Cum Level Mon Cum Level Mon Cum
Sebia CAPILLARYS
Mean 11.00 9.04 −− −− −− −−
SD 1 0.000 1.43 2 −− −− 3 −− −−
CV 0.0 15.8 −− −− −− −−
# Points 2 19 −− −− −− −−
# Labs 1 1

Method Group • Capillary Electrophoresis
Mean 11.00 9.04 −− −− −− −−
SD 1 0.000 1.43 2 −− −− 3 −− −−
CV 0.0 15.8 −− −− −− −−
# Points 2 19 −− −− −− −−
# Labs 1 1

Bicarbonate Calculated mEq/L
Level Mon Cum Level Mon Cum Level Mon Cum
IL Gem Premier 3000 Series
Mean −− 19.00 −− 21.00 −− −−
SD 1 −− 0.000 2 −− 0.000 3 −− −−
CV −− 0.0 −− 0.0 −− −−
# Points −− 2 −− 2 −− −−
# Labs 1 1

Method Group • Calculated
Mean −− 19.00 −− 21.00 −− −−
SD 1 −− 0.000 2 −− 0.000 3 −− −−
CV −− 0.0 −− 0.0 −− −−
# Points −− 2 −− 2 −− −−
# Labs 1 1

Bicarbonate Enzymatic mEq/L
Level Mon Cum Level Mon Cum Level Mon Cum
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 15.06 15.03 18.82 18.87 26.05 26.06
SD 1 0.981 1.08 2 1.12 1.37 3 1.72 1.71
CV 6.5 7.2 5.9 7.2 6.6 6.6
# Points 304 1927 112 658 192 1276
# Labs 9 12 2 2 7 10

Roche cobas 6000/8000/c 311
Mean 14.35 14.16 −− −− 24.11 23.95
SD 1 0.857 0.976 2 −− −− 3 1.27 1.68
CV 6.0 6.9 −− −− 5.3 7.0
# Points 127 1066 −− −− 127 1129
# Labs 3 3 3 3

Roche cobas INTEGRA
Mean −− 15.19 −− 18.36 −− 25.29
SD 1 −− 0.963 2 −− 1.09 3 −− 1.56
CV −− 6.3 −− 5.9 −− 6.2
# Points −− 131 −− 131 −− 130
# Labs 1 1 1

Siemens ADVIA Chemistry Systems
Mean 16.45 16.37 19.31 19.26 28.52 28.54
SD 1 1.48 1.43 2 1.35 1.46 3 2.12 2.01
CV 9.0 8.7 7.0 7.6 7.4 7.0
# Points 68 300 40 189 27 109
# Labs 3 3 2 2 1 1

Siemens Dimension Series
Mean 17.78 17.64 20.99 20.69 −− −−
SD 1 0.920 1.24 2 0.771 1.04 3 −− −−
CV 5.2 7.0 3.7 5.0 −− −−
# Points 22 26 22 26 −− −−
# Labs 2 3 2 3

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 72

0 7.112 CV −− −− 4.7 # Points 64 188 −− −− 61 179 # Labs 2 2 2 2 Copyright © 2015 Bio−Rad Laboratories.9 11.2 −− −− −− 9.61 SD 1 −− 0.4 # Points −− 119 −− −− −− 116 # Labs 3 3 VITROS Microslide Series • Slide generation #10 Mean 0.6 4.053 CV −− 59.063 2 −− −− 3 −− 0.7 # Points −− 20 −− −− −− 14 # Labs 2 1 VITROS Microslide Series • Slide generation #04 Mean −− 0.223 CV 32.159 2 0.09 1.45 SD 1 −− 0.9 28.045 2 −− −− 3 −− 0.0 8.52 2.3 # Points −− −− 20 557 20 509 # Labs 5 5 5 5 VITROS Microslide Series • Slide generation #03 Mean −− 0.90 19.2 # Points 31 35 −− −− 31 34 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #11 Mean 0.559 1.1 11.9 # Points −− 235 −− −− 30 316 # Labs 4 1 5 VITROS Microslide Series • Slide generation #07 Mean −− 0.565 0.223 0.034 2 −− −− 3 −− 0.63 SD 1 −− −− 2 0.62 1.040 0.6 1.065 2 −− −− 3 −− 0.512 −− −− 1.7 8.052 2 −− −− 3 0.5 # Points −− 17 −− −− −− 96 # Labs 2 1 VITROS Microslide Series • Slide generation #08 Mean 0.1 −− −− 5.7 −− −− 9.37 1.32 1.04 2.26 2 1.18 SD 1 −− 0.151 0.09 CV 8.37 SD 1 −− 0.108 CV −− 69.21 18.280 CV −− 6.2. Inc.09 1.219 3 0.6 −− −− −− 20.3 # Points 521 3450 174 1004 346 2644 # Labs 17 22 6 8 11 15 Bilirubin.186 0.090 2 −− −− 3 0.67 SD 1 0.0 5.5 # Points 28 68 21 39 25 25 # Labs 3 3 2 3 3 3 VITROS Microslide Series • Slide generation #09 Mean −− 0.152 CV 11.18 14.9 −− −− 10.34 1.075 −− −− −− 1.052 0.5 7.248 CV −− 12.442 −− −− 1.469 0.3 9.090 0. Worldwide Report April 2016 Multiqual 1.150 0.4 # Points −− 83 −− −− −− 84 # Labs 2 2 VITROS Microslide Series • Slide generation #06 Mean −− 0.8 −− −− −− 15.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bicarbonate Enzymatic mEq/L Level Mon Cum Level Mon Cum Level Mon Cum Method Group • Enzymatic Mean 15.509 −− −− −− 1.1 20.489 −− −− 1.53 25.93 25. Direct/BC (DBIL) Calculated mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Mindray BS 200E/380/400/480/800/2000 Mean −− −− 1.091 −− −− −− 1.127 0.246 CV −− 18.077 3 0.2 17.00 1.38 2.4 12.9 −− −− −− 4.36 SD 1 0.29 1.5 20.22 SD 1 1.12 SD 1 −− 0.509 −− −− −− 1. Generated 22−May−2016 17:45:01 Page 73 .064 0.09 SD 1 0.7 20.088 2 −− −− 3 0.40 3 2.050 0.450 0.4 8.30 1.0 16.162 CV 19.

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Bilirubin, Direct/BC (DBIL) Calculated mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
VITROS Microslide Series • Slide generation #45
Mean −− −− −− 0.633 1.19 1.20
SD 1 −− −− 2 −− 0.124 3 0.156 0.152
CV −− −− −− 19.5 13.1 12.7
# Points −− −− −− 241 71 248
# Labs 2 2 2

VITROS Microslide Series • Slide generation #46
Mean −− 0.040 −− −− −− 1.23
SD 1 −− 0.026 2 −− −− 3 −− 0.066
CV −− 65.9 −− −− −− 5.3
# Points −− 88 −− −− −− 151
# Labs 1 1

VITROS Microslide Series • Slide generation #48
Mean −− 0.489 −− 1.04 −− 1.70
SD 1 −− 0.070 2 −− 0.068 3 −− 0.200
CV −− 14.4 −− 6.5 −− 11.8
# Points −− 173 −− 171 −− 170
# Labs 2 2 2

Method Group • Calculated
Mean 0.486 0.447 1.15 1.13 1.44 1.74
SD 1 0.120 0.169 2 0.180 0.324 3 0.405 0.584
CV 24.7 37.9 15.6 28.6 28.1 33.6
# Points 123 1026 41 1008 238 1942
# Labs 6 22 7 12 14 28

Bilirubin, Direct/BC (DBIL) Diazotization mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models)
Mean 0.311 0.312 1.55 1.56 2.66 2.66
SD 1 0.022 0.026 2 0.052 0.058 3 0.087 0.103
CV 7.2 8.4 3.3 3.7 3.3 3.9
# Points 4582 24328 3527 17682 3890 21765
# Labs 131 151 87 102 110 131

Abbott AEROSET/ARCHITECT (c, i, ci models) • Alternate Calibration
Mean 0.300 0.300 1.49 1.49 2.53 2.51
SD 1 0.000 0.000 2 0.049 0.057 3 0.066 0.089
CV 0.0 0.0 3.3 3.9 2.6 3.5
# Points 47 397 79 662 45 392
# Labs 2 2 2 2 2 2

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 0.299 0.299 1.41 1.41 2.54 2.54
SD 1 0.049 0.051 2 0.099 0.095 3 0.130 0.132
CV 16.4 16.9 7.0 6.8 5.1 5.2
# Points 3221 18906 2001 11216 2437 13903
# Labs 95 117 66 84 85 105

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Wako
Mean −− −− 1.56 1.57 2.89 2.90
SD 1 −− −− 2 0.095 0.105 3 0.170 0.187
CV −− −− 6.1 6.6 5.9 6.4
# Points −− −− 45 215 45 214
# Labs 2 2 2 2

Beckman Coulter LX20, LXi725 Chemistry Systems
Mean 0.230 0.237 1.12 1.03 1.85 1.84
SD 1 0.020 0.027 2 0.048 0.106 3 0.114 0.091
CV 8.7 11.6 4.3 10.3 6.1 4.9
# Points 24 78 19 151 46 199
# Labs 1 1 1 1 2 2

Beckman Coulter UniCel DxC Series
Mean 0.225 0.222 1.09 1.07 1.86 1.86
SD 1 0.046 0.041 2 0.077 0.077 3 0.070 0.067
CV 20.4 18.7 7.1 7.2 3.7 3.6
# Points 1093 6770 515 4146 823 4870
# Labs 36 49 22 37 26 29

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 74

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Bilirubin, Direct/BC (DBIL) Diazotization mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Dirui CS Series
Mean 0.370 0.276 1.15 1.08 1.91 1.89
SD 1 0.070 0.061 2 0.240 0.194 3 0.180 0.257
CV 18.9 22.3 20.9 18.0 9.4 13.5
# Points 10 378 15 374 11 58
# Labs 1 7 1 7 1 1

DIRUI−CS−240
Mean −− 3.00 0.890 0.814 1.83 1.43
SD 1 −− 0.000 2 0.000 0.193 3 0.000 0.203
CV −− 0.0 0.0 23.7 0.0 14.2
# Points −− 1 1 77 1 67
# Labs 1 1 1 1 1

Hitachi Chemistry Series
Mean 0.287 0.273 1.36 1.44 2.59 2.60
SD 1 0.011 0.012 2 0.066 0.068 3 0.014 0.039
CV 3.7 4.5 4.9 4.7 0.5 1.5
# Points 6 115 28 317 22 199
# Labs 1 1 2 2 1 1

Horiba ABX Pentra 400
Mean −− −− 1.37 1.37 −− −−
SD 1 −− −− 2 0.190 0.190 3 −− −−
CV −− −− 13.9 13.9 −− −−
# Points −− −− 6 6 −− −−
# Labs 1 1

ILab 600
Mean 0.240 0.240 1.26 1.26 −− −−
SD 1 0.011 0.013 2 0.074 0.064 3 −− −−
CV 4.7 5.6 5.9 5.1 −− −−
# Points 115 700 132 702 −− −−
# Labs 3 4 4 4

ILab 650
Mean 0.240 0.248 −− −− 2.00 2.00
SD 1 0.021 0.012 2 −− −− 3 0.160 0.160
CV 8.8 4.9 −− −− 8.0 8.0
# Points 21 105 −− −− 4 4
# Labs 2 2 1 1

JEOL BioMajesty JCA−BM Series
Mean −− −− 1.39 1.39 2.64 2.64
SD 1 −− −− 2 0.084 0.071 3 0.067 0.064
CV −− −− 6.1 5.1 2.5 2.4
# Points −− −− 50 129 21 48
# Labs 2 2 1 1

Mindray BS 200E/380/400/480/800/2000
Mean 0.451 0.429 1.77 1.71 −− 2.67
SD 1 0.021 0.026 2 0.156 0.134 3 −− 0.087
CV 4.7 6.1 8.8 7.9 −− 3.3
# Points 12 54 10 37 −− 84
# Labs 1 1 1 1 3

Mindray BS 200E/380/400/480/800/2000 • Alternate Formulation/Standardization
Mean −− 0.305 −− 1.53 −− 2.83
SD 1 −− 0.011 2 −− 0.066 3 −− 0.170
CV −− 3.8 −− 4.3 −− 6.0
# Points −− 20 −− 19 −− 20
# Labs 1 1 1

Roche cobas 6000/8000/c 311
Mean 0.258 0.257 1.72 1.69 2.48 2.49
SD 1 0.065 0.073 2 0.066 0.161 3 0.621 0.638
CV 25.2 28.4 3.8 9.5 25.1 25.7
# Points 792 5184 316 1912 752 5069
# Labs 29 42 8 13 23 36

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 75

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Bilirubin, Direct/BC (DBIL) Diazotization mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Roche cobas 6000/8000/c 311 • Roche BILD2 (Doumas, US/Canada)
Mean 0.204 0.207 −− −− 2.00 2.02
SD 1 0.012 0.014 2 −− −− 3 0.068 0.051
CV 5.9 6.7 −− −− 3.4 2.5
# Points 68 506 −− −− 66 506
# Labs 1 1 1 1

Roche cobas 6000/8000/c 311 • Roche BILD2 (International)
Mean 0.327 0.327 1.72 1.72 3.13 3.13
SD 1 0.015 0.017 2 0.043 0.074 3 0.125 0.133
CV 4.7 5.0 2.5 4.3 4.0 4.2
# Points 551 2009 296 1214 476 1769
# Labs 16 19 11 12 14 17

Roche cobas 6000/8000/c 311 • Roche Direct Bilirubin (Doumas)
Mean 0.211 0.204 1.64 1.49 2.56 2.20
SD 1 0.010 0.021 2 0.124 0.282 3 0.548 0.489
CV 4.8 10.4 7.5 19.0 21.4 22.2
# Points 55 1481 53 602 110 1883
# Labs 2 11 3 6 5 15

Roche cobas 6000/8000/c 311 • Roche Direct Bilirubin (Jendrassik−Grof)
Mean 0.330 0.326 1.73 1.71 3.16 3.12
SD 1 0.016 0.019 2 0.054 0.088 3 0.101 0.151
CV 4.7 5.9 3.1 5.2 3.2 4.9
# Points 495 2443 457 1581 314 2018
# Labs 22 29 19 23 14 20

Roche cobas 6000/8000/c 311 • Roche c BILD2 ACN 734/8734 (Cfas)
Mean 0.319 0.321 1.68 1.66 3.02 2.96
SD 1 0.024 0.073 2 0.111 0.186 3 0.289 0.386
CV 7.5 22.8 6.6 11.2 9.6 13.1
# Points 363 824 337 717 145 487
# Labs 10 12 9 9 5 7

Roche cobas 6000/8000/c 311 • Roche c BILD2 ACN 735/8735 (Cfas)
Mean 0.200 0.200 −− −− 2.05 2.09
SD 1 0.000 0.000 2 −− −− 3 0.070 0.072
CV 0.0 0.0 −− −− 3.4 3.5
# Points 65 480 −− −− 65 483
# Labs 2 2 2 2

Roche cobas 6000/8000/c 311 • Roche c D−BIL ACN 103
Mean 0.200 0.200 1.09 1.11 2.00 2.00
SD 1 0.000 0.000 2 0.050 0.044 3 0.070 0.071
CV 0.0 0.0 4.6 4.0 3.5 3.6
# Points 26 179 26 180 26 181
# Labs 1 1 1 1 1 1

Roche cobas 6000/8000/c 311 • Roche c DBILI ACN 006/8006
Mean 0.200 0.200 −− −− 2.03 2.08
SD 1 0.000 0.000 2 −− −− 3 0.089 0.103
CV 0.0 0.2 −− −− 4.4 4.9
# Points 121 1431 −− −− 124 1477
# Labs 4 6 4 6

Roche cobas INTEGRA
Mean 0.204 0.213 1.06 1.14 1.94 2.00
SD 1 0.040 0.047 2 0.215 0.244 3 0.062 0.101
CV 19.5 22.1 20.2 21.4 3.2 5.0
# Points 94 1004 89 853 86 883
# Labs 7 10 6 8 5 7

Roche cobas INTEGRA • Roche BILD2 (International)
Mean 0.330 0.334 1.70 1.72 −− −−
SD 1 0.000 0.014 2 0.000 0.058 3 −− −−
CV 0.0 4.2 0.0 3.4 −− −−
# Points 1 15 1 17 −− −−
# Labs 1 1 1 1

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 76

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Bilirubin, Direct/BC (DBIL) Diazotization mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Roche cobas INTEGRA • Roche Direct Bilirubin (Doumas)
Mean 0.191 0.193 1.05 1.08 1.93 1.97
SD 1 0.011 0.011 2 0.042 0.055 3 0.061 0.091
CV 5.6 5.8 4.0 5.1 3.2 4.6
# Points 145 1160 43 399 145 1163
# Labs 6 6 2 2 6 6

Roche cobas INTEGRA • Roche Direct Bilirubin (Jendrassik−Grof)
Mean 0.340 0.339 1.84 1.84 2.86 2.88
SD 1 0.010 0.018 2 0.107 0.105 3 0.055 0.061
CV 2.9 5.3 5.8 5.7 1.9 2.1
# Points 30 126 35 128 3 8
# Labs 2 4 3 3 1 1

Roche cobas INTEGRA • Roche c BILD2 ACN 734/8734 (Cfas)
Mean −− 0.337 −− −− −− 3.11
SD 1 −− 0.011 2 −− −− 3 −− 0.074
CV −− 3.2 −− −− −− 2.4
# Points −− 175 −− −− −− 175
# Labs 1 1

Roche Hitachi Systems (International)
Mean 0.216 0.236 1.34 1.40 2.63 2.65
SD 1 0.009 0.025 2 0.150 0.159 3 0.209 0.207
CV 4.3 10.6 11.2 11.3 7.9 7.8
# Points 30 153 216 1325 167 991
# Labs 1 2 11 14 9 10

Roche Hitachi Systems (International) • DiaSys Diagnostic Systems
Mean −− −− 1.61 1.62 −− −−
SD 1 −− −− 2 0.020 0.028 3 −− −−
CV −− −− 1.2 1.8 −− −−
# Points −− −− 20 112 −− −−
# Labs 1 1

Roche MODULAR (ISE, D, P, E170)
Mean 0.320 0.329 1.69 1.71 2.95 3.05
SD 1 0.018 0.018 2 0.081 0.071 3 0.073 0.090
CV 5.6 5.4 4.8 4.2 2.5 3.0
# Points 129 932 129 939 63 513
# Labs 9 10 9 10 3 3

Roche MODULAR (ISE, D, P, E170) • Roche Direct Bilirubin (Doumas)
Mean −− 0.318 −− −− −− 3.12
SD 1 −− 0.018 2 −− −− 3 −− 0.079
CV −− 5.7 −− −− −− 2.5
# Points −− 34 −− −− −− 34
# Labs 1 1

Roche MODULAR (ISE, D, P, E170) • Roche Direct Bilirubin (Jendrassik−Grof)
Mean −− 0.316 −− −− −− 3.13
SD 1 −− 0.013 2 −− −− 3 −− 0.074
CV −− 4.0 −− −− −− 2.4
# Points −− 42 −− −− −− 42
# Labs 1 1

Roche MODULAR (ISE, D, P, E170) • Roche Hitachi MODULAR, BILD2 ACN 734
Mean −− 0.325 −− 1.72 −− −−
SD 1 −− 0.011 2 −− 0.078 3 −− −−
CV −− 3.5 −− 4.6 −− −−
# Points −− 36 −− 19 −− −−
# Labs 2 2

Roche MODULAR (ISE, D, P, E170) • Roche c BILD2 ACN 734/8734 (Cfas)
Mean 0.331 0.324 1.69 1.68 −− −−
SD 1 0.024 0.019 2 0.092 0.061 3 −− −−
CV 7.2 6.0 5.4 3.6 −− −−
# Points 85 375 82 366 −− −−
# Labs 3 3 3 3

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 77

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Bilirubin, Direct/BC (DBIL) Diazotization mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Siemens ADVIA Chemistry Systems
Mean 0.320 0.327 1.67 1.64 3.11 3.03
SD 1 0.028 0.036 2 0.112 0.113 3 0.183 0.187
CV 8.9 11.1 6.7 6.9 5.9 6.2
# Points 93 438 137 1074 128 802
# Labs 4 6 8 12 7 9

Siemens ADVIA Chemistry Systems • Lachema
Mean −− −− −− −− −− 2.86
SD 1 −− −− 2 −− −− 3 −− 0.043
CV −− −− −− −− −− 1.5
# Points −− −− −− −− −− 25
# Labs 2

Siemens Dimension Series
Mean 0.204 0.204 1.11 1.11 2.01 2.00
SD 1 0.025 0.026 2 0.068 0.064 3 0.079 0.089
CV 12.0 12.9 6.1 5.7 3.9 4.4
# Points 2569 18692 1590 10223 1943 15948
# Labs 81 109 46 59 65 92

Siemens Dimension Series • Siemens Dimension DBI (REF DF125)
Mean 0.203 0.203 1.10 1.11 2.01 2.01
SD 1 0.023 0.030 2 0.047 0.067 3 0.089 0.102
CV 11.6 14.9 4.3 6.1 4.4 5.1
# Points 2807 22241 834 7658 2538 20051
# Labs 94 127 26 43 87 114

Siemens Dimension Vista
Mean 0.207 0.211 1.10 1.12 1.99 2.00
SD 1 0.025 0.027 2 0.049 0.057 3 0.077 0.081
CV 12.3 12.6 4.5 5.1 3.9 4.1
# Points 5371 54064 1963 19954 5207 51092
# Labs 152 207 52 73 145 200

Siemens Dimension Vista • Siemens Dimension DBI (REF DF125)
Mean 0.204 0.209 1.04 1.09 1.99 2.00
SD 1 0.019 0.045 2 0.062 0.068 3 0.062 0.236
CV 9.5 21.3 6.0 6.3 3.1 11.8
# Points 1575 15947 682 6396 1511 13987
# Labs 39 56 12 23 37 54

Toshiba TBA−120FR
Mean −− −− 1.58 1.51 2.97 2.86
SD 1 −− −− 2 0.141 0.118 3 0.135 0.170
CV −− −− 8.9 7.8 4.5 5.9
# Points −− −− 42 278 40 310
# Labs 1 1 1 1

Toshiba TBA−40FR (Accute)
Mean −− −− −− −− −− 2.88
SD 1 −− −− 2 −− −− 3 −− 0.057
CV −− −− −− −− −− 2.0
# Points −− −− −− −− −− 140
# Labs 2

Toshiba−TBA
Mean −− −− −− 1.57 −− −−
SD 1 −− −− 2 −− 0.037 3 −− −−
CV −− −− −− 2.4 −− −−
# Points −− −− −− 27 −− −−
# Labs 1

VITROS Microslide Series • Slide generation #99
Mean 0.517 0.513 −− −− 1.67 1.67
SD 1 0.046 0.071 2 −− −− 3 0.210 0.218
CV 8.8 13.8 −− −− 12.6 13.0
# Points 37 102 −− −− 35 99
# Labs 2 2 2 2

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 78

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Bilirubin, Direct/BC (DBIL) Diazotization mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Method Group • Diazotization
Mean 0.249 0.239 1.35 1.30 2.26 2.20
SD 1 0.060 0.058 2 0.249 0.238 3 0.388 0.364
CV 24.2 24.3 18.5 18.3 17.1 16.6
# Points 24586 182K 13697 90999 21244 161K
# Labs 759 1005 422 563 667 883

Bilirubin, Direct/BC (DBIL) Direct measure mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 0.300 0.299 1.46 1.44 2.54 2.53
SD 1 0.000 0.007 2 0.069 0.062 3 0.092 0.092
CV 0.0 2.5 4.7 4.3 3.6 3.6
# Points 41 182 20 114 41 182
# Labs 2 2 1 1 2 2

VITROS Microslide Series • Slide generation #04
Mean −− −− −− 0.760 −− 1.12
SD 1 −− −− 2 −− 0.043 3 −− 0.067
CV −− −− −− 5.7 −− 6.0
# Points −− −− −− 15 −− 15
# Labs 1 1

VITROS Microslide Series • Slide generation #07
Mean 0.075 0.075 0.836 0.797 1.33 1.32
SD 1 0.051 0.051 2 0.051 0.091 3 0.091 0.127
CV 68.7 68.7 6.1 11.4 6.8 9.6
# Points 29 29 29 141 29 136
# Labs 1 1 1 1 1 1

VITROS Microslide Series • Slide generation #09
Mean −− −− −− 0.842 −− 1.24
SD 1 −− −− 2 −− 0.066 3 −− 0.073
CV −− −− −− 7.8 −− 5.9
# Points −− −− −− 80 −− 67
# Labs 1 1

VITROS Microslide Series • Slide generation #99
Mean 0.608 0.556 −− 1.14 1.62 1.78
SD 1 0.093 0.112 2 −− 0.103 3 0.132 0.259
CV 15.3 20.2 −− 9.0 8.1 14.6
# Points 19 76 −− 54 8 21
# Labs 3 3 2 3 4

Method Group • Direct measure
Mean 0.292 0.345 1.09 1.08 2.00 1.96
SD 1 0.199 0.156 2 0.313 0.302 3 0.591 0.612
CV 68.2 45.1 28.8 28.1 29.6 31.2
# Points 89 287 49 324 78 354
# Labs 6 6 2 5 6 8

Bilirubin, Direct/BC (DBIL) Oxidation by Nitrite mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Mindray BS 200E/380/400/480/800/2000
Mean −− 0.271 −− 1.40 −− 2.49
SD 1 −− 0.015 2 −− 0.055 3 −− 0.229
CV −− 5.7 −− 3.9 −− 9.2
# Points −− 18 −− 45 −− 46
# Labs 1 1 1

Method Group • Oxidation by Nitrite
Mean −− 0.271 −− 1.40 −− 2.49
SD 1 −− 0.015 2 −− 0.055 3 −− 0.229
CV −− 5.7 −− 3.9 −− 9.2
# Points −− 18 −− 45 −− 46
# Labs 1 1 1

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 79

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Bilirubin, Direct/BC (DBIL) Spectrophotometric mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
VITROS Microslide Series
Mean 0.560 0.429 −− 0.790 −− −−
SD 1 0.000 0.080 2 −− 0.000 3 −− −−
CV 0.0 18.7 −− 0.0 −− −−
# Points 1 7 −− 1 −− −−
# Labs 1 2 1

VITROS Microslide Series • Slide generation #01
Mean 0.012 0.150 1.02 0.810 1.32 1.36
SD 1 0.011 0.128 2 0.150 0.126 3 0.138 0.579
CV 93.3 85.5 14.7 15.5 10.4 42.5
# Points 16 203 13 341 30 238
# Labs 1 6 1 5 2 5

VITROS Microslide Series • Slide generation #02
Mean −− 0.048 −− 0.785 −− 1.03
SD 1 −− 0.029 2 −− 0.056 3 −− 0.139
CV −− 60.5 −− 7.2 −− 13.5
# Points −− 24 −− 31 −− 117
# Labs 3 3 2

VITROS Microslide Series • Slide generation #03
Mean −− 0.038 0.855 0.784 1.34 1.23
SD 1 −− 0.002 2 0.063 0.110 3 0.087 0.143
CV −− 6.0 7.3 14.1 6.5 11.6
# Points −− 2 30 261 30 277
# Labs 1 1 4 1 6

VITROS Microslide Series • Slide generation #04
Mean −− 0.057 0.722 0.778 1.13 1.18
SD 1 −− 0.056 2 0.107 0.092 3 0.062 0.106
CV −− 99.8 14.8 11.9 5.5 9.0
# Points −− 286 24 633 24 879
# Labs 12 2 15 2 18

VITROS Microslide Series • Slide generation #05
Mean −− 0.088 0.697 0.739 −− 1.10
SD 1 −− 0.048 2 0.079 0.103 3 −− 0.156
CV −− 55.0 11.4 14.0 −− 14.1
# Points −− 219 59 2010 −− 1712
# Labs 7 2 22 21

VITROS Microslide Series • Slide generation #06
Mean 0.037 0.042 0.793 0.780 1.30 1.29
SD 1 0.035 0.046 2 0.076 0.068 3 0.075 0.106
CV 94.4 110.2 9.6 8.8 5.8 8.2
# Points 70 425 110 2531 192 3116
# Labs 6 15 4 23 9 31

VITROS Microslide Series • Slide generation #07
Mean −− 0.017 −− 0.675 1.14 1.17
SD 1 −− 0.055 2 −− 0.057 3 0.080 0.163
CV −− 336.0 −− 8.5 7.0 13.8
# Points −− 129 −− 71 29 384
# Labs 2 1 1 3

VITROS Microslide Series • Slide generation #08
Mean 0.006 0.053 0.740 0.771 1.23 1.28
SD 1 0.025 0.136 2 0.085 0.083 3 0.129 0.104
CV 387.1 255.3 11.4 10.7 10.5 8.2
# Points 47 288 66 390 86 671
# Labs 4 8 4 10 3 9

VITROS Microslide Series • Slide generation #09
Mean 0.097 0.095 0.821 0.810 1.24 1.22
SD 1 0.057 0.125 2 0.099 0.103 3 0.118 0.127
CV 59.1 131.3 12.0 12.7 9.6 10.4
# Points 88 531 553 2394 477 1983
# Labs 6 14 24 29 22 28

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 80

2 6.072 0.051 CV −− −− −− 8.081 CV −− −− −− −− −− 8.022 2 0.076 3 −− −− CV −− −− −− 13.083 0.059 0.106 0.706 0.701 −− 0.13 SD 1 −− −− 2 −− 0. Generated 22−May−2016 17:45:01 Page 81 .3 6.063 3 −− 0.1 # Points −− −− −− 143 −− 140 # Labs 1 1 VITROS Microslide Series • Slide generation #39 Mean −− 0.8 117.25 1.966 SD 1 −− −− 2 −− −− 3 −− 0. Inc.8 12. Direct/BC (DBIL) Spectrophotometric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #10 Mean 0.084 CV −− −− −− 10.669 SD 1 −− −− 2 −− 0.100 CV −− −− −− −− −− 12.820 SD 1 −− −− 2 −− −− 3 −− 0.000 2 −− −− 3 −− 0.5 # Points −− −− −− 136 −− 136 # Labs 1 1 VITROS Microslide Series • Slide generation #27 Mean −− −− −− 0.700 −− −− SD 1 −− −− 2 −− 0.068 CV −− −− −− 9.085 3 0.099 0.789 1.099 CV 119.800 0.4 8.8 12.0 # Points 138 274 217 702 250 771 # Labs 8 12 10 11 11 15 VITROS Microslide Series • Slide generation #11 Mean 0.2. Worldwide Report April 2016 Multiqual 1.24 SD 1 0.16 SD 1 0.513 −− 1.070 2 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.15 1.6 79.762 −− 0.020 0.063 3 −− 0.3 # Points −− −− −− 127 −− 134 # Labs 1 1 VITROS Microslide Series • Slide generation #35 Mean −− −− −− −− −− 0.4 # Points −− −− −− −− −− 142 # Labs 1 VITROS Microslide Series • Slide generation #37 Mean −− −− −− 0.091 CV −− 0.560 −− −− SD 1 −− −− 2 −− 0.030 −− −− −− 0.700 SD 1 −− −− 2 −− 0.0 −− −− −− 10.026 0.2 # Points −− −− −− −− −− 16 # Labs 1 VITROS Microslide Series • Slide generation #33 Mean −− −− −− 0.028 0.696 1.2 −− 7.083 3 0.907 SD 1 −− 0.0 −− 7.076 CV 76.6 −− −− # Points −− −− −− 16 −− −− # Labs 1 VITROS Microslide Series • Slide generation #32 Mean −− −− −− −− −− 0.062 0.5 8.5 8.3 10.000 3 −− −− CV −− −− −− 0.051 3 −− 0.1 # Points −− 1 −− −− −− 152 # Labs 1 1 Copyright © 2015 Bio−Rad Laboratories.069 0.5 # Points 15 17 138 223 218 326 # Labs 2 2 6 8 8 8 VITROS Microslide Series • Slide generation #12 Mean −− −− −− 0.1 −− 10.0 −− −− # Points −− −− −− 4 −− −− # Labs 2 VITROS Microslide Series • Slide generation #23 Mean −− −− −− 0.

