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Lyphochek® Immunoassay Plus Control

Levels 1, 2 and 3
370 Trilevel 12 x 5 mL
Level 1 40381
371 Level 1 12 x 5 mL
0459 2022-08-31 40380 Level 2 40382
372 Level 2 12 x 5 mL
Level 3 40383
373 Level 3 12 x 5 mL
370X MiniPak 3 x 5 mL

http://www.myeinserts.com/40380

METHOD (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
17-ALPHA-HYDROXYPROGESTERONE (2)
Diagnostics Biochem Canada ELISA ng/mL § § §
DRG ELISA (EIA-1292) ng/mL 0.600 0.330 – 0.870 2.73 1.50 – 3.97 6.50 3.57 – 9.42
IBL ELISA ng/mL 0.500 0.170 – 0.820 2.39 1.32 – 3.47 7.17 3.94 – 10.4
MP BioMedicals ImmuChem CT RIA ng/mL § § §
MP BioMedicals ImmuChem DA RIA ng/mL § § §
ACETAMINOPHEN
Emit µg/mL 9.40 <10.0 – 12.4 33.4 25.3 – 41.4 105 82.1 – 128
SEKURE (Sekisui Diagnostics) (2) µg/mL 10.0 7.00 – 13.0 34.0 25.0 – 43.0 111 83.0 – 139
ACTH (2)
Biomerica ELISA (5) pg/mL 33.6 22.2 – 45.0 170 113 – 227 130 75.1 – 185
AFP (2)
DRG ELISA (EIA-1468) ng/mL 31.6 20.8 – 42.2 147 97.3 – 198 >193
Monobind AccuBind ELISA ng/mL 16.9 11.3 – 22.5 100 67.2 – 133 226 151 – 301
Monobind AccuLite CLIA ng/mL 16.1 10.8 – 21.4 107 71.4 – 142 228 153 – 303
ALDOSTERONE (2)
Beckman Coulter RIA (DSL8600) pg/mL 147 103 – 191 308 216 – 401 889 667 – 1112
AMIKACIN
Emit µg/mL 5.39 3.78 – 7.01 15.9 10.7 – 21.2 27.8 18.3 – 37.2
AMITRIPTYLINE
HPLC ng/mL § § §
ANDROSTENEDIONE (2)
Beckman Coulter RIA (DSL3800) ng/mL 0.560 0.330 – 0.780 1.41 0.990 – 1.83 2.67 1.87 – 3.48
Calbiotech ELISA ng/mL 1.62 1.08 – 2.16 3.66 2.44 – 4.88 8.17 5.45 – >10.0
Diagnostics Biochem Canada ELISA ng/mL § § §
DRG ELISA (EIA-3265) ng/mL 0.570 0.320 – 0.830 1.67 0.920 – 2.43 3.96 2.18 – 5.74
MP BioMedicals ImmuChem DA RIA ng/mL § § §
CAFFEINE
Emit µg/mL 2.10 1.28 – 2.91 6.93 4.71 – 9.14 14.9 10.4 – 19.4
CALCITONIN (2)
Biomerica ELISA pg/mL
CARBAMAZEPINE
CEDIA II (2) µg/mL 2.95 1.99 – 3.91 8.37 6.70 – 10.1 13.2 10.5 – 15.8
Emit 2000 µg/mL 2.99 2.08 – 3.90 8.48 6.71 – 10.3 13.0 10.5 – 15.6
CEA (2)
Monobind AccuBind ELISA ng/mL 1.41 0.940 – 1.87 13.1 8.78 – 17.4 21.9 14.7 – 29.1
Monobind AccuLite CLIA ng/mL 1.35 0.820 – 1.88 12.8 8.54 – 17.0 20.7 13.9 – 27.6
CHLORAMPHENICOL
HPLC µg/mL § § §
CORTISOL (2)
DRG ELISA (EIA-1887) ng/mL 40.4 25.8 – 54.9 211 135 – 287 345 221 – 469
IBL LIA µg/dL § § §

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Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
CORTISOL (2) (continued)
MP BioMedicals Corti-Cote RIA µg/dL § § §
MP BioMedicals ImmuChem CT RIA µg/dL § § §
C-PEPTIDE (2)
Calbiotech ELISA ng/mL 1.33 0.890 – 1.78 5.02 3.34 – 6.69 6.85 4.58 – 9.12
DRG ELISA (EIA-1293) ng/mL 1.05 0.580 – 1.53 5.07 2.79 – 7.35 7.46 4.10 – 10.8
Monobind AccuBind ELISA ng/mL 1.09 0.730 – 1.45 3.48 2.33 – 4.63 5.28 3.54 – 7.02
Monobind AccuLite CLIA ng/mL 1.00 0.670 – 1.33 3.87 2.59 – 5.15 5.41 3.62 – 7.19
DEHYDROEPIANDROSTERONE-SULFATE (DHEA-SULFATE) (2)
Beckman Coulter RIA DHEA-S-7 (DSL2700) ng/mL 571 428 – 714 1937 1356 – 2518 5347 3476 – 7219
Calbiotech ELISA µg/mL 1.06 0.700 – 1.42 2.70 1.79 – 3.60 8.60 5.73 – 11.5
DRG ELISA (EIA-1562) µg/mL 0.600 0.330 – 0.860 1.75 0.960 – 2.53 5.43 2.98 – 7.87
IBL ELISA µg/mL 0.780 0.500 – 1.05 2.11 1.37 – 2.85 6.82 4.43 – 9.21
Monobind AccuBind ELISA µg/mL 0.710 0.470 – 0.940 1.98 1.32 – 2.63 5.89 3.94 – 7.83
Monobind AccuLite CLIA µg/mL 0.780 0.520 – 1.03 1.99 1.33 – 2.65 6.49 4.35 – >8.00
MP BioMedicals ImmuChem CT RIA ng/mL § § §
DESIPRAMINE
HPLC ng/mL § § §
DIGOXIN
Emit 2000 ng/mL 0.843 0.483 – 1.20 2.10 1.60 – 2.60 3.65 3.00 – 4.29
Monobind AccuBind ELISA (2) ng/mL 0.800 0.530 – 1.06 2.22 1.49 – 2.96 3.69 2.47 – >4.00
Monobind AccuLite CLIA (2) ng/mL 0.850 0.570 – 1.14 2.26 1.51 – 3.00 3.60 2.41 – >4.00
DISOPYRAMIDE
Emit µg/mL § § §
ESTRADIOL (2)
Beckman Coulter RIA US Estradiol (DSL4800) pg/mL 48.4 29.0 – 67.8 73.0 43.8 – 102 158 95.1 – 222
BioCheck EIA pg/mL
Calbiotech ELISA pg/mL 84.2 55.1 – 113 281 187 – 374 793 529 – >1000
DRG ELISA (EIA-2963) pg/mL 170 95.4 – 245 490 274 – 705 922 516 – 1328
Monobind AccuBind ELISA pg/mL 97.4 65.3 – 130 194 130 – 258 363 243 – 482
Monobind AccuLite CLIA pg/mL 93.7 62.8 – 125 200 134 – 266 360 225 – 495
MP BioMedicals ImmuChem CT RIA pg/mL § § §
MP BioMedicals ImmuChem DA RIA pg/mL § § §
Pantex 100 uL Direct 125I pg/mL § § §
ESTRIOL (FREE) (2)
Calbiotech ELISA ng/mL 3.84 2.55 – 5.12 11.8 7.89 – 15.8 15.9 10.6 – 21.2
DRG ELISA (EIA-1612) ng/mL 1.70 0.930 – 2.46 5.12 2.82 – 7.42 12.0 6.63 – 17.5
Monobind AccuBind ELISA ng/mL 2.68 1.80 – 3.57 9.57 6.41 – 12.7 14.0 9.39 – 18.6
Monobind AccuLite CLIA ng/mL 2.68 1.80 – 3.57 9.57 6.41 – 12.7 14.0 9.39 – 18.6
ESTROGEN (TOTAL) (2)
MP BioMedicals ImmuChem DA RIA pg/mL § § §
ETHOSUXIMIDE
Emit µg/mL 31.0 23.5 – 38.6 69.8 51.5 – 88.1 107 78.9 – 135
FERRITIN (2)
BioCheck EIA ng/mL
Monobind AccuBind ELISA ng/mL 72.0 48.3 – 95.8 155 104 – 207 347 232 – 461
Monobind AccuLite CLIA ng/mL 72.4 48.5 – 96.3 171 114 – 227 378 253 – 502
FOLATE
MP BioMedicals SimulTRAC SNB RIA ng/mL § § §
MP BioMedicals SimulTRAC SP RIA ng/mL § § §
FOLLICLE STIMULATING HORMONE (FSH) (2)
BioCheck EIA mIU/mL
Calbiotech ELISA mIU/mL 2.69 1.79 – 3.59 12.1 8.00 – 16.1 21.0 14.0 – 28.0
DRG ELISA (EIA-1288) mIU/mL 4.75 2.61 – 6.89 21.9 12.0 – 31.7 40.8 22.4 – 59.1
Monobind AccuBind ELISA mIU/mL 5.19 3.43 – 6.91 21.7 14.6 – 28.9 45.7 30.7 – 60.8
Monobind AccuLite CLIA mIU/mL 4.56 3.03 – 6.08 21.6 14.4 – 28.7 42.8 28.7 – 56.9