8 # Points 411 2617 1241 10795 1367 12050 # Labs 31 93 56 146 61 165 Bilirubin.747 0.06 SD 1 0.58 2.094 CV −− 45.123 CV 12.5 4.137 0.080 CV −− −− 2.094 3 −− 0.8 # Points −− −− 12 158 12 157 # Labs 2 2 2 2 Abbott AEROSET/ARCHITECT (c.770 1.23 1.075 0.1 13.7 # Points −− −− 8 27 9 28 # Labs 1 1 1 1 Copyright © 2015 Bio−Rad Laboratories.5 2.4 −− −− −− 7.117 CV −− −− 3.049 0.3 # Points 13 30 −− −− −− 11 # Labs 1 4 3 Method Group • Spectrophotometric Mean 0.9 # Points 23 104 31 339 31 357 # Labs 2 2 2 3 2 3 VITROS Microslide Series • Slide generation #44 Mean −− 0.037 3 0.14 1. Inc.090 0.2 −− 8.3 30.791 0.189 CV 173.079 0.131 CV −− −− −− 11.5 2.052 CV −− −− −− 7.3 20. i.041 0.34 2.3 # Points −− −− −− −− −− 7 # Labs 1 VITROS Microslide Series • Slide generation #99 Mean 0. Direct/BC (DBIL) Spectrophotometric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #43 Mean 0. ci models) • Alternate Formulation/Standardization Mean −− −− 1.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.0 −− 4.4 13.019 0.7 2. ci models) Mean −− −− 1.19 SD 1 0.709 −− 1.8 −− 10.53 1.036 2 −− 0.127 0. i.730 0.09 SD 1 −− −− 2 −− 0.036 −− 0.9 4.52 SD 1 −− −− 2 0.11 SD 1 −− −− 2 −− −− 3 −− 0.022 2 −− 0.4 2.3 10.041 0.17 SD 1 −− 0.4 55. Worldwide Report April 2016 Multiqual 1.183 2 −− −− 3 −− 0. Generated 22−May−2016 17:45:01 Page 82 .8 # Points −− −− −− 140 −− 142 # Labs 1 1 VITROS Microslide Series • Slide generation #48 Mean −− 0.038 0.104 0.221 CV 45.830 −− 1.2 −− 13.15 SD 1 −− 0.100 3 0.3 15.80 SD 1 −− −− 2 0.060 3 −− 0.3 # Points −− 77 −− 227 −− 264 # Labs 2 3 4 VITROS Microslide Series • Slide generation #49 Mean −− −− −− −− −− 1.9 # Points −− −− −− 75 −− 75 # Labs 1 1 VITROS Microslide Series • Slide generation #47 Mean −− −− −− 0.023 2 0.047 0.68 SD 1 0.795 −− 1.033 3 0.52 2.050 3 −− 0.2.082 3 −− 0.7 151.076 0.1 # Points −− 5 −− 13 −− 17 # Labs 1 1 2 VITROS Microslide Series • Slide generation #46 Mean −− −− −− 0.153 CV −− 62.716 1.103 CV −− −− −− −− −− 9.34 1.79 2.1 4.025 0.5 −− 7.114 2 0.8 3.072 3 0. Direct/BC (DBIL) Vanadate Oxidation mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.0 9.32 SD 1 −− −− 2 −− 0.8 −− 9.114 0.801 −− 1.602 −− −− −− 1.080 −− 0.

301 1.020 3 −− 0.019 3 −− 0.048 0.68 3. Generated 22−May−2016 17:45:01 Page 83 .38 −− 2.012 2 0.2.94 SD 1 0.014 2 −− −− 3 −− 0.44 2.4 3.5 4.9 3.1 −− 1.9 4.043 3 0.268 −− −− −− 3.2 9.0 # Points −− −− −− 40 −− 49 # Labs 1 1 JEOL BioMajesty JCA−BM Series • Zhong Sheng Mean −− −− −− 1.94 SD 1 0.230 0.2 −− −− 2.9 6.021 2 −− −− 3 0. ci models) • PROLABS Mean −− 0.6 2.54 SD 1 −− −− 2 −− 0.297 −− 1.0 2.341 0.091 CV −− 5.45 1.91 2.7 0.230 −− −− 2.39 −− 2.073 CV 9.28 SD 1 −− −− 2 −− 0.1 # Points 60 122 −− −− 60 122 # Labs 1 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Wako Mean 0.282 0.9 2.96 2.48 SD 1 0. Inc.144 0.5 −− 1.9 10.8 # Points −− 58 −− 54 −− 54 # Labs 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean −− −− 1.073 0.010 2 −− −− 3 0.023 CV −− −− −− 1. Direct/BC (DBIL) Vanadate Oxidation mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.48 2.11 SD 1 0.9 # Points −− 190 −− −− −− 187 # Labs 1 1 Hitachi Chemistry Series • MAKER Mean −− −− −− 1.072 CV 3.50 2.069 0.2 4.285 −− −− 2.23 −− 2.93 1.157 CV −− −− 5.081 0.36 1.137 CV 10. LXi725 Chemistry Systems • LEADMAN Mean −− −− 1.3 −− −− −− 2.5 −− 6.14 3.012 0.93 SD 1 −− −− 2 0.081 3 0.066 CV −− 8. Worldwide Report April 2016 Multiqual 1.297 0.33 SD 1 −− 0.035 2 0.5 −− −− 1.089 0.1 3.334 1.155 CV −− −− −− 1.9 # Points 149 149 −− −− 150 150 # Labs 3 3 3 3 Beckman Coulter LX20.043 0.5 5.4 # Points 4309 24002 2893 16266 2877 16803 # Labs 113 147 85 117 83 109 Copyright © 2015 Bio−Rad Laboratories.44 2.3 # Points −− −− 21 185 12 109 # Labs 2 2 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beijing Bai Tai Mean 0.021 0.014 CV −− −− 3.050 0.8 4.014 0.061 CV 2.3 2.024 2 −− 0.18 SD 1 −− 0.22 1.1 # Points −− −− −− 44 −− 34 # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean 0.9 6.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.69 1.22 1.008 0. i.7 # Points −− −− 3 3 3 3 # Labs 1 1 1 1 Beckman Coulter UniCel DxC Series • Beijing Bai Tai Mean −− 0.037 0.4 −− 2.48 SD 1 −− −− 2 0.142 0.5 3.092 3 0.5 0.021 3 −− 0.4 # Points 44 269 20 123 26 154 # Labs 3 3 1 1 2 2 Siemens ADVIA Chemistry Systems Mean 0.4 5.045 3 0.

054 2 0.6 4.336 0.6 4.76 1.209 0.1 # Points 25 773 14 363 39 1051 # Labs 2 8 1 4 3 8 Copyright © 2015 Bio−Rad Laboratories.0 1. Indirect/BU Direct measure mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #01 Mean −− 0.93 SD 1 −− 0.9 4.75 4.248 CV −− 92.3 # Points −− 306 63 1602 −− 1350 # Labs 9 2 18 18 VITROS Microslide Series • Slide generation #06 Mean 0.8 # Points −− 144 32 432 32 277 # Labs 5 2 6 2 4 VITROS Microslide Series • Slide generation #02 Mean −− 0.150 CV −− 19.174 1.130 0.2.0 74.2 8.114 0.6 2. Generated 22−May−2016 17:45:01 Page 84 .4 3.316 −− 1.94 5. Worldwide Report April 2016 Multiqual 1.037 0.70 SD 1 −− 0.060 1.9 1.052 0.2 4.78 4.91 5.5 11.219 CV −− 82.49 −− 2.6 5.060 0.05 5.86 1.96 1.98 1.173 CV 12.042 0.0 3.2 4.036 CV −− −− 4.109 0.2 4.09 1.6 3.099 1.025 3 −− 0. Inc.118 2 0.0 −− 1.107 2 0.332 1.07 SD 1 0.053 3 0.07 4.0 7.00 SD 1 −− 0.8 3.07 −− 5.093 −− 2.09 SD 1 0.086 3 −− 0.0 # Points −− 444 20 647 20 962 # Labs 12 1 14 1 20 VITROS Microslide Series • Slide generation #05 Mean −− 0.92 1.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.93 4.070 0.485 1.3 42.088 3 0.96 SD 1 −− −− 2 0.67 3.098 0.5 6.5 # Points −− 43 30 263 30 294 # Labs 4 1 4 1 7 VITROS Microslide Series • Slide generation #04 Mean −− 0. Direct/BC (DBIL) Vanadate Oxidation mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens ADVIA Chemistry Systems • LEADMAN Mean −− −− 1.4 −− 4.4 # Points −− 22 −− 23 −− 12 # Labs 1 1 1 Method Group • Vanadate Oxidation Mean 0.1 6.98 4.9 5.2 −− 3.261 CV −− 61.095 3 0.036 2 0.098 3 0.064 CV −− 4.208 CV 14.6 # Points 4562 24811 2953 16900 3146 17839 # Labs 120 157 92 128 94 125 Bilirubin.018 2 −− 0.94 1.075 0.042 2 0.93 5.0 −− 5.04 SD 1 0.7 −− 2.092 3 0.3 3.016 0.212 0.053 0.0 5.127 0.68 1.1 3.1 3.83 SD 1 −− 0.91 5.93 −− 4.05 SD 1 −− 0.116 3 −− 0.054 0.97 SD 1 −− 0.142 3 0.241 CV −− 187.8 # Points −− −− 4 4 6 6 # Labs 1 1 1 1 Tokyo Boeki BIOLIS 50i Mean −− 0.036 0.09 3.09 1.8 1.170 0.030 0.9 # Points 81 635 81 2306 169 2849 # Labs 6 17 3 20 8 27 VITROS Microslide Series • Slide generation #07 Mean 0.908 2 0.1 2.143 1.195 CV 71.072 1.9 5.174 0.82 1.013 2 −− 0.142 3 0.8 5.8 5.055 2 0.7 7.0 # Points −− 66 −− 31 −− 65 # Labs 1 3 1 VITROS Microslide Series • Slide generation #03 Mean −− 0.

4 47.9 3.048 2 0.08 SD 1 0.0 2.0 4.055 0.135 0.4 5.160 CV −− −− −− 3.011 2 −− −− 3 −− 0.9 # Points 116 156 131 195 182 267 # Labs 4 4 6 6 6 6 VITROS Microslide Series • Slide generation #12 Mean −− −− −− 1.85 SD 1 −− 0.083 3 0.146 0.8 # Points 180 787 530 2491 587 2210 # Labs 10 16 24 30 23 29 VITROS Microslide Series • Slide generation #10 Mean 0.096 1.1 # Points −− 86 −− 104 −− 111 # Labs 1 1 1 VITROS Microslide Series • Slide generation #35 Mean −− 0.96 −− 5.05 5.87 1.045 1.010 2 −− −− 3 −− 0.03 1.098 0.027 2 0.9 # Points −− 13 −− −− −− 16 # Labs 1 1 VITROS Microslide Series • Slide generation #33 Mean −− 0.1 2.8 −− −− # Points −− −− −− 16 −− −− # Labs 1 VITROS Microslide Series • Slide generation #32 Mean −− 0.216 CV 40.083 3 0.5 4.050 3 −− −− CV −− −− −− 2.036 2.89 4.90 1.073 2 0.1 −− −− −− 4.074 3 −− −− CV −− −− −− 3.216 −− −− −− 4.6 # Points 40 384 64 396 85 654 # Labs 3 7 3 8 2 6 VITROS Microslide Series • Slide generation #09 Mean 0.038 2 0.2 −− −− −− 2.86 SD 1 0.87 4.2 4.093 0.243 0.4 59.033 0.048 0.92 −− −− SD 1 −− −− 2 −− 0.16 −− 5.6 3.2 4.2.093 3 0.088 0.140 CV −− 6.06 SD 1 0.200 0.9 −− 14.041 0.181 CV 267.130 3 0.93 −− −− SD 1 −− −− 2 −− 0.89 4.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.297 −− 2.7 7.099 1.78 SD 1 −− 0.305 3 −− 0.063 3 −− 0.9 5.160 −− −− −− 4.119 0.87 4.202 CV −− 5.95 5. Generated 22−May−2016 17:45:01 Page 85 .132 0.2 2. Inc.9 108.1 6.013 0.192 CV 38.112 CV −− 3.1 −− 2.25 SD 1 −− 0.9 76. Indirect/BU Direct measure mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #08 Mean 0.18 SD 1 −− −− 2 −− 0.0 3.1 # Points −− −− −− 136 −− 136 # Labs 1 1 VITROS Microslide Series • Slide generation #27 Mean −− −− −− 1.4 # Points 138 341 193 579 238 638 # Labs 7 10 9 10 10 13 VITROS Microslide Series • Slide generation #11 Mean 0.141 CV 67.95 1.7 4.97 5.036 0.012 2 −− 0.2 # Points −− 108 −− −− −− 108 # Labs 1 1 Copyright © 2015 Bio−Rad Laboratories.89 SD 1 0.8 4. Worldwide Report April 2016 Multiqual 1.6 −− −− # Points −− −− −− 4 −− −− # Labs 2 VITROS Microslide Series • Slide generation #23 Mean −− −− −− 1.028 0.2 −− 3.11 5.

Indirect/BU Direct measure mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #37 Mean −− 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.015 2 −− −− 3 −− 0.029 2 −− 0.15 SD 1 0.5 −− 2.01 SD 1 −− −− 2 −− 0.016 2 −− −− 3 −− 0.5 1.114 3 0.9 −− 3.7 # Points −− 135 −− 186 −− 135 # Labs 2 1 1 VITROS Microslide Series • Slide generation #39 Mean −− 0.20 SD 1 −− 0.084 0.6 −− 3.99 SD 1 −− 0.13 SD 1 −− −− 2 0.181 CV −− 29.01 5.0 −− 3.062 0. Worldwide Report April 2016 Multiqual 1.547 CV −− 38.8 # Points −− −− −− 135 −− 135 # Labs 1 1 VITROS Microslide Series • Slide generation #48 Mean −− 0.189 CV −− 8.23 SD 1 −− 0.9 −− 3.2 −− 4.3 −− 2.7 2.24 4.99 1.125 2 0.077 3 −− 0.138 CV −− −− −− 3.2.2 1.030 0.8 −− −− −− 3.4 # Points −− 126 −− 75 −− 227 # Labs 1 1 2 VITROS Microslide Series • Slide generation #47 Mean −− −− −− 1.97 2.00 −− 4.99 5.023 0.98 −− 5.149 CV −− −− −− 3.066 −− 1.0 # Points −− 5 −− −− −− 4 # Labs 1 1 VITROS Microslide Series • Slide generation #45 Mean −− 0.7 # Points −− 94 −− −− −− 102 # Labs 1 1 VITROS Microslide Series • Slide generation #40 Mean −− −− 1.192 1.14 5.141 CV −− 14.7 65.00 −− 5.2 # Points −− −− 35 35 49 146 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #43 Mean 0.0 # Points −− 70 −− −− 71 425 # Labs 1 2 2 VITROS Microslide Series • Slide generation #46 Mean −− 0.114 3 −− 0.2 −− −− −− 3.030 3 0.063 2 −− 0.083 0.151 CV −− 8.83 −− 5.0 # Points −− −− −− 29 −− 41 # Labs 1 1 Copyright © 2015 Bio−Rad Laboratories.167 −− −− −− 5.6 11.95 SD 1 −− 0. Inc.040 2 −− −− 3 0.2 −− 6.15 SD 1 −− 0.5 1.059 3 −− 0.30 −− 5.070 3 −− 0.097 −− 2.02 5.047 0.00 SD 1 −− −− 2 −− 0.071 3 −− 0.7 1.427 −− 2.6 # Points −− 228 −− 310 −− 349 # Labs 3 3 4 VITROS Microslide Series • Slide generation #49 Mean −− −− −− 2.015 2 −− 0.060 CV −− −− 1.4 5.96 SD 1 −− 0. Generated 22−May−2016 17:45:01 Page 86 .105 −− −− 5.232 CV −− 23.4 2.149 CV 27.1 −− −− 3.9 # Points 31 212 31 378 31 369 # Labs 2 3 2 3 2 3 VITROS Microslide Series • Slide generation #44 Mean −− 0.187 0.190 −− −− −− 4.

3 4.8 4.099 2.19 6.63 −− 6.1 −− 3.016 0.9 3.146 CV −− 31.67 6.0 70.2 1.022 2 0.4 4.05 6.8 4.1 22.7 2. Worldwide Report April 2016 Multiqual 1.100 0.021 2 −− −− 3 −− 0.6 4.4 5.61 2.130 3 0.69 SD 1 −− 0.274 0.087 2.9 2.8 4.33 SD 1 −− 0.18 SD 1 −− 0.19 SD 1 0.160 0.050 0.4 154.080 −− 2.102 0.133 CV 11.6 # Points 24 60 −− 376 23 488 # Labs 1 1 5 1 6 VITROS Microslide Series • Slide generation #07 Mean 0.60 2.326 −− 2.4 # Points −− 27 20 160 20 285 # Labs 3 1 3 1 7 VITROS Microslide Series • Slide generation #05 Mean −− −− −− 2.016 2 0.052 0.99 5.08 SD 1 −− −− 2 −− 0.4 # Points −− 62 −− −− −− 61 # Labs 1 1 VITROS Microslide Series • Slide generation #09 Mean 0.125 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.8 2.35 6.8 25.0 −− 4.70 6.8 48.124 3 0.2 5.8 3.097 2.030 2 0.207 0.5 −− −− −− 1.046 2 −− 0.02 SD 1 0.101 0.242 CV 62.098 3 0.4 # Points 173 491 78 210 307 765 # Labs 8 11 3 5 9 12 Method Group • Direct measure Mean 0.8 # Points 784 5642 1302 10923 1840 13682 # Labs 42 118 58 144 70 171 Bilirubin.1 2.143 3 −− 0.042 2 0.200 CV 25.3 # Points −− −− −− 276 −− 209 # Labs 4 4 VITROS Microslide Series • Slide generation #06 Mean 0.180 2 0.0 5. Inc.75 6.2 # Points 24 542 16 93 37 610 # Labs 2 4 1 1 3 4 VITROS Microslide Series • Slide generation #08 Mean −− 0.081 3 0.116 0.18 6.104 3 0.5 1.086 0.9 # Points −− 10 −− 6 −− 78 # Labs 2 1 2 VITROS Microslide Series • Slide generation #04 Mean −− 0.021 0.062 0.3 3.142 0.089 CV −− 26.93 1.050 0.013 0.078 −− −− −− 6.067 2 −− 0.61 2.99 SD 1 0.6 −− 3.01 4.267 CV 59.142 CV −− −− −− 5.062 2.057 0.355 CV 20.2 −− 2.1 45.036 2 −− 0.63 6. Generated 22−May−2016 17:45:01 Page 87 .122 0.90 4.00 2.2 6.75 −− −− SD 1 0.117 1.2 # Points 8 8 63 240 181 414 # Labs 2 2 4 4 7 7 Copyright © 2015 Bio−Rad Laboratories.7 2.2.096 −− 2.119 3 0.29 SD 1 0.089 3 −− −− CV 0. Neonatal/NBIL Calculated mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series Mean 0.080 0.37 −− 5.061 0.4 −− 2.16 SD 1 0.167 CV −− 14.000 0. Indirect/BU Direct measure mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #99 Mean 0.0 2.229 0.6 5.94 4.2 −− −− # Points 1 9 −− 4 −− −− # Labs 1 2 2 VITROS Microslide Series • Slide generation #03 Mean −− 0.099 3 −− 0.

179 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.002 2 −− −− 3 −− 0.7 1.2 # Points −− −− 17 535 17 497 # Labs 5 5 5 5 Roche cobas INTEGRA • Alternate Formulation/Standardization Mean −− 0.4 24.9 # Points 3 54 13 111 13 102 # Labs 1 1 1 1 1 1 VITROS Microslide Series • Slide generation #34 Mean −− −− −− 2.13 6.119 2 0.500 −− 2.82 −− 6.4 3.3 6.182 CV −− −− −− 3.081 0.2 36.3 0.144 3 0.6 7.011 CV −− 7.120 2.075 −− −− −− −− SD 1 −− 0.5 4.217 0.225 0.045 2 0.57 5.050 0.8 −− 2.029 2 0.092 3 −− 0.021 2 −− −− 3 0.125 CV 35.6 3.100 0.104 0.020 0.030 3.19 6. Total/TBIL Calculated mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Mindray BS 200E/380/400/480/800/2000 Mean −− −− 3.030 −− −− −− 0.002 2 0.7 # Points 11 20 32 43 15 27 # Labs 1 2 2 2 2 2 Method Group • Calculated Mean 0.056 0.96 SD 1 0.082 3 −− 0.8 # Points −− 18 −− −− −− 18 # Labs 1 1 Method Group • Calculated Mean −− 0.17 SD 1 0.2 # Points −− 18 17 535 17 497 # Labs 1 5 5 5 5 Copyright © 2015 Bio−Rad Laboratories.54 SD 1 −− −− 2 −− 0.219 2.3 −− −− −− 2.104 0.6 5.56 2.00 7. Inc.018 0.6 −− −− 2.3 2.9 # Points −− 45 −− 45 −− 45 # Labs 1 1 1 VITROS Microslide Series • Slide generation #17 Mean −− 0.020 0.13 3.235 CV 12.23 7.23 7.4 3.122 0.2.254 CV 76.95 5.159 CV −− −− 0.2 7.97 2.7 3.0 2.6 3.24 SD 1 −− 0.7 1.300 0.2 3.0 3.5 2.63 6.058 −− −− 6.1 # Points 103 920 144 1320 321 2350 # Labs 9 21 9 24 16 36 Bilirubin.69 2.69 6. Generated 22−May−2016 17:45:01 Page 88 .0 7.094 3 0.9 −− 2. Neonatal/NBIL Calculated mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #11 Mean 0.120 3 0.5 2.159 CV −− 7.13 3.205 0.5 46.3 −− 2.91 −− 6.026 2 −− −− 3 −− −− CV −− 35.55 SD 1 0.8 # Points −− −− −− 11 −− 9 # Labs 1 1 VITROS Microslide Series • Slide generation #43 Mean −− 0.098 2.220 0.436 CV 33.24 SD 1 −− −− 2 0.14 SD 1 0.0 −− −− −− −− # Points −− 63 −− −− −− −− # Labs 2 VITROS Microslide Series • Slide generation #47 Mean 0.400 SD 1 −− 0.106 0.0 # Points 32 65 −− −− 32 67 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #30 Mean 0.49 SD 1 −− 0. Worldwide Report April 2016 Multiqual 1.006 0.3 54.94 6.188 CV −− 5.00 7.030 2 −− 0.120 3 0.216 3 0.047 0.

4 3.78 SD 1 0.388 SD 1 0.004 2 0.90 SD 1 0.73 6.003 0.58 5.173 0.75 6.563 −− 3.2 4.537 2.8 # Points −− −− 22 197 22 197 # Labs 1 1 1 1 Mindray BS 200E/380/400/480/800/2000 • Alternate Formulation/Standardization Mean −− 0.660 3.8 5.534 −− 3.4 1.4 13.6 18.015 CV 10.162 3 0.107 0.384 0. Generated 22−May−2016 17:45:01 Page 89 .006 0.100 0.2 4.4 −− 4.5 3.121 3 0.6 4. Inc.99 3.48 7.8 # Points 22 56 22 45 21 45 # Labs 1 1 1 1 1 1 Bilirubin.040 2 0.391 0.174 0.242 0.79 SD 1 −− 0.8 # Points 22 56 22 45 21 45 # Labs 1 1 1 1 1 1 Method Group • Cholecyanin (700 nm) Mean 0.141 3 −− 0.8 2.98 6.64 2. Worldwide Report April 2016 Multiqual 1.388 SD 1 0.5 −− 5.97 2.032 0.027 0.28 SD 1 −− 0.008 3 0.167 0.1 3.006 0. ci models) • Alternate Calibration Mean −− 0.8 5.596 3. Total/TBIL Cholecyanin (700 nm) mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #22 Mean 0.5 # Points −− 21 −− 20 −− 19 # Labs 1 1 1 Copyright © 2015 Bio−Rad Laboratories.81 7.6 4.37 3.3 2. i.580 0.3 4.584 −− 2.2.331 CV −− 4.9 −− 4.109 3 0.535 0.00 −− 6.68 SD 1 0.300 CV −− −− 4.003 0.305 0.4 # Points 11 326 −− 329 12 66 # Labs 1 7 7 1 1 Hitachi Chemistry Series Mean −− −− 2.7 4.054 2 0.5 # Points −− 353 −− 367 −− 265 # Labs 2 2 2 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 0.0 −− 1.2 # Points 49 587 76 583 29 654 # Labs 3 5 7 9 3 5 Dirui CS Series Mean 0.25 −− 7.04 CV 16.028 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.200 1.35 6.47 SD 1 −− −− 2 0.9 3.004 2 0.4 3.38 SD 1 −− −− 2 0.565 0.124 0.173 3 0. LXi725 Chemistry Systems Mean −− −− 3.1 −− 1.138 0.6 4.2 4.032 3 −− 0.028 0.092 0.304 CV 22. Total/TBIL Diazonium Ion mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.6 3.32 6.4 # Points 4225 22761 2892 15314 3652 21254 # Labs 122 141 76 88 110 130 Abbott AEROSET/ARCHITECT (c.021 2 −− 0.190 3 0.38 7.12 6.384 0.080 0.44 3.0 16.22 SD 1 0.109 2 0.610 0.028 0.3 # Points 24 536 32 495 34 453 # Labs 2 5 3 5 3 4 Beckman Coulter LX20.7 6.028 2 −− 0.290 0.013 0.028 0.181 CV −− −− 1.015 CV 10.9 10. ci models) Mean 0. i.8 5.5 6.27 3.6 5.174 0.0 # Points −− −− 19 132 18 131 # Labs 1 1 1 1 Beckman Coulter UniCel DxC Series Mean 0.099 CV −− 4.161 3 0.6 4.1 4.042 0.013 0.061 2 −− 0.4 10.008 3 0.1 3.173 0.436 CV 4.1 3.5 3.299 CV 7.4 13.73 6.