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Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
GASTRIN (2)
MP BioMedicals RIA pg/mL § § §
GENTAMICIN
CEDIA II (2) µg/mL 2.25 1.38 – 3.12 4.82 3.68 – 5.96 7.76 6.20 – 9.32
Emit 2000 µg/mL 2.32 1.81 – 2.84 4.90 3.99 – 5.80 7.64 6.32 – 8.96
HCG (2)
BioCheck EIA mIU/mL
DRG ELISA (EIA-1469) mIU/mL 27.9 17.3 – 38.5 148 92.0 – 205
Monobind AccuBind ELISA mIU/mL 6.37 4.27 – 8.48 24.6 16.5 – 32.7 173 116 – 230
Monobind AccuLite CLIA mIU/mL 5.30 3.55 – 7.05 21.0 14.1 – 28.0 168 112 – 223
HCG-BETA SUBUNIT (2)
DRG ELISA (EIA-1911) mIU/mL 3.60 2.23 – 4.97 11.1 6.86 – 15.3 67.3 41.7 – 92.8
HUMAN GROWTH HORMONE (HGH) (2)
BioCheck EIA ng/mL
Calbiotech ELISA ng/mL 5.08 3.38 – 6.77 16.3 10.9 – 21.7 27.2 18.1 – 36.3
MEDIAGNOST ELISA µIU/mL 13.5 10.2 – 16.9 33.2 26.0 – 40.4 58.2 48.5 – 67.8
Monobind AccuBind ELISA µIU/mL 12.0 8.03 – 16.0 28.2 18.9 – 37.6 51.4 34.4 – 68.4
Monobind AccuLite CLIA µIU/mL 11.7 7.82 – 15.5 31.3 20.9 – 41.6 56.0 37.5 – 74.5
MP BioMedicals ImmuChem DA RIA ng/mL § § §
IGF-1/SOMATOMEDIN C (2)
MEDIAGNOST IGF-1 ELISA (IGFBP Blocked) ng/mL 110 89.0 – 131 125 88.0 – 163 114 87.0 – 141
MEDIAGNOST IGF-1 RIA (IGFBP Blocked) ng/mL 110 89.0 – 131 125 88.0 – 163 114 87.0 – 141
IMIPRAMINE
HPLC ng/mL § § §
IMMUNOGLOBULIN E (IGE) (2)
BioCheck EIA IU/mL
ImmunoCAP total IgE IU/mL § § §
Monobind AccuBind ELISA IU/mL 375 254 – >400 119 79.4 – 158 74.3 49.8 – 98.8
Monobind AccuLite CLIA IU/mL 373 250 – >400 126 84.2 – 167 80.5 53.9 – 107
INSULIN (2)
Calbiotech ELISA µIU/mL 18.3 12.2 – 24.4 61.4 40.9 – 81.8 >100
DRG ELISA (EIA-2935) µIU/mL 15.4 8.47 – 22.3 68.0 37.4 – 98.6 >100
Monobind AccuBind ELISA µIU/mL 11.0 7.36 – 14.6 44.0 29.5 – 58.6 145 97.0 – 193
Monobind AccuLite CLIA µIU/mL 11.6 7.77 – 15.4 43.3 29.0 – 57.6 146 97.6 – 194
MP BioMedicals ImmuChem CT RIA µIU/mL § § §
LIDOCAINE
Emit µg/mL 1.53 1.06 – 1.99 4.08 3.20 – 4.95 6.69 5.39 – 7.99
LUTEINIZING HORMONE (LH) (2)
BioCheck EIA mIU/mL
Calbiotech ELISA mIU/mL 1.15 0.770 – 1.54 19.2 12.8 – 25.6 34.0 – >50.0
DRG Serum ELISA (EIA-1289) mIU/mL 2.62 1.44 – 3.81 23.7 13.0 – 34.4 63.8 35.1 – 92.5
Monobind AccuBind ELISA mIU/mL 1.89 1.26 – 2.51 29.6 19.8 – 39.4 93.1 62.4 – 124
Monobind AccuLite CLIA mIU/mL <5.00 28.9 19.4 – 38.5 91.3 61.2 – 121
N-ACETYL PROCAINAMIDE (NAPA)
CEDIA (2) µg/mL 1.73 <0.600 – 3.41 4.36 2.26 – 6.46 8.20 5.74 – 10.7
Emit 2000 µg/mL § § §
NORTRIPTYLINE
HPLC ng/mL § § §
PHENOBARBITAL
CEDIA II (2) µg/mL 8.92 5.92 – 11.9 23.0 18.4 – 27.6 47.3 37.9 – 56.8
Emit 2000 µg/mL 9.86 6.93 – 12.8 23.4 18.2 – 28.6 47.5 38.2 – 56.8
PHENYTOIN
CEDIA II (2) µg/mL 7.19 5.75 – 8.63 14.4 11.5 – 17.3 26.3 21.0 – 31.5
Emit 2000 µg/mL 6.45 5.15 – 7.74 12.9 10.3 – 15.4 24.9 20.0 – 29.9
PRIMIDONE
Emit µg/mL 2.87 <2.50 – 3.42 5.76 4.77 – 6.76 10.7 8.91 – 12.6

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Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
PROCAINAMIDE
CEDIA (2) µg/mL 1.92 0.720 – 3.12 8.69 6.29 – 11.1 12.8 10.4 – 15.2
Emit 2000 µg/mL § § §
PROGESTERONE (2)
BioCheck EIA ng/mL
Calbiotech ELISA ng/mL § § §
Diagnostics Biochem Canada ELISA ng/mL § § §
DRG ELISA (EIA-1561) ng/mL 0.950 0.520 – 1.37 14.5 7.99 – 21.1 >40.0
Monobind AccuBind ELISA ng/mL 1.03 0.690 – 1.37 14.3 9.56 – 19.0 34.9 23.4 – 46.4
Monobind AccuLite CLIA ng/mL 1.19 0.800 – 1.59 14.0 9.40 – 18.7 45.7 30.6 – >60.0
MP BioMedicals ImmuChem CT RIA ng/mL § § §
MP BioMedicals ImmuChem DA RIA ng/mL § § §
PROLACTIN (2)
BioCheck EIA ng/mL
Calbiotech ELISA ng/mL 7.41 4.94 – 9.88 20.3 13.5 – 27.1 46.3 30.9 – 61.8
DRG ELISA (EIA-1291) ng/mL 5.98 3.29 – 8.67 15.4 8.45 – 22.3 32.5 17.9 – 47.2
Monobind AccuBind ELISA ng/mL 8.97 6.01 – 11.9 25.0 16.7 – 33.2 52.4 35.1 – 69.7
Monobind AccuLite CLIA ng/mL 8.75 5.86 – 11.6 24.5 16.4 – 32.5 50.5 33.8 – 67.1
MP BioMedicals ImmuChem CT IRMA ng/mL § § §
PROPRANOLOL
HPLC ng/mL § § §
PSA (TOTAL) (2)
Monobind AccuBind ELISA ng/mL <2.00 4.21 2.82 – 5.59 28.0 18.8 – 37.3
Monobind AccuLite CLIA ng/mL <2.00 3.79 2.54 – 5.04 26.9 18.0 – 35.8
SALICYLATE
Emit mg/dL 4.26 1.44 – 7.09 15.9 10.6 – 21.2 44.6 32.7 – 56.5
SEKURE (Sekisui Diagnostics) (2) mg/dL <5.30 16.3 12.2 – 20.4 44.7 33.5 – 55.9
T3 (FREE) (2)
Calbiotech ELISA pg/mL 2.98 1.98 – 3.97 5.84 3.89 – 7.78 9.00 6.00 – 12.0
Monobind AccuBind ELISA pg/mL 2.35 1.57 – 3.12 5.48 3.67 – 7.29 7.75 5.19 – 10.3
Monobind AccuLite CLIA pg/mL 2.39 1.60 – 3.18 5.39 3.61 – 7.17 7.72 5.17 – 10.3
MP BioMedicals SPCS RIA pg/mL § § §
T3 (TOTAL) (2)
BioCheck EIA ng/mL
Monobind AccuBind ELISA ng/mL 0.910 0.550 – 1.27 2.47 1.65 – 3.28 3.73 2.50 – 4.96
Monobind AccuLite CLIA ng/mL 1.06 0.710 – 1.41 2.56 1.71 – 3.40 3.71 2.49 – 4.94
MP BioMedicals SPCS RIA ng/dL § § §
T3 UPTAKE/T UPTAKE (2)
CEDIA (2) % Uptake 35.2 31.1 – 39.2 43.3 38.2 – 48.4 47.5 42.1 – >50.0
DRI % Uptake
Monobind AccuBind ELISA % Uptake 30.9 28.0 – 33.8 36.5 33.7 – 39.4 42.8 40.2 – 45.5
Monobind AccuLite CLIA % Uptake 30.2 27.8 – 32.7 36.1 33.7 – 38.4 42.8 40.3 – 45.3
MP BioMedicals SPCS RIA % Uptake § § §
T4 (FREE) (2)
EUROIMMUN RIA CT ng/dL 1.42 1.06 – 1.78 3.29 2.47 – 4.11 5.16 3.87 – 6.44
Monobind AccuBind ELISA ng/dL 1.00 0.670 – 1.33 2.35 1.58 – 3.13 3.73 2.50 – 4.96
Monobind AccuLite CLIA ng/dL 0.960 0.640 – 1.27 2.34 1.57 – 3.11 3.84 2.57 – 5.10
MP BioMedicals SPCS RIA ng/dL § § §
T4 (TOTAL) (2)
BioCheck EIA µg/dL
CEDIA (2) µg/dL 6.10 5.00 – 7.30 10.3 8.70 – 11.9 14.5 12.2 – 16.7
DRI µg/dL
Monobind AccuBind ELISA µg/dL 5.54 3.71 – 7.36 10.2 6.84 – 13.6 14.0 9.38 – 18.6
Monobind AccuLite CLIA µg/dL 5.91 3.96 – 7.86 10.4 6.93 – 13.8 14.8 9.90 – 19.7
MP BioMedicals SPCS RIA µg/dL § § §

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Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
TESTOSTERONE (2)
BioCheck EIA ng/mL
DRG ELISA (EIA-1559) ng/mL 1.57 0.910 – 2.23 4.65 2.70 – 6.61 10.5 6.12 – 15.0
IBL LIA ng/dL § § §
MP BioMedicals ImmuChem DA RIA ng/mL § § §
TESTOSTERONE (FREE) (2)
Beckman Coulter RIA (DSL4900) pg/mL 2.99 1.94 – 4.03 12.6 8.16 – 16.9 29.1 20.4 – 37.9
THEOPHYLLINE
CEDIA II (2) µg/mL 4.24 2.29 – 6.19 14.0 10.7 – 17.3 26.9 21.5 – 32.2
Emit 2000 µg/mL 4.68 3.45 – 5.91 14.7 12.2 – 17.1 28.5 24.5 – 32.5
THYROID STIMULATING HORMONE (TSH) (2)
BioCheck EIA µIU/mL
Fortress Diagnostics µIU/mL
Monobind AccuBind ELISA µIU/mL 0.480 0.320 – 0.630 5.85 3.92 – 7.79 33.4 22.4 – >40.0
Monobind AccuLite CLIA µIU/mL 0.480 0.320 – 0.640 5.59 3.74 – 7.43 29.9 20.0 – 39.7
MP BioMedicals ImmuChem CT IRMA µIU/mL § § §
TOBRAMYCIN
CEDIA µg/mL
Emit 2000 µg/mL 1.10 0.796 – 1.41 3.20 2.71 – 3.69 8.47 7.65 – 9.28
VALPROIC ACID
CEDIA II (2) µg/mL 30.7 23.2 – 38.2 72.6 58.1 – 87.2 106 84.5 – 127
Emit 2000 µg/mL 34.9 26.0 – 43.8 76.0 60.2 – 91.7 108 86.4 – 129
VANCOMYCIN
Emit 2000 µg/mL 6.89 5.10 – 8.68 16.2 12.9 – 19.5 29.1 23.6 – 34.5
VITAMIN B12 (2)
MP BioMedicals SimulTRAC SNB RIA pg/mL § § §
MP BioMedicals SimulTRAC SP RIA pg/mL § § §