05 3.1 # Points 187 849 126 290 109 636 # Labs 4 6 3 3 2 4 Roche cobas 6000/8000/c 311 • Roche BILT2 Mean 0.3 6.024 2 0.9 −− −− # Points −− −− 26 75 −− −− # Labs 1 1 Roche cobas 6000/8000/c 311 Mean 0.49 6.6 4.343 0.63 6.363 CV 3.59 SD 1 0. Generated 22−May−2016 17:45:01 Page 90 .7 2.8 12.90 2.0 # Points 550 3810 360 2352 431 3170 # Labs 23 26 15 17 17 19 Copyright © 2015 Bio−Rad Laboratories. Inc.194 CV 0.1 4.98 2.483 2.83 6.85 2. Blanked (Roche) mg/dL Level Mon Cum Level Mon Cum Level Mon Cum JEOL BioMajesty JCA−BM Series Mean −− −− 3.48 6.134 0.2 3. Total/TBIL Diazonium Ion mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/8000/c 311 Mean 0.057 2 −− −− 3 0.4 3.197 CV 5.86 6.5 −− −− 2.1 # Points 3556 21210 1764 7142 3025 19756 # Labs 100 123 57 65 77 100 Roche cobas 6000/8000/c 311 • 3rd Generation Mean 0.111 3 0.143 3 0.019 0.4 11.8 4.79 2.204 CV 6.088 0.52 6.80 2.152 0.1 3.0 2.8 5.025 0.8 # Points 4382 24734 3056 17207 3831 23232 # Labs 132 162 90 113 123 146 Bilirubin.0 3.70 SD 1 −− 0.91 SD 1 0.7 3.21 6.6 3.482 2.1 4.030 0.42 SD 1 0.451 −− −− 6.9 5.9 3.9 3.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.043 2 −− −− 3 −− 0.478 0. Total/TBIL Diazonium Ion.541 2.3 # Points 51 335 15 157 42 288 # Labs 2 2 2 2 2 2 Roche cobas c 111 Mean 0.479 0.128 0.79 SD 1 0.000 0.500 −− −− 6.2 # Points 1 12 −− −− 1 12 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #17 Mean −− 0.173 0.3 −− −− −− 3.144 CV 14.0 3.535 0.0 2.473 0.43 SD 1 0.6 2.520 −− −− −− 6.72 6.000 0.1 2.5 7.045 0.234 0.99 6.137 0.9 4.068 0.297 3 0.21 6.208 CV −− 8.7 2.82 6.051 0.057 3 0.468 2.329 CV 8.9 8.7 10.3 3.09 SD 1 0.048 0.2 # Points 21 177 −− −− 21 177 # Labs 1 1 1 1 Roche Reflotron Mean 0.15 −− −− SD 1 −− −− 2 0.092 3 −− −− CV −− −− 1.54 SD 1 0.1 2.1 4.3 1.457 0.497 0.2 5.0 0.0 −− −− 0.034 2 0.251 CV 10.40 6.108 0.6 1.060 2 0.000 2 −− −− 3 0.503 2.500 0.209 0. Worldwide Report April 2016 Multiqual 1.031 2 0.90 6.473 0.081 0.2.022 2 0.043 2 0.1 # Points −− 39 −− −− −− 38 # Labs 1 1 Method Group • Diazonium Ion Mean 0.023 0.83 2.483 2.050 0.084 3 0.27 SD 1 0.086 3 0.80 6.141 CV 4.1 # Points 137 607 124 569 99 512 # Labs 6 7 6 7 4 5 Roche cobas INTEGRA Mean 0.132 0.

10 −− 7. Total/TBIL Diphylline.058 2 0.5 3.50 3.2 7.470 −− 2.4 6.228 0.098 0.1 411. Inc. P.561 2.5 3. Total/TBIL Dichloroaniline mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean −− 0.162 CV −− 10.049 0.063 0.190 3 0.836 −− 4.74 SD 1 −− 0.8 1.1 # Points −− 39 −− 39 −− 39 # Labs 1 1 1 Horiba ABX Pentra 400 Mean −− 3.2.183 0.8 2.1 3.05 3.3 −− 5.6 # Points 26 214 15 180 40 322 # Labs 1 3 1 3 2 4 VITROS Microslide Series • Slide generation #02 Mean −− 0.7 3.479 0.0 −− −− # Points 31 91 30 92 −− −− # Labs 1 1 1 1 Method Group • Dichloroaniline Mean 0. Worldwide Report April 2016 Multiqual 1.045 2 −− 0.9 3.2 3.518 2.177 CV 9.0 12.0 −− 2.096 3 0.50 SD 1 0.516 3.058 0.3 2.81 2.103 3 −− −− CV −− −− −− 3.7 # Points 194 1189 197 1225 71 514 # Labs 10 13 10 14 3 3 Method Group • Diazonium Ion.4 −− 3.7 # Points 31 271 36 139 −− 104 # Labs 1 2 2 3 1 Bilirubin.5 # Points 4624 27665 2597 11653 3735 24588 # Labs 143 175 92 107 103 131 Bilirubin.51 SD 1 −− 0.630 0.5 3.63 6.05 −− 7.2 6.50 −− 9.220 0.3 −− 0.24 SD 1 −− 12.072 2 0. Total/TBIL Diazonium Ion.040 0.102 3 −− 0.7 # Points −− 180 6 6 −− 104 # Labs 1 1 1 1 Roche Hitachi Systems (International) • DiaSys Diagnostic Systems Mean −− −− −− 3.91 2.5 3.021 0.05 3.5 7. Generated 22−May−2016 17:45:01 Page 91 .000 3 −− 0.081 0.2 −− 5.2 −− −− # Points −− −− −− 41 −− −− # Labs 1 Siemens ADVIA Chemistry Systems Mean 0.099 3 0.4 4.7 11.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.14 −− 6.048 2 −− 0.86 6.033 2 0.136 3 −− 0.517 2.402 CV −− 5.220 3 −− 0. E170) Mean 0.51 3.46 6.021 10.518 0.414 CV −− 357.57 6.94 6.8 3.06 −− −− SD 1 0.1 1.65 SD 1 0.31 2 0.034 0.05 3.19 −− −− SD 1 −− −− 2 −− 0. Blanked (Roche) Mean 0.2 2.484 2.9 2.509 0.24 SD 1 0.85 2.5 # Points −− 281 −− 1 −− 270 # Labs 2 1 2 Copyright © 2015 Bio−Rad Laboratories.061 3 −− −− CV 4.414 CV 4. Blanked (Roche) mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Roche MODULAR (ISE. D.92 6.0 −− 4. Diazonium Salt−VITROS mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #01 Mean 0.228 CV 7.099 0.302 CV 10.54 2 0.61 SD 1 0.224 0.016 2 0.

2 4.03 6.93 6.083 2 0.167 CV −− 9.4 # Points −− 96 −− −− −− 96 # Labs 1 1 VITROS Microslide Series • Slide generation #07 Mean 0. Diazonium Salt−VITROS mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #03 Mean 0.13 6.3 −− 2.7 2.3 # Points 33 553 33 468 33 591 # Labs 2 8 2 7 2 9 VITROS Microslide Series • Slide generation #08 Mean −− 0.278 CV 9.6 12.95 SD 1 −− 0.8 −− 4.517 −− 3.042 0.7 17.190 CV −− 9.0 2.1 4.3 15.7 # Points −− 22 −− 27 −− 22 # Labs 1 2 1 VITROS Microslide Series • Slide generation #09 Mean 0.058 0.2 # Points 41 1502 −− 777 41 1459 # Labs 2 20 9 2 19 VITROS Microslide Series • Slide generation #10 Mean 0. Worldwide Report April 2016 Multiqual 1.197 0.513 0.91 2.8 4.497 0.091 0.58 SD 1 0. Generated 22−May−2016 17:45:01 Page 92 .096 2 0.4 5.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.7 −− 3.087 0.2 6.3 2.59 SD 1 0.3 # Points 101 2757 120 2221 120 2648 # Labs 5 29 6 21 6 31 Copyright © 2015 Bio−Rad Laboratories.251 0.1 3.309 CV −− 14.354 CV 8.2 3.50 6. Total/TBIL Diphylline.1 −− 4.494 0.523 −− 2.42 SD 1 0.482 −− −− −− 6.121 3 0.2 2.20 3.145 0.53 6.01 −− 6.039 0.9 # Points 375 3170 146 1087 397 3169 # Labs 13 28 6 12 14 28 VITROS Microslide Series • Slide generation #05 Mean 0.1 4.4 −− 2.100 3 0.073 0.107 3 −− 0.0 3.144 CV 9.2 11.255 CV 14.140 0.69 6.568 2.69 SD 1 0.145 3 −− 0.044 2 −− −− 3 −− 0.9 11.2.594 0.472 3.035 0.2 3. Inc.150 0.2 3.055 2 0.154 3 0.56 SD 1 0.2 4.080 3 0.5 # Points 51 227 35 66 80 242 # Labs 2 3 1 2 2 3 VITROS Microslide Series • Slide generation #06 Mean −− 0.118 3 0.095 0.0 5.78 SD 1 −− 0.57 6.073 2 −− 0.6 # Points −− 463 −− 395 −− 374 # Labs 4 3 2 VITROS Microslide Series • Slide generation #14 Mean 0.3 3.057 0.50 6.045 0.0 3.069 2 0.6 3.551 2.070 2 0.95 6.1 17.0 3.77 SD 1 0.656 0.193 0.505 2.077 2 0.93 2.1 # Points 610 2828 280 1553 584 2782 # Labs 27 37 14 21 26 35 VITROS Microslide Series • Slide generation #13 Mean −− 0.177 3 0.1 6.042 2 −− 0.347 0.93 6.496 0.88 6.627 0.214 0.8 12.0 4.276 CV 7.73 6.074 0.5 5.059 2 −− 0.93 2.207 0.95 6.2 2.99 SD 1 −− 0.432 −− 3.167 CV 6.61 6.75 SD 1 0.02 2.292 CV 7.117 3 0.95 3.490 2.4 # Points 17 160 17 150 17 150 # Labs 1 3 1 2 1 2 VITROS Microslide Series • Slide generation #15 Mean 0.3 5.2 −− −− −− 2.12 −− 6.573 3.

060 2 0.111 0.236 0.64 SD 1 −− −− 2 −− 0.206 CV 3.121 3 0.62 6.77 SD 1 −− 0.164 3 0.95 2.552 0. Diazonium Salt−VITROS mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #16 Mean 0. Inc.566 0.232 0.181 3 0.0 5.172 CV −− 7.5 13.2 14.59 6.036 2 −− −− 3 −− 0.15 7.3 1. Total/TBIL Diphylline.1 −− −− −− 2.2 2.84 6.7 5.510 −− −− −− 6.625 3.036 2 −− −− 3 −− 0.8 13.532 3.52 SD 1 0.567 3.86 SD 1 0.186 0.134 0.163 0.115 0.119 0.1 # Points −− −− −− 136 −− 136 # Labs 1 1 VITROS Microslide Series • Slide generation #39 Mean 0.601 3.3 4.5 4.189 3 0.0 4.093 2 0.2 # Points 20 333 22 328 19 335 # Labs 1 2 1 2 1 2 VITROS Microslide Series • Slide generation #34 Mean −− 0.75 SD 1 0.4 4.075 3 −− 0.72 6.6 3.6 1.077 2 0.169 3 0.3 3.142 CV −− −− −− 2.286 CV 14.065 0.8 3.5 6.00 6.01 2.02 6.13 2.026 0. Diazonium Salt−VITROS Mean 0.4 5.172 CV −− 7.6 4.6 # Points −− 87 −− −− −− 87 # Labs 1 1 VITROS Microslide Series • Slide generation #99 Mean 0.2.9 6.95 6.279 CV 13.3 5.078 0.26 3.137 3 0.1 # Points 60 544 63 557 70 574 # Labs 1 1 1 1 1 1 VITROS Microslide Series • Slide generation #47 Mean 0.4 # Points 663 2509 514 2320 810 3377 # Labs 34 45 27 34 40 50 VITROS Microslide Series • Slide generation #22 Mean 0.535 2.222 CV 3.021 0.536 2.1 3.536 0.8 15.14 6.5 # Points −− 29 −− −− −− 31 # Labs 1 1 VITROS Microslide Series • Slide generation #38 Mean −− −− −− 2.8 1.8 5. Generated 22−May−2016 17:45:01 Page 93 .5 3.4 −− −− −− 2.98 6.0 3.89 6.089 0.20 3.83 −− 6.053 0.082 2 0.0 11.228 CV 10.3 5.2 # Points 44 314 44 181 45 283 # Labs 1 4 1 3 1 4 VITROS Microslide Series • Slide generation #48 Mean −− 0.580 0.2 # Points 2585 19861 1461 11882 2731 20464 # Labs 114 242 72 152 118 246 Copyright © 2015 Bio−Rad Laboratories.054 0.57 6.59 SD 1 0.165 3 0.7 3.670 0. Worldwide Report April 2016 Multiqual 1.489 −− −− −− 6.2 # Points 129 2650 52 1061 128 2603 # Labs 5 27 2 17 5 30 VITROS Microslide Series • Slide generation #17 Mean 0.64 SD 1 0.275 CV 11.5 3.201 0.2 # Points 415 1122 120 374 347 913 # Labs 19 22 9 11 15 19 Method Group • Diphylline.203 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.623 0.080 2 0.56 SD 1 −− 0.341 CV 19.163 0.523 3.064 2 0.7 −− 2.3 4.7 13.62 6.99 3.593 0.19 6.285 0.62 SD 1 0.056 0.163 0.2 4.071 2 0.74 SD 1 0.1 5.08 3.1 12.

254 3 0.84 SD 1 0.7 # Points 21 174 −− −− 21 152 # Labs 1 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Alternate Formulation/Standardization Mean −− −− 3.020 2 −− −− 3 0.574 −− −− 6.121 3 0.0 5.24 3.7 9.5 6.17 SD 1 −− −− 2 0.534 2.86 SD 1 0.232 CV 5.78 −− −− SD 1 0.0 1.105 0.7 4.433 0.000 2 −− 0.01 3.080 0.144 3 −− −− CV 9.171 0.68 2.115 3 −− −− CV −− 0.119 CV 1.2.6 4.02 6.080 0.77 6.2 2.276 CV −− −− 2.594 3.025 2 0. Inc.449 CV −− −− 6.013 0.039 2 0.40 7.65 6.212 0.5 8.430 CV −− −− −− 5.0 4.3 3.126 3 0.2 5.2 # Points −− −− 60 237 60 237 # Labs 2 2 2 2 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Wako Mean −− −− 3.4 −− −− # Points 13 76 18 77 −− −− # Labs 1 1 1 1 Roche Reflotron Mean −− 0.72 −− −− SD 1 0.495 2.096 3 −− −− CV 2.049 0.049 0.18 3.59 SD 1 −− −− 2 0.04 −− 6.92 2.491 0.8 2.97 6.010 0.5 −− −− 1.7 5.87 6.508 0.78 SD 1 −− −− 2 −− 0.3 6.3 3.75 2.3 −− −− # Points −− 10 −− 14 −− −− # Labs 1 1 Method Group • Dipstick Mean 0.166 3 −− 0.5 6.5 −− −− # Points 11 122 11 121 −− −− # Labs 1 1 1 1 Mindray BS 200E/380/400/480/800/2000 Mean −− −− −− 3.7 12.4 # Points 2650 15886 1725 9632 2296 12591 # Labs 88 113 58 77 83 104 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Alternate Calibration Mean 0.62 SD 1 −− −− 2 0.23 7.064 2 0.227 0.0 −− 4.1 8.68 2.60 6. Total/TBIL Dipstick mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Fuji Dri−Chem NX500/i Mean 0.033 0.213 3 0.5 −− 6.8 3.067 2 0.9 # Points −− −− 2 125 2 114 # Labs 1 1 1 1 Hitachi Chemistry Series Mean 0.595 0.3 −− −− # Points 13 86 18 91 −− −− # Labs 1 2 1 2 Bilirubin.3 # Points −− −− −− 123 −− 84 # Labs 4 3 Copyright © 2015 Bio−Rad Laboratories.3 3.069 0.500 −− 2. Generated 22−May−2016 17:45:01 Page 94 .8 3.425 CV −− −− 2.3 6.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.2 5.508 0.119 0. Total/TBIL DPD mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 0.7 12. Worldwide Report April 2016 Multiqual 1.564 0.67 −− −− SD 1 −− 0.6 3.9 # Points −− −− 45 216 45 215 # Labs 2 2 2 2 DIRUI−CS−240 Mean −− −− 2.220 0.160 0.73 −− −− SD 1 0.17 6.538 2.220 0.147 3 −− −− CV 9.

4 # Points 24 75 24 75 24 75 # Labs 1 2 1 2 1 2 Copyright © 2015 Bio−Rad Laboratories.2 3.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.3 4. ci models) Mean 0.060 3 −− −− CV −− −− −− 1.35 SD 1 0.050 0.159 CV 11.88 6.1 6.191 CV −− −− −− 3.030 0.050 0. Total/TBIL DPD mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas INTEGRA Mean 0.078 3 −− 0.87 SD 1 0.7 4.6 1.420 2. Total/TBIL Enzymatic mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.95 2.079 2 0.110 CV −− 5.045 2 0.9 3.565 −− 3.4 1.7 7.127 0.309 3 0.080 0.14 −− 6. Inc.9 17.76 6.8 4.75 SD 1 0.68 SD 1 −− −− 2 −− 0.42 3.077 0.0 2.040 0.251 0.510 0.420 0.081 3 −− −− CV −− −− 1.6 2.485 2.9 # Points −− −− 30 513 34 450 # Labs 5 6 5 5 Roche Hitachi Systems (International) • DiaSys Diagnostic Systems Mean −− −− 2.028 2 −− 0.9 # Points −− −− −− 130 −− 180 # Labs 2 2 Toshiba−TBA Mean −− −− −− 3. Generated 22−May−2016 17:45:01 Page 95 .0 −− 2.205 3 0.0 3.594 0.034 0.90 SD 1 −− −− 2 0. i.3 −− 2.66 SD 1 0.9 7.6 2.0 6.7 0.172 CV 5.1 # Points 24 50 24 50 24 50 # Labs 1 1 1 1 1 1 VITROS Microslide Series • Slide generation #01 Mean −− 0.103 0.097 3 −− 0.55 7.468 2.69 6.7 3.9 10.7 # Points 4 372 25 238 22 292 # Labs 2 7 3 4 1 2 Roche Hitachi Systems (International) Mean −− −− 3.69 6.89 6.7 −− −− # Points −− −− 22 62 −− −− # Labs 1 1 Toshiba TBA−40FR (Accute) Mean −− −− −− 2.420 0. Worldwide Report April 2016 Multiqual 1.17 6.9 −− −− # Points −− −− −− 26 −− −− # Labs 1 Method Group • DPD Mean 0.81 2.17 3.75 2.100 0.080 0.6 2.0 2.94 SD 1 −− 0.337 CV 5.2.98 −− −− SD 1 −− −− 2 0.030 2 0.81 6.1 0.30 6.026 0.5 −− 1.102 3 0.2 8.9 # Points 2665 16380 1860 10907 2399 13662 # Labs 91 121 71 92 92 114 Bilirubin.6 # Points −− 25 −− 25 −− 25 # Labs 1 1 1 Method Group • Enzymatic Mean 0.040 0.591 3.7 1.076 CV 11.46 7.92 −− 6.189 3 0.043 2 0.133 0.385 CV −− −− 2.75 2.095 3 0.17 −− −− SD 1 −− −− 2 −− 0.

69 6.0 −− −− 4.680 0.275 0.559 0.96 SD 1 0.707 −− −− 7.668 3.7 2.3 −− −− 2.484 −− −− 6. Generated 22−May−2016 17:45:01 Page 96 .011 0.9 3.47 SD 1 0.601 0.97 6.673 0.501 0.6 # Points −− 36 28 235 28 240 # Labs 1 1 2 1 1 Copyright © 2015 Bio−Rad Laboratories.26 −− −− SD 1 0. Inc.151 0.3 2.0 3.1 −− −− # Points 116 698 132 697 −− −− # Labs 3 4 4 4 ILab 650 Mean 0.476 −− −− 6.1 # Points 26 83 −− −− 25 90 # Labs 2 2 2 2 Bilirubin.0 0.25 3.5 7. Total/TBIL Evelyn Malloy mg/dL Level Mon Cum Level Mon Cum Level Mon Cum ILab 650 Mean 0.123 0.148 0.23 7.5 4.484 3.560 3.0 2.078 2 −− −− 3 0.175 0.59 6.6 # Points 21 78 −− −− 21 86 # Labs 1 1 1 1 Method Group • Evelyn Malloy Mean 0.254 CV 15.7 2.1 2.167 CV 4.053 0.5 4.230 3 0.9 −− −− 4.025 2 −− −− 3 0.174 3 0.529 0.038 2 −− −− 3 0.26 SD 1 0.477 0. Total/TBIL Jendrassik Grof mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.6 4.000 0.330 0.8 # Points 25 80 −− −− 27 65 # Labs 1 1 1 1 Beckman Coulter UniCel DxC Series Mean 0.080 0.38 3.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.218 0.050 2 0.233 CV 8.330 CV 0.5 # Points 766 5322 464 3761 651 4216 # Labs 27 41 20 33 21 23 ILab 600 Mean 0.203 CV 10. ci models) Mean 0.5 2.069 0.1 2.47 SD 1 0.020 0.2 4.77 SD 1 −− 0.207 0.027 2 0.0 4.8 16.2 5.263 0.5 # Points 660 4039 666 4169 183 1349 # Labs 12 13 12 13 5 7 Beckman Coulter LX20.2.535 0.8 2.3 3.027 2 0.87 7.541 −− −− −− −− SD 1 0.106 0.0 −− −− 2.600 0. i.95 2.180 0.1 3.124 3 0.7 4.043 0.068 3 −− −− CV 4.316 CV 3.8 11.529 2.92 6.49 SD 1 0.000 2 −− −− 3 0.022 0.122 3 0.074 0.013 2 −− −− 3 −− −− CV 2.96 6.4 7. LXi725 Chemistry Systems Mean 0.2 5.4 −− −− −− −− # Points 17 101 −− −− −− −− # Labs 1 1 Roche Hitachi Systems (International) Mean −− 0.596 3.7 # Points 5 5 −− −− 4 4 # Labs 1 1 1 1 Roche cobas 6000/8000/c 311 Mean 0.600 −− −− 6.200 CV −− 5.51 6.4 4.209 CV 11.1 9.028 2 0. Worldwide Report April 2016 Multiqual 1.021 0.25 7.8 2.2 4.31 7.97 SD 1 0.18 3.27 3.26 7.138 0.1 4.69 SD 1 0.17 6.9 2.5 # Points 706 2924 680 2746 441 1848 # Labs 18 18 15 15 9 9 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 0.110 2 0.

2 4.89 SD 1 0.060 2 0.536 0.6 −− 8.95 SD 1 0.537 3.027 2 −− 0. Inc.2 2.0 2.047 2 0.135 0.612 −− 3.96 SD 1 0.103 0.68 7.4 2.3 3.130 0.532 3.05 3.141 CV 8.523 3.38 SD 1 −− −− 2 0.7 2.26 3.181 0.9 2.98 SD 1 0.074 0.38 7.521 3.016 0.157 0.09 3.04 3.189 CV 8.053 3 −− 0.6 2.535 0.597 3.7 2.0 # Points −− 18 −− 40 −− 40 # Labs 1 1 1 Method Group • Oxidation by Nitrite Mean −− 0.7 # Points 2927 21312 1653 10867 2328 19052 # Labs 94 125 53 66 73 107 Siemens Dimension Series • Siemens Dimension TBI (REF DF167) Mean 0.268 0.9 9.592 0.127 3 0.4 −− 1.96 6.2 2.071 0.106 3 0.070 3 0.045 0.073 3 0.132 CV 8.203 CV 8.210 CV 11.0 3.9 # Points 5694 57108 2027 21060 5516 53970 # Labs 161 219 54 77 153 211 Siemens Dimension Vista • Siemens Dimension TBI (REF DF167) Mean 0.0 # Points 1556 15244 694 6230 1493 13536 # Labs 38 54 12 23 36 52 Toshiba TBA−120FR Mean −− −− 3.5 2.92 6.65 SD 1 0.37 −− 7.3 3.3 1.7 10.2.5 9.0 5.044 0.091 3 0.053 3 −− 0.91 6.08 3.2 3.217 0.048 0.3 3.129 0.0 # Points −− 18 −− 40 −− 40 # Labs 1 1 1 Copyright © 2015 Bio−Rad Laboratories.112 3 0.2 4.027 2 −− 0.126 0.045 0.90 SD 1 0.588 CV −− 4.08 6.0 # Points 16172 133K 8031 62974 14030 119K # Labs 468 626 218 299 406 551 Bilirubin.171 3 0.08 3.23 7.521 0.066 0.053 2 0.4 # Points −− −− 38 273 36 303 # Labs 1 1 1 1 Method Group • Jendrassik Grof Mean 0.538 0. Total/TBIL Jendrassik Grof mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens ADVIA Chemistry Systems Mean 0.6 −− 8.588 CV −− 4. Total/TBIL Oxidation by Nitrite mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Mindray BS 200E/380/400/480/800/2000 Mean −− 0.0 1.3 # Points 207 896 274 1729 320 1678 # Labs 5 10 10 14 10 15 Siemens Dimension Series Mean 0.014 2 0.256 CV 2.4 −− 1.538 3.3 2.5 3.31 SD 1 −− 0.97 6. Generated 22−May−2016 17:45:01 Page 97 .06 6.07 6.0 3.612 −− 3.200 0.09 6.100 0.25 7.9 # Points 3498 25547 1375 11207 3007 22704 # Labs 108 139 36 51 96 124 Siemens Dimension Vista Mean 0.2 11.052 2 0.99 6.5 8.1 3.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.8 2.31 SD 1 −− 0. Worldwide Report April 2016 Multiqual 1.516 0.060 0.1 3.174 CV −− −− 4.047 2 0.3 2.8 2.40 3.04 6.37 −− 7.4 2.

6 7.000 3 0.6 7.27 −− 7.5 −− 4.305 CV −− 0. ci models) • Alternate Formulation/Standardization Mean −− −− 3.13 −− 6.016 0.67 7.127 3 0.6 # Points −− −− 6 25 7 26 # Labs 1 1 1 1 Abbott AEROSET/ARCHITECT (c.217 0.073 0.3 # Points −− −− 21 184 12 108 # Labs 2 2 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beijing Bai Tai Mean 0.571 −− −− 6.3 7.163 0.015 2 −− −− 3 0.13 −− −− SD 1 0.113 3 −− 0.1 −− 1.92 6.13 3. LXi725 Chemistry Systems • LEADMAN Mean −− −− 3.0 −− −− 1.536 0.080 0.057 2 0.261 0.50 7.337 CV −− −− 2.86 7.2 1.6 −− −− 1.84 6.047 0.542 0.215 0.98 3.7 1.069 3 0.8 4.225 3 −− −− CV 8.119 0.45 7.047 0.5 2.087 CV −− −− 0.6 # Points −− 57 −− 54 −− 54 # Labs 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean −− −− 3. Worldwide Report April 2016 Multiqual 1.98 3.269 0.91 SD 1 −− 0. Inc.1 2.536 −− −− 6.47 3.0 0.7 9.0 3.64 SD 1 0.057 2 0.297 CV −− −− 5.000 0.593 2.113 CV −− 7.3 4.087 0. i. Lithium/Sodium dodecyl sulfate mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Mindray BS 200E/380/400/480/800/2000 Mean 0.89 SD 1 0.2 # Points 146 146 −− −− 147 147 # Labs 3 3 3 3 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Zhong Sheng Mean −− 3.7 9.9 4.64 6. Total/TBIL Sulphanilic acid.593 2.033 3 −− 0.13 −− −− SD 1 0.05 SD 1 −− −− 2 0. ci models) Mean −− −− 3.542 0. Total/TBIL Vanadate Oxidation mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.016 2 −− −− 3 0.0 −− 3.1 # Points −− −− 1 1 3 3 # Labs 1 1 1 1 Copyright © 2015 Bio−Rad Laboratories.12 SD 1 −− 0.70 7.217 0. i.17 6.6 3.575 0.8 4.16 −− 3.000 2 −− 0.124 CV 2.3 # Points −− 1 −− 126 −− 126 # Labs 1 1 1 Beckman Coulter LX20.0 2.70 SD 1 −− −− 2 0.1 1.080 CV 3.287 CV −− −− 1.88 SD 1 −− −− 2 0.2 −− −− # Points 15 56 15 42 −− −− # Labs 1 1 1 1 Bilirubin.1 −− 1. Lithium/Sodium dodecyl sulfate Mean 0.050 0. ci models) • PROLABS Mean −− 0.569 −− 3.06 3. i.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.225 3 −− −− CV 8. Generated 22−May−2016 17:45:01 Page 98 .1 # Points −− −− 12 155 12 155 # Labs 2 2 2 2 Abbott AEROSET/ARCHITECT (c.8 # Points 60 125 −− −− 60 118 # Labs 1 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Wako Mean 0.2 −− −− # Points 15 56 15 42 −− −− # Labs 1 1 1 1 Method Group • Sulphanilic acid.36 SD 1 −− −− 2 0.015 0.041 2 −− 0.0 1.2.0 3.108 3 0.18 6.4 3.45 3.3 7.

9 # Points −− −− −− 45 −− 35 # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean 0.0 −− −− −− 2.3 # Points −− −− 25 53 25 52 # Labs 1 1 1 1 JEOL BioMajesty JCA−BM Series • Zhong Sheng Mean −− −− −− 2.169 3 0.025 2 0.32 3.263 0.50 SD 1 −− −− 2 0.2.4 −− 3.384 CV 4.034 3 −− 0.227 CV −− 6.86 6.059 3 −− 0.111 3 0.5 3.44 −− 6.1 6.095 0.203 3 0.572 0. Total/TBIL Vanadate Oxidation mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter UniCel DxC Series • Beijing Bai Tai Mean −− 0.291 0.597 0.44 7.24 11.3 0. Worldwide Report April 2016 Multiqual 1.32 3.187 CV 5.9 0.03 SD 1 −− 0.028 2 −− 0.144 0.38 SD 1 −− 0.066 CV −− −− −− 1.00 −− 7.526 −− 3.7 3.114 0.8 −− 3.075 3 0.2 6.2 1.25 5.72 SD 1 0.070 0.8 # Points 4652 27104 3235 19346 3110 18520 # Labs 118 149 87 120 86 110 Siemens ADVIA Chemistry Systems • LEADMAN Mean −− −− 3.4 # Points 28 189 −− 29 28 156 # Labs 2 3 1 2 2 Roche Hitachi Systems (International) Mean −− −− 3.598 3.599 3.76 SD 1 −− −− 2 0.0 −− 1.28 7. Generated 22−May−2016 17:45:01 Page 99 .250 0. Inc.41 7.121 0.1 3.1 3.124 3 0.210 0.9 # Points −− −− 4 4 6 6 # Labs 1 1 1 1 Tokyo Boeki BIOLIS 50i Mean −− 0.88 SD 1 −− −− 2 0.69 11.032 2 −− 0.6 # Points −− −− 111 360 100 269 # Labs 4 4 3 4 Siemens ADVIA Chemistry Systems Mean 0.027 0.43 SD 1 −− −− 2 −− 0.32 7.9 2.485 0.28 3.6 4.283 CV 4.175 CV −− 4.3 2.0 4.247 CV −− −− −− 1.32 7.029 3 −− 0.3 2.5 2.558 −− −− −− 7.1 # Points 4886 27833 3409 20291 3503 19886 # Labs 124 159 98 136 101 131 Copyright © 2015 Bio−Rad Laboratories.84 −− 6.38 SD 1 −− −− 2 −− 0.1 6.53 7.022 2 −− −− 3 −− 0.5 3.6 3.2 4.5 2.097 3 0.50 SD 1 0.595 0.0 −− 3.024 2 0.5 5.4 # Points −− 195 −− −− −− 193 # Labs 1 1 Hitachi Chemistry Series • MAKER Mean −− −− −− 2.248 CV −− −− 3.50 7.025 0.265 CV −− −− 2.075 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Bilirubin.12 7.3 5.2 # Points −− 18 −− 19 −− 22 # Labs 1 1 1 Method Group • Vanadate Oxidation Mean 0.1 −− 2.07 3.0 # Points −− −− −− 41 −− 49 # Labs 1 1 JEOL BioMajesty JCA−BM Series Mean −− −− 5.14 6.587 −− 3.070 CV −− −− 2.029 0.48 SD 1 0.

78 2. kinetic mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter IMMAGE Mean 124.8 148.2 2. Generated 22−May−2016 17:45:01 Page 100 .54 3.60 31.0 # Points 75 1078 4 15 73 1071 # Labs 4 8 1 2 3 7 C3 Immunonephelometric.0 2.96 2.4 5.1 178.4 1. Inc.6 −− −− SD 1 10.6 2.20 92.74 118.1 3.1 20.49 3 −− −− CV 6.30 89.5 142.32 3 −− −− CV 8.29 2.17 7.08 2 2.1 SD 1 3.4 −− 2.3 −− 135.10 4.1 −− −− # Points 9 20 9 20 −− −− # Labs 1 2 1 2 C3 Immunoturbidimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.68 −− 125.07 2.60 31.00 2.1 1.1 −− −− # Points 9 20 9 20 −− −− # Labs 1 2 1 2 Method Group • Immunonephelometric.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units C3 Immunonephelometric.6 140.82 2 7.6 3.0 99.1 103. i. kinetic Mean 89.08 2 2.6 −− 3.2 1.4 # Points 32 162 31 162 30 160 # Labs 1 1 1 1 1 1 Beckman Coulter UniCel DxC Series Mean −− 83.55 3 3.0 2.98 2 2.51 −− 114.6 # Points −− 60 −− 36 −− 47 # Labs 3 3 1 ILab 600 Mean 94.7 9.1 20.0 136.9 2.3 146.9 # Points 73 348 36 182 53 245 # Labs 5 5 3 3 3 3 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 87.1 119.0 139.6 −− −− SD 1 10.87 3 −− 3. ci models) Mean 85.41 138.2 1.32 3 −− −− CV 8.6 1.1 178.1 148.9 4.35 2 17.7 8.45 3 3.9 21. fixed time.87 3.0 # Points 72 1065 −− 3 73 1071 # Labs 3 7 1 3 7 Method Group • Immunonephelometric.58 2.99 3 −− −− CV 1.26 2.1 −− −− # Points 3 13 4 12 −− −− # Labs 1 1 1 1 Siemens Dimension Vista Mean 88.2.6 8.79 138.90 2 −− 2. kinetic mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens BN Series Nephelometers Mean 100. kinetic Mean 124.2 −− 2.10 4.0 141.38 86.3 SD 1 −− 2.46 CV −− 2.1 3.40 CV 2.5 146.7 117.37 CV 2.9 21.58 6.04 21.1 148.67 83.86 89.0 SD 1 2.1 3.3 −− −− SD 1 1.7 9.2 3.78 128.7 2.52 3 3.6 −− −− SD 1 6.0 SD 1 1.29 10.68 CV 4.2 −− −− # Points 24 167 24 167 −− −− # Labs 1 1 1 1 Copyright © 2015 Bio−Rad Laboratories.1 103.35 2 17.51 2 1.5 2.17 2 −− 3.9 2.8 148.9 1.88 2. fixed time.55 121.66 3 2.04 21.8 141.40 CV 3.9 127.8 2. Worldwide Report April 2016 Multiqual 1.6 SD 1 2.

2 113.6 2.00 2.7 5.79 86.1 2. fixed time.37 25. kinetic mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens BN Series Nephelometers Mean 15.2 −− −− # Points −− −− 11 162 −− −− # Labs 1 2 Roche Hitachi Systems (International) • DiaSys Diagnostic Systems Mean −− −− 108.04 2 6.6 −− 0.3 −− −− SD 1 −− −− 2 0.13 SD 1 0.14 7.03 1.4 # Points 189 1145 108 757 161 973 # Labs 10 13 8 13 7 8 C4 Chemiluminescence mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.02 2 −− −− 3 −− −− CV 6.85 86.8 −− −− 3.19 88.9 3.39 2.8 143.0 118.000 2.9 −− −− SD 1 −− −− 2 3.00 21.4 −− −− # Points −− −− 1 7 −− −− # Labs 1 1 Siemens Dimension Series Mean 83.6 6.03 1. Inc.88 −− −− −− −− SD 1 1.1 119.345 2 1.64 21.14 4.322 0.1 6.80 17.5 143.58 3 −− −− CV 9.74 3 −− −− CV −− −− 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units C3 Immunoturbidimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/8000/c 311 Mean 89.8 5.23 0.45 2 −− −− 3 4.75 119.98 5.65 2 2.2 5.0 −− −− SD 1 8.95 CV 5.7 SD 1 1.9 2.4 −− −− −− −− # Points 9 41 −− −− −− −− # Labs 2 2 Method Group • Chemiluminescence Mean 15.18 −− −− 145.97 121.0 2.582 0.115 3 0.63 15.0 115.6 6.4 2.9 4.3 2. Generated 22−May−2016 17:45:01 Page 101 .5 2.8 # Points 76 1063 −− 3 76 1074 # Labs 3 7 1 3 7 Copyright © 2015 Bio−Rad Laboratories. ci models) Mean 15.7 2.7 SD 1 4.48 −− −− SD 1 0.4 −− −− −− −− # Points 9 41 −− −− −− −− # Labs 2 2 C4 Immunonephelometric.83 5.72 26.3 −− −− # Points 3 13 4 12 −− −− # Labs 1 1 1 1 Siemens Dimension Vista Mean 16.10 6.21 −− 22.46 4.6 2.7 146. i.02 CV 1.929 3 −− −− CV 0.7 −− −− # Points 13 43 5 41 −− −− # Labs 1 1 1 2 Method Group • Immunoturbidimetric Mean 87.0 2.55 3 −− −− CV −− −− 2.7 7.02 2 −− −− 3 −− −− CV 6.4 4.88 −− −− −− −− SD 1 1.058 0.742 CV 1.455 2 −− 0.2.70 15. Worldwide Report April 2016 Multiqual 1.7 # Points 47 365 −− −− 78 521 # Labs 2 2 3 3 Roche Hitachi Systems (International) Mean −− −− 114.18 3 4.70 15.

81 14.38 −− −− SD 1 2.04 20.01 24.55 19.485 2 1.72 26.3 2.9 4.65 19.934 CV 3.21 3 −− −− CV 5.03 2 2.0 7. Inc.6 7.23 0.57 16.4 10.08 2.49 3 1.8 6.955 3 −− 1.49 25.49 25.654 2 0.4 8.40 22.8 7.00 21.0 −− −− # Points −− −− 12 161 −− −− # Labs 2 2 Copyright © 2015 Bio−Rad Laboratories.753 3 −− −− CV −− −− 5. kinetic mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Method Group • Immunonephelometric.72 SD 1 −− 1.8 5.942 1.69 19.48 22.890 1.0 3.66 21.9 10.86 25.2 4.02 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units C4 Immunonephelometric.3 4.2.5 3. kinetic mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter IMMAGE Mean 19.41 22.65 SD 1 0.97 −− −− SD 1 0.3 −− 6.32 15.508 0. fixed time. fixed time.1 2.1 −− −− 4.4 4.7 # Points 30 156 31 159 30 159 # Labs 1 1 1 1 1 1 Beckman Coulter UniCel DxC Series Mean −− 12.12 14.08 2.9 −− −− # Points 7 29 7 29 −− −− # Labs 1 1 1 1 C4 Immunoturbidimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.331 0.08 CV 2.48 1. Worldwide Report April 2016 Multiqual 1.595 2 −− −− 3 0.1 # Points 36 246 30 151 41 231 # Labs 3 3 3 3 3 3 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 15.7 6.1 # Points −− 57 −− 33 −− 44 # Labs 3 3 1 ILab 600 Mean 15.06 −− 21.76 3 −− −− CV 10.54 2.89 18.582 0. i.63 CV 8.7 10.0 4.55 1.9 −− −− # Points 7 29 7 29 −− −− # Labs 1 1 1 1 Method Group • Immunonephelometric.3 −− 5. ci models) Mean 14.9 10.8 # Points 79 1076 4 15 76 1074 # Labs 4 8 1 2 3 7 C4 Immunonephelometric.7 10.93 −− −− SD 1 −− −− 2 1.06 18.33 CV −− 9.76 17.54 −− −− 22. kinetic Mean 19.8 # Points 49 370 −− −− 81 524 # Labs 2 2 3 3 Roche Hitachi Systems (International) Mean −− −− 18. kinetic Mean 16.904 3 0.76 3 −− −− CV 10.19 21.523 0.13 SD 1 0.87 SD 1 1.388 0.742 CV 2.26 1.42 19.3 2.535 0.82 −− 18.03 2 2.4 4.08 2 1.65 25.662 3 0.94 24.2 2.952 1.54 2.10 2 0.38 −− −− SD 1 2.06 18.5 7.4 10.94 24.2 2.19 2 −− 0.0 −− −− # Points 24 168 24 168 −− −− # Labs 1 1 1 1 Roche cobas 6000/8000/c 311 Mean 14. Generated 22−May−2016 17:45:01 Page 102 .22 SD 1 0.

9 2.284 CV 2.164 3 0. Inc.3 1.9 1.62 10. Generated 22−May−2016 17:45:01 Page 103 .3 2.78 3 −− −− CV 8.118 0.227 3 0.9 2.8 6.81 9.42 19.67 SD 1 −− −− 2 0.99 10.0 1.3 2.2.97 9.83 12.1 9.45 13.63 13.1 1.5 2. ci models) Mean 6.146 2 0. i.2 # Points 3792 20905 2738 13981 3530 18639 # Labs 105 127 75 89 100 121 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Wako Mean −− 10.255 0.0 6.25 1.43 SD 1 0.324 CV −− −− 2.81 14.196 0.96 13.116 2 0.44 18.90 5.26 13.8 7.91 9.43 SD 1 0.0 1.166 0.3 7.86 12.249 0.133 2 0.17 2 1.5 # Points −− 213 4 364 4 150 # Labs 4 3 7 3 3 Copyright © 2015 Bio−Rad Laboratories.0 1.5 2.158 0.9 8.3 6.12 10.16 13.6 1.1 −− −− # Points 12 42 6 43 −− −− # Labs 1 1 1 2 Method Group • Immunoturbidimetric Mean 14.171 CV 1.93 9.9 1.2 1.186 3 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units C4 Immunoturbidimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Series Mean 14.11 6.0 1.000 2 −− −− 3 −− −− CV −− 0.24 −− −− −− −− SD 1 −− 0.05 13.91 19.166 0.02 6.12 10.30 SD 1 0.6 # Points −− −− 45 217 45 216 # Labs 2 2 2 2 Beckman Coulter UniCel DxC Series Mean −− 5.01 1.564 1.63 13.098 0.11 6.39 3 1.62 10.126 0.31 1.75 22.171 CV 1.55 −− −− SD 1 1.32 2 0.133 2 0.0 1.45 13.3 1.44 1.0 −− −− −− −− # Points −− 1 −− −− −− −− # Labs 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Zhong Sheng Mean −− −− 9.141 0.68 15.244 0.244 0.3 # Points 23 49 26 50 22 45 # Labs 1 1 1 1 1 1 Calcium Arsenazo III mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.58 12.75 12.5 2.15 SD 1 0.92 SD 1 −− 0.3 2.118 0.211 3 0.05 9.73 19. Worldwide Report April 2016 Multiqual 1.196 CV −− 2.2 2.211 3 0.124 2 0.79 9.5 1.7 1.5 # Points 4694 25948 3261 17958 3864 23348 # Labs 142 160 90 104 121 141 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 5.6 3.8 # Points 151 1032 103 715 152 958 # Labs 8 10 8 12 7 8 Calcium AAS (Atomic Absorption Spectroscopy) mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #04 Mean 6.09 SD 1 1.323 0.152 3 0.9 2.6 1.141 0.3 # Points 23 49 26 50 22 45 # Labs 1 1 1 1 1 1 Method Group • AAS (Atomic Absorption Spectroscopy) Mean 6.57 CV 6.88 23.6 2.145 0.193 CV 1.2 2.

148 CV −− −− −− 1.9 2.94 −− 13.34 −− −− SD 1 −− −− 2 0.01 5.235 2 −− −− 3 −− 0.00 SD 1 0.376 3 −− 0.00 9.48 SD 1 −− −− 2 0.100 0.00 6.435 0.99 13.819 CV −− −− −− −− −− 6.60 12.96 10.3 3.4 0.0 1.3 0.8 −− 4.4 0.284 3 −− −− CV −− −− −− 2.4 # Points −− −− −− −− −− 29 # Labs 2 Copyright © 2015 Bio−Rad Laboratories.214 3 0. Generated 22−May−2016 17:45:01 Page 104 .312 0.3 3.306 2 −− 0. Inc.60 9.0 −− −− # Points −− −− 6 6 −− −− # Labs 1 1 JEOL BioMajesty JCA−BM Series • Zhong Sheng Mean −− −− −− −− −− 12.3 3.157 0.157 2 0.2 1.1 # Points −− −− −− 40 −− 49 # Labs 1 1 Horiba ABX Pentra 400 Mean −− −− 10.249 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Calcium Arsenazo III mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Hitachi Chemistry Series • MAKER Mean −− −− −− 9.83 −− 9.83 SD 1 −− −− 2 −− −− 3 −− 0.95 9.97 SD 1 0.3 4.48 12.1 # Points 65 353 38 202 27 191 # Labs 4 5 2 3 2 3 Mindray BS 200E/380/400/480/800/2000 • Alternate Formulation/Standardization Mean −− 5.288 CV 4.31 13.52 −− −− SD 1 −− −− 2 −− 0.263 CV 2.040 3 0.20 SD 1 0.05 −− −− −− 12.040 CV −− −− 0.196 0.7 −− −− # Points −− −− −− 49 −− −− # Labs 1 Siemens ADVIA Chemistry Systems Mean 6.34 10.2 # Points 111 312 −− −− −− 307 # Labs 2 2 2 Siemens ADVIA Chemistry Systems • LEADMAN Mean −− −− 9.2 −− 3.81 SD 1 −− 0.97 SD 1 −− −− 2 −− −− 3 −− 0. Worldwide Report April 2016 Multiqual 1.262 0.96 13.9 −− −− −− 2.3 3.100 3 −− −− CV −− −− 1.08 6.02 13.84 −− 12.5 # Points −− −− −− −− −− 4 # Labs 1 Mindray BS 200E/380/400/480/800/2000 Mean 6.8 2.195 2 0.1 # Points −− 20 −− 20 −− 18 # Labs 1 1 1 Roche Hitachi Systems (International) • BIODEVICE Srl Mean −− −− −− 10.0 # Points 3916 22940 3121 17506 2849 17616 # Labs 95 118 79 101 77 92 Siemens ADVIA Chemistry Systems • DiaSys Diagnostic Systems Mean 6.330 CV −− −− −− −− −− 2.163 3 −− 0.20 9.529 CV −− 5.407 CV 3.6 1.30 SD 1 −− −− 2 −− 0.040 0.375 3 0.2.040 0.6 2.180 0.3 # Points −− −− 4 4 6 6 # Labs 1 1 1 1 Siemens ADVIA Chemistry Systems • Lachema Mean −− −− −− −− −− 12.6 −− 1.8 2.

1 # Points 12578 70683 9217 50350 10325 60575 # Labs 348 417 253 311 306 370 Calcium Arsenazo III−VITROS mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #00 Mean 5.6 −− −− −− 0.243 0.197 3 0.9 −− 2.59 5.1 1.134 0.9 −− 1.26 SD 1 0. Generated 22−May−2016 17:45:01 Page 105 .00 13.85 10.6 2.38 12.386 CV 1.095 0.09 SD 1 0.3 −− −− 1.7 1.6 1.94 −− −− −− 12.0 0. Worldwide Report April 2016 Multiqual 1.18 SD 1 −− 0.1 2.8 3.0 1.117 CV −− 1.6 # Points 24 325 1 340 24 388 # Labs 2 4 1 6 2 6 VITROS Microslide Series • Slide generation #02 Mean −− 5.6 4.150 0.2.091 2 −− −− 3 −− 0.8 2.175 3 0.308 CV 3. Inc.077 0.02 SD 1 0.04 10.60 5.8 −− 3.16 13.106 3 0.000 0.16 SD 1 0.289 2 −− −− 3 0.0 # Points −− 12 −− 23 −− 20 # Labs 1 1 1 Method Group • Arsenazo III Mean 5.97 9.3 3.0 1.9 # Points −− 322 −− 228 33 393 # Labs 2 1 1 2 VITROS Microslide Series • Slide generation #04 Mean 5.152 2 0.115 2 −− 0.99 −− 10.31 13.4 0.110 2 −− 0.223 2 0.9 # Points −− 111 −− −− −− 111 # Labs 1 1 VITROS Microslide Series • Slide generation #07 Mean 5.78 13.24 12.5 3.85 −− −− 13.9 −− −− 1.9 # Points 20 74 −− −− 86 401 # Labs 1 1 3 3 VITROS Microslide Series • Slide generation #01 Mean 5.3 # Points 129 893 23 324 122 831 # Labs 4 5 1 2 4 5 VITROS Microslide Series • Slide generation #05 Mean 5.135 0.16 SD 1 0.92 −− 10.247 0.198 2 0.141 3 0.5 1.79 13.241 3 0.107 CV 1.92 5.77 −− 13.99 13.27 13.194 0.98 5.9 −− −− −− 0.271 3 −− 0.57 10.3 1.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Calcium Arsenazo III mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Tokyo Boeki BIOLIS 50i Mean −− 5.78 5.8 −− 1.070 0.173 0.0 0.78 SD 1 −− 0.90 −− −− 12.7 2.279 CV 2.27 12.065 CV −− 1.087 0.96 10.093 0.7 1.249 CV −− 1.231 2 −− 0.96 −− 9.91 SD 1 0.9 2.252 CV 1.340 CV 1.9 # Points 32 309 −− 227 32 338 # Labs 1 3 1 1 2 VITROS Microslide Series • Slide generation #08 Mean −− 5.13 SD 1 −− 0.4 2.5 # Points −− 22 −− −− −− 21 # Labs 1 1 Copyright © 2015 Bio−Rad Laboratories.60 −− −− −− 12.389 CV −− 1.144 0.37 12.99 13.8 # Points 35 142 −− −− 31 127 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #06 Mean −− 5.60 5.99 9.076 2 −− −− 3 0.7 1.4 0.115 2 −− −− 3 −− 0.9 2.62 SD 1 −− 0.220 0.082 0.

189 3 0.080 0.8 # Points 203 2638 112 1220 263 2738 # Labs 5 30 4 11 7 31 VITROS Microslide Series • Slide generation #21 Mean −− 6.090 3 −− 0.04 SD 1 −− 0.1 1.242 CV 1.29 SD 1 0.092 CV −− 1.3 0. Generated 22−May−2016 17:45:01 Page 106 .176 3 0.330 CV 1.5 # Points 31 615 31 449 31 612 # Labs 1 10 1 7 1 10 VITROS Microslide Series • Slide generation #18 Mean 5.68 −− −− −− 13.192 2 0.84 5.102 0.192 CV −− 2.068 2 −− −− 3 −− 0. Inc.7 −− 0.103 0.186 2 −− −− 3 −− 0.04 SD 1 −− 0.136 3 0.2 1.0 # Points −− 25 −− −− −− 25 # Labs 1 1 VITROS Microslide Series • Slide generation #15 Mean −− 5.94 −− 10.7 2.1 1.1 1.072 3 −− 0.3 1.120 0.9 −− 0.23 10.0 1.7 2.9 0.125 2 −− 0.212 0.232 0.1 0.23 13.24 10.1 −− 1.0 1.9 # Points −− 11 −− 24 −− 24 # Labs 1 2 2 VITROS Microslide Series • Slide generation #16 Mean −− 5.87 SD 1 −− 0.243 CV 2.3 2.165 0.5 −− 0.49 SD 1 −− 0.93 5.115 3 −− 0.5 −− 0.7 # Points −− 46 −− 45 −− 46 # Labs 1 1 1 Copyright © 2015 Bio−Rad Laboratories.80 5.2 −− −− −− 0.120 2 0.89 10.2 −− −− −− 1.098 CV −− 1.5 −− 0.5 # Points −− 176 −− 63 −− 124 # Labs 6 1 5 VITROS Microslide Series • Slide generation #17 Mean 5.24 13.19 SD 1 −− 0.02 SD 1 0.090 0.146 2 −− 0.87 −− 10.0 1.4 3.02 6.8 2.097 3 0.7 # Points −− 38 −− −− −− 39 # Labs 1 1 VITROS Microslide Series • Slide generation #14 Mean −− 5.84 13.16 13.274 0.134 2 0.07 13.212 CV 3.8 # Points 77 1609 32 1028 76 1444 # Labs 3 22 1 16 3 20 VITROS Microslide Series • Slide generation #20 Mean 6.93 −− 10.272 0.88 −− −− −− 12.094 2 −− 0.080 0.38 12.1 # Points 30 99 −− 99 30 99 # Labs 1 1 1 1 1 VITROS Microslide Series • Slide generation #12 Mean −− 5.06 10.2.24 −− 13.086 2 −− 0.129 2 0.6 2.93 10.17 SD 1 0.54 −− 13.31 13.121 CV −− 1.113 3 0.40 13.100 0.279 CV 1.6 2.21 SD 1 0.080 0.28 13.133 CV −− 3.3 1.24 SD 1 0.6 # Points 65 2313 65 1358 66 2305 # Labs 2 27 2 18 2 29 VITROS Microslide Series • Slide generation #19 Mean 6.25 −− 13.31 10.6 2.02 10.7 2.03 6.09 −− 10.14 13.129 0.1 −− 1.8 1.8 2. Worldwide Report April 2016 Multiqual 1.12 10.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Calcium Arsenazo III−VITROS mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #11 Mean 5.

91 10.22 13.45 13.284 CV 2.166 0.01 10.05 SD 1 0.00 13.03 SD 1 2.147 2 0.4 0. Generated 22−May−2016 17:45:01 Page 107 .0 −− 0.170 3 0.130 0.217 0.0 1.4 # Points 5 5 3 3 3 3 # Labs 4 4 3 3 2 2 VITROS Microslide Series • Slide generation #33 Mean −− 6.295 3 0.249 CV 1.58 SD 1 −− −− 2 −− 0.0 # Points −− −− −− 136 −− 136 # Labs 1 1 VITROS Microslide Series • Slide generation #25 Mean 5.3 0.152 0.220 0.93 SD 1 0.6 1.2 1.30 6.195 2 0.26 13.17 5.2 # Points 64 1624 44 791 65 1442 # Labs 3 19 2 10 3 17 VITROS Microslide Series • Slide generation #27 Mean 5.3 2.0 2.210 3 0.5 1.36 10.69 10.66 10.04 12.6 2.26 10.9 1.4 56.140 0.5 1.3 2.38 10.89 12.53 10.25 2.220 CV 2.185 0.289 CV 3.30 10.1 2.139 3 0.72 −− 13.197 CV 2.0 # Points 178 275 57 79 175 273 # Labs 7 7 3 3 7 7 VITROS Microslide Series • Slide generation #31 Mean 5.134 2 0.156 3 0.137 CV −− −− −− 1.24 13.9 1.7 0.218 3 0.16 10.15 SD 1 −− 0.211 2 0.1 −− 1.08 6.0 48.9 # Points 268 2645 95 1255 273 2691 # Labs 12 27 4 17 12 29 VITROS Microslide Series • Slide generation #28 Mean 6.7 # Points 341 397 235 285 334 391 # Labs 18 18 13 13 18 18 VITROS Microslide Series • Slide generation #32 Mean 6.184 3 0.2.2 # Points 584 1643 318 970 519 1376 # Labs 28 31 16 19 25 28 VITROS Microslide Series • Slide generation #30 Mean 4.100 0.7 1.000 3 −− 0.099 3 5.2 1.41 13.1 1.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Calcium Arsenazo III−VITROS mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #23 Mean 6.34 13.262 0.95 6.0 1.87 5.147 2 0.118 0.05 10.24 13.00 10.052 0.294 0.2 # Points 147 895 142 833 208 1315 # Labs 8 12 7 7 10 14 VITROS Microslide Series • Slide generation #29 Mean 5.102 0.94 10.62 CV 46. Worldwide Report April 2016 Multiqual 1.103 0.5 2.31 10.000 2 −− 0.8 1.117 3 −− 0.65 5.16 SD 1 0.000 CV −− 0.24 −− 13.4 2.7 2.7 2.1 3.0 −− 0.13 13.5 # Points 126 2589 68 1402 134 2437 # Labs 9 28 7 19 7 29 VITROS Microslide Series • Slide generation #24 Mean −− −− −− 10.282 CV 3.295 0.183 0.156 0.42 SD 1 0.8 1.152 2 0.33 10.8 3.05 −− 10.7 2.156 2 0.6 2.197 0.27 SD 1 0.0 1.89 4.1 2.83 10.0 2.5 1.5 1.097 0.94 5.13 SD 1 0.58 10.1 2.052 CV 3.48 2 0.11 10.7 1.26 13.83 13.144 0.195 0.39 SD 1 0.1 54.42 13. Inc.1 1.186 0.01 6.0 # Points −− 1 −− 1 −− 1 # Labs 1 1 1 Copyright © 2015 Bio−Rad Laboratories.