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Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
Abbott Alinity c Analyzer
Amikacin µg/mL 5.18 3.87 – 6.50 14.3 12.3 – 16.3 24.7 21.9 – 27.4
Lithium mmol/L 0.485 0.342 – 0.628 1.24 1.05 – 1.43 1.89 1.66 – 2.13
Salicylate mg/dL <5.00 16.3 13.9 – 18.7 46.5 41.4 – 51.7
Vancomycin µg/mL 7.74 5.70 – 9.79 19.5 15.2 – 23.8 35.6 28.1 – 43.2
Abbott Alinity i Analyzer
Estradiol pg/mL 92.6 59.2 – 126 182 129 – 236 367 272 – 462
Ferritin ng/mL 66.7 50.4 – 83.1 207 155 – 258 513 395 – 631
Follicle Stimulating Hormone (FSH) mIU/mL 5.07 4.05 – 6.08 21.1 16.7 – 25.5 42.0 33.1 – 50.9
hCG mIU/mL 5.77 3.42 – 8.12 20.6 15.8 – 25.3 158 131 – 185
Progesterone ng/mL 0.519 <0.500 – 0.669 8.36 6.65 – 10.1 30.7 24.6 – 36.9
T3 Uptake/T Uptake T Uptake Unit 0.957 0.793 – 1.12 0.853 0.707 – 0.999 0.843 0.699 – 0.988
T4 (Free) ng/dL 0.862 0.654 – 1.07 1.85 1.46 – 2.23 3.14 2.52 – 3.76
T4 (Total) µg/dL 5.82 4.30 – 7.34 10.1 7.65 – 12.5 15.0 11.5 – 18.5
Testosterone ng/dL 187 129 – 244 398 288 – 508 888 656 – 1121
Thyroid Stimulating Hormone (TSH) µIU/mL 0.372 0.271 – 0.472 4.59 3.59 – 5.58 24.6 19.3 – 29.8
ABBOTT ARCHITECT cSYSTEMS
Acetaminophen (MULTIGENT) µg/mL 9.33 6.81 – 11.9 33.5 28.2 – 38.8 110 96.3 – 124
Carbamazepine (5P05-21) µg/mL 2.02 <1.90 – 2.86 7.70 5.71 – 9.69 11.8 9.52 – 14.2
Digoxin (MULTIGENT) ng/mL 0.783 0.508 – 1.06 1.90 1.52 – 2.28 3.22 2.71 – 3.72
Gentamicin (MULTIGENT) µg/mL 2.39 1.72 – 3.07 4.96 4.02 – 5.90 7.99 6.74 – 9.24
Immunoglobulin A (IgA) mg/dL 165 159 – 171 143 137 – 148 143 137 – 148
Immunoglobulin E (IgE) (MULTIGENT) IU/mL 350 292 – 408 116 78.2 – 153 71.8 39.2 – 105
Immunoglobulin G (IgG) mg/dL 812 726 – 898 739 661 – 816 733 656 – 810
Immunoglobulin M (IgM) mg/dL 51.6 43.0 – 60.3 52.1 43.4 – 60.8 60.5 51.2 – 69.8
Iron µg/dL 104 99.8 – 109 74.0 70.1 – 77.9 76.5 72.5 – 80.4
Lithium (MULTIGENT) mEq/L 0.490 0.368 – 0.612 1.23 1.06 – 1.41 1.85 1.63 – 2.07
Phenobarbital (5P07-21) µg/mL 9.86 6.95 – 12.8 23.6 18.9 – 28.4 45.3 37.7 – 53.0
Phenytoin (5P08-21) µg/mL 7.06 5.74 – 8.39 13.6 10.8 – 16.4 27.4 22.2 – 32.6
Salicylate (MULTIGENT) mg/dL <5.00 15.6 13.2 – 18.0 45.1 40.8 – 49.4
Theophylline (5P06-21) µg/mL 4.94 4.23 – 5.64 14.6 12.6 – 16.7 30.8 26.4 – 35.1
Tobramycin (MULTIGENT) µg/mL 0.850 0.637 – 1.06 2.97 2.41 – 3.52 7.88 6.79 – 8.98
Valproic Acid (MULTIGENT) µg/mL 33.0 26.1 – 39.8 74.8 64.5 – 85.1 113 99.7 – 127
Vancomycin (MULTIGENT) µg/mL 7.74 5.70 – 9.79 19.5 15.2 – 23.8 35.6 28.1 – 43.2
ABBOTT ARCHITECT iSYSTEMS
AFP ng/mL 16.6 12.5 – 20.8 90.7 67.3 – 114 196 142 – 250
Carbamazepine (1P36-27) µg/mL 3.00 2.47 – 3.53 8.21 6.94 – 9.48 12.6 10.7 – 14.5
CEA ng/mL 2.34 1.66 – 3.02 19.1 15.4 – 22.7 40.7 33.1 – 48.2
Cortisol µg/dL 3.07 2.19 – 3.94 14.1 11.0 – 17.2 21.6 17.0 – 26.1
C-Peptide ng/mL 1.45 0.865 – 2.03 5.49 3.79 – 7.19 7.44 5.20 – 9.69
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) µg/dL 70.2 57.5 – 82.9 181 152 – 209 577 491 – 662
Digoxin ng/mL 0.605 0.447 – 0.763 1.67 1.41 – 1.93 2.85 2.47 – 3.22
Estradiol pg/mL 95.5 74.9 – 116 198 168 – 228 399 356 – 441
Ferritin ng/mL 66.6 52.2 – 81.0 195 146 – 245 467 343 – 591
Folate ng/mL 4.35 2.66 – 6.04 11.1 8.00 – 14.3 15.3 – >20.0
Follicle Stimulating Hormone (FSH) mIU/mL 5.10 4.17 – 6.04 21.4 17.8 – 25.0 43.6 36.4 – 50.9
Gentamicin µg/mL 2.28 1.95 – 2.61 5.02 4.14 – 5.90 8.38 6.81 – 9.94
hCG mIU/mL 6.06 3.70 – 8.41 19.7 15.1 – 24.3 146 120 – 171
Insulin µIU/mL 14.4 12.1 – 16.7 48.7 42.2 – 55.2 160 140 – 181
Luteinizing Hormone (LH) mIU/mL 1.13 0.891 – 1.36 16.4 12.7 – 20.1 49.8 38.3 – 61.2
Phenobarbital µg/mL 10.2 8.41 – 12.0 24.1 20.1 – 28.0 47.6 40.0 – 55.2
Phenytoin µg/mL 6.95 5.82 – 8.08 13.8 11.7 – 15.8 26.4 22.8 – 30.0
Progesterone ng/mL 0.633 0.417 – 0.849 9.97 7.24 – 12.7 29.6 21.1 – 38.1
Prolactin ng/mL 6.90 5.50 – 8.29 20.6 16.7 – 24.5 41.5 33.7 – 49.3
PSA (Free) ng/mL 0.334 0.274 – 0.393 1.78 1.44 – 2.12 14.2 11.1 – 17.4
PSA (Total) ng/mL 0.716 0.571 – 0.861 2.57 2.05 – 3.08 16.5 13.2 – 19.8

Page 6 English • 2019-10 • 1536-00

7
Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
ABBOTT ARCHITECT iSYSTEMS (continued)
T3 (Free) pg/mL 1.99 1.40 – 2.59 6.22 4.78 – 7.66 10.6 8.23 – 12.9
T3 (Free) (7K63-02) pg/mL 1.87 1.28 – 2.47 6.12 4.70 – 7.54 10.6 8.24 – 12.9
T3 (Total) ng/mL 0.558 0.373 – 0.743 1.77 1.43 – 2.10 2.71 2.25 – 3.18
T3 Uptake/T Uptake T Uptake Unit 1.14 0.980 – 1.31 0.946 0.792 – 1.10 0.920 0.768 – 1.07
T4 (Free) ng/dL 0.910 0.763 – 1.06 2.04 1.53 – 2.56 2.38 – >5.00
T4 (Total) µg/dL 5.59 4.34 – 6.83 9.70 7.29 – 12.1 13.9 10.3 – 17.5
Testosterone ng/dL 194 133 – 254 408 309 – 507 865 685 – 1046
Theophylline µg/mL 4.51 3.61 – 5.42 13.9 11.1 – 16.6 24.3 19.4 – 29.2
Thyroid Stimulating Hormone (TSH) µIU/mL 0.362 0.234 – 0.489 4.50 3.75 – 5.26 25.8 21.6 – 30.0
Valproic Acid µg/mL 31.1 24.7 – 37.4 72.2 58.4 – 86.0 101 82.2 – 120
Vancomycin (1P30-28) µg/mL 8.04 6.80 – 9.29 20.4 16.9 – 23.9 36.4 30.0 – 42.8
Vitamin B12 pg/mL 353 226 – 479 507 349 – 665 655 460 – 850
BECKMAN COULTER ACCESS / 2 / 2i
AFP ng/mL 18.2 13.1 – 23.3 94.6 70.2 – 119 211 157 – 265
CEA (CEA2) ng/mL 1.64 1.15 – 2.12 16.9 13.6 – 20.3 37.3 30.0 – 44.5
Cortisol µg/dL 3.13 2.12 – 4.15 16.2 12.6 – 19.8 24.8 19.5 – 30.0
Digoxin ng/mL 0.803 0.540 – 1.07 1.93 1.47 – 2.39 3.36 2.67 – 4.04
Estradiol pg/mL 138 107 – 169 329 273 – 385 774 698 – 849
Estradiol (Sensitive) pg/mL § § §
Estriol (Free) (Unconjugated Estriol) ng/mL 1.02 0.667 – 1.37 3.54 2.69 – 4.20 >6.90
Ferritin ng/mL 45.4 35.0 – 55.8 115 88.9 – 142 269 207 – 331
Folate (FOLW) ng/mL 4.23 2.96 – 5.50 9.51 6.84 – 12.2 16.2 11.8 – 20.7
Follicle Stimulating Hormone (FSH) (hFSH) mIU/mL 6.42 4.78 – 8.05 20.1 15.3 – 24.8 39.5 30.2 – 48.7
hCG (Total ßhCG) (5th IS) mIU/mL 5.94 4.57 – 7.32 20.5 16.8 – 24.3 154 129 – 180
Insulin (Ultrasensitive Insulin) µIU/mL 14.8 11.7 – 17.8 49.0 40.0 – 57.9 161 133 – 190
Luteinizing Hormone (LH) (hLH) mIU/mL 1.07 0.761 – 1.38 18.6 14.5 – 22.6 59.3 46.6 – 71.9
Progesterone ng/mL 0.667 0.453 – 0.880 11.6 8.42 – 14.8 33.1 23.9 – >40.0
Progesterone (P4DE) ng/mL 0.400 0.260 – 0.540 9.26 6.51 – 12.1 29.4 20.5 – 38.5
Prolactin ng/mL 5.24 4.26 – 6.22 15.0 12.4 – 17.7 29.8 24.6 – 35.0
PSA (Free) (Hybritech free PSA) ng/mL 0.471 0.363 – 0.580 2.16 1.78 – 2.54 17.1 14.2 – 20.0
PSA (Free) (WHO 96/668) ng/mL 0.371 0.286 – 0.456 1.75 1.44 – 2.06 13.5 11.2 – 15.8
PSA (Total) (Hybritech PSA) ng/mL 0.943 0.789 – 1.10 3.35 2.81 – 3.89 22.6 19.0 – 26.3
PSA (Total) (WHO 96/670) ng/mL 0.797 0.667 – 0.929 2.61 2.19 – 3.03 18.3 15.4 – 21.3
T3 (Free) (Free T3) (2) pg/mL 2.16 1.72 – 2.60 5.66 4.52 – 6.80 8.75 6.99 – 10.5
T3 (Total) (Total T3) ng/mL 0.728 0.489 – 0.967 1.86 1.44 – 2.29 2.95 2.35 – 3.55
T3 Uptake/T Uptake % Uptake 44.7 36.3 – 53.1 49.6 40.4 – 58.8 53.7 43.9 – 63.4
T4 (Free) (Free T4) ng/dL 0.912 0.741 – 1.08 2.25 1.81 – 2.69 3.70 2.98 – 4.43
T4 (Total) (Total T4) µg/dL 6.46 4.75 – 8.16 11.3 8.74 – 13.9 16.1 12.6 – 19.5
Testosterone ng/mL 1.19 0.924 – 1.47 3.55 2.84 – 4.26 7.94 6.41 – 9.48
Thyroid Stimulating Hormone (TSH) (3rd IS) (2) µIU/mL 0.406 0.324 – 0.489 5.46 4.23 – 6.68 30.5 23.7 – 37.4
Thyroid Stimulating Hormone (TSH) (hTSH, Fast) µIU/mL § § §
Thyroid Stimulating Hormone (TSH) (hTSH, HYPERsensitive) µIU/mL 0.407 0.321 – 0.492 5.26 4.04 – 6.47 28.9 22.1 – 35.6
Vitamin B12 pg/mL 263 196 – 330 432 327 – 536 587 425 – 748
BECKMAN COULTER AU SYSTEMS
Acetaminophen µg/mL <10.0 33.8 25.3 – 42.2 104 79.7 – 128
Carbamazepine µg/mL 2.88 <2.00 – 3.91 8.43 6.44 – 10.4 13.5 10.6 – 16.3
Digoxin ng/mL 0.683 <0.200 – 1.28 1.73 0.976 – 2.49 3.05 2.07 – 4.03
Ferritin ng/mL 53.4 35.6 – 71.3 121 98.8 – 144 273 239 – 307
Gentamicin µg/mL 2.30 1.74 – 2.86 4.95 3.56 – 6.34 7.78 5.56 – 10.0
Immunoglobulin A (IgA) mg/dL 167 143 – 191 146 123 – 169 148 125 – 170
Immunoglobulin G (IgG) mg/dL 759 644 – 873 697 594 – 800 704 599 – 808
Immunoglobulin M (IgM) mg/dL
Lithium mEq/L 0.483 0.282 – 0.685 1.25 1.07 – 1.43 1.80 1.62 – 1.98
Phenobarbital µg/mL 9.72 6.94 – 12.5 23.1 17.6 – 28.5 47.0 36.6 – 57.5
Phenytoin µg/mL 6.15 4.43 – 7.87 12.0 8.29 – 15.7 23.4 15.8 – 31.0

Page 7 English • 2019-10 • 1536-00

7
Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
BECKMAN COULTER AU SYSTEMS (continued)
Salicylate mg/dL 4.26 1.44 – 7.09 15.9 10.6 – 21.2 44.6 32.7 – 56.5
T4 (Total) (DRI) µg/dL 7.38 5.73 – 9.03 11.8 8.83 – 14.7 13.5 10.1 – 17.0
Theophylline µg/mL 4.69 3.18 – 6.20 14.6 11.9 – 17.3 27.7 23.4 – 32.0
Tobramycin µg/mL 1.20 0.907 – 1.49 3.21 2.85 – 3.58 8.70 8.34 – 9.07
Valproic Acid µg/mL 35.3 25.9 – 44.7 76.0 59.6 – 92.4 109 86.5 – 130
Vancomycin µg/mL 6.48 4.89 – 8.06 15.3 9.90 – 20.6 27.6 16.6 – 38.6
BECKMAN COULTER SYNCHRON / UniCel DxC SERIES
Acetaminophen µg/mL 12.1 <10.0 – 18.5 39.8 29.7 – 49.9 122 101 – 143
Carbamazepine µg/mL 2.50 <2.00 – 3.15 8.42 6.84 – 10.0 13.0 10.7 – 15.3
Digoxin ng/mL 0.753 0.356 – 1.15 1.78 1.27 – 2.28 3.10 2.46 – 3.75
Gentamicin µg/mL 2.68 1.80 – 3.55 5.81 4.70 – 6.93 9.28 7.88 – 10.7
Immunoglobulin A (IgA) mg/dL § § §
Immunoglobulin G (IgG) mg/dL § § §
Immunoglobulin M (IgM) mg/dL § § §
Iron µg/dL 102 93.5 – 111 71.7 66.1 – 77.3 75.4 69.4 – 81.4
Lithium (Infinity) mEq/L 0.450 0.293 – 0.607 1.20 0.990 – 1.41 1.88 1.61 – 2.14
Phenobarbital µg/mL 10.2 7.95 – 12.4 24.3 19.4 – 29.3 47.3 38.0 – 56.6
Phenytoin µg/mL 6.84 5.74 – 7.94 13.4 11.3 – 15.5 24.6 21.0 – 28.3
Salicylate mg/dL <4.00 – 5.75 16.4 13.8 – 19.0 45.8 40.7 – 50.9
Theophylline µg/mL 4.43 3.63 – 5.24 13.9 11.8 – 15.9 26.6 22.8 – 30.3
Tobramycin µg/mL 1.08 0.568 – 1.60 3.83 3.16 – 4.50 9.63 8.69 – 10.6
Valproic Acid µg/mL 22.8 10.4 – 35.2 72.9 56.7 – 89.1 105 86.6 – 124
Vancomycin µg/mL 6.93 4.65 – 9.22 16.7 13.0 – 20.3 33.3 27.3 – 39.2
BECKMAN COULTER UniCel DxI
AFP ng/mL 17.2 11.8 – 22.7 89.8 65.6 – 114 197 144 – 250
CEA (CEA2) ng/mL 1.52 1.02 – 2.02 16.4 12.4 – 20.3 34.6 26.2 – 43.1
Cortisol µg/dL 3.16 2.02 – 4.30 15.0 11.4 – 18.7 24.2 18.6 – 29.8
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-S) µg/dL 57.5 43.2 – 71.8 148 113 – 183 449 344 – 554
Digoxin ng/mL 0.803 0.540 – 1.07 1.93 1.47 – 2.39 3.36 2.67 – 4.04
Estradiol pg/mL 96.2 39.3 – 153 250 149 – 351 554 365 – 742
Estradiol (Sensitive) (2) pg/mL
Estriol (Free) (Unconjugated Estriol) ng/mL 1.02 0.667 – 1.37 3.45 2.69 – 4.20 >6.90
Ferritin ng/mL 44.0 33.7 – 54.3 120 90.1 – 149 273 205 – 342
Folate (FOLW) ng/mL 4.26 2.94 – 5.57 10.0 7.20 – 12.8 17.2 12.7 – 21.7
Follicle Stimulating Hormone (FSH) (hFSH) mIU/mL 6.42 4.78 – 8.05 20.1 15.3 – 24.8 39.5 30.2 – 48.7
hCG (Total ßhCG) (5th IS) mIU/mL 6.06 4.65 – 7.46 21.3 17.1 – 25.4 160 131 – 189
Immunoglobulin E (IgE) (Total IgE) IU/mL § § §
Insulin (Ultrasensitive Insulin) µIU/mL 14.2 11.4 – 16.9 50.7 41.0 – 60.4 159 129 – 189
Luteinizing Hormone (LH) (hLH) mIU/mL 1.07 0.761 – 1.38 18.6 14.5 – 22.6 59.3 46.6 – 71.9
Progesterone ng/mL 0.800 0.579 – 1.02 13.0 9.42 – 16.7 36.8 27.5 – >40.0
Progesterone (P4DE) ng/mL 0.490 0.340 – 0.640 10.5 7.37 – 13.8 33.0 23.9 – >36.2
Prolactin ng/mL 5.14 4.07 – 6.21 14.8 12.0 – 17.5 30.0 24.4 – 35.6
PSA (Free) (Hybritech free PSA) ng/mL 0.428 0.297 – 0.558 2.07 1.63 – 2.51 16.5 13.1 – 19.8
PSA (Free) (WHO 96/668) ng/mL 0.337 0.234 – 0.439 1.68 1.32 – 2.04 13.0 10.4 – 15.6
PSA (Total) (Hybritech PSA) ng/mL 0.977 0.781 – 1.17 3.37 2.71 – 4.02 21.5 17.3 – 25.8
PSA (Total) (WHO 96/670) ng/mL 0.826 0.660 – 0.989 2.63 2.11 – 3.13 18.3 15.4 – 21.3
T3 (Free) (Free T3) pg/mL 2.29 1.57 – 3.01 5.44 3.57 – 7.31 8.15 5.24 – 11.0
T3 (Total) (Total T3) ng/mL 0.788 0.528 – 1.05 1.95 1.43 – 2.47 3.29 2.47 – 4.12
T3 Uptake/T Uptake % Uptake 46.3 37.6 – 54.9 51.7 42.1 – 61.3 55.0 45.3 – 64.7
T4 (Free) (Free T4) ng/dL 0.912 0.698 – 1.12 2.23 1.75 – 2.72 4.03 3.15 – 4.91
T4 (Total) (Total T4) µg/dL 5.94 4.30 – 7.59 10.3 7.89 – 12.7 15.0 11.7 – 18.2
Testosterone ng/mL 1.27 0.991 – 1.54 3.59 2.72 – 4.45 7.70 5.79 – 9.62
Thyroid Stimulating Hormone (TSH) (3rd IS) µIU/mL 0.410 0.318 – 0.501 5.75 4.33 – 7.17 31.9 23.9 – 39.8
Thyroid Stimulating Hormone (TSH) (hTSH, Fast) µIU/mL § § §
Thyroid Stimulating Hormone (TSH) (hTSH, HYPERsensitive) µIU/mL 0.373 0.290 – 0.456 5.08 3.82 – 6.34 28.1 21.1 – 35.1