096 2 −− −− 3 −− 0.79 −− 10.82 5.51 −− −− −− 12.2 # Points −− 220 −− 164 −− 223 # Labs 2 1 2 VITROS Microslide Series • Slide generation #47 Mean −− 5.0 1.98 10.124 3 −− 0.22 −− 12.239 2 −− 0.5 1.211 3 1.7 2.8 # Points 21 177 −− −− 21 177 # Labs 1 1 1 1 Roche cobas INTEGRA Mean 5.80 5.2.41 0.325 CV 3.8 1.74 12.237 3 −− −− CV 2. Generated 22−May−2016 17:45:01 Page 108 . P.5 # Points 378 1085 121 374 332 905 # Labs 18 22 9 11 16 19 Method Group • Arsenazo III−VITROS Mean 5.188 0.0 2.218 0.82 10.223 0.23 SD 1 0.158 CV −− 4.03 6.3 2.88 5.153 2 0.87 −− −− 13.97 10.7 2.171 0.649 0.0 3.173 0.90 13.23 10.93 10.27 10.9 1.1 1.9 # Points 2797 21953 1407 12133 2898 22051 # Labs 129 292 75 171 127 291 Calcium BAPTA mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/8000/c 311 Mean 5.374 2 0.93 SD 1 0.37 13.095 CV −− 1.39 SD 1 0.1 1.366 CV −− 1.9 1.1 −− 1.04 13.193 3 0.8 # Points −− 121 −− −− −− 121 # Labs 1 1 VITROS Microslide Series • Slide generation #99 Mean 5. D.188 0.29 13.101 CV 0.97 6.10 SD 1 0.3 −− −− # Points 95 483 77 352 −− −− # Labs 4 4 4 4 Copyright © 2015 Bio−Rad Laboratories.19 −− −− SD 1 0.127 2 0.8 2.13 13.80 SD 1 −− 0.06 10.223 2 0.79 5.9 # Points −− 139 −− −− −− 138 # Labs 1 1 VITROS Microslide Series • Slide generation #49 Mean −− 5.22 13.94 SD 1 0.96 12.8 3.00 10.43 SD 1 −− 0.144 3 0.253 CV 2.8 3.189 2 0.258 0.0 # Points 281 1897 134 745 240 1635 # Labs 12 14 6 7 10 11 Roche MODULAR (ISE.088 2 −− −− 3 −− 0.29 12.9 1.091 0.146 CV 2.94 9.3 2.070 2 −− −− 3 0.155 0.0 1.3 2.233 0.143 0.62 −− −− −− 12.175 0.2 6.1 10.196 0.9 5.17 10.774 CV 11.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Calcium Arsenazo III−VITROS mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #35 Mean 5.7 −− −− −− 2. Inc.7 2.309 3 0.33 SD 1 0.6 −− −− −− 0.222 0.7 0.135 2 0.19 12.9 # Points 2876 17077 1286 5847 2523 16178 # Labs 85 108 46 57 68 90 Roche cobas c 111 Mean 5.84 9.3 2.2 −− −− 0.20 12.1 # Points 60 546 60 547 61 546 # Labs 1 1 1 1 1 1 VITROS Microslide Series • Slide generation #46 Mean −− 5. Worldwide Report April 2016 Multiqual 1.135 0.10 10.5 2.97 SD 1 −− 0.2 −− 1.266 CV 2. E170) Mean 6.6 2.199 3 0.4 1.2 1.348 0.4 3.75 5.051 0.

9 1.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Calcium BAPTA mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Method Group • BAPTA Mean 5.6 3.01 10.85 12.148 2 0.211 0.4 2.91 SD 1 −− −− 2 0.83 12.7 # Points 148 809 89 899 59 305 # Labs 3 4 2 4 1 2 Beckman Coulter LX20.00 10.199 0.245 CV 2.400 0. Generated 22−May−2016 17:45:01 Page 109 .222 0. Worldwide Report April 2016 Multiqual 1.40 13.000 3 −− −− CV −− −− −− 0.240 0.92 SD 1 −− −− 2 0.3 1.9 1.4 2.83 SD 1 0.78 9.79 12.12 −− −− SD 1 −− −− 2 −− 0.1 2.4 2.2 2.0 2.95 5.190 0.91 13.9 2.08 −− −− SD 1 −− −− 2 0.144 0.88 5.01 10.9 # Points 1199 8986 436 3705 1002 8280 # Labs 32 40 20 30 23 29 JEOL BioMajesty JCA−BM Series Mean −− −− 10.199 3 0.91 5.83 9.9 # Points 3273 19634 1497 6944 2784 17990 # Labs 102 127 56 68 79 102 Calcium Chlorophosphonazo III mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Roche Hitachi Systems (International) • DiaSys Diagnostic Systems Mean −− −− 10.7 1.9 1.3 2.12 −− −− SD 1 −− −− 2 −− 0.89 9.8 2.5 3.188 0. Inc.0 −− −− # Points −− −− −− 5 −− −− # Labs 5 Method Group • ISE direct Mean −− −− −− 10.7 2.146 2 0.359 CV 2.181 2 0.08 −− −− SD 1 −− −− 2 0.84 13.0 1.1 # Points −− −− 22 155 22 155 # Labs 2 2 2 2 Beckman Coulter UniCel DxC Series Mean 5.37 SD 1 0.257 0. LXi725 Chemistry Systems Mean −− −− 9.4 2.09 10.353 3 0.289 CV −− −− 2.150 0.0 3.16 SD 1 0.87 9.190 0.0 −− −− # Points −− −− −− 5 −− −− # Labs 5 Calcium ISE indirect mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 5.257 CV 2.8 −− −− # Points −− −− 21 62 −− −− # Labs 1 1 Method Group • Chlorophosphonazo III Mean −− −− 10.000 3 −− −− CV −− −− −− 0.81 12.5 1.15 13.2.13 13.166 0.180 3 −− −− CV −− −− 1.186 0.1 # Points −− −− 20 159 20 158 # Labs 1 1 1 1 Copyright © 2015 Bio−Rad Laboratories.35 13.7 1.8 −− −− # Points −− −− 21 62 −− −− # Labs 1 1 Calcium ISE direct mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Mindray BS 200E/380/400/480/800/2000 Mean −− −− −− 10.180 3 −− −− CV −− −− 1.98 10.168 0.320 0.266 CV −− −− 1.73 9.265 3 0.223 3 0.242 3 0.4 2.

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Calcium ISE indirect mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Toshiba TBA−120FR
Mean −− −− 10.27 10.26 13.13 13.07
SD 1 −− −− 2 0.243 0.345 3 0.320 0.423
CV −− −− 2.4 3.4 2.4 3.2
# Points −− −− 39 272 39 306
# Labs 1 1 1 1

VITROS Microslide Series • Slide generation #01
Mean −− −− −− 10.36 −− 13.08
SD 1 −− −− 2 −− 0.480 3 −− 0.240
CV −− −− −− 4.6 −− 1.8
# Points −− −− −− 24 −− 25
# Labs 1 1

Method Group • ISE indirect
Mean 5.89 5.89 9.83 9.87 12.86 12.87
SD 1 0.165 0.152 2 0.232 0.308 3 0.302 0.303
CV 2.8 2.6 2.4 3.1 2.4 2.4
# Points 1347 9795 606 5214 1142 9229
# Labs 35 44 26 39 28 36

Calcium o−cresolphthalein complexone mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models)
Mean −− −− 10.04 10.11 −− −−
SD 1 −− −− 2 0.120 0.103 3 −− −−
CV −− −− 1.2 1.0 −− −−
# Points −− −− 30 105 −− −−
# Labs 1 1

Abbott AEROSET/ARCHITECT (c, i, ci models) • Alternate Formulation/Standardization
Mean −− −− 9.64 9.88 13.08 13.23
SD 1 −− −− 2 0.240 0.379 3 0.400 0.467
CV −− −− 2.5 3.8 3.1 3.5
# Points −− −− 10 29 11 30
# Labs 1 1 1 1

Abbott AEROSET/ARCHITECT (c, i, ci models) • PROLABS
Mean −− 5.49 −− 10.28 −− 14.18
SD 1 −− 0.234 2 −− 0.359 3 −− 0.389
CV −− 4.3 −− 3.5 −− 2.7
# Points −− 56 −− 56 −− 54
# Labs 1 1 1

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 5.80 5.93 9.77 9.86 12.87 12.71
SD 1 0.050 0.197 2 0.069 0.171 3 0.113 0.330
CV 0.9 3.3 0.7 1.7 0.9 2.6
# Points 30 435 31 498 31 483
# Labs 1 4 2 5 2 4

Beckman Coulter UniCel DxC Series
Mean −− 5.84 9.80 9.84 −− −−
SD 1 −− 0.077 2 0.145 0.153 3 −− −−
CV −− 1.3 1.5 1.6 −− −−
# Points −− 15 53 236 −− −−
# Labs 1 2 3

Hitachi Chemistry Series
Mean −− −− 9.56 9.66 12.40 12.61
SD 1 −− −− 2 0.160 0.205 3 0.160 0.263
CV −− −− 1.7 2.1 1.3 2.1
# Points −− −− 22 195 22 193
# Labs 1 1 1 1

Horiba ABX Pentra 400
Mean −− 5.45 −− −− −− 13.35
SD 1 −− 0.261 2 −− −− 3 −− 0.309
CV −− 4.8 −− −− −− 2.3
# Points −− 165 −− −− −− 176
# Labs 1 1

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 110

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Calcium o−cresolphthalein complexone mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
ILab 600
Mean 5.81 5.82 10.17 10.16 −− −−
SD 1 0.117 0.170 2 0.155 0.197 3 −− −−
CV 2.0 2.9 1.5 1.9 −− −−
# Points 116 697 107 672 −− −−
# Labs 3 4 3 4

ILab 650
Mean 5.76 5.77 −− −− −− −−
SD 1 0.109 0.098 2 −− −− 3 −− −−
CV 1.9 1.7 −− −− −− −−
# Points 17 97 −− −− −− −−
# Labs 1 1

JEOL BioMajesty JCA−BM Series
Mean −− −− 10.24 10.35 −− −−
SD 1 −− −− 2 0.240 0.251 3 −− −−
CV −− −− 2.3 2.4 −− −−
# Points −− −− 28 74 −− −−
# Labs 1 1

Mindray BS 200E/380/400/480/800/2000
Mean −− −− −− −− −− 12.97
SD 1 −− −− 2 −− −− 3 −− 0.448
CV −− −− −− −− −− 3.5
# Points −− −− −− −− −− 114
# Labs 3

Roche cobas 6000/8000/c 311
Mean 5.97 5.99 10.14 10.15 13.38 13.40
SD 1 0.145 0.128 2 0.177 0.182 3 0.265 0.235
CV 2.4 2.1 1.7 1.8 2.0 1.8
# Points 853 5120 493 1970 652 4573
# Labs 31 34 19 19 20 23

Roche cobas INTEGRA
Mean 5.80 5.83 9.96 9.99 13.23 13.26
SD 1 0.209 0.202 2 0.261 0.285 3 0.362 0.332
CV 3.6 3.5 2.6 2.9 2.7 2.5
# Points 230 2093 178 1781 214 2002
# Labs 12 17 10 12 8 10

Roche Hitachi Systems (International)
Mean −− −− 9.81 9.86 13.20 13.15
SD 1 −− −− 2 0.346 0.487 3 0.245 0.307
CV −− −− 3.5 4.9 1.9 2.3
# Points −− −− 106 582 96 447
# Labs 4 6 3 4

Roche MODULAR (ISE, D, P, E170)
Mean 5.99 6.01 10.23 10.23 13.42 13.46
SD 1 0.169 0.173 2 0.195 0.252 3 0.269 0.274
CV 2.8 2.9 1.9 2.5 2.0 2.0
# Points 132 905 134 894 69 527
# Labs 8 9 8 9 3 3

Roche MODULAR (ISE, D, P, E170) • 2nd Generation
Mean −− 6.11 −− 10.16 −− −−
SD 1 −− 0.145 2 −− 0.194 3 −− −−
CV −− 2.4 −− 1.9 −− −−
# Points −− 36 −− 19 −− −−
# Labs 2 2

Siemens ADVIA Chemistry Systems
Mean 5.65 5.67 9.99 10.05 13.31 13.34
SD 1 0.200 0.193 2 0.279 0.290 3 0.298 0.370
CV 3.5 3.4 2.8 2.9 2.2 2.8
# Points 1317 7918 814 6749 945 5564
# Labs 31 43 22 37 21 32

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 111

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Calcium o−cresolphthalein complexone mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Siemens Dimension Series
Mean 5.78 5.75 9.63 9.65 12.82 12.84
SD 1 0.198 0.205 2 0.255 0.242 3 0.317 0.318
CV 3.4 3.6 2.6 2.5 2.5 2.5
# Points 6451 47092 3011 22277 5567 43660
# Labs 201 260 87 117 173 232

Siemens Dimension Vista
Mean 5.66 5.67 9.49 9.52 12.67 12.71
SD 1 0.187 0.197 2 0.238 0.240 3 0.273 0.289
CV 3.3 3.5 2.5 2.5 2.2 2.3
# Points 7924 84678 3291 31432 7837 81097
# Labs 201 274 68 102 195 266

Toshiba−TBA
Mean −− −− −− 10.63 −− −−
SD 1 −− −− 2 −− 0.433 3 −− −−
CV −− −− −− 4.1 −− −−
# Points −− −− −− 21 −− −−
# Labs 1

Method Group • o−cresolphthalein complexone
Mean 5.73 5.71 9.67 9.67 12.80 12.81
SD 1 0.207 0.210 2 0.331 0.322 3 0.360 0.355
CV 3.6 3.7 3.4 3.3 2.8 2.8
# Points 17070 149K 8298 67540 15433 139K
# Labs 489 651 228 320 426 577

Carbamazepine (Tegretol) Chemiluminescence µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models)
Mean 3.40 3.42 10.00 10.00 11.36 11.38
SD 1 0.245 0.224 2 0.000 0.000 3 0.600 0.669
CV 7.2 6.5 0.0 0.0 5.3 5.9
# Points 34 326 1 1 29 273
# Labs 3 3 1 1 1 1

Method Group • Chemiluminescence
Mean 3.40 3.42 10.00 10.00 11.36 11.38
SD 1 0.245 0.224 2 0.000 0.000 3 0.600 0.669
CV 7.2 6.5 0.0 0.0 5.3 5.9
# Points 34 326 1 1 29 273
# Labs 3 3 1 1 1 1

Carbamazepine (Tegretol) EIA µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models)
Mean 4.07 4.14 9.58 10.18 15.02 15.38
SD 1 0.288 0.328 2 0.562 0.691 3 1.05 1.07
CV 7.1 7.9 5.9 6.8 7.0 6.9
# Points 292 1779 233 1344 193 1298
# Labs 11 14 8 10 8 10

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 4.26 4.28 9.43 9.53 14.00 13.95
SD 1 0.429 0.400 2 0.601 0.665 3 0.924 0.925
CV 10.1 9.3 6.4 7.0 6.6 6.6
# Points 318 1818 98 657 288 1612
# Labs 12 14 5 7 11 11

Roche cobas 6000/8000/c 311
Mean 3.66 3.93 −− 9.22 12.06 12.70
SD 1 0.320 0.596 2 −− 0.751 3 0.470 0.928
CV 8.7 15.2 −− 8.1 3.9 7.3
# Points 27 80 −− 41 29 82
# Labs 1 2 1 1 2

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 112

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Carbamazepine (Tegretol) EIA µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Roche MODULAR (ISE, D, P, E170)
Mean 3.53 3.54 7.80 8.10 −− −−
SD 1 0.612 0.545 2 0.280 0.860 3 −− −−
CV 17.3 15.4 3.6 10.6 −− −−
# Points 10 45 2 45 −− −−
# Labs 2 2 1 2

Siemens ADVIA Chemistry Systems
Mean 4.32 4.04 9.74 9.66 14.45 13.54
SD 1 0.592 0.550 2 1.44 1.16 3 1.34 1.23
CV 13.7 13.6 14.7 12.1 9.3 9.1
# Points 109 626 16 27 121 678
# Labs 4 5 1 1 5 5

VITROS Microslide Series • Slide generation #01
Mean −− 3.27 −− 7.10 −− 11.67
SD 1 −− 0.000 2 −− 0.000 3 −− 0.000
CV −− 0.0 −− 0.0 −− 0.0
# Points −− 1 −− 1 −− 1
# Labs 1 1 1

VITROS Microslide Series • Slide generation #14
Mean 3.49 3.81 8.19 8.56 12.39 12.86
SD 1 0.173 0.320 2 0.357 0.522 3 0.338 0.688
CV 5.0 8.4 4.4 6.1 2.7 5.4
# Points 15 50 23 58 14 46
# Labs 1 1 1 1 1 1

VITROS Microslide Series • Slide generation #23
Mean −− 3.48 −− 8.18 −− 12.25
SD 1 −− 0.231 2 −− 0.263 3 −− 0.404
CV −− 6.6 −− 3.2 −− 3.3
# Points −− 170 −− 169 −− 170
# Labs 2 2 2

VITROS Microslide Series • Slide generation #25
Mean 3.57 3.64 −− −− 12.16 12.19
SD 1 0.502 0.289 2 −− −− 3 0.630 0.801
CV 14.1 7.9 −− −− 5.2 6.6
# Points 67 391 −− −− 34 405
# Labs 2 2 1 2

VITROS Microslide Series • Slide generation #28
Mean −− −− −− −− 12.60 12.57
SD 1 −− −− 2 −− −− 3 0.497 0.412
CV −− −− −− −− 3.9 3.3
# Points −− −− −− −− 33 176
# Labs 1 1

VITROS Microslide Series • Slide generation #29
Mean −− 3.33 −− −− −− 11.89
SD 1 −− 0.223 2 −− −− 3 −− 0.721
CV −− 6.7 −− −− −− 6.1
# Points −− 139 −− −− −− 144
# Labs 3 3

VITROS Microslide Series • Slide generation #30
Mean 3.65 3.68 −− −− 11.91 12.16
SD 1 0.158 0.197 2 −− −− 3 0.574 0.426
CV 4.3 5.4 −− −− 4.8 3.5
# Points 43 276 −− −− 30 191
# Labs 3 3 2 2

VITROS Microslide Series • Slide generation #31
Mean 3.44 3.60 8.03 8.52 11.62 12.05
SD 1 0.278 0.339 2 0.000 0.230 3 0.635 1.00
CV 8.1 9.4 0.0 2.7 5.5 8.3
# Points 39 90 1 8 40 88
# Labs 3 3 1 1 3 3

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 113

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Carbamazepine (Tegretol) EIA µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
VITROS Microslide Series • Slide generation #99
Mean 3.68 3.67 8.40 8.40 12.71 12.60
SD 1 0.120 0.151 2 0.320 0.320 3 0.940 0.865
CV 3.3 4.1 3.8 3.8 7.4 6.9
# Points 20 28 20 20 20 26
# Labs 1 3 1 1 1 3

Method Group • EIA
Mean 4.05 4.05 9.40 9.73 13.85 13.82
SD 1 0.485 0.462 2 0.739 0.923 3 1.44 1.50
CV 12.0 11.4 7.9 9.5 10.4 10.8
# Points 940 5493 393 2370 802 4917
# Labs 40 55 18 27 34 46

Carbamazepine (Tegretol) Fluorescence Polarization−Roche µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Roche cobas INTEGRA
Mean −− 4.11 −− 8.81 −− −−
SD 1 −− 0.255 2 −− 0.458 3 −− −−
CV −− 6.2 −− 5.2 −− −−
# Points −− 29 −− 39 −− −−
# Labs 1 1

Method Group • Fluorescence Polarization−Roche
Mean −− 4.11 −− 8.81 −− −−
SD 1 −− 0.255 2 −− 0.458 3 −− −−
CV −− 6.2 −− 5.2 −− −−
# Points −− 29 −− 39 −− −−
# Labs 1 1

Carbamazepine (Tegretol) Immunoturbidimetric µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models)
Mean 4.08 4.19 9.60 10.20 14.86 15.08
SD 1 0.154 0.295 2 0.572 0.811 3 1.08 1.26
CV 3.8 7.0 6.0 7.9 7.3 8.4
# Points 73 381 68 249 22 109
# Labs 2 3 2 3 1 2

Abbott AEROSET/ARCHITECT (c, i, ci models) • Abbott ARCH c, Carbamazepine, REF 5P05
Mean 4.10 4.17 9.79 10.27 −− 9.90
SD 1 0.260 0.242 2 0.607 0.669 3 −− 0.000
CV 6.4 5.8 6.2 6.5 −− 0.0
# Points 46 281 39 255 −− 1
# Labs 1 1 1 1 1

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 4.93 4.91 10.11 10.06 −− −−
SD 1 0.334 0.296 2 0.392 0.406 3 −− −−
CV 6.8 6.0 3.9 4.0 −− −−
# Points 37 172 36 171 −− −−
# Labs 2 2 2 2

Beckman Coulter UniCel DxC Series
Mean 3.47 3.46 8.52 8.46 12.52 12.79
SD 1 0.207 0.253 2 0.364 0.436 3 0.667 0.576
CV 6.0 7.3 4.3 5.2 5.3 4.5
# Points 141 1073 56 857 113 890
# Labs 7 10 4 7 5 6

Siemens ADVIA Chemistry Systems
Mean 3.78 4.06 8.77 9.10 13.09 13.15
SD 1 0.346 0.527 2 0.473 0.806 3 1.77 1.09
CV 9.1 13.0 5.4 8.8 13.5 8.3
# Points 87 353 83 390 14 118
# Labs 3 5 3 6 2 3

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 114

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Carbamazepine (Tegretol) Immunoturbidimetric µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Siemens Dimension Series
Mean 3.86 3.86 8.81 8.77 13.52 13.42
SD 1 0.207 0.211 2 0.345 0.401 3 0.369 0.487
CV 5.3 5.5 3.9 4.6 2.7 3.6
# Points 220 1508 78 862 180 1528
# Labs 10 20 3 10 9 19

Siemens Dimension Vista
Mean 3.94 3.95 8.67 8.82 13.10 13.25
SD 1 0.162 0.191 2 0.348 0.365 3 0.481 0.549
CV 4.1 4.8 4.0 4.1 3.7 4.1
# Points 478 7660 224 2848 707 8207
# Labs 21 39 10 15 25 42

Method Group • Immunoturbidimetric
Mean 3.90 3.92 8.96 8.94 13.14 13.25
SD 1 0.331 0.302 2 0.641 0.676 3 0.651 0.611
CV 8.5 7.7 7.1 7.6 5.0 4.6
# Points 1082 11428 584 5632 1036 10853
# Labs 46 80 25 44 42 73

Carbamazepine (Tegretol) KIMS (Roche) µg/mL
Level Mon Cum Level Mon Cum Level Mon Cum
Roche cobas 6000/8000/c 311
Mean 3.57 3.57 8.05 8.15 12.15 12.18
SD 1 0.361 0.316 2 0.441 0.443 3 0.800 0.873
CV 10.1 8.9 5.5 5.4 6.6 7.2
# Points 317 1156 173 424 221 906
# Labs 16 19 10 12 10 12

Method Group • KIMS (Roche)
Mean 3.57 3.57 8.05 8.15 12.15 12.18
SD 1 0.361 0.316 2 0.441 0.443 3 0.800 0.873
CV 10.1 8.9 5.5 5.4 6.6 7.2
# Points 317 1156 173 424 221 906
# Labs 16 19 10 12 10 12

Ceruloplasmin Immunoturbidimetric mg/dL
Level Mon Cum Level Mon Cum Level Mon Cum
Roche cobas 6000/8000/c 311
Mean −− −− 23.00 23.00 −− −−
SD 1 −− −− 2 0.000 0.000 3 −− −−
CV −− −− 0.0 0.0 −− −−
# Points −− −− 3 3 −− −−
# Labs 1 1

Method Group • Immunoturbidimetric
Mean −− −− 23.00 23.00 −− −−
SD 1 −− −− 2 0.000 0.000 3 −− −−
CV −− −− 0.0 0.0 −− −−
# Points −− −− 3 3 −− −−
# Labs 1 1

Chloride Coulometric mEq/L
Level Mon Cum Level Mon Cum Level Mon Cum
Mindray BS 200E/380/400/480/800/2000
Mean −− −− −− 100.1 −− −−
SD 1 −− −− 2 −− 0.000 3 −− −−
CV −− −− −− 0.0 −− −−
# Points −− −− −− 5 −− −−
# Labs 5

Method Group • Coulometric
Mean −− −− −− 100.1 −− −−
SD 1 −− −− 2 −− 0.000 3 −− −−
CV −− −− −− 0.0 −− −−
# Points −− −− −− 5 −− −−
# Labs 5

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 115

Worldwide Report April 2016
Multiqual 1,2,3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units

Chloride Enzymatic mEq/L
Level Mon Cum Level Mon Cum Level Mon Cum
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 78.07 78.03 97.97 97.95 109.7 109.8
SD 1 0.626 0.646 2 0.847 0.850 3 1.04 1.05
CV 0.8 0.8 0.9 0.9 0.9 1.0
# Points 62 64 63 65 60 62
# Labs 2 2 2 2 2 2

Method Group • Enzymatic
Mean 78.07 78.03 97.97 97.95 109.7 109.8
SD 1 0.626 0.646 2 0.847 0.850 3 1.04 1.05
CV 0.8 0.8 0.9 0.9 0.9 1.0
# Points 62 64 63 65 60 62
# Labs 2 2 2 2 2 2

Chloride ISE direct mEq/L
Level Mon Cum Level Mon Cum Level Mon Cum
Abbott AEROSET/ARCHITECT (c, i, ci models)
Mean 78.94 80.24 −− 100.6 110.9 111.8
SD 1 0.280 2.27 2 −− 1.56 3 0.400 1.22
CV 0.4 2.8 −− 1.5 0.4 1.1
# Points 24 92 −− 56 24 89
# Labs 1 2 1 1 2

Beckman Coulter AU 400/480/600/640/680/2700/5400/5800
Mean 77.83 77.33 99.70 98.27 109.3 109.5
SD 1 1.69 1.12 2 0.000 1.24 3 1.69 1.53
CV 2.2 1.4 0.0 1.3 1.5 1.4
# Points 40 558 1 244 40 556
# Labs 2 4 1 2 2 4

Beckman Coulter UniCel DxC Series
Mean −− 78.07 −− 99.11 −− −−
SD 1 −− 1.39 2 −− 1.45 3 −− −−
CV −− 1.8 −− 1.5 −− −−
# Points −− 213 −− 217 −− −−
# Labs 4 4

Horiba ABX Pentra 400
Mean −− 79.18 113.0 113.0 −− 118.9
SD 1 −− 1.37 2 3.11 3.11 3 −− 6.57
CV −− 1.7 2.8 2.8 −− 5.5
# Points −− 205 6 6 −− 204
# Labs 1 1 1 1

ILab 650
Mean 76.20 76.20 −− −− 110.2 110.2
SD 1 0.837 0.837 2 −− −− 3 1.26 1.26
CV 1.1 1.1 −− −− 1.1 1.1
# Points 5 5 −− −− 4 4
# Labs 1 1 1 1

Mindray BS 200E/380/400/480/800/2000
Mean 79.20 78.15 100.6 100.1 −− −−
SD 1 1.23 1.02 2 2.01 2.10 3 −− −−
CV 1.6 1.3 2.0 2.1 −− −−
# Points 10 52 11 38 −− −−
# Labs 1 1 1 1

SFRI − ISE Series
Mean 80.47 80.71 103.8 102.5 −− −−
SD 1 3.38 1.99 2 4.03 3.17 3 −− −−
CV 4.2 2.5 3.9 3.1 −− −−
# Points 52 347 52 348 −− −−
# Labs 2 4 2 4

Siemens ADVIA Chemistry Systems
Mean 78.95 78.85 −− −− 112.0 111.9
SD 1 0.700 0.715 2 −− −− 3 0.960 0.913
CV 0.9 0.9 −− −− 0.9 0.8
# Points 37 79 −− −− 37 77
# Labs 1 1 1 1

Copyright © 2015 Bio−Rad Laboratories, Inc. Generated 22−May−2016 17:45:01 Page 116

28 2 1.41 3 −− 2.2 99.877 2 −− −− 3 1.8 111.7 1.6 3.51 2 2.95 2 −− −− 3 −− 7.0 3.3 1.688 1.7 1.9 SD 1 1.9 1.9 2.6 0.31 1.1 1.4 101.61 2 6.000 1.86 −− −− 115.10 1.9 −− 1.4 SD 1 0.56 79.69 101.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Chloride ISE direct mEq/L Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Xpand/EXL Series Mean 76.3 # Points 20 74 −− −− 82 400 # Labs 1 1 3 3 VITROS Microslide Series • Slide generation #01 Mean 77.39 99.2 114.15 1.49 2.815 0.59 97.55 98.0 1.9 SD 1 −− 1.4 1. Worldwide Report April 2016 Multiqual 1.12 1.4 1.1 SD 1 0.0 1.1 115.56 2 −− 1.30 3.63 115.40 98.5 1.760 0.30 2 3.63 2.7 2.2 # Points 19 72 47 208 19 138 # Labs 1 1 2 3 1 3 VITROS Microslide Series • Slide generation #02 Mean 76.34 3 2.2 SD 1 −− 1.09 1.42 3 1.8 114.2 SD 1 0.32 3 1.6 4.1 1.6 0.6 0.3 101.51 102.30 79.26 2 0.9 SD 1 1.64 CV 0.7 0.48 CV 1.35 1.45 3 0.3 2.05 110.00 CV 1.5 114.1 # Points −− −− 40 275 39 305 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #00 Mean 80.9 −− −− −− 3.15 CV −− −− 0.2 −− 127.000 1.20 77.71 3 2.7 # Points 2661 21236 1474 12317 2699 20924 # Labs 90 112 53 68 90 113 VITROS Microslide Series • Slide generation #29 Mean −− 103.55 79.0 1.63 76.3 0.1 1.3 SD 1 −− −− 2 0.5 # Points 1 173 1 175 1 175 # Labs 1 1 1 1 1 1 VITROS Microslide Series • Slide generation #05 Mean 79.4 114.1 −− −− 1.0 112.5 0.4 1.1 # Points −− 7 −− −− −− 9 # Labs 1 1 VITROS Microslide Series • Slide generation #99 Mean 79.6 SD 1 1.19 CV 1.0 # Points 62 589 33 132 29 461 # Labs 2 3 1 1 1 2 Tokyo Boeki BIOLIS 50i Mean −− 83.659 3 0.8 # Points −− 8 −− 8 −− 10 # Labs 1 1 1 Toshiba TBA−120FR Mean −− −− 98.1 6.71 CV 1.789 3 0.74 111.32 CV −− 1.1 1.46 79.38 103.03 CV 1.0 1.940 1.5 114.83 4.6 1.76 CV −− 1.3 −− 1. Generated 22−May−2016 17:45:01 Page 117 .7 101.985 2 0.637 0.32 75.8 # Points 422 1150 122 372 355 928 # Labs 19 22 9 11 16 19 Method Group • ISE direct Mean 79.52 CV 0.7 114.2 2.3 114.7 SD 1 0.3 2.3 103.000 1.41 −− 108.2.47 101.2 # Points 3353 24860 1787 14396 3329 24280 # Labs 122 160 72 99 118 153 Copyright © 2015 Bio−Rad Laboratories. Inc.09 2.639 0.62 101.8 0.30 99.0 2.44 2.3 −− −− −− 251.442 1.6 1.

50 2.0 109.7 1.28 110.0 2.24 99.6 # Points 48 293 22 138 27 173 # Labs 3 4 1 2 2 3 Copyright © 2015 Bio−Rad Laboratories.2 1.10 3 1.37 CV −− −− 1. ci models) Mean 79.7 1.63 97.01 2 1.87 CV 2.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Chloride ISE indirect mEq/L Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.62 77.42 2 −− −− 3 −− −− CV 2.98 96.3 SD 1 −− −− 2 0.5 107.5 2.2 # Points −− −− 22 196 22 193 # Labs 1 1 1 1 Hitachi Chemistry Series • MAKER Mean −− −− −− 95.24 107.4 0.1 1.18 1.94 99.1 # Points −− −− 58 270 29 188 # Labs 2 2 1 1 Mindray BS 200E/380/400/480/800/2000 Mean 76. LXi725 Chemistry Systems Mean 78.28 2 0.0 SD 1 1.770 1.16 97.88 2.0 1.11 79.855 1.91 78.05 1.9 # Points −− −− −− 41 −− 51 # Labs 1 1 ILab 600 Mean 76.99 2.14 2.03 113.2 SD 1 −− −− 2 −− 0.1 SD 1 −− −− 2 1.3 # Points 4714 26899 3553 19715 4499 24135 # Labs 105 132 76 95 99 122 Beckman Coulter LX20.00 2 1.61 3 1.1 1.74 CV 2.975 1.67 2 1. Inc.0 2.08 2 1.00 −− 108.95 74.3 112.2.64 3 1.1 1.78 95.65 97.4 1. Worldwide Report April 2016 Multiqual 1.7 3.2 # Points 5944 34404 3870 19420 4860 30559 # Labs 149 169 99 113 124 145 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 77.941 CV −− −− −− 0.3 1.6 SD 1 2.29 76.736 3 −− 0.5 110.815 0.35 99.9 2.28 111.00 2.8 2.35 3 1.48 1.83 3.6 1.4 111.1 1.8 1.61 1. i.53 96.41 CV 1.83 −− −− SD 1 0.15 3 1.4 111.9 −− −− −− −− # Points 2 20 −− −− −− −− # Labs 1 1 JEOL BioMajesty JCA−BM Series Mean −− −− 97.37 99.28 99.82 −− −− −− −− SD 1 1.8 SD 1 0.1 3.1 1.37 CV 1.6 1.2 # Points 26 85 20 153 49 224 # Labs 1 1 2 2 3 3 Beckman Coulter UniCel DxC Series Mean 78.0 1.52 78.08 3 3.77 109.04 2 3.0 1.0 1.0 1.0 −− −− # Points 111 694 125 691 −− −− # Labs 3 4 4 4 ILab 650 Mean 73.1 1.979 1.2 SD 1 0.15 1. Generated 22−May−2016 17:45:01 Page 118 .7 # Points 1257 9240 503 4154 1057 8528 # Labs 34 43 25 36 28 34 Hitachi Chemistry Series Mean −− −− 95.930 1.4 1.8 −− 0.03 1.29 99.76 111.18 1.7 0.6 SD 1 0.57 99.94 77.615 1.39 3 0.55 100.3 1.3 1.3 3.2 1.7 109.5 2.5 1.1 110.16 1.29 CV −− −− 1.995 3 −− −− CV 1.71 1.43 CV 1.

72 1.16 100.2 1.5 113.91 1.04 1.02 3 1.40 99.5 100.80 96.05 1.19 2 1.4 # Points 6241 45699 2976 22026 5526 41720 # Labs 184 237 78 100 160 208 Siemens Dimension Xpand/EXL Series • Dilution Mean 76.41 115.964 CV 1.0 1.0 1.80 CV 1.0 # Points 912 6939 521 3640 828 6444 # Labs 26 32 18 20 18 21 Roche Hitachi Systems (International) Mean −− −− 95.1 109.11 3 1.22 79.60 78.74 3 1.1 110.46 1.0 SD 1 1.24 73. E170) Mean 74.73 CV 2.56 1.54 99.994 2 −− −− 3 −− −− CV 1.81 109.3 1.90 3 1.8 2.2 2.7 SD 1 1.3 # Points 9007 94833 3635 34924 8461 90095 # Labs 203 275 74 105 195 266 Siemens Dimension Xpand/EXL Series Mean 76.8 2.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Chloride ISE indirect mEq/L Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/8000/c 311 Mean 72.5 115.17 2 1.57 2 1.34 1.2 1.5 1.67 1.4 1.6 # Points 6186 35288 4682 26619 4350 24793 # Labs 129 161 104 140 98 127 Siemens Dimension Series Mean 74.6 116.05 1.32 2 −− −− 3 1.0 1.908 0.3 1.5 1.59 3 1.60 CV 1. P.43 1.6 1.3 −− −− −− −− # Points 125 196 −− −− −− −− # Labs 2 2 Copyright © 2015 Bio−Rad Laboratories.78 2.1 1.75 1.9 2.1 SD 1 1.51 CV 1.42 94.15 CV 2.88 94.0 0.85 −− −− −− −− SD 1 0.8 1.5 1.71 CV −− −− 1.7 # Points 500 3304 207 1384 453 2722 # Labs 19 25 10 15 17 24 Siemens Dimension Vista Mean 78.1 109.23 1.5 1.01 −− −− 112.57 3 1.3 SD 1 1.7 112.0 SD 1 −− −− 2 1.8 1.1 1.3 1.95 CV 1.2 1.4 2.1 1.43 96.2 SD 1 1.0 SD 1 1.2.24 1.56 1.4 113.15 1.94 1.1 116.6 112.9 # Points 21 177 −− −− 21 177 # Labs 1 1 1 1 Roche cobas INTEGRA Mean 77.8 1.29 3 1.62 74.21 1.6 # Points −− −− 149 631 114 406 # Labs 5 5 3 3 Roche MODULAR (ISE.84 2.50 76.17 2 1.88 2 1.58 2 1.70 1.77 1.7 −− −− 1.5 1.65 112. D.14 78.88 109.3 SD 1 1.20 110.29 CV 2.45 2 1.6 2.6 1.5 101.5 SD 1 1.5 1.1 1.1 2.08 0.72 76.1 # Points 209 1224 209 1216 42 365 # Labs 11 14 11 14 2 2 Siemens ADVIA Chemistry Systems Mean 79.0 1.06 1.79 72.6 # Points 4877 26675 2314 8938 4303 25615 # Labs 119 146 66 79 94 120 Roche cobas c 111 Mean 77.1 1.39 96.7 1.98 99.6 2. Inc.51 112.2 113.74 1.7 1.51 95. Generated 22−May−2016 17:45:01 Page 119 .2 1.71 1.62 94.85 101.3 1. Worldwide Report April 2016 Multiqual 1.9 1.51 98.85 3 1.03 76.

06 −− −− 72.3 5.6 # Points −− 18 −− 45 −− 47 # Labs 1 1 1 Copyright © 2015 Bio−Rad Laboratories.03 4.8 6.4 −− 3.8 6.49 CV 4.7 5.83 3 −− 2.5 SD 1 2.31 3 3.1 −− 4.3 4718 4600 3757 1353 SD 1 1166 866.70 24.68 −− 41.9 260.01 −− −− −− 74.2 # Points −− 129 −− −− −− 131 # Labs 1 1 VITROS Microslide Series • Slide generation #10 Mean 23.7 # Points −− 24 −− −− −− 24 # Labs 1 1 VITROS Microslide Series • Slide generation #08 Mean −− 24.84 −− 61.73 CV −− −− −− 4.74 3 −− 7.9 260.2 −− −− −− 7.81 CV −− 2.3 −− 116. Generated 22−May−2016 17:45:01 Page 120 .1 204.7 2 270.1 # Points −− −− −− 102 −− 142 # Labs 2 2 VITROS Microslide Series • Slide generation #01 Mean −− −− −− 102.26 2 −− −− 3 −− 5.50 77.36 2.7 5.55 SD 1 1.73 CV −− 5.7 99.76 SD 1 −− 1.7 # Points 40055 286K 22866 144K 34641 256K # Labs 988 1245 576 735 846 1083 Cholesterol.31 2 −− −− 3 2.7 5.657 2 −− 3.17 99. Worldwide Report April 2016 Multiqual 1.0 3.62 SD 1 −− 1.53 112.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Chloride ISE indirect mEq/L Level Mon Cum Level Mon Cum Level Mon Cum Toshiba TBA−40FR (Accute) Mean −− −− −− 101.3 2.5 −− −− 2.22 CV −− −− −− 6.1 # Points 27 234 −− −− 27 244 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #22 Mean 2330 2292 4718 4600 7441 7245 SD 1 106.1 SD 1 −− −− 2 −− 4.3 # Points 27 50 28 50 27 53 # Labs 1 1 1 1 1 1 Method Group • Concanavaline A Mean 1177 423.03 CV 3.2.3 3 3735 2757 CV 99.0 2.5 −− 9. HDL Concanavaline A mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #07 Mean −− 23.4 2.8 458. HDL Dextran sulfate 50K mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Mindray BS 200E/380/400/480/800/2000 Mean −− 26.4 2 270.9 113.50 3 −− 3.6 −− 6.05 3.33 2 2.69 SD 1 −− 0.70 99.2 −− −− −− 3. Inc.03 1.34 2.9 CV 4.3 SD 1 −− −− 2 −− 6.22 2 −− −− 3 −− 2.4 −− 122.6 4.7 # Points 54 284 28 50 54 297 # Labs 2 2 1 1 2 2 Cholesterol.38 CV −− 5.7 2.6 5.7 6.3 3 504.75 −− −− −− 73.4 203.52 73.8 104.2 # Points −− −− −− 24 −− 25 # Labs 1 1 Method Group • ISE indirect Mean 77.

16 2.932 2 −− −− 3 −− 2.35 CV −− 6.3 # Points −− 37 −− 37 −− 37 # Labs 1 1 1 VITROS Microslide Series • Slide generation #06 Mean −− 21.7 3.67 3 2. HDL Dextran sulfate 50K−VITROS mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #03 Mean 20.1 4.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.1 # Points 9 411 −− 283 13 707 # Labs 1 6 4 1 8 VITROS Microslide Series • Slide generation #04 Mean −− 20.4 −− −− −− 4.48 3 −− 2.7 −− −− −− 3.0 −− 3.8 7.85 CV 1.2.16 1.14 2 −− 1.50 72.1 3.2 # Points −− 91 −− −− −− 91 # Labs 1 1 VITROS Microslide Series • Slide generation #49 Mean −− 22.7 # Points −− 102 −− −− −− 103 # Labs 1 1 VITROS Microslide Series • Slide generation #48 Mean −− 24.657 2 −− 3.11 −− −− −− 72.2 −− 5.83 3 −− 2.08 69.8 # Points 134 247 53 138 126 251 # Labs 6 6 2 2 6 6 VITROS Microslide Series • Slide generation #46 Mean −− 24.40 −− −− −− 69. Generated 22−May−2016 17:45:01 Page 121 . Inc.1 −− 4.23 2 −− 1.47 −− 69.37 2.37 3 −− 2.4 −− 3.1 −− −− −− 4.2 2.42 1.6 # Points −− 18 −− 45 −− 47 # Labs 1 1 1 Cholesterol.62 −− 41.41 CV −− 3.39 CV −− 4.12 43.60 SD 1 −− 1.9 3.5 3.0 3.380 0.755 2 −− −− 3 −− 3.64 SD 1 0.11 2 1.17 22.95 SD 1 −− 0.23 CV −− 3.72 72.43 SD 1 −− 1.8 −− 4. HDL Dextran sulfate 50K mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Method Group • Dextran sulfate 50K Mean −− 26.4 # Points −− 208 94 488 92 589 # Labs 3 3 3 3 4 VITROS Microslide Series • Slide generation #08 Mean −− 21.81 CV −− 2.98 SD 1 −− 1.1 6.10 SD 1 1.94 CV −− 5.5 # Points −− 59 −− 59 −− 58 # Labs 2 2 2 VITROS Microslide Series • Slide generation #07 Mean −− 22.22 SD 1 −− 0.88 −− −− −− 75.66 68.21 3 5.61 CV −− 5.76 −− 72.49 43.0 # Points −− 427 −− 231 −− 628 # Labs 7 4 9 VITROS Microslide Series • Slide generation #10 Mean 22.50 68. Worldwide Report April 2016 Multiqual 1.02 43.26 69.46 −− 42.34 3 2.7 −− 4.989 2 −− −− 3 −− 3.68 −− 41.03 2 −− 1.69 SD 1 −− 0.37 22.2 2.864 2 −− 1.42 CV −− 5.91 −− 43.6 # Points −− 160 −− −− −− 163 # Labs 1 1 Copyright © 2015 Bio−Rad Laboratories.2 5.5 −− 9.3 −− 4.67 43.0 3.84 −− 61.23 SD 1 −− 1.54 −− 44.90 CV 5.86 3 −− 3.18 1.11 4.17 SD 1 −− 0.37 2 1.75 −− 68.2 −− 3.

688 2 −− 1.33 CV 5.0 # Points −− 56 −− 54 −− 55 # Labs 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean −− 29.05 CV 6.10 5.52 70.3 2.13 49.5 3.4 # Points 11 301 17 312 13 60 # Labs 1 6 1 7 1 1 Mindray BS 200E/380/400/480/800/2000 • Alternate Formulation/Standardization Mean −− 25.39 CV −− 2.54 1.2 # Points 178 1854 184 1344 237 2644 # Labs 10 34 8 19 12 37 Cholesterol.2 3.9 3.76 54.6 −− 3.0 2.77 −− 73.28 SD 1 0.50 3.737 2 1.23 1.6 5.25 1.4 5.01 CV 4.62 55.7 9.81 43.09 SD 1 −− −− 2 1.47 73.50 SD 1 −− 1.97 3 1.21 44. ci models) Mean 30.45 2 1.29 SD 1 −− 0.25 0.7 −− 3.706 2 −− 1.45 2. ci models) • PROLABS Mean −− 26.13 3 3.397 0.53 −− −− 69.05 22.69 70.740 2.6 −− 3.31 2 3.83 70.6 4.92 50.03 −− −− SD 1 0.4 3.37 3.32 29.8 4. HDL Direct Enzymatic Colorimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.5 2.7 6.35 1.29 1.36 3 1.6 3.96 22.8 −− 3.85 44.70 2 2.60 2 2.89 43.59 1.61 85.44 3 3.8 3.5 −− 3.4 4.02 −− 47.13 27.5 4.2 6.2.54 SD 1 1.7 −− −− 10.34 61.21 42.06 2 −− 2.5 8.21 43.3 # Points 35 112 37 108 6 17 # Labs 3 6 3 3 2 4 Method Group • Dextran sulfate 50K−VITROS Mean 21.61 −− 50.00 3 −− 2.57 20.2 3.81 43.05 2.67 CV −− −− 3.88 CV −− 3. i.21 3 −− −− CV 1.2 7. Inc.30 −− 91.3 # Points 99 642 −− −− 99 646 # Labs 3 3 3 3 Roche Hitachi Systems (International) Mean −− −− 38.872 2 −− −− 3 7.86 69.15 23.5 3.2 7.77 3 −− 2. Worldwide Report April 2016 Multiqual 1. Generated 22−May−2016 17:45:01 Page 122 .8 8.1 # Points −− 138 −− 37 −− 138 # Labs 2 1 2 Dirui CS Series Mean 26.3 8.8 −− −− # Points 105 814 105 756 −− −− # Labs 3 9 3 9 Copyright © 2015 Bio−Rad Laboratories.3 # Points −− −− 95 231 95 230 # Labs 3 3 3 3 Siemens ADVIA Chemistry Systems Mean 22.02 3.49 −− 57.56 CV −− 2.55 CV 2.17 SD 1 1. HDL Dextran sulfate 50K−VITROS mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #99 Mean 21.34 54.5 # Points 94 416 86 344 79 365 # Labs 4 4 4 4 4 4 Abbott AEROSET/ARCHITECT (c.53 SD 1 1.3 # Points −− 19 −− 19 −− 20 # Labs 1 1 1 Roche cobas 6000/8000/c 311 Mean 23.1 4.05 39.17 84.06 1.40 3.19 4.5 3.86 39.80 −− 71.66 CV 5.82 3 4.37 SD 1 −− 0.79 3 −− 6.06 SD 1 1.2 5. i.5 −− 9.

42 SD 1 −− −− 2 −− 3.63 25.40 1.73 48.71 32.2.31 2 2.21 73.2 15.89 70.887 2 1.14 51.51 1.58 CV 5.26 76.8 3.22 CV −− −− 2.2 3. i.4 2 6.57 SD 1 −− 0. OSR6X87 Mean 25.1 # Points −− −− −− 103 −− 92 # Labs 1 1 Copyright © 2015 Bio−Rad Laboratories. Inc.2 # Points −− −− 54 345 −− 120 # Labs 2 5 3 DIRUI−CS−240 Mean −− −− −− 38.6 # Points 24 50 36 203 36 202 # Labs 1 1 3 3 3 3 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 26.4 3.70 66.60 2207 CV 14. ci models) Mean 33.96 CV 2.844 2 2.06 157.1 10.6 7.8 384.0 # Points −− −− −− −− 3 3 # Labs 1 1 Beckman Coulter UniCel DxC Series Mean −− −− 48.15 SD 1 0.75 45.72 606.3 4.9 3.2 3.0 22.41 SD 1 −− −− 2 2.510 0.35 2.38 51.90 CV 4.68 74.8 3.47 26.1 8.8 5.16 SD 1 1.3 4.79 75.93 3 2.15 73.25 51.79 SD 1 −− −− 2 −− −− 3 0.3 # Points −− 12 −− −− −− 14 # Labs 1 1 Method Group • Direct Enzymatic Colorimetric Mean 25.35 3 5.52 52.43 7.79 −− 91.42 4.00 −− −− −− 68.58 2.9 44.2 2.69 5.0 4.8 # Points 309 2600 303 1734 286 1727 # Labs 11 27 11 25 11 16 Cholesterol.66 3 7.47 677.8 3.2 SD 1 3.30 4.5 −− 4.773 0.4 2. Generated 22−May−2016 17:45:01 Page 123 .0 325.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.1 # Points 1544 8391 878 4488 1405 7226 # Labs 34 43 28 36 33 42 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Alternate Formulation/Standardization Mean −− −− 50.82 CV −− −− 6.60 SD 1 0.23 50.0 3.63 CV −− 0.11 26.9 # Points 28 148 28 151 28 155 # Labs 2 2 2 2 2 2 Beckman Coulter LX20.40 3 −− 3.60 76.96 4. immunoinhibition mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.2 6.55 2.2 3.0 5.7 # Points 85 668 74 360 137 535 # Labs 2 5 3 5 4 4 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Wako Mean 26.773 CV −− −− −− −− 1.021 2 −− −− 3 −− 3. LXi725 Chemistry Systems • LEADMAN Mean −− −− −− −− 75.5 9. HDL Direct measure.79 51.96 3 14.1 6.23 71.44 1. Worldwide Report April 2016 Multiqual 1.87 49.06 1.49 1.03 74.75 75.5 # Points −− −− 62 237 61 238 # Labs 2 2 2 2 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU HDL.1 −− −− −− 5.37 3.0 13.0 1.04 81.758 0.95 50.72 51.30 SD 1 1.92 SD 1 −− −− 2 1.64 3 2.59 3 2.00 CV 2.68 2 3.11 CV −− −− −− 8.12 3 −− 5.2 −− 9. HDL Direct Enzymatic Colorimetric mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Xpand Plus Mean −− 20.4 5.3 9.16 −− 56.

1 5.5 −− −− # Points −− 46 17 46 −− −− # Labs 1 1 1 JEOL BioMajesty JCA−BM Series • Zhong Sheng Mean −− −− −− 46. ci models) • Zhong Sheng Mean −− −− 51.13 SD 1 −− −− 2 −− 0.86 25.39 45.0 9.844 0.63 SD 1 −− −− 2 0.000 1.78 2 0.61 50.6 7.31 −− −− SD 1 −− −− 2 1.3 −− 1.1 4.64 CV 6.7 1. ci models) Mean 29. polymer−polyanion mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.6 5.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.5 3.50 SD 1 0.734 2 1.24 50.38 53.27 74.43 78. immunoinhibition Mean 26.9 # Points 27 127 25 119 2 2 # Labs 2 2 1 1 1 1 Siemens ADVIA Chemistry Systems Mean −− −− 43.14 CV −− −− −− 2.47 47.22 SD 1 1.26 1.55 3 −− −− CV −− −− 3.62 5.72 1.58 2.3 # Points 4119 22175 2907 15799 3360 19746 # Labs 120 137 77 90 97 116 Abbott AEROSET/ARCHITECT (c.9 0.16 CV −− −− 0.7 # Points −− −− −− 39 −− 48 # Labs 1 1 ILab 600 Mean −− 26.39 CV −− −− 0.7 # Points −− −− 3 3 3 3 # Labs 1 1 1 1 Toshiba TBA−120FR Mean −− −− 42.4 # Points −− −− 39 266 37 299 # Labs 1 1 1 1 Method Group • Direct measure. HDL Direct measure.707 0.63 3 −− −− CV −− 6.9 7.36 2 3.57 CV 4.000 5. Generated 22−May−2016 17:45:01 Page 124 .22 SD 1 −− −− 2 0. immunoinhibition mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Hitachi Chemistry Series • MAKER Mean −− −− −− 42.0 0.53 3 −− 0.16 1.0 # Points −− −− 1 20 1 20 # Labs 1 1 1 1 Copyright © 2015 Bio−Rad Laboratories.24 44.514 2.10 3 0.19 26.28 3.04 44.43 29.36 2 1.2.7 5.8 4.50 −− −− SD 1 −− 1.50 78.02 60.56 50.05 −− 66.22 69.80 3 0.6 −− −− # Points −− −− 21 21 −− −− # Labs 1 1 Siemens ADVIA Chemistry Systems • LEADMAN Mean −− −− 52.40 1.0 4.59 52.31 43.2 # Points −− −− −− 44 −− 35 # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean 25.5 6.7 1.77 SD 1 −− −− 2 −− 1.6 3. i.8 4.387 3 1.43 3.707 CV 3. Inc.65 SD 1 1.57 59.3 2.77 50.1 −− 1.2 0.26 3 2.1 4.45 3.55 1.792 CV −− −− −− 3.38 53.46 3 5.64 76.387 0.01 3 3.1 5.47 74.52 CV −− −− 3.7 0.39 −− 67.78 SD 1 −− −− 2 1.8 1.6 3.45 82.82 83. Worldwide Report April 2016 Multiqual 1. i.5 2.89 2. HDL Direct measure.6 # Points 1708 9430 1175 6188 1651 8720 # Labs 41 54 43 59 46 61 Cholesterol.59 69.8 2.2 6.868 3 −− 1.48 64.

03 SD 1 −− −− 2 −− −− 3 −− 4.35 9.48 2 2.8 5.67 3.4 3.9 4.67 65.62 1. HDL Direct measure.71 87.18 SD 1 −− −− 2 0.13 53.55 87.74 54.33 −− −− SD 1 1.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.90 3 −− −− CV 5.55 54.48 −− −− 86.32 28.3 5.68 SD 1 1.89 2.0 10.87 2 2.48 CV 2.76 3 4.08 1.95 52.9 3.61 3 3.29 CV 5.6 # Points −− −− −− 34 19 107 # Labs 1 1 1 Beckman Coulter UniCel DxC Series Mean 27.2 3.22 CV −− −− −− −− −− 6.47 52.2 4.2 −− −− # Points −− −− 6 6 −− −− # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean −− −− −− −− −− 63.89 CV −− −− 0.00 85.80 3 0.0 5.2 5.9 6.716 0.1 14.78 SD 1 0.50 3.66 3 2.53 52.73 85.18 2.9 2.98 CV −− −− −− 14.70 3 7.387 2.4 −− −− 1.27 87.47 −− −− SD 1 −− −− 2 2.77 88.5 3.3 4.00 0.04 28.863 2 −− −− 3 2.1 5.3 # Points 286 3542 96 1705 248 3454 # Labs 10 19 6 13 9 16 Beckman Coulter UniCel DxC Series • BC DxC HDL.70 68.35 67.18 3 −− −− CV −− −− 4. REF A15625 Mean 27.56 CV 3.18 −− −− 88.7 4.8 5.19 SD 1 −− −− 2 −− 5. LXi725 Chemistry Systems Mean −− −− −− 40.83 CV 3.73 27. REF 650207 Mean 27.07 SD 1 1.31 4.7 # Points −− −− −− −− −− 72 # Labs 3 Copyright © 2015 Bio−Rad Laboratories.971 2 −− −− 3 1.50 4.63 2.2 4.8 4.3 # Points 328 1083 60 72 248 965 # Labs 9 9 2 2 6 6 Beckman Coulter UniCel DxC Series • BC DxC HDLD. polymer−polyanion mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 28.98 54.1 3.31 SD 1 1.9 −− −− # Points 87 494 86 426 −− −− # Labs 6 8 6 8 Hitachi Chemistry Series Mean −− −− 42.00 28.8 2.55 86. Worldwide Report April 2016 Multiqual 1.9 6.72 26.9 # Points 1236 8149 639 4941 926 6781 # Labs 45 53 26 34 33 45 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU HDL.41 1.19 56. Inc.67 2.10 2 2.82 72. Generated 22−May−2016 17:45:01 Page 125 .773 3.2.8 # Points −− −− 22 197 22 194 # Labs 1 1 1 1 Horiba ABX Pentra 400 Mean −− −− 52.9 # Points 22 192 −− −− 22 192 # Labs 1 1 1 1 Beckman Coulter LX20.30 53.3 1.14 SD 1 1.9 6.49 2.70 CV 5.79 2.8 4.2 # Points 11 99 −− −− 9 97 # Labs 1 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Genzyme Mean 28. OSR6X95 Mean 29.54 44.1 −− −− 2.77 87.7 3.06 2 1.4 7.97 27.66 1.