Page 8 English • 2019-10 • 1536-00

7
Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
BECKMAN COULTER UniCel DxI (continued)
Vitamin B12 pg/mL 272 195 – 348 438 315 – 560 609 425 – 794
BIOMÉRIEUX VIDAS
AFP ng/mL 16.9 7.97 – 25.9 101 71.2 – 130 217 163 – 272
CEA (S) ng/mL 1.20 0.502 – 1.90 8.60 6.37 – 10.8 13.8 10.4 – 17.2
Digoxin ng/mL 0.608 0.339 – 0.878 1.79 1.26 – 2.31 3.22 2.39 – 4.05
Estradiol (II) pg/mL 115 82.1 – 148 366 288 – 443 824 680 – 968
Ferritin ng/mL 53.8 34.5 – 73.0 119 76.0 – 162 265 168 – 362
Follicle Stimulating Hormone (FSH) mIU/mL 5.76 4.49 – 7.03 24.6 19.6 – 29.6 46.6 37.0 – 56.1
hCG mIU/mL 7.15 4.50 – 9.80 27.3 19.3 – 35.2 204 150 – 259
Immunoglobulin E (IgE) (Total) IU/mL 354 222 – 486 120 78.5 – 162 73.6 49.7 – 97.5
Luteinizing Hormone (LH) mIU/mL 1.42 1.09 – 1.74 17.4 14.1 – 20.7 61.1 49.9 – 72.3
Progesterone ng/mL 0.977 0.452 – 1.50 17.1 12.7 – 21.6 54.6 45.6 – 63.6
Prolactin ng/mL 6.33 3.86 – 8.79 18.5 13.5 – 23.6 35.8 27.1 – 44.6
PSA (Total) ng/mL 1.10 0.725 – 1.47 3.57 2.58 – 4.56 21.9 16.3 – 27.5
T3 (Free) pg/mL 1.91 1.31 – 2.50 7.08 5.22 – 8.94 12.5 9.31 – 15.7
T3 (Total) ng/mL 0.706 0.394 – 1.02 2.08 1.51 – 2.65 3.08 2.32 – 3.83
T4 (Free) (FT4N) (30459) ng/dL 1.15 0.810 – 1.48 3.02 2.17 – 3.86 5.59 4.46 – 6.72
T4 (Total) µg/dL 6.38 4.82 – 7.95 11.6 9.09 – 14.1 16.5 13.1 – 19.8
Thyroid Stimulating Hormone (TSH) µIU/mL 0.420 0.203 – 0.637 6.31 4.99 – 7.63 33.8 27.2 – 40.4
DIASORIN LIAISON (2)
Aldosterone ng/dL 11.4 7.98 – 14.8 21.6 15.1 – 28.1 68.7 48.1 – 89.3
CEA ng/mL 1.90 1.37 – 2.44 15.1 12.2 – 17.9 35.0 28.5 – 41.5
Cortisol µg/dL 2.81 1.74 – 3.87 20.0 15.0 – 25.0 32.3 23.1 – 41.5
C-Peptide ng/mL 1.76 1.31 – 2.21 6.43 5.14 – 7.71 8.69 6.96 – 10.4
Estradiol (II Gen) (310680) pg/mL 86.2 57.8 – 115 187 131 – 244 394 276 – 512
Follicle Stimulating Hormone (FSH) (US only) mIU/mL 5.64 3.94 – 7.34 24.1 17.4 – 30.8 51.2 39.8 – 62.6
Luteinizing Hormone (LH) (US only) mIU/mL 1.76 1.14 – 2.38 30.3 24.2 – 36.3 109 84.5 – >125
Progesterone (II Gen) (310690) ng/mL 0.730 0.290 – 1.17 11.5 7.68 – 15.3 30.0 20.1 – 39.9
Prolactin (xt) µIU/mL 161 127 – 195 468 375 – 562 963 770 – 1155
T3 (Free) pg/mL 1.94 1.49 – 2.40 9.75 8.29 – 11.2 20.7 16.5 – 25.0
T4 (Free) (US only) ng/dL 1.15 0.978 – 1.32 3.28 2.79 – 3.77 7.21 6.13 – >7.70
Testosterone ng/mL 0.730 0.470 – 1.00 2.14 1.50 – 2.78 4.63 3.24 – 6.02
DIASORIN LIAISON XL (2)
Aldosterone ng/dL 10.9 7.62 – 14.2 21.5 15.0 – 27.9 66.2 46.3 – 86.0
CEA ng/mL 1.90 1.27 – 2.52 15.6 13.3 – 18.0 37.2 31.7 – 42.8
Cortisol µg/dL 2.20 1.82 – 2.57 19.8 16.8 – 22.8 35.0 28.5 – 41.4
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 51.5 36.0 – 66.9 136 95.5 – 177 467 250 – 684
Estradiol (II Gen) (310680) pg/mL 85.2 57.1 – 113 171 119 – 222 365 255 – 474
Follicle Stimulating Hormone (FSH) (US only) mIU/mL 6.08 4.87 – 7.30 26.6 19.8 – 33.4 54.5 40.0 – 69.0
hCG (XL hCG) (REF 312321) mIU/mL 5.33 4.06 – 6.60 21.7 18.4 – 25.0 168 143 – 193
Luteinizing Hormone (LH) (US only) mIU/mL 2.14 1.53 – 2.75 32.5 26.0 – 39.0 112 90.0 – >125
Progesterone (II Gen) (310690) ng/mL 0.630 0.250 – 1.01 10.8 7.25 – 14.4 29.6 19.8 – 39.4
Prolactin (xt) µIU/mL 164 113 – 216 473 365 – 581 982 706 – 1258
T3 (Free) pg/mL 2.14 1.39 – 2.90 10.2 8.63 – 11.7 21.6 18.2 – 25.0
T4 (Free) (US only) ng/dL 1.16 0.986 – 1.33 3.58 3.04 – 4.11 >7.70
T4 (Total) µg/dL 4.57 3.88 – 5.26 7.04 5.98 – 8.10 9.99 8.49 – 11.5
Testosterone ng/mL 0.560 0.360 – 0.760 1.73 1.21 – 2.25 3.59 2.52 – 4.67
Thyroid Stimulating Hormone (TSH) µIU/mL 0.600 0.505 – 0.695 7.03 5.89 – 8.17 36.5 31.1 – 42.0
IDS-iSYS (2)
Human Growth Hormone (hGH) (IS-3700) ng/mL 3.70 2.70 – 4.70 8.91 6.77 – 11.0 14.9 11.8 – 18.1
ORTHO VITROS MICROSLIDE SERIES
Acetaminophen (ACET) µg/mL 10.7 <10.0 – 12.2 39.6 36.6 – 42.5 131 124 – 139
Carbamazepine (CRBM) µg/mL <3.00 7.96 6.17 – 9.74 12.3 9.53 – 15.1
Digoxin (DGXN) ng/mL 0.818 <0.400 – 1.30 1.88 1.38 – 2.38 3.27 2.74 – 3.79
Iron (Fe) µg/dL 108 93.9 – 123 69.1 48.2 – 90.0 69.2 48.3 – 90.1

Page 9 English • 2019-10 • 1536-00

7
Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
ORTHO VITROS MICROSLIDE SERIES (continued)
Lithium (Li) mmol/L 0.722 0.527 – 0.917 1.58 1.33 – 1.84 2.33 2.03 – 2.64
Phenytoin (PHYT) µg/mL 6.32 4.76 – 7.87 12.7 10.1 – 15.3 23.4 19.4 – 27.5
Salicylate (SALI) mg/dL 5.18 4.42 – 5.94 18.0 15.6 – 20.3 >40.0
Theophylline (THEO) µg/mL 3.77 2.23 – 5.31 14.6 11.4 – 17.8 30.3 24.7 – 36.0
ORTHO VITROS MICROTIP SERIES
Gentamicin (GENT) µg/mL 2.35 1.80 – 2.90 4.84 3.94 – 5.75 7.50 6.20 – 8.79
Tobramycin (TOBRA) µg/mL 1.17 0.945 – 1.39 3.24 2.73 – 3.75 9.12 8.00 – >10.0
Valproic Acid (VALP) µg/mL 35.1 24.0 – 46.2 78.7 61.0 – 96.3 111 88.2 – 133
Vancomycin (VANC) µg/mL 6.41 <5.00 – 8.10 15.5 12.5 – 18.4 27.6 23.0 – 32.3
ORTHO VITROS MICROWELL SERIES
AFP (2) (3) IU/mL 14.6 11.7 – 17.5 77.6 62.5 – 92.7 176 137 – 215
CEA ng/mL 2.14 1.47 – 2.82 18.3 15.2 – 21.5 38.0 31.9 – 44.2
Cortisol (Cort) µg/dL 3.00 2.14 – 3.86 16.1 11.5 – 20.7 26.1 18.6 – 33.5
C-Peptide (2) ng/mL 1.38 1.04 – 1.73 5.44 3.99 – 6.89 7.45 5.46 – 9.44
Estradiol pg/mL 79.4 45.4 – 113 305 223 – 388 785 615 – 954
Ferritin (Ferr) ng/mL 46.4 33.6 – 59.2 105 77.1 – 133 242 178 – 305
Folate (Fol/RCFol) ng/mL 3.95 2.32 – 5.57 11.2 8.05 – 14.4 >20.0
Follicle Stimulating Hormone (FSH) mIU/mL 3.94 2.96 – 4.92 19.0 15.8 – 22.3 36.5 30.6 – 42.4
hCG (B-hCG) mIU/mL 8.23 5.98 – 10.5 29.3 23.5 – 35.1 192 159 – 226
Insulin (2) (3) µIU/mL 15.5 9.83 – 21.2 54.8 38.0 – 71.6 177 123 – 231
Luteinizing Hormone (LH) mIU/mL 0.920 0.452 – 1.39 21.3 17.8 – 24.9 65.1 55.7 – 74.5
Progesterone ng/mL 0.610 0.398 – 0.823 10.7 7.82 – 13.6 33.1 23.8 – 42.3
Prolactin (Prol) ng/mL
PSA (Total) (PSA) ng/mL 0.794 0.632 – 0.957 2.45 2.01 – 2.89 13.9 11.5 – 16.3
T3 (Free) (FT3 II) (2) pg/mL 3.97 2.97 – 4.97 13.9 11.4 – 16.4 >22.7
T3 (Free) (FT3) (2) pg/mL 3.98 2.98 – 4.99 16.9 12.3 – 21.4 >22.7
T3 (Total) (TT3) ng/mL 0.857 0.682 – 1.03 2.16 1.74 – 2.58 3.61 2.91 – 4.30
T3 Uptake/T Uptake (T3U) % Uptake 37.0 32.3 – 41.6 51.6 46.2 – 57.0 62.7 56.6 – >65.0
T4 (Free) (FT4) ng/dL 1.35 0.804 – 1.90 5.29 4.88 – 5.70 >6.98
T4 (Total) (TT4) µg/dL 6.05 4.66 – 7.44 11.1 8.49 – 13.7 16.1 12.3 – 19.9
Testosterone ng/dL 120 83.2 – 157 525 416 – 635 1371 1120 – 1622
Thyroid Stimulating Hormone (TSH) µIU/mL 0.307 0.225 – 0.390 5.22 4.30 – 6.14 29.3 24.2 – 34.4
Vitamin B12 pg/mL 352 220 – 483 556 410 – 702 731 572 – 891
PerkinElmer AUTODELFIA (2)
Follicle Stimulating Hormone (FSH) (hFSH) mIU/mL 4.80 3.80 – 5.80 20.0 16.0 – 24.0 41.0 33.0 – 49.0
hCG mIU/mL 9.20 6.40 – 12.0 31.0 23.0 – 39.0 196 157 – 235
Luteinizing Hormone (LH) (hLH) mIU/mL 1.20 0.900 – 1.50 19.0 15.0 – 23.0 63.0 50.0 – 76.0
Prolactin ng/mL 4.40 3.30 – 5.50 13.0 10.0 – 16.0 27.0 22.0 – 32.0
T3 (Total) ng/mL 1.40 0.770 – 2.00 3.20 2.60 – 3.80 4.90 3.90 – 5.90
T4 (Free) ng/dL 1.24 0.853 – 1.63 4.57 3.64 – 5.50 >6.20
T4 (Total) µg/dL 6.05 4.26 – 7.83 9.53 7.60 – 11.5 13.0 10.4 – 15.7
Thyroid Stimulating Hormone (TSH) (hTSH Ultra) µIU/mL 0.440 0.350 – 0.530 5.50 4.40 – 6.60 32.0 26.0 – 38.0
ROCHE / HITACHI COBAS C SYSTEMS
Acetaminophen (ACET2) (REF 06769942190) µg/mL 9.28 6.07 – 12.5 33.0 24.7 – 41.3 107 81.7 – 131
Acetaminophen (ACETA) (REF 20767174160) µg/mL § § §
Amikacin µg/mL 4.84 3.63 – 6.04 14.1 12.2 – 15.9 25.5 22.9 – 28.1
Carbamazepine (CARB3) µg/mL § § §
Carbamazepine (CARB4) µg/mL 2.85 2.08 – 3.62 8.29 6.85 – 9.73 13.4 11.3 – 15.4
Digoxin ng/mL 0.838 0.541 – 1.14 2.12 1.71 – 2.52 3.61 3.09 – 4.14
Ferritin ng/mL 71.2 59.3 – 83.2 160 123 – 196 350 259 – 441
Gentamicin (QMS) µg/mL 2.31 1.52 – 3.10 4.81 3.81 – 5.82 7.78 6.50 – 9.05
Iron µg/dL 103 95.9 – 109 75.7 69.1 – 82.3 79.1 72.5 – 85.8
Iron (TIBC) µg/dL 289 254 – 323 249 229 – 269 257 234 – 280
Lithium mg/dL 0.456 0.370 – 0.542 1.15 1.05 – 1.24 1.73 1.62 – 1.83
Phenobarbital µg/mL 10.3 8.31 – 12.3 25.4 21.8 – 29.0 50.2 43.9 – 56.4

Page 10 English • 2019-10 • 1536-00

7
Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
ROCHE / HITACHI COBAS C SYSTEMS (continued)
Phenytoin µg/mL 6.37 4.85 – 7.88 13.1 10.5 – 15.6 24.2 20.1 – 28.4
Salicylate mg/dL 4.17 3.57 – 4.78 15.8 14.1 – 17.5 38.7 34.8 – 42.5
Theophylline µg/mL 4.50 3.70 – 5.30 13.9 11.9 – 15.8 28.2 24.6 – 31.8
Tobramycin µg/mL 1.13 0.867 – 1.40 3.26 2.82 – 3.70 8.33 7.61 – 9.05
Valproic Acid µg/mL 34.4 25.6 – 43.1 73.3 57.8 – 88.7 104 83.2 – 125
Vancomycin (VANC2) µg/mL § § §
Vancomycin (VANC3) µg/mL 6.60 5.94 – 7.26 17.4 16.0 – 18.9 32.0 29.5 – 34.5
ROCHE COBAS INTEGRA
Acetaminophen (ACET2) µg/mL 8.70 5.52 – 11.9 30.5 22.9 – 38.2 96.9 74.5 – 119
Carbamazepine µg/mL 2.75 2.38 – 3.12 8.34 7.12 – 9.57 13.4 11.4 – 15.4
Digoxin ng/mL § § §
Gentamicin µg/mL 2.17 1.74 – 2.59 4.35 3.48 – 5.21 6.54 5.22 – 7.85
Lithium mEq/L 0.501 0.297 – 0.705 1.36 1.15 – 1.56 2.16 1.93 – 2.38
Phenobarbital µg/mL 10.1 8.88 – 11.3 23.5 21.0 – 26.0 46.2 41.6 – 50.8
Phenytoin µg/mL 6.30 5.58 – 7.02 12.5 10.7 – 14.3 23.4 19.7 – 27.0
Salicylate mg/dL § § §
Theophylline µg/mL 4.67 3.91 – 5.43 14.2 12.7 – 15.8 27.1 24.5 – 29.8
Tobramycin µg/mL § § §
Valproic Acid µg/mL 33.4 29.4 – 37.3 73.5 66.3 – 80.7 105 94.9 – 114
Vancomycin µg/mL 8.17 5.95 – 10.4 20.1 16.6 – 23.7 37.6 32.2 – 43.0
ROCHE ELECSYS / E170 / COBAS e SYSTEMS
ACTH (5) pg/mL § § §
AFP ng/mL 18.9 14.3 – 23.5 102 81.3 – 123 225 181 – 270
Calcitonin pg/mL 34.8 22.8 – 46.9 <1.00 <1.00
CEA ng/mL 2.14 1.58 – 2.70 15.8 12.7 – 19.0 31.6 25.4 – 37.8
Cortisol µg/dL 3.48 2.40 – 4.56 15.8 12.3 – 19.3 27.6 21.8 – 33.5
Cortisol (II) µg/dL 3.49 2.59 – 4.39 15.7 13.0 – 18.4 24.9 20.8 – 29.0
C-Peptide ng/mL 1.64 1.22 – 2.06 5.66 4.53 – 6.79 7.85 6.34 – 9.36
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 82.3 61.0 – 104 210 163 – 257 691 547 – 835
Digoxin (Ref. 11820796) restand. ng/mL 0.790 0.583 – 0.996 1.95 1.60 – 2.30 3.50 2.95 – 4.04
Estradiol (III) pg/mL 92.0 67.6 – 116 199 160 – 238 432 362 – 502
Ferritin ng/mL 72.7 57.3 – 88.0 162 128 – 196 350 276 – 424
Folate (cobas e801) ng/mL 3.07 2.10 – 4.03 8.11 5.82 – 10.4 15.2 11.1 – 19.4
Folate (III) (E170/e601/e602) (Ref. 07559992) restand. ng/mL 3.00 2.05 – 3.95 7.55 5.40 – 9.70 13.9 10.0 – 17.7
Folate (III) (e411) (Ref. 07559992) restand. ng/mL § § §
Follicle Stimulating Hormone (FSH) mIU/mL 5.18 4.22 – 6.14 20.7 17.0 – 24.3 41.3 33.9 – 48.7
hCG (+ ß) mIU/mL 5.46 4.36 – 6.55 20.1 16.1 – 24.1 158 125 – 190
hCG (STAT) mIU/mL 4.55 3.55 – 5.55 19.0 15.2 – 22.8 146 116 – 176
Human Growth Hormone (hGH) ng/mL 4.11 2.94 – 5.28 9.23 6.77 – 11.7 15.3 11.4 – 19.2
Immunoglobulin E (IgE) ng/mL 959 805 – 1113 348 292 – 404 224 188 – 261
Insulin µIU/mL 16.8 13.9 – 19.7 60.0 50.7 – 69.2 190 162 – 218
Luteinizing Hormone (LH) mIU/mL 1.90 1.58 – 2.23 23.8 20.3 – 27.3 72.7 63.1 – 82.3
Progesterone ng/mL 0.757 0.566 – 0.948 12.5 10.1 – 15.0 35.6 29.5 – 41.6
Progesterone (III) ng/mL 0.692 0.508 – 0.877 12.3 9.79 – 14.8 34.3 28.0 – 40.6
Prolactin ng/mL 8.18 6.86 – 9.50 23.8 20.0 – 27.5 50.3 42.4 – 58.2
Prostate Specific Antigen, Free (fPSA) (Cobas e411/e601/602) (Ref. Cat.
08828601) ng/mL 0.330 0.251 – 0.409 1.63 1.29 – 1.97 12.4 9.80 – 15.0
Prostate Specific Antigen, Free (fPSA) (Cobas e801) (Ref. Cat. 08828610) ng/mL 0.339 0.258 – 0.420 1.62 1.28 – 1.96 12.3 9.72 – 14.9
Prostate Specific Antigen, Total (e411/e601/602) (tPSA) (Ref. Cat.
08791686) ng/mL 0.890 0.676 – 1.10 3.20 2.43 – 3.97 20.3 15.4 – 25.2
Prostate specific Antigen, Total (tPSA) (Cobas e801) (Ref. Cat. 08791732) ng/mL 0.854 0.649 – 1.06 3.06 2.33 – 3.79 19.4 14.7 – 24.1
PSA (Free) ng/mL 0.328 0.262 – 0.395 1.58 1.33 – 1.82 12.2 10.3 – 14.1
PSA (Total) ng/mL 0.886 0.746 – 1.03 3.17 2.68 – 3.66 20.0 16.9 – 23.1
T3 Total ng/mL 0.910 0.686 – 1.13 2.31 1.82 – 2.81 3.48 2.76 – 4.20
T3 Uptake/T-Uptake TBI 0.921 0.801 – 1.04 0.614 0.462 – 0.766 0.364 <0.200 – 0.542
T3 (Free) pg/mL 2.44 1.94 – 2.94 7.75 6.49 – 9.00 13.7 11.6 – 15.8