92 3 7.85 44.6 −− 1.910 0.2 5.9 9.09 1.61 SD 1 −− −− 2 −− 1.5 9.72 SD 1 0.985 2 −− −− 3 1.27 1.4 5.46 CV 5. polymer−polyanion Mean 26.23 3 3.4 5.98 SD 1 1.54 26.60 2 2.30 21.31 4.87 44. HDL Direct measure.9 9.87 4.9 −− −− # Points −− −− −− 25 −− −− # Labs 1 Method Group • Direct measure.14 1. PTA/MgCl2−VITROS mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #00 Mean 21.8 10.50 CV 6.21 CV 5.71 3.5 5.55 −− −− SD 1 −− −− 2 −− 2.07 71.30 2 2.44 45.5 4.49 46.2 5.816 0.5 4.29 2.57 46.16 3.6 3.65 8.12 CV 4.3 4.84 3.90 3 3.2 5.05 2 4.94 3 3.9 6.9 5.90 68.00 −− 84. Worldwide Report April 2016 Multiqual 1.00 −− 57.47 25.0 # Points 193 1473 136 1181 243 2019 # Labs 8 20 7 12 10 22 VITROS Microslide Series • Slide generation #04 Mean 21.3 # Points −− 23 −− 3 −− 14 # Labs 1 1 1 Toshiba TBA−40FR (Accute) Mean −− −− −− 47.9 8.0 4.43 2 1.62 4.35 68.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.84 3 2.08 2 2.72 3.82 22.0 −− 2.3 4.09 CV −− 0.50 SD 1 1.76 68.6 −− −− 2.7 # Points 651 5515 232 1692 552 5120 # Labs 24 35 9 16 20 30 Siemens Dimension Vista • Siemens Dimension Vista HDLC (K3048) Mean 25. Inc.61 2.3 6.86 SD 1 0.74 −− 78.94 SD 1 1.33 49.38 70.1 4.62 20.38 CV 3.37 26.24 CV 5. polymer−polyanion mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens ADVIA Chemistry Systems Mean 22.10 CV 11.0 4.19 44.1 6.6 5.73 SD 1 1.99 45.74 2.5 3.8 2.92 70.1 4.9 11.3 # Points 11210 67996 7138 43155 8857 57323 # Labs 333 415 214 283 269 349 Cholesterol.1 # Points 138 2259 27 603 102 1779 # Labs 7 18 2 8 5 16 Copyright © 2015 Bio−Rad Laboratories.58 78.93 3 −− 1.67 CV −− −− −− 4.71 3 −− −− CV −− −− −− 5.05 78.1 # Points −− −− −− 90 −− 138 # Labs 2 2 Toshiba−TBA Mean −− −− −− 45.83 50.61 1.55 −− −− 65.000 2 −− 3.07 1.7 4.67 1.0 −− 6.0 # Points 527 5369 179 1944 533 5321 # Labs 15 23 5 7 15 22 Tokyo Boeki BIOLIS 50i Mean −− 24.55 75.06 69.47 SD 1 3.50 SD 1 −− 0.2 5.2.47 3 3.57 21.8 4.42 43.03 74.806 2 1.5 # Points 20 74 −− −− 20 74 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #03 Mean 21.74 3 −− 1.05 49.38 70.51 49.1 5. HDL Direct measure.77 3.25 68. Generated 22−May−2016 17:45:01 Page 126 .8 # Points 3943 21355 2910 16316 2917 15312 # Labs 102 128 80 108 84 108 Siemens Dimension Series • Siemens Dimension AHDL (DF48A) Mean 27.

Inc.19 43.1 5.44 2.3 6.29 CV −− 5.2 4.41 3 2.6 5.7 4.13 74.76 44.5 5.926 2 2. PTA/MgCl2−VITROS mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #05 Mean 22.25 1.9 6.39 20.2 4.79 SD 1 1.8 5.4 −− 4.78 CV −− 4.1 6.9 4.1 4.09 3 4.2 6.810 2 −− −− 3 3.86 3.7 3.23 SD 1 −− 0.1 # Points −− 160 −− 161 −− 169 # Labs 1 1 1 VITROS Microslide Series • Slide generation #22 Mean 22.30 4.85 68.23 44.11 45.14 2 2.6 3.9 −− −− 4.70 4.2.1 5.3 5.60 73.55 CV 2.07 21.7 # Points 61 649 61 654 65 721 # Labs 1 1 1 1 1 1 VITROS Microslide Series • Slide generation #49 Mean 20.43 69.76 3 4.50 SD 1 1.64 3 3.39 SD 1 −− 1.06 1.06 1.47 1.13 42.7 5.19 0.636 1.2 3.78 3.5 4.34 72.37 2.9 # Points 23 221 23 197 23 238 # Labs 1 2 1 2 1 2 VITROS Microslide Series • Slide generation #38 Mean 21.27 1.7 −− 6.43 3 −− 4.58 CV 5.2 # Points 313 592 167 326 317 629 # Labs 15 15 10 10 14 14 VITROS Microslide Series • Slide generation #17 Mean −− 22.11 3 3.1 5.09 1.6 −− 5.01 71.4 6.9 # Points 243 676 49 200 230 620 # Labs 14 14 4 6 12 12 Copyright © 2015 Bio−Rad Laboratories.7 5.61 SD 1 1.56 46.9 # Points 32 241 −− −− 35 249 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #99 Mean 22.5 6.8 4.1 5.99 CV 4.52 21.01 SD 1 1.63 44.5 3.10 72.7 6.17 2 −− 2.62 70.0 5.72 SD 1 1.27 2 2.77 CV 3.21 22.87 3 3.30 70.811 2 1.38 CV 4. HDL Direct measure.08 2 1.96 22. Worldwide Report April 2016 Multiqual 1.40 44.9 5.44 4.06 2 1.85 4.27 2 1.65 −− 68.46 4.78 45.3 3.02 44.39 43.3 5.85 22.51 3 1.88 −− 42.66 CV 5.85 74.10 72.1 −− 3.50 CV 5.8 3.18 70.82 69.90 20.8 3.7 # Points 313 917 186 641 366 1094 # Labs 13 18 9 11 15 21 VITROS Microslide Series • Slide generation #08 Mean 22.7 2.911 2 −− 1.01 SD 1 0.26 CV 4.81 −− −− 72.34 −− 43.71 1.1 # Points −− 252 −− 253 −− 249 # Labs 2 2 2 VITROS Microslide Series • Slide generation #21 Mean −− 20.95 SD 1 0.89 44.48 72.15 22.0 # Points 322 4049 84 1821 322 4100 # Labs 14 36 5 20 14 38 VITROS Microslide Series • Slide generation #10 Mean 21.3 2.16 44.54 3.00 SD 1 1. Generated 22−May−2016 17:45:01 Page 127 .33 2.8 3.38 2.8 # Points 31 277 31 263 31 277 # Labs 2 3 2 2 2 3 VITROS Microslide Series • Slide generation #07 Mean 22.588 0.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.50 73.50 3 −− 2.00 0.55 45.36 −− 70.

7 # Points 40 210 15 43 25 156 # Labs 2 2 1 1 1 1 Copyright © 2015 Bio−Rad Laboratories.33 3.32 2 2.6 4.8 −− −− 0.04 7. ci models) Mean −− −− 51. HDL Direct measure−PEG mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.80 49.2 2.17 4. Inc.49 2 3.55 2.06 45.99 2.01 −− −− SD 1 0.74 −− −− SD 1 0.93 97.820 3 −− −− CV 1.08 70.416 2 0.5 5.6 1.6 5.67 44.49 3 −− −− CV −− 8.6 # Points 107 331 107 330 107 330 # Labs 4 4 4 4 4 4 Hitachi Chemistry Series Mean 21.96 21.6 7.71 3.66 −− −− SD 1 −− 2.36 1.500 CV 3.17 −− −− SD 1 −− −− 2 2.7 # Points 22 106 −− −− 4 4 # Labs 2 2 1 1 JEOL BioMajesty JCA−BM Series Mean −− −− 57.96 1.16 1.73 80.25 SD 1 0.914 1.2 7.03 1.27 23.15 2 −− 5.19 28.38 25.45 49.23 97.5 3.7 1.38 −− −− 71.500 0.2. Worldwide Report April 2016 Multiqual 1.4 6.7 2.74 SD 1 1.8 −− −− # Points 92 447 88 443 −− −− # Labs 2 2 2 2 ILab 650 Mean 25.1 4. PTA/MgCl2−VITROS mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Method Group • Direct measure.19 61.3 5.7 6.7 1.79 2 1.54 CV 5.6 −− −− # Points −− −− 29 36 −− −− # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean 26.3 6.34 3 4.7 # Points 126 126 −− −− 126 126 # Labs 3 3 3 3 Beckman Coulter UniCel DxC Series Mean 28.97 3 1.7 0.96 CV 5.82 52.4 # Points 1689 11840 764 6300 1754 12218 # Labs 77 132 41 75 76 134 Cholesterol.8 −− −− # Points −− 7 −− 6 −− −− # Labs 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Sekisui Diagnostics Mean 25.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.74 71.32 3 −− −− CV −− −− 2. PTA/MgCl2−VITROS Mean 21.9 2.9 4.03 SD 1 1.08 −− 46.29 1. HDL Direct measure.25 68.773 1.83 25.65 26.3 5.420 0.62 57.72 3 −− −− CV 3.79 46.49 44.3 5.06 42.98 78.76 3 −− −− CV −− −− 4.75 SD 1 1.26 1.18 2 −− −− 3 0.99 70.6 6.10 2 1.9 6.45 SD 1 1.0 6.02 2. i.80 −− −− 68.6 4.1 2.6 −− 11.96 CV 3.44 CV 4.23 1.4 −− −− # Points 7 116 7 117 −− −− # Labs 1 1 1 1 ILab 600 Mean 24.5 −− −− # Points −− −− 30 80 −− −− # Labs 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean −− 25.31 24.92 −− −− SD 1 −− −− 2 1. Generated 22−May−2016 17:45:01 Page 128 .84 3 6.18 61.36 2 −− −− 3 1.3 −− −− 2.60 39.710 0.5 3.

669 2 1.0 3.46 −− −− 67.19 87.442 0.3 5.32 3 3.2 5.2.1 4.42 3 3.43 CV 3.46 1.7 # Points 694 5758 468 2224 587 5771 # Labs 27 36 14 14 23 32 Copyright © 2015 Bio−Rad Laboratories.5 # Points 121 782 131 855 154 1117 # Labs 5 5 5 5 4 4 Siemens ADVIA Chemistry Systems • Randox Mean 23.71 3.77 46.10 3 1.92 3.00 76.04 71. E170) Mean 25.6 2.62 45. Generated 22−May−2016 17:45:01 Page 129 .625 2 −− −− 3 1.89 74.8 2.5 7.95 SD 1 0.49 69.15 1.46 CV 6.4 4.9 2.8 # Points 54 163 −− −− −− 166 # Labs 2 2 2 Siemens ADVIA Chemistry Systems • Siemens Dimension AHDL (DF48B) Mean 23.75 4. P. HDL Direct measure−PEG mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/8000/c 311 Mean 23.7 5.9 5.23 1.68 23. Worldwide Report April 2016 Multiqual 1.790 0.850 2 2.34 SD 1 0.9 # Points 161 704 139 607 160 681 # Labs 4 6 4 6 4 6 Roche cobas c 111 Mean 25.5 2.55 25.12 3 11.4 3. D.821 0.997 3 2.5 # Points 281 1739 197 1005 211 1499 # Labs 13 14 9 10 10 10 Roche Hitachi Systems (International) Mean −− −− 47.33 2.0 2.46 49.24 SD 1 0.18 2.893 2 3.3 3.684 2 −− −− 3 1.4 # Points 26 120 −− −− 26 122 # Labs 1 1 1 1 Siemens Dimension Series Mean 26.2 2.77 53.12 0.52 1.3 # Points 2465 12916 1072 4083 2006 11511 # Labs 75 92 47 52 57 74 Roche cobas 6000/8000/c 311 • 3rd Generation Mean 23.9 −− −− 2.65 23.85 CV 3.2 3.66 CV 2.33 76.80 SD 1 1.1 7.4 2.97 SD 1 0.20 48.55 77.6 4.8 4.7 13.12 2 2.29 49.3 3.9 # Points 155 1047 151 999 23 305 # Labs 11 14 10 13 2 2 Siemens ADVIA Chemistry Systems Mean 22.89 SD 1 0.7 4.26 3 3.1 7.06 CV 2.59 −− −− −− 77.523 2 1.05 44.72 9.3 −− −− −− 2.06 1.56 72.789 2 −− −− 3 −− 2.64 CV 1. Inc.89 2.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.89 69.23 45.6 4.7 6.542 0.18 CV 4.11 67.2 # Points 13 140 −− −− 13 140 # Labs 1 1 1 1 Roche cobas INTEGRA Mean 24.5 2.99 49.3 5.502 0.24 2.91 73.35 23.33 68.81 45.2 2.78 68.99 CV 2.97 52.941 0.14 CV 7.18 SD 1 1.3 2.2 −− −− # Points −− −− 20 179 −− −− # Labs 1 2 Roche MODULAR (ISE.4 10.48 86.79 26.21 25.44 SD 1 0.24 SD 1 0.2 3.17 −− −− 76.34 22.66 2.8 2.56 24.04 2 3.22 −− −− SD 1 −− −− 2 1.73 48.15 23.5 −− −− 1.01 43.25 4.670 0.7 4.54 3 −− −− CV −− −− 2.9 7.83 3.

07 1.5 2.20 3 4.3 2.6 # Points 50 604 −− −− 50 610 # Labs 2 3 2 3 Copyright © 2015 Bio−Rad Laboratories.93 0.29 72.72 26.6 −− 2.5 # Points 63 356 −− −− 86 387 # Labs 1 1 1 1 Siemens Dimension Series • Siemens Dimension AHDL (DF48B) Mean 26.74 4.9 7.37 SD 1 1.40 SD 1 −− 0.25 71.3 3.3 7. HDL Direct measure−PEG mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Series • Siemens Dimension AHDL (DF48A) Mean 24.20 74.27 CV 4.36 25.9 # Points 968 11536 277 3813 883 11275 # Labs 25 40 8 17 24 41 Siemens Dimension Vista • Factored (excluding IFCC) Mean −− 26.16 CV 7.9 # Points 393 3273 129 1208 321 2689 # Labs 11 13 3 3 9 11 Siemens Dimension Vista • Siemens Dimension Vista HDLC (K3048A) Mean 25.99 48.36 71.387 1.8 6.38 CV −− −− 4.4 4.37 47.35 CV 3.72 CV 4.874 2 −− −− 3 4.36 2.28 2 1.00 2 4.56 23.9 4.2 4.2.1 4.10 2 1.773 1.98 72.60 70.59 47.96 SD 1 0.24 SD 1 1. Inc.4 3. Generated 22−May−2016 17:45:01 Page 130 .05 72.6 3. Rgt Lot EB5002 and later Mean 27.914 3 0.6 5.79 2 3.88 1.30 SD 1 1.8 3.26 3.91 −− 73.54 4.6 4.85 26.927 0.20 1.28 71.67 26.4 6.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol. Rgt Lot 13353BD and later Mean 25.7 −− −− 6.3 4.77 68.92 3 3.6 6.1 −− 2.87 50.3 6.8 3.7 # Points 901 6151 445 3458 729 4898 # Labs 30 37 13 19 27 34 Siemens Dimension Vista Mean 26.95 SD 1 1.6 6.03 0.44 74.75 3.25 CV 7.71 3 2.4 4.3 3.11 SD 1 −− −− 2 1.75 CV −− 3.6 4. HDL Polyethylene glycol (PEG) mg/dL Level Mon Cum Level Mon Cum Level Mon Cum JEOL BioMajesty JCA−BM Series Mean −− −− 44.47 43.98 1.7 4.6 3.88 3 3.13 3.97 2.2 2.9 3.35 2 −− −− 3 2. Worldwide Report April 2016 Multiqual 1.67 1.4 3.1 4.6 # Points 3772 38939 1148 11287 3773 36874 # Labs 111 147 32 41 107 140 Method Group • Direct measure−PEG Mean 25.14 −− −− 73.3 3.01 72.1 0.29 2 1.49 4.83 27.64 72.11 3 4.8 # Points 1941 15333 567 4699 1705 14802 # Labs 64 89 19 29 61 84 Siemens Dimension Series • Siemens Dimension HDL.4 −− −− 3.96 26.04 47.43 26.934 2 1.52 47.29 46.32 48.5 8.7 # Points 12402 101K 5020 35918 10939 93300 # Labs 395 515 175 224 340 454 Cholesterol.5 6.32 3.4 # Points −− 453 −− 446 −− 447 # Labs 2 2 2 Siemens Dimension Vista • Siemens Dimension Vista HDL.830 2 −− 1.3 3.79 1.56 2.94 73.23 50.85 CV 4.22 1.20 70.87 −− −− 70.2 5.1 5.86 74.38 SD 1 1.72 SD 1 0.11 3.0 # Points −− −− 2 136 2 136 # Labs 1 1 1 1 Roche cobas 6000/8000/c 311 Mean 23.82 47.58 3 2.57 47.17 47.73 −− 48.51 CV 3.82 CV 4.34 1.23 73.31 SD 1 1.26 3 −− 1.

47 3 2.914 2 1.8 17.83 25.8 124.3 3.28 2 −− −− 3 3.8 # Points 23 121 −− −− 23 121 # Labs 1 1 1 1 Method Group • Calculated Mean 68.28 45.61 2 1.16 2.4 1.58 3 −− −− CV 1.942 1.5 1.833 0.2.18 3.3 −− 1.27 45.52 −− 101.30 SD 1 −− 0.90 26.28 CV −− 2. Worldwide Report April 2016 Multiqual 1.14 68.5 2.34 68.75 SD 1 3.57 63.3 SD 1 0. Inc.58 3 −− −− CV −− 2.5 2.6 52.2 −− −− SD 1 0.52 117.68 105.64 CV 4.76 3 3.40 CV 3.69 4.8 −− −− −− 3.05 SD 1 0.6 117.46 68.39 2 2.5 −− 3.07 3 −− −− CV 1.4 2.52 CV −− 3.8 −− −− # Points 71 79 75 83 −− −− # Labs 2 2 2 2 Siemens Dimension Vista Mean −− 18.3 # Points −− 414 −− 6 −− 407 # Labs 2 2 2 VITROS Microslide Series • Slide generation #21 Mean 63.29 1.42 70.8 # Points 109 1274 122 923 113 1395 # Labs 4 6 3 3 5 7 Cholesterol.34 1.50 1.31 −− −− 124.5 −− −− # Points 91 482 89 480 −− −− # Labs 2 2 2 2 Roche Hitachi Systems (International) Mean −− 62. Generated 22−May−2016 17:45:01 Page 131 .88 2 2.960 2 1.5 # Points 59 397 120 787 61 395 # Labs 2 2 2 2 2 2 Method Group • Polyethylene glycol (PEG) Mean 24.80 70.46 SD 1 −− 0.21 22.43 SD 1 1.8 1.753 2 −− −− 3 −− 2.3 1.2 3.18 33.9 3. LDL Calculated mg/dL Level Mon Cum Level Mon Cum Level Mon Cum ILab 600 • Alternate Formulation/Standardization Mean 68.6 108.57 67.15 2.1 # Points −− 273 −− −− −− 254 # Labs 1 1 Siemens Dimension Vista • Siemens Dimension Vista HDLC (K3048A) Mean 25.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.16 18.95 −− −− −− 73.2 3.860 0.0 −− −− 2.0 1.8 3.8 # Points 94 650 75 125 23 528 # Labs 3 6 2 5 1 3 Copyright © 2015 Bio−Rad Laboratories.8 5.609 2 −− 0.6 −− −− SD 1 1.6 2.7 −− 1.31 1.30 −− 31.68 2 −− 1.7 64.469 3 −− 1.78 46. HDL Polyethylene glycol (PEG) mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Siemens Dimension Series Mean −− 26.80 46.6 −− −− # Points −− 36 −− 36 −− −− # Labs 1 1 Siemens ADVIA Chemistry Systems Mean 70.2 1.1 125.0 6.75 35.1 63.4 5.9 2.47 117.3 106.48 CV 1.4 2.98 3 3.4 −− −− SD 1 −− 1.50 −− 45.06 CV 6.39 1.

53 CV 10.0 3.6 # Points 383 2523 127 1034 378 2702 # Labs 13 17 5 7 13 17 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Sekisui Diagnostics Mean 63.30 94.74 118.29 4.3 4.44 −− −− 127.7 # Points −− 18 −− 43 −− 45 # Labs 1 1 1 Method Group • Dextran sulfate 50K Mean −− 57.26 4.95 70.90 114.6 SD 1 1.7 12.9 −− −− 2.000 2 −− −− 3 −− −− CV −− 0. OSR6X83 Mean 74.85 1.07 2.3 13.62 −− 111.20 121.3 −− 168.9 127.83 97.70 2 3.3 2.6 2.8 3.34 4.72 7.8 SD 1 −− 1.8 # Points 127 127 −− −− 127 127 # Labs 3 3 3 3 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Sentinel Mean 70.3 127.2 114.1 150.08 2.11 CV 3.0 4.12 3. Inc.40 2 −− 3.62 −− 111.08 2 2.4 12.32 3 4.9 SD 1 −− −− 2 1.0 SD 1 1.01 5.2 3.59 65.6 3.8 2.3 130.56 3.15 CV 3.0 153.6 2.89 2.9 2.2 128.4 5.42 17.5 # Points 625 3165 542 3018 415 1815 # Labs 25 26 23 27 17 21 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU LDL.9 −− 4.4 −− 2.51 CV 2.26 3 2.7 # Points −− 18 −− 43 −− 45 # Labs 1 1 1 Cholesterol.19 3 −− 7.0 −− −− −− −− SD 1 −− 0.7 115.9 −− 4.0 # Points 22 150 23 156 22 154 # Labs 1 1 1 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Wako Mean −− 109.60 3 17. Worldwide Report April 2016 Multiqual 1.8 SD 1 −− 1.19 122.0 10.1 3.3 −− 168.61 CV 2.3 SD 1 1. i.61 CV 2.6 2.61 3.5 128.2.2 3.1 121.55 2.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.2 12. OSR6X96 Mean 59.4 SD 1 2. LDL Direct measure mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.40 2 −− 3.1 # Points −− −− 10 29 11 30 # Labs 1 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 69.71 6. LDL Dextran sulfate 50K mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Mindray BS 200E/380/400/480/800/2000 Mean −− 57.0 # Points 1769 8989 1167 6204 1319 7142 # Labs 59 69 40 46 45 54 Abbott AEROSET/ARCHITECT (c.16 2 2.05 115.0 # Points 440 2463 216 1091 468 1996 # Labs 13 16 9 11 13 14 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU LDL.0 SD 1 7.1 4.0 −− −− −− −− # Points −− 1 −− −− −− −− # Labs 1 Copyright © 2015 Bio−Rad Laboratories. ci models) • Zhong Sheng Mean −− −− 97.83 59.45 3 3.89 3 3.7 141.29 8.71 2 3.19 3 −− 7.1 3.57 102.87 CV −− 2.7 2.4 152.02 74.9 2.44 63.2 5. i.4 101.8 3.4 −− 2.97 68.78 2.87 CV −− 2.1 2.61 94.0 SD 1 2.61 3 6.69 14.85 2 −− −− 3 3.2 4. Generated 22−May−2016 17:45:01 Page 132 .60 CV −− −− 1.30 2 11.9 151.06 2.1 117. ci models) Mean 65.9 2.2 2.

9 115.99 103.7 3.27 3.3 136.09 3 −− −− CV −− 3.3 10. Worldwide Report April 2016 Multiqual 1.3 # Points 62 308 37 147 25 155 # Labs 3 3 2 2 1 1 Mindray BS 200E/380/400/480/800/2000 • Alternate Formulation/Standardization Mean −− 74.2 3.61 111.53 4.8 4.4 4.9 6.2 −− 2.2 8.4 SD 1 1.64 CV 1.1 # Points −− −− 19 134 20 134 # Labs 1 1 1 1 Beckman Coulter UniCel DxC Series Mean 61.6 2.36 3 −− 2.2 3.50 9.1 −− −− SD 1 −− 2.5 131.773 1.60 3 13.82 CV −− −− 7.76 3 1.50 67.58 3 3.9 5.8 SD 1 −− 2.54 CV −− 2.95 103.0 10.87 5.3 −− −− # Points −− −− 25 74 −− −− # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean 72.01 2 5.52 61.8 −− 2.33 2 3.9 2.17 5.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.9 136.0 # Points 802 4579 405 1829 654 4320 # Labs 30 43 22 28 21 33 Copyright © 2015 Bio−Rad Laboratories.1 152.45 3 −− 6.75 CV 2.42 3 8.2 # Points −− 14 −− 13 −− 10 # Labs 1 1 1 Roche cobas 6000/8000/c 311 Mean 69.4 121.65 116.9 9.95 3 4.6 SD 1 2.92 13.0 SD 1 1.46 3 −− −− CV −− −− 1.35 6.4 132.06 112.1 # Points −− −− −− 39 −− 48 # Labs 1 1 ILab 600 Mean −− 68.36 −− 119.9 −− −− SD 1 −− −− 2 1. LDL Direct measure mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter LX20.90 CV −− −− −− 2.6 # Points 10 291 16 319 12 71 # Labs 1 6 1 6 1 1 Hitachi Chemistry Series Mean 65.58 CV 5.96 CV 4.5 180.6 154.0 −− −− # Points −− 46 17 46 −− −− # Labs 1 1 1 JEOL BioMajesty JCA−BM Series Mean −− −− 98.3 3.97 96.61 2 2.55 4.05 3.5 117.8 4. Generated 22−May−2016 17:45:01 Page 133 .43 123.87 2.79 96.1 111.23 6.6 4.01 3.7 112.2 2.2 SD 1 −− −− 2 −− 2.2 3.55 4.9 5.57 3.9 −− 4.69 CV 1.6 5.04 2 13. Inc.28 2 1.30 3.5 104.3 SD 1 4.5 3.6 4.1 3.7 2.2.5 5.1 # Points 623 4605 344 2408 415 3703 # Labs 22 30 14 26 13 20 Dirui CS Series Mean 71.9 7.2 3.12 9.0 −− 154.35 62.0 2. LXi725 Chemistry Systems Mean −− −− 112.54 2 7.0 SD 1 0.93 3.4 # Points 5 117 27 311 22 191 # Labs 1 1 2 2 1 1 Hitachi Chemistry Series • MAKER Mean −− −− −− 105.6 10.3 SD 1 −− −− 2 8.1 104.11 2 −− 3.01 72.0 −− 136.90 70.4 1.68 4.8 143.5 180.07 106.6 144.92 3 4.6 1.