Page 11 English • 2019-10 • 1536-00

7
Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
ROCHE ELECSYS / E170 / COBAS e SYSTEMS (continued)
T3 (Free) (III) pg/mL 2.54 2.05 – 3.03 8.31 7.02 – 9.59 14.7 12.5 – 16.9
T4 Total µg/dL 6.14 4.80 – 7.48 10.1 7.89 – 12.3 13.7 10.7 – 16.6
T4 (Free) (II) ng/dL 1.11 0.986 – 1.23 2.56 2.09 – 3.03 4.82 3.76 – 5.87
T4 (Free) (III) ng/dL 1.12 0.999 – 1.24 2.70 2.20 – 3.19 5.10 4.00 – 6.21
Testosterone (II) ng/mL 1.68 1.15 – 2.22 4.14 3.24 – 5.05 8.37 6.84 – 9.89
Thyroid Stimulating Hormone (TSH) µIU/mL 0.546 0.486 – 0.606 6.69 5.95 – 7.44 38.3 34.0 – 42.6
Thyroid Stimulating Hormone (TSH) (Ref. 08429324/08443432) µIU/mL 0.503 0.450 – 0.555 6.11 5.48 – 6.73 33.7 30.2 – 37.1
Vitamin B12 II (E170/e601/e602) pg/mL 395 320 – 470 568 473 – 663 736 622 – 850
Vitamin B12 II (e411) pg/mL 361 287 – 435 536 445 – 628 701 591 – 811
Vitamin B12 (cobas e801) pg/mL 383 309 – 457 562 468 – 656 741 626 – 856
Vitamin B12 (E170/e601/e602) pg/mL 371 296 – 445 547 453 – 640 720 607 – 834
Vitamin B12 (e411) pg/mL § § §
ROCHE HITACHI / MODULAR
Carbamazepine µg/mL § § §
Digoxin ng/mL § § §
Gentamicin µg/mL § § §
Iron µg/dL § § §
Phenobarbital µg/mL 10.3 7.45 – 13.1 25.4 21.2 – 29.6 50.2 43.7 – 56.6
Phenytoin µg/mL 6.37 4.86 – 7.87 13.1 10.9 – 15.3 24.2 20.8 – 27.6
Theophylline µg/mL § § §
Tobramycin µg/mL § § §
Valproic Acid µg/mL § § §
SIEMENS ADVIA CENTAUR CP
AFP ng/mL 18.2 12.9 – 23.5 95.0 62.3 – 128 208 135 – 282
Carbamazepine (CARB) µg/mL 2.87 1.86 – 3.89 8.33 5.76 – 10.9 12.5 8.71 – 16.2
CEA ng/mL 1.79 1.02 – 2.56 16.7 12.5 – 20.9 37.9 30.1 – 45.7
Cortisol (COR) µg/dL 3.21 2.24 – 4.18 18.5 13.3 – 23.7 28.0 20.2 – 35.8
C-Peptide (CpS) ng/mL 1.83 1.29 – 2.38 4.66 3.45 – 5.87 6.92 5.18 – 8.66
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEAS) µg/dL 59.0 42.6 – 75.4 152 112 – 192 480 356 – 604
Digoxin (DIG) ng/mL 0.797 0.585 – 1.01 2.12 1.70 – 2.53 3.68 3.07 – 4.29
Estradiol (eE2) pg/mL 86.8 54.2 – 119 285 208 – 363 787 595 – 979
Ferritin (FER) ng/mL 54.3 35.1 – 73.4 145 97.7 – 192 328 224 – 432
Ferritin (FER) (reagent lots 310 & higher) (2) ng/mL 52.0 39.0 – 65.0 139 104 – 174 314 236 – 393
fOLATE (FOL) (IM) DTT/ Releasing Agent lots expiring May 28, 2021 or
later. (2) ng/mL 2.89 1.97 – 3.80 7.06 5.03 – 9.08 13.2 9.47 – 16.8
Folate (FOL) ng/mL 3.28 2.24 – 4.31 7.65 5.45 – 9.84 12.0 8.61 – 15.3
Follicle Stimulating Hormone (FSH) (2) mIU/mL 5.94 4.45 – 7.42 29.3 22.0 – 36.6 59.8 44.8 – 74.7
Gentamicin (GENT) µg/mL 1.99 1.36 – 2.63 4.37 3.02 – 5.72 7.79 5.23 – 10.3
hCG (ThCG) mIU/mL 8.20 5.84 – 10.6 22.7 18.1 – 27.2 168 141 – 194
Immunoglobulin E (IgE) (tIgE) IU/mL 399 280 – 518 137 93.5 – 181 81.9 52.4 – 111
Insulin (IRI) µIU/mL 16.8 12.4 – 21.2 58.6 46.1 – 71.1 182 145 – 219
Luteinizing Hormone (LH) mIU/mL 1.36 0.920 – 1.80 21.5 16.9 – 26.2 64.2 50.5 – 77.8
Phenobarbital (PHNB) µg/mL 11.5 8.43 – 14.5 26.4 17.6 – 35.3 54.8 34.9 – 74.6
Phenytoin (PHTN) µg/mL 7.17 5.20 – 9.13 14.6 11.0 – 18.3 30.2 22.9 – 37.4
Progesterone (PRGE) ng/mL 0.970 0.357 – 1.58 10.6 7.88 – 13.3 30.4 24.5 – 36.2
Prolactin (PRL) ng/mL 5.59 4.44 – 6.73 14.4 10.5 – 18.3 32.0 22.7 – 41.3
PSA (Total) (PSA) ng/mL 0.756 0.563 – 0.949 2.65 1.98 – 3.31 16.6 12.5 – 20.7
PSA, Complexed (cPSA) ng/mL 0.418 0.296 – 0.539 1.00 0.753 – 1.25 4.43 3.43 – 5.42
T3 (Free) (FT3) pg/mL 2.54 2.09 – 2.99 7.14 6.24 – 8.03 11.3 10.1 – 12.5
T3 (Total) (T3) ng/mL 0.799 0.624 – 0.974 2.36 1.85 – 2.87 3.83 3.00 – 4.66
T3 Uptake/T Uptake (TUp) T Uptake Unit 1.20 0.994 – 1.41 1.57 1.30 – 1.84 1.87 1.55 – 2.19
T4 (Free) (FT4) ng/dL 0.980 0.748 – 1.21 2.12 1.65 – 2.59 3.65 2.87 – 4.43
T4 (Total) (T4) µg/dL 6.22 4.59 – 7.86 12.1 9.30 – 14.8 17.6 13.7 – 21.4
Testosterone (TSTO) ng/dL 120 82.0 – 158 323 242 – 404 699 539 – 860
Testosterone II (TSTII) ng/dL 153 108 – 198 364 274 – 453 734 566 – 902

Page 12 English • 2019-10 • 1536-00

7
Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
SIEMENS ADVIA CENTAUR CP (continued)
Theophylline (THEO2) µg/mL 4.45 2.62 – 6.27 13.4 9.78 – 17.0 25.6 19.3 – 31.9
Thyroid Stimulating Hormone (TSH) µIU/mL 0.510 0.344 – 0.677 7.15 4.36 – 9.94 37.0 22.4 – 51.6
Thyroid Stimulating Hormone (TSH) (TSH3-UL) µIU/mL 0.382 0.298 – 0.466 5.22 4.32 – 6.11 29.6 24.6 – 34.6
Valproic Acid (VALP) µg/mL 35.8 28.8 – 42.8 77.7 62.3 – 93.0 111 89.0 – 133
Vancomycin (VANC) µg/mL 5.47 3.78 – 7.16 13.4 10.1 – 16.7 24.4 18.9 – 29.9
Vitamin B12 (VB12) pg/mL 324 212 – 436 498 362 – 633 680 509 – 850
SIEMENS ADVIA CENTAUR SYSTEMS
AFP ng/mL 20.3 15.8 – 24.8 103 83.2 – 123 227 184 – 270
Carbamazepine (CARB) µg/mL 2.62 1.63 – 3.60 7.96 5.49 – 10.4 12.4 8.66 – 16.1
CEA (2) ng/mL 1.70 1.20 – 2.20 16.0 12.5 – 19.5 34.6 26.0 – 43.1
Cortisol (COR) µg/dL 3.04 2.12 – 3.96 17.8 12.8 – 22.7 28.4 20.5 – 36.2
C-Peptide (CpS) ng/mL 1.11 0.760 – 1.47 4.32 3.26 – 5.38 6.28 4.79 – 7.77
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEAS) µg/dL 61.5 38.6 – 84.5 153 108 – 199 448 330 – 566
Digoxin (DIG) ng/mL 0.886 0.626 – 1.15 2.15 1.71 – 2.59 3.63 3.02 – 4.24
Estradiol (eE2) pg/mL 87.7 52.8 – 123 256 186 – 326 708 542 – 873
Ferritin (FER) ng/mL 55.0 42.8 – 67.2 149 114 – 184 361 275 – 448
Ferritin (FER) (reagent lots 310 & higher) (2) ng/mL 49.9 37.5 – 62.4 135 101 – 169 316 237 – 394
Folate (FOL) (2) ng/mL 2.32 1.49 – 3.14 5.77 4.03 – 7.50 10.9 7.77 – 14.0
Folate (FOL) (IM) DTT/ Releasing Agent lots expiring May 28, 2021 or
later. (2) ng/mL 2.35 1.51 – 3.18 6.13 4.28 – 7.96 11.0 7.83 – 14.2
Follicle Stimulating Hormone (FSH) (2) mIU/mL 5.60 4.20 – 6.99 29.1 21.9 – 36.4 54.1 40.6 – 67.6
Gentamicin (GENT) µg/mL 1.93 1.44 – 2.42 5.41 4.04 – 6.77 7.97 5.95 – 9.99
hCG (ThCG) mIU/mL 8.06 5.34 – 10.8 23.6 18.3 – 28.9 160 132 – 188
Immunoglobulin E (IgE) (tIgE) IU/mL 415 336 – 494 145 116 – 174 86.8 70.0 – 104
Insulin (IRI) µIU/mL 17.5 12.6 – 22.3 58.9 44.5 – 73.3 191 146 – 236
Luteinizing Hormone (LH) mIU/mL 1.19 0.908 – 1.46 19.9 16.0 – 23.8 62.8 50.4 – 75.1
Phenobarbital (PHNB) µg/mL 11.9 8.75 – 15.1 27.8 20.4 – 35.2 53.6 39.3 – 67.8
Phenytoin (PHTN) µg/mL 7.29 5.34 – 9.23 14.5 10.8 – 18.1 29.9 22.6 – 37.2
Progesterone (PRGE) ng/mL 0.808 0.514 – 1.10 9.94 6.93 – 12.9 27.0 19.5 – 34.5
Prolactin (PRL) ng/mL 5.39 4.41 – 6.37 14.7 11.9 – 17.6 32.4 25.9 – 38.9
PSA (Total) (PSA) ng/mL 0.732 0.599 – 0.865 2.68 2.20 – 3.15 18.4 15.0 – 21.8
PSA, Complexed (cPSA) ng/mL 0.441 0.345 – 0.536 1.04 0.828 – 1.25 4.63 3.73 – 5.53
T3 (Free) (FT3) pg/mL 2.44 2.09 – 2.79 7.17 6.26 – 8.09 11.3 9.92 – 12.7
T3 (Total) (T3) ng/mL 0.727 0.476 – 0.978 2.19 1.71 – 2.67 3.46 2.78 – 4.13
T3 Uptake/T Uptake (TUp) (Unit) T Uptake Unit 1.16 0.943 – 1.37 1.50 1.24 – 1.76 1.70 1.41 – 2.00
T4 (Free) (FT4) ng/dL 0.862 0.646 – 1.08 1.88 1.45 – 2.31 3.32 2.59 – 4.05
T4 (Total) (T4) µg/dL 5.93 4.47 – 7.38 10.9 8.47 – 13.4 16.4 12.9 – 19.9
Testosterone (TSTII) ng/dL 186 121 – 251 386 262 – 509 769 533 – 1005
Testosterone (TSTO) ng/dL § § §
Theophylline (THEO2) µg/mL 4.32 2.46 – 6.18 13.7 9.82 – 17.6 24.9 18.4 – 31.3
Thyroid Stimulating Hormone (TSH) µIU/mL 0.524 0.357 – 0.691 7.38 4.57 – 10.2 39.5 24.3 – 54.6
Thyroid Stimulating Hormone (TSH) (TSH3-UL) µIU/mL 0.413 0.276 – 0.550 5.33 3.31 – 7.35 29.6 18.2 – 41.0
Valproic Acid (VALP) µg/mL 34.6 27.9 – 41.4 75.4 62.3 – 88.4 105 87.3 – 123
Vancomycin (VANC) µg/mL 5.42 3.72 – 7.13 14.6 11.0 – 18.2 25.6 19.7 – 31.4
Vitamin B12 (VB12) pg/mL 343 237 – 449 564 415 – 713 751 561 – 940
SIEMENS ADVIA CHEMISTRY SYSTEMS
Acetaminophen (ACET) mg/dL 0.984 0.686 – 1.28 3.22 2.66 – 3.78 10.5 9.06 – 11.9
Carbamazepine (CARB_2) µg/mL 3.08 2.20 – 3.96 9.06 7.22 – 10.9 13.4 10.8 – 15.9
Digoxin (DIG) ng/mL 0.661 0.268 – 1.05 1.83 1.45 – 2.20 3.26 2.90 – 3.62
Ferritin (FRT) ng/mL 53.7 37.9 – 69.4 114 87.8 – 140 233 185 – 280
Gentamicin (GENT_2) µg/mL 2.29 1.64 – 2.93 4.51 3.56 – 5.46 7.01 5.73 – 8.30
Immunoglobulin A (IgA) (IGA_2) mg/dL 182 167 – 197 159 147 – 171 162 150 – 175
Immunoglobulin G (IgG) (IGG_2) mg/dL 760 704 – 817 692 652 – 732 694 654 – 735
Immunoglobulin M (IgM) (IGM_2) mg/dL 53.7 48.7 – 58.6 54.1 49.2 – 59.1 62.5 57.7 – 67.4
Iron (IRON_2) µg/dL 101 97.3 – 105 71.7 67.0 – 76.4 75.3 70.7 – 79.9