6 SD 1 2.1 3.73 3 2.0 −− 1.51 SD 1 −− 0.4 −− 142.6 2.3 3.36 66.34 5.4 # Points 1576 13145 584 5595 1349 12630 # Labs 56 77 22 37 50 70 Siemens Dimension Vista Mean 68.08 −− 1.43 66.9 SD 1 1.4 # Points 3717 35754 1059 10208 3671 34503 # Labs 105 141 26 38 101 134 Tokyo Boeki BIOLIS 50i Mean −− 1.36 2. E170) Mean 72.0 5.6 146.6 3.76 CV 3.7 SD 1 2.55 114.9 # Points 29 115 40 430 −− 214 # Labs 1 1 2 3 1 Roche Hitachi Systems (International) • Alternate Formulation/Standardization Mean −− −− 109.27 3 −− 4.6 3.31 5.3 2.18 4.43 3 4. Generated 22−May−2016 17:45:01 Page 134 .67 CV 3.73 2 4.1 139.0 107.0 SD 1 2.4 136.7 4.2.18 CV 2.08 73.9 137.47 3.7 1.91 70.3 4.6 # Points 126 602 96 598 89 513 # Labs 6 6 5 5 4 4 Roche cobas INTEGRA • 3rd Generation Mean −− 72.5 3.87 3 5.85 3.45 69. Worldwide Report April 2016 Multiqual 1. LDL Direct measure mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/8000/c 311 • 3rd Generation Mean 68.01 113.040 CV −− 3.9 −− −− SD 1 −− 1.8 111.0 2.9 107.58 4.7 2.80 CV 3.56 3.6 −− 1.1 110.77 −− 113.92 2 4.42 2.84 3 4.1 # Points 1422 9494 1073 7701 1045 6105 # Labs 43 61 34 54 37 47 Siemens Dimension Series Mean 67.22 2 2.5 −− −− SD 1 2.5 3.6 # Points 24 128 51 122 36 139 # Labs 2 2 2 2 2 2 Roche cobas INTEGRA Mean 73.90 5.9 SD 1 −− −− 2 4.5 1.6 3.0 4.4 105.3 3.13 109.8 4.3 2.80 3.0 112.25 6.08 4.5 112.1 3.49 3 5.6 4.8 2.2 3.8 −− −− # Points 56 317 59 319 −− −− # Labs 6 6 6 6 Siemens ADVIA Chemistry Systems Mean 66.88 CV 3.9 5.66 2.3 139.36 4.36 3 −− −− CV 3.13 110.30 2 3.17 1.18 3 2.63 3 −− −− CV −− 1.6 # Points −− 16 −− 7 −− 7 # Labs 1 1 1 Copyright © 2015 Bio−Rad Laboratories.55 1.6 142.040 2 −− 0.10 107.4 140. D.1 131.66 3.4 2.66 CV 1.3 3.5 137.75 2 4.70 2 1.76 5.3 148.52 106.9 SD 1 2.3 # Points −− −− 97 228 95 225 # Labs 3 3 3 3 Roche MODULAR (ISE.99 115.0 2.4 4.6 SD 1 1.66 69. P.6 −− 2.3 133.0 115.000 3 −− 0.26 2.82 69.1 3.0 142.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.6 4.73 3.77 2 2.80 −− 2.97 CV −− −− 4.9 4.4 −− −− # Points −− 59 −− 60 −− −− # Labs 1 1 Roche Hitachi Systems (International) Mean 68.19 2 −− 1. Inc.5 4.6 4.7 −− 0.

95 3 −− −− CV −− −− 5.4 −− −− SD 1 −− −− 2 −− 1.0 2.15 3 10.9 3.3 SD 1 1.4 107. LDL Direct measure mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Toshiba TBA−120FR Mean −− −− 102.4 136.81 −− −− −− 124.7 −− −− 3.0 0.6 134.1 3.1 136.09 3.0 0.19 3 5.5 102.34 CV 2.0 3.55 60.76 63.6 7.04 2 2.52 CV 6.1 4.57 4.61 8.1 3.74 CV 3.4 −− −− # Points −− −− −− 26 −− −− # Labs 1 VITROS Microslide Series • Slide generation #21 Mean 61.4 3.5 2.0 2.3 5.29 CV −− −− 2.8 4.9 # Points 1 38 55 261 1 18 # Labs 1 2 3 4 1 1 Copyright © 2015 Bio−Rad Laboratories.4 # Points 201 613 11 104 201 598 # Labs 10 13 2 2 10 13 VITROS Microtip Series Mean 63.2 # Points 1 104 −− −− −− 105 # Labs 1 2 2 VITROS Microslide Series • Slide generation #22 Mean 59.0 103.8 7.23 87.2 0.82 3 4.42 3.2 2.55 10.37 107.3 123.77 101.2 # Points 69 185 −− −− 63 174 # Labs 2 2 2 2 VITROS Microslide Series • Slide generation #99 Mean 63.70 3 4.2. LDL Immunoprecipitation mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter UniCel DxC Series Mean −− −− 86.21 CV 2.6 SD 1 1.9 128.24 CV 0.98 3.1 433. Inc.79 64.90 2 2.3 1678 3 0.51 1.1 7.7 −− −− # Points −− −− 54 223 −− −− # Labs 2 2 Siemens ADVIA Chemistry Systems Mean 3740 1808 6770 3226 10170 10018 SD 1 0.9 SD 1 −− −− 2 2.02 4.5 127.000 3338 3 0.00 4.14 CV 0.79 3 −− −− CV −− −− −− 1.8 308.000 1863 2 0.9 # Points 1 38 1 38 1 18 # Labs 1 2 1 2 1 1 Method Group • Immunoprecipitation Mean 3740 1808 207.7 # Points 656 5579 436 3708 441 3493 # Labs 27 34 18 23 19 28 Method Group • Direct measure Mean 67.7 102.1 SD 1 1.71 5.000 88.000 1863 2 901.24 61.65 2 −− −− 3 4.0 128. Worldwide Report April 2016 Multiqual 1.96 2 −− −− 3 −− 5.11 −− −− 123.8 544.0 103. Generated 22−May−2016 17:45:01 Page 135 .57 −− −− SD 1 −− −− 2 4.8 127.23 4.58 1.42 101.53 2.4 SD 1 4.16 2 7.1 0.14 CV 0.8 3.000 1.5 100.0 3.000 88.8 SD 1 0.0 6.4 # Points −− −− 38 268 38 306 # Labs 1 1 1 1 Toshiba−TBA Mean −− −− −− 126.91 2.5 10170 10018 SD 1 0.24 67.1 134.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.0 103.5 0.5 2.2 7.2 −− −− −− 4.7 # Points 12745 93474 6422 45959 10821 81375 # Labs 430 563 241 334 357 474 Cholesterol.7 3.5 3.

9 −− 249. ci models) • CENTRONIC Mean −− 117.7 # Points 39 411 −− −− 38 414 # Labs 3 4 3 4 Cholesterol.9 257.7 0.55 2.6 SD 1 −− 1.1 1. ci models) Mean 110.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.2 # Points 4406 23717 3249 17812 3656 20721 # Labs 126 142 85 98 104 122 Abbott AEROSET/ARCHITECT (c.2 −− −− 257.7 −− −− 1.9 # Points 56 249 −− −− 56 249 # Labs 2 2 2 2 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Sekisui Diagnostics Mean 109.4 1.4 1.3 1.0 3.3 112.70 3 10.8 1.10 CV −− −− 0.5 272.7 258. peroxidase mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.3 185. esterase.802 1.802 1.55 3.1 196.8 # Points −− 57 −− 55 −− 55 # Labs 1 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 108.67 2 1.55 2.2 105.4 SD 1 0.90 3 −− 4.82 3.6 1.27 7.1 SD 1 4.6 1. i.8 111.59 3.1 1.000 3 −− 0.6 # Points 140 602 84 342 142 516 # Labs 7 7 6 6 7 7 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU US Calibrator DR0070 Mean 105.8 1. Inc.5 −− −− 1.00 2 −− −− 3 4.2 109.0 # Points −− 1 −− 1 −− 1 # Labs 1 1 1 Abbott AEROSET/ARCHITECT (c.30 CV 4.82 1.38 3 1.6 # Points −− −− 3 22 4 23 # Labs 1 1 1 1 Abbott AEROSET/ARCHITECT (c.7 146.1 1.9 249.6 248.7 108.5 −− 1. i.7 189.95 2.2 SD 1 1.2 4.2 SD 1 −− −− 2 1.29 3.0 269.05 2 −− −− 3 1.3 # Points 129 129 −− −− 129 129 # Labs 3 3 3 3 Copyright © 2015 Bio−Rad Laboratories.68 2.62 CV 1.1 1.0 247.2.1 1.56 CV 1.8 # Points 2383 15433 1801 11367 2319 14483 # Labs 81 108 61 81 74 99 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU International Calibrator OE 66300 Mean 112.42 CV −− 1.11 3 2.12 CV 1.0 −− 1.8 1.18 −− −− 145.18 −− −− 145.8 257.5 −− −− 1.42 2 7.59 4. i.0 −− 196. LDL Polyethylene glycol (PEG) mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Roche cobas 6000/8000/c 311 Mean 71.6 241.9 −− −− 1.36 4.54 1.5 SD 1 1.8 SD 1 1. Generated 22−May−2016 17:45:01 Page 136 . Worldwide Report April 2016 Multiqual 1. Total Cholesterol oxidase.71 2 −− 1.000 2 −− 0. i.7 184.07 9.1 −− 184.34 72.3 4.82 2 −− −− 3 3.5 −− −− 241.42 3 4.8 189.6 2.0 −− 0.00 CV 1. ci models) • PROLABS Mean −− 112.9 4.1 1.8 249.4 SD 1 0.3 1.8 1.1 185.7 # Points 39 411 −− −− 38 414 # Labs 3 4 3 4 Method Group • Polyethylene glycol (PEG) Mean 71.34 72.7 1.1 SD 1 1.000 CV −− 0.55 7.5 1.29 CV 1.63 4.1 3.0 −− 263. ci models) • MAKER Mean −− −− 201.56 CV 1.82 2 2.7 146.2 185.49 1.1 1.0 −− 0.05 2 −− −− 3 1.0 SD 1 −− 0.

4 261.2 241.4 −− 5. peroxidase mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Shanghai Kehua Bio−engineering (KHB) Mean −− 199.5 SD 1 −− −− 2 3.9 2.0 −− 2.3 2.0 1.5 2. Inc.55 6.3 2.7 188.87 3.47 3 −− −− CV −− −− 2. LXi725 Chemistry Systems Mean −− −− 180. LXi725 Chemistry Systems • LEADMAN Mean −− −− 194.5 −− 260.34 3.99 CV −− −− 1. Worldwide Report April 2016 Multiqual 1.4 252.1 # Points 10 388 −− 375 14 64 # Labs 1 7 7 1 1 DIRUI−CS−240 Mean −− −− −− 181.8 −− 175.0 2.1 1.4 184.6 # Points −− −− −− 40 −− 49 # Labs 1 1 Horiba ABX Pentra 400 Mean −− −− 188.5 188.45 2 4.8 −− 241.75 3 −− −− CV 2.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.5 2.4 2.60 6.14 3 −− 4.4 188.46 CV 2.5 # Points 832 5976 426 3526 622 4946 # Labs 28 41 19 36 19 28 Dirui CS Series Mean 100.9 3. esterase.0 255.5 −− −− SD 1 −− −− 2 5.6 256.2.77 2 7.0 SD 1 3.6 189.4 109.25 14.48 4.2 247.4 103.43 3 4.3 249.60 5.1 SD 1 2.13 CV −− −− −− 1.8 108.2 183.09 4.68 2 4.48 5.9 −− −− # Points −− −− 6 6 −− −− # Labs 1 1 ILab 600 Mean 108.1 318.47 5.7 # Points −− −− 19 136 19 136 # Labs 1 1 1 1 Beckman Coulter LX20.9 2.9 −− −− −− −− SD 1 −− 0.9 3.0 −− −− −− −− # Points −− 1 −− −− −− −− # Labs 1 Beckman Coulter LX20.2 3.95 2.4 −− −− SD 1 2.1 194.3 SD 1 −− −− 2 3.7 SD 1 4.4 2.25 6.87 3 7.37 CV −− −− −− 3.64 2 −− 9.49 2.000 2 −− −− 3 −− −− CV −− 0.2 2. Total Cholesterol oxidase.6 # Points −− −− −− 118 −− 106 # Labs 1 1 Hitachi Chemistry Series Mean 118.4 1.6 9.3 SD 1 −− −− 2 −− 2.35 CV −− −− 2.6 4.5 261.3 185.75 CV 4.5 SD 1 −− −− 2 −− 5.1 −− 1.73 3 23.38 5.13 CV 2.1 187.7 2.3 # Points −− −− 3 3 3 3 # Labs 1 1 1 1 Beckman Coulter UniCel DxC Series Mean 108.0 −− −− # Points 116 697 129 693 −− −− # Labs 3 4 4 4 Copyright © 2015 Bio−Rad Laboratories.4 6.43 3 6.6 # Points 11 124 32 319 22 195 # Labs 1 1 2 2 1 1 Hitachi Chemistry Series • MAKER Mean −− −− −− 188.44 3 −− 6.7 113.7 2.35 7.74 3 3.3 318.0 2. Generated 22−May−2016 17:45:01 Page 137 .5 6.

4 1.3 0.1 # Points 29 159 200 1268 161 939 # Labs 1 2 11 13 9 9 Roche Hitachi Systems (International) • BIODEVICE Srl Mean −− −− −− 191.80 2 2.2 116.45 2.9 −− 0.8 −− −− 1.1 190.10 2.0 # Points −− −− 53 214 28 144 # Labs 2 2 1 1 JEOL BioMajesty JCA−BM Series • Zhong Sheng Mean −− −− −− 185.7 3.8 247.04 CV 1.61 2.6 108.4 249.2 SD 1 −− −− 2 −− 1.9 SD 1 3.5 109.33 3 5.9 245.4 1.8 # Points −− −− −− 44 −− 35 # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean 108.6 183.6 179.6 # Points 67 378 57 754 44 703 # Labs 4 6 7 9 7 9 Roche cobas 6000/8000/c 311 Mean 110.3 251.78 CV 4.61 5.2 182.98 3 5.76 5.8 1.8 184.06 CV 1.3 108.96 4.57 2.5 1.9 −− −− # Points −− −− −− 26 −− −− # Labs 1 Copyright © 2015 Bio−Rad Laboratories.8 2.04 3.28 3 1.2 # Points 109 472 96 431 112 465 # Labs 4 5 4 5 4 5 Roche cobas c 111 Mean 108.6 # Points 13 140 −− −− 13 140 # Labs 1 1 1 1 Roche cobas INTEGRA Mean 109.8 2.3 2.6 256.8 1.6 1.1 2.77 2 7.6 247.2 −− −− 247.4 SD 1 3.9 178.4 247.6 183.0 2.87 7.0 2.72 3. Generated 22−May−2016 17:45:01 Page 138 . Total Cholesterol oxidase.2.3 6.29 8.6 190.26 2 −− −− 3 2.71 3 −− −− CV −− −− −− 1.0 # Points 283 1766 201 1055 214 1493 # Labs 13 14 9 10 10 10 Roche Hitachi Systems (International) Mean 117.33 3 4.04 4.4 248.5 SD 1 1.91 CV 2.6 250. peroxidase mg/dL Level Mon Cum Level Mon Cum Level Mon Cum ILab 650 Mean 111.02 4. esterase.4 1.6 2.4 2.6 # Points 19 100 −− −− 4 4 # Labs 2 2 1 1 JEOL BioMajesty JCA−BM Series Mean −− −− 182.1 −− −− 0.55 2.0 108.3 # Points 2790 15906 1294 5978 2382 14701 # Labs 90 113 51 58 70 91 Roche cobas 6000/8000/c 311 • 2nd Generation Mean 109.2 2.1 2.50 3.30 2 3.2 114.8 SD 1 2.3 2.5 184.9 2.71 2.95 5.28 CV 3.5 247.7 245.0 182.46 2 4.25 2 4.11 3 6.44 5.08 2 −− −− 3 4.5 4.6 SD 1 5.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol. Worldwide Report April 2016 Multiqual 1.0 1.2 −− 251.72 CV 3.4 253.3 −− −− SD 1 −− −− 2 −− 3.3 110.09 CV 1.3 2.8 1.4 SD 1 1.50 3 3.95 CV −− −− −− 0.8 SD 1 1.6 3.5 2.1 249. Inc.06 4.3 2.5 −− −− 251.6 256.7 SD 1 −− −− 2 2.65 3 −− 1.7 1.6 1.3 2.33 3.7 185.60 CV −− −− 1.95 1.

1 SD 1 2.8 3.1 2.5 SD 1 −− 1.0 2.9 1.36 CV −− −− −− 4.3 236.36 4.8 −− −− −− 247.24 CV 3.2.80 2.53 CV −− −− 1.1 109.0 3.6 # Points −− −− 4 4 6 6 # Labs 1 1 1 1 Siemens Dimension Series Mean 102.8 2.71 2 −− 2.40 5.4 2.87 2.64 4.9 256.64 CV −− −− 0.1 184.6 1.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.0 297.5 SD 1 3.7 # Points 57 348 109 463 51 332 # Labs 2 4 2 2 2 4 Tokyo Boeki BIOLIS 50i Mean −− 113.12 3 −− 6.74 3 5.27 4.68 CV 3.3 2.5 −− 256.5 # Points −− −− −− 135 −− 210 # Labs 3 3 Copyright © 2015 Bio−Rad Laboratories. E170) Mean 110.8 # Points 4433 33922 1765 13086 3779 32027 # Labs 150 199 58 82 133 180 Siemens Dimension Vista Mean 102.85 2 5.69 2. esterase.3 # Points 6866 27622 3595 20271 3293 18869 # Labs 120 150 99 132 96 121 Siemens ADVIA Chemistry Systems • DiaSys Diagnostic Systems Mean 108.55 3 4.7 # Points −− −− 40 266 37 301 # Labs 1 1 1 1 Toshiba TBA−40FR (Accute) Mean −− −− −− 174.11 3.7 2.3 185.2 267.92 2 4.3 235.91 CV 2. D.7 2.3 −− 1.1 175. Worldwide Report April 2016 Multiqual 1.6 180.3 2.3 SD 1 3.7 184.2 SD 1 2.35 3 5.82 6.6 2.0 248.09 3 5.0 # Points 102 304 −− −− −− 307 # Labs 2 2 2 Siemens ADVIA Chemistry Systems • LEADMAN Mean −− −− 180.2 103.08 3.7 3.64 4.1 2.6 174. Total Cholesterol oxidase.5 177.4 2. peroxidase mg/dL Level Mon Cum Level Mon Cum Level Mon Cum Roche MODULAR (ISE.7 SD 1 −− −− 2 −− 7.67 6.4 −− 257.6 −− 189.6 2.8 3.9 102.0 2.2 237.6 2.13 2 4.84 3 6. Inc.8 241.7 # Points 6082 61528 1943 20137 5901 58946 # Labs 170 220 51 71 162 215 Siemens Dimension Vista • Siemens Dimension Vista HDLC (K3048) Mean 104.5 237.4 SD 1 3.56 3 5.5 2.1 101.6 2.88 3.4 −− −− −− 2.86 3 5.2 176.39 4.17 4.1 # Points 153 1044 166 1019 45 354 # Labs 9 13 10 14 2 2 Siemens ADVIA Chemistry Systems Mean 109. Generated 22−May−2016 17:45:01 Page 139 .64 2 −− −− 3 −− 4.6 # Points −− 20 −− 24 −− 24 # Labs 1 1 1 Toshiba TBA−120FR Mean −− −− 196.96 2 6.3 2.50 3.1 2.3 254.8 108.81 5.4 3.7 108.3 2.4 2.6 297.38 CV 3.55 3 −− 4.34 CV 2.55 1.7 196.15 CV −− 1.7 2.9 0.7 SD 1 2.9 247. P.17 2 4.0 1.0 SD 1 −− −− 2 1.4 241.0 SD 1 −− −− 2 2.90 6.1 −− 2.4 1.85 CV 2.5 −− 1.7 184.3 174.42 2.3 174.2 267.1 2.

peroxidase Mean 107.2 2.5 181.1 1.80 2 3.40 3.4 104. Worldwide Report April 2016 Multiqual 1.8 2.25 3 6.39 6.9 184.08 2.91 2 6.2 106.3 253.6 −− 2.57 2 5.4 250.6 # Points 125 860 −− 248 120 855 # Labs 3 5 2 3 5 VITROS Microslide Series • Slide generation #26 Mean 105.3 SD 1 1.05 3 6.5 2.6 SD 1 3.78 CV −− 2.2 1.6 245.25 5.62 2.36 6.2.4 2.08 2 −− 3.35 6. esterase.8 1.5 2.38 2.7 −− 180. peroxidase mg/dL Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #00 Mean 107.26 6.33 9.23 2.75 3 9.1 103.5 2.1 105.39 3.33 CV 2.6 SD 1 2.6 # Points 1361 9461 739 4667 1409 9053 # Labs 52 67 31 38 53 67 VITROS Microslide Series • Slide generation #43 Mean 106.54 CV 1.4 1.7 2.9 2.0 246.21 3 10.9 2.7 3.5 # Points 130 2775 12 1309 129 2999 # Labs 7 36 1 17 7 37 VITROS Microslide Series • Slide generation #29 Mean 104.20 1.9 # Points −− 191 −− 193 −− 200 # Labs 1 1 1 VITROS Microslide Series • Slide generation #15 Mean 100.01 CV 1.0 −− 1.0 181.8 4.4 251.4 250.0 182.7 −− 1.2 SD 1 2.2 101.6 2.4 1.9 183.5 2.5 2.0 # Points 31 505 31 265 31 525 # Labs 2 3 2 2 2 3 VITROS Microslide Series • Slide generation #22 Mean 107.4 251.1 106.9 2. Generated 22−May−2016 17:45:01 Page 140 .7 249.3 1.4 # Points 60 543 60 551 60 552 # Labs 1 1 1 1 1 1 VITROS Microslide Series • Slide generation #19 Mean 106.1 SD 1 2.5 2.71 3 7.71 2 2.58 2.45 1.0 2.7 2.3 SD 1 −− 2.43 3 3. Total Cholesterol oxidase.50 4.80 2 −− −− 3 5.7 1.7 −− −− 2.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholesterol.45 CV 2.7 183.6 # Points 45 407 49 439 46 410 # Labs 2 2 2 2 2 2 VITROS Microslide Series • Slide generation #99 Mean 103.99 CV 1.58 2 3.69 5.3 249.4 1.41 2 3.30 CV 2.02 9. esterase.3 4.6 SD 1 2.3 253.0 106.7 182.8 104.54 CV 3.59 3 4. Inc.4 2.4 250.1 3.0 1.3 186.6 182.2 2.0 SD 1 4.1 −− 247.6 243.4 1.56 3.8 104.56 CV 2.7 # Points 20 74 −− −− 20 74 # Labs 1 1 1 1 VITROS Microslide Series • Slide generation #01 Mean −− 101.9 SD 1 2.7 3.0 2.75 5.68 6.1 186.4 187.0 2.8 3.9 # Points 246 735 88 314 254 675 # Labs 16 20 7 9 15 17 Method Group • Cholesterol oxidase.15 3 −− 4.5 3.37 CV 4.0 248.6 3.9 256.0 −− −− 247.75 2 −− 4.64 4.7 255.3 3.53 2 2.5 SD 1 1.0 185.8 # Points 31104 207K 16254 108K 25125 187K # Labs 904 1185 531 717 798 1059 Copyright © 2015 Bio−Rad Laboratories.22 3 4.0 −− 180.3 254.65 4.4 180.60 3.00 6.8 1.6 186.6 245.

6 1.41 3 −− 130.2.3 4.1 5.1 CV 8.0 4.22 66.9 2 236.5 # Points 12 80 −− 46 −− 47 # Labs 1 2 1 1 Copyright © 2015 Bio−Rad Laboratories.9 −− 3.5 # Points −− 18 −− 46 −− 47 # Labs 1 1 1 Method Group • Benzoylcholine Mean 4348 4304 −− 5083 −− 5869 SD 1 27.4 560.3 8.6 # Points 17 78 17 78 17 78 # Labs 1 1 1 1 1 1 Roche MODULAR (ISE.1 # Points −− −− −− 136 −− 136 # Labs 1 1 Cholinesterase.53 2 −− −− 3 −− 94.0 236.0 521.5 3 −− 223.6 8.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholinesterase.8 CV 8.5 −− 4.8 CV −− −− −− 1. Serum (PCHE) Acetyl choline U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum VITROS Microslide Series • Slide generation #33 Mean −− −− −− 5339 −− 6095 SD 1 −− −− 2 −− 84.3 6.8 CV −− −− −− 1.34 CV −− 1.4 272.3 # Points 77 417 17 319 17 361 # Labs 3 6 1 5 1 6 Cholinesterase. Serum (PCHE) Acetylthiocholine U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter UniCel DxC Series Mean 4530 4927 −− 6259 −− 7102 SD 1 377. Worldwide Report April 2016 Multiqual 1.5 −− −− −− −− # Points 12 62 −− −− −− −− # Labs 1 1 Mindray BS 200E/380/400/480/800/2000 Mean −− 4008 −− 5083 −− 5869 SD 1 −− 195.1 −− 2.7 3 −− 1084 CV −− 4.0 202.1 3 253.9 −− −− −− 1. E170) Mean −− 4027 −− −− −− 6176 SD 1 −− 74. P.7 3 −− 1084 CV 0.1 # Points −− −− −− 136 −− 136 # Labs 1 1 Method Group • Acetyl choline Mean −− −− −− 5339 −− 6095 SD 1 −− −− 2 −− 84.9 2 236.3 4.9 3 253. Serum (PCHE) Benzoylcholine U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum ILab 650 Mean 4348 4390 −− −− −− −− SD 1 27. D.5 # Points −− 38 −− −− −− 38 # Labs 1 1 Method Group • Acetylthiocholine Mean 4434 4680 5184 5985 5958 6752 SD 1 391.5 −− 18.6 2 −− 230.8 10.6 −− 2.9 −− 4.6 4.2 2 −− 230. Generated 22−May−2016 17:45:01 Page 141 .51 2 −− −− 3 −− −− CV 0.6 −− 2.0 CV 5.6 4.2 2 −− 183.22 193. Inc.4 302.5 −− 18.1 # Points 60 301 −− 241 −− 245 # Labs 2 4 4 4 Roche cobas 6000/8000/c 311 Mean 4093 4043 5184 5139 5958 5933 SD 1 210.7 4.3 482.41 3 −− 130.6 4.

1 # Points 533 2272 353 1679 284 1092 # Labs 28 28 20 22 15 17 Abbott AEROSET/ARCHITECT (c.6 CV 8.3 2 317.0 CV 2. Serum (PCHE) Butyrylthiocholine (Trinder) U/L @ 37° C Level Mon Cum Level Mon Cum Level Mon Cum Abbott AEROSET/ARCHITECT (c.0 0.2 9.6 −− 1.3 2.84 189.8 # Points 1003 4873 664 3452 684 2811 # Labs 26 35 22 32 21 24 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Beckman Coulter AU International Calibrator OE 66300 Mean 3922 3916 4919 4895 5640 5640 SD 1 83. Inc.7 3 231.9 1.0 214. Generated 22−May−2016 17:45:01 Page 142 .5 3 −− 156. ci models) Mean 5052 5159 6433 6405 7024 6906 SD 1 409.4 4.4 # Points 10 92 10 89 10 95 # Labs 1 1 1 1 1 1 Method Group • Butyrylthiocholine (Trinder) Mean 4073000 4069576 5153000 5118944 5776000 5759400 SD 1 54050 82807 2 44850 95790 3 89020 135763 CV 1. i.2.9 −− 1.4 # Points 10 92 10 89 10 95 # Labs 1 1 1 1 1 1 Cholinesterase.8 # Points 35 355 52 956 −− 263 # Labs 2 3 2 3 3 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 3961 3965 5001 5000 5614 5591 SD 1 145.6 3.5 416.7 3.3 2. i.8 138.8 13.7 5.6 2 218.6 2.5 3 570.7 577.2 2.1 2.5 2.1 10.9 3 221.4 2.50 85.9 6.61 2 128.0 0. Serum (PCHE) Butyrylthiocholine (Trinder) U/L @ 25° C Level Mon Cum Level Mon Cum Level Mon Cum Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 Mean 4073000 4069576 5153000 5118944 5776000 5759400 SD 1 54050 82807 2 44850 95790 3 89020 135763 CV 1.9 1.5 8.6 CV 3.8 CV 1.6 # Points −− −− 45 214 45 213 # Labs 2 2 2 2 Copyright © 2015 Bio−Rad Laboratories.3 • Lot 45720 • Exp 31−Oct−2017 Conventional Units Cholinesterase.5 560.9 1.6 4.8 628.9 4.31 3 −− 67.4 204.9 1.0 −− −− −− −− # Points −− 1 −− −− −− −− # Labs 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Zhong Sheng Mean −− −− 5306 5173 6033 5938 SD 1 −− −− 2 544. i.6 118.1 1.8 932.87 279.8 10.8 141.5 2 77.26 CV −− −− −− 1. Worldwide Report April 2016 Multiqual 1.2 2.3 # Points −− −− −− 54 −− 53 # Labs 2 2 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • Wako Mean −− 5162000 −− −− −− −− SD 1 −− 0.5 698.000 2 −− −− 3 −− −− CV −− 0.3 3 110.3 11.3 2. ci models) • Alternate Formulation/Standardization Mean −− −− 5209 5278 5846 6835 SD 1 −− −− 2 170.1 3.7 3 592.1 10.4 CV −− −− 3.0 # Points 104 231 61 188 43 43 # Labs 3 3 2 2 1 1 Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 • DiaSys Diagnostic Systems Mean −− −− −− 3533 −− 5374 SD 1 −− −− 2 −− 57.1 4. ci models) • Sentinel Mean 5145 5432 6375 6512