Page 13 English • 2019-10 • 1536-00

7
Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
SIEMENS ADVIA CHEMISTRY SYSTEMS (continued)
Lithium (LITH) mEq/L 0.509 0.403 – 0.615 1.26 1.09 – 1.43 1.95 1.71 – 2.19
Phenobarbital (PHNB_2) µg/mL 10.0 7.83 – 12.2 23.7 17.3 – 30.1 48.0 33.7 – 62.3
Phenytoin (PHNY_2) µg/mL 6.26 4.76 – 7.76 13.2 9.79 – 16.6 25.4 18.8 – 32.0
Salicylate (SAL) mg/dL 3.83 1.67 – 5.98 17.5 14.1 – 20.9 50.3 43.9 – 56.8
Theophylline (THEO_2) µg/mL 4.67 2.66 – 6.69 14.7 9.39 – 20.0 29.3 18.4 – 40.1
Tobramycin (TOB_2) µg/mL 0.920 0.628 – 1.21 3.09 2.59 – 3.59 7.71 6.87 – 8.55
Valproic Acid (VPA_2) µg/mL 35.3 25.6 – 45.0 74.5 57.2 – 91.8 103 79.9 – 127
Vancomycin (VANC_2) µg/mL 6.95 4.66 – 9.24 16.5 12.9 – 20.1 28.6 23.3 – 33.9
SIEMENS BN SERIES NEPHELOMETERS
Immunoglobulin A (IgA) mg/dL 185 149 – 221 153 124 – 181 154 125 – 182
Immunoglobulin E (IgE) IU/mL 355 247 – 463 116 82.3 – 150 75.0 53.9 – 96.0
Immunoglobulin G (IgG) mg/dL 820 663 – 977 768 623 – 913 765 621 – 909
Immunoglobulin M (IgM) mg/dL 64.6 54.2 – 75.0 61.9 51.9 – 71.9 70.7 59.3 – 82.1
SIEMENS DIMENSION SERIES
Acetaminophen (ACTM) µg/mL 12.4 8.76 – 16.1 41.6 36.7 – 46.5 124 115 – 132
Carbamazepine (CRBM) µg/mL 2.53 1.96 – 3.10 7.90 6.59 – 9.21 12.4 10.5 – 14.3
Digoxin (DGNA) ng/mL 0.775 0.559 – 0.991 1.97 1.65 – 2.29 3.37 2.93 – 3.81
Ferritin (FERR) ng/mL 69.7 52.0 – 87.4 156 123 – 189 343 277 – 409
Folate (FOLA) (EXL LOCI MODULE) (RF644) ng/mL 2.63 1.59 – 3.67 6.23 3.97 – 8.48 11.4 7.43 – 15.5
Gentamicin (GENT) µg/mL 1.95 1.48 – 2.42 4.33 3.63 – 5.04 6.97 6.00 – 7.93
hCG mIU/mL 8.72 6.28 – 11.2 29.4 23.9 – 35.0 215 181 – 248
Immunoglobulin A (IgA) mg/dL § § §
Immunoglobulin G (IgG) mg/dL § § §
Immunoglobulin M (IgM) mg/dL § § §
Iron µg/dL 99.8 93.3 – 106 73.0 68.9 – 77.0 75.3 71.1 – 79.6
Iron (TIBC) µg/dL 285 255 – 315 252 222 – 281 259 229 – 289
Lithium (LI) mmol/L 0.415 0.257 – 0.573 1.17 0.971 – 1.37 1.82 1.59 – 2.05
Phenobarbital (PHNO) µg/mL 11.4 7.72 – 15.1 24.7 19.2 – 30.1 50.1 41.0 – 59.1
Phenytoin (PTN) µg/mL 6.36 4.57 – 8.14 13.7 11.0 – 16.5 27.1 22.7 – 31.5
PSA (Free) (FPSA) ng/mL 0.299 0.155 – 0.443 1.67 1.31 – 2.02 13.2 10.8 – 15.5
PSA (Total) (TPSA) ng/mL 0.815 0.613 – 1.02 2.95 2.39 – 3.51 19.0 15.8 – 22.3
Salicylate (SAL) mg/dL 5.00 4.11 – 5.89 16.8 15.4 – 18.3 44.3 41.4 – 47.1
T3 (Free) (FT3) pg/mL 2.07 1.66 – 2.48 8.38 7.57 – 9.19 15.5 14.2 – 16.8
T3 Uptake/T Uptake (%, TU) % Uptake 35.7 30.2 – 41.1 41.2 35.0 – 47.4 45.0 38.3 – 51.7
T4 (Free) (EXL LOCI Module) ng/dL 1.02 0.797 – 1.25 2.42 1.91 – 2.92 5.87 4.68 – 7.07
T4 (Free) (Heterogeneous Module) ng/dL
T4 (Total) (T4) µg/dL 5.92 4.28 – 7.55 10.7 8.59 – 12.7 15.5 13.0 – 18.0
Theophylline (THEO) µg/mL 4.44 3.54 – 5.33 14.3 11.7 – 16.9 29.4 24.2 – 34.6
Thyroid Stimulating Hormone (TSH) µIU/mL
Thyroid Stimulating Hormone (TSH) (EXL LOCI Module) (TSHL) µIU/mL 0.458 0.385 – 0.531 6.01 4.31 – 7.71 37.8 25.3 – 50.4
Tobramycin (TOBR) µg/mL 0.667 0.304 – 1.03 2.57 2.01 – 3.13 7.45 6.51 – 8.39
Valproic Acid (VALP) µg/mL 32.3 26.7 – 37.9 72.5 60.2 – 84.7 99.7 82.6 – 117
Vancomycin (VANC) µg/mL 6.75 5.04 – 8.46 17.7 14.4 – 20.9 32.2 26.8 – 37.5
Vitamin B12 (VB12) (EXL LOCI MODULE) (RF642) pg/mL 370 266 – 474 546 400 – 692 694 513 – 875
SIEMENS DIMENSION VISTA SYSTEMS
Acetaminophen (ACTM) µg/mL 13.9 9.71 – 18.0 43.3 37.4 – 49.1 129 118 – 140
AFP ng/mL 17.1 14.4 – 19.8 90.4 80.7 – 100 199 179 – 220
Amikacin µg/mL 5.39 3.78 – 7.01 15.9 10.7 – 21.2 27.8 18.3 – 37.2
Caffeine µg/mL 2.10 1.28 – 2.91 6.93 4.71 – 9.14 14.9 10.4 – 19.4
Carbamazepine (CRBM) µg/mL 2.77 2.26 – 3.28 8.13 6.96 – 9.30 12.9 11.1 – 14.6
CEA ng/mL 1.60 1.24 – 1.96 15.9 13.9 – 17.9 36.1 31.5 – 40.6
Digoxin (DGXN) ng/mL 0.832 0.735 – 0.928 2.01 1.84 – 2.18 3.53 3.27 – 3.79
Estradiol pg/mL 87.0 66.2 – 108 233 201 – 266 524 473 – 574
Ferritin (FERR) ng/mL 51.2 41.5 – 60.8 127 105 – 149 284 235 – 333
Folate (FOL) ng/mL 2.32 1.51 – 3.12 5.67 3.97 – 7.36 10.3 7.33 – 13.2

Page 14 English • 2019-10 • 1536-00

7
Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
SIEMENS DIMENSION VISTA SYSTEMS (continued)
Follicle Stimulating Hormone (FSH) mIU/mL 5.18 4.55 – 5.80 17.5 15.8 – 19.1 35.8 32.7 – 39.0
Gentamicin (GENT) µg/mL 2.11 1.65 – 2.58 4.64 3.90 – 5.38 7.47 6.42 – 8.51
hCG (Beta, BHCG) mIU/mL 8.22 7.37 – 9.06 28.5 26.0 – 31.0 190 174 – 205
Immunoglobulin A (IgA) mg/dL 190 170 – 210 158 139 – 177 159 140 – 178
Immunoglobulin E (IgE) IU/mL 369 271 – 467 123 91.6 – 154 76.1 57.7 – 94.4
Immunoglobulin G (IgG) mg/dL 831 739 – 924 745 650 – 840 747 652 – 842
Immunoglobulin M (IgM) mg/dL 62.2 51.2 – 73.1 59.3 48.3 – 70.3 67.3 56.5 – 78.2
Iron µg/dL 101 93.0 – 109 73.8 66.4 – 81.3 76.6 69.1 – 84.0
Iron (TIBC) µg/dL 289 264 – 313 249 215 – 284 252 218 – 286
Lidocaine (LIDO) µg/mL 1.66 1.18 – 2.14 4.05 3.40 – 4.70 6.80 5.93 – 7.67
Lithium (LITH) mmol/L 0.494 0.373 – 0.615 1.22 1.05 – 1.39 1.88 1.66 – 2.10
Luteinizing Hormone (LH) mIU/mL 1.49 1.03 – 1.94 24.8 21.8 – 27.9 82.6 73.4 – 91.7
N-Acetyl Procainamide (NAPA) µg/mL 1.73 1.21 – 2.24 4.74 3.44 – 6.04 8.80 6.36 – 11.2
Phenobarbital (PHNO) µg/mL 11.1 7.93 – 14.3 25.3 20.9 – 29.7 47.8 41.5 – 54.0
Phenytoin (PTN) µg/mL 6.84 5.35 – 8.33 13.5 11.2 – 15.8 26.1 22.3 – 30.0
Procainamide (PROC) µg/mL 2.22 1.55 – 2.89 9.61 7.76 – 11.5 15.0 12.3 – 17.7
Progesterone (PROG) ng/mL 0.969 0.544 – 1.39 10.8 7.62 – 13.9 29.3 21.0 – 37.7
Prolactin (PRL) ng/mL 5.55 4.80 – 6.30 18.2 16.1 – 20.2 40.8 36.4 – 45.1
PSA (Free) (FPSA) ng/mL 0.284 0.209 – 0.359 1.54 1.30 – 1.77 12.2 10.3 – 14.1
PSA (Total) (TPSA) ng/mL 0.777 0.710 – 0.844 2.70 2.30 – 3.09 18.0 15.0 – 21.0
Salicylate (SAL) mg/dL 5.14 4.39 – 5.90 16.7 15.3 – 18.1 45.2 42.2 – 48.2
T3 (Free) (FT3) pg/mL 1.90 1.48 – 2.32 7.94 7.18 – 8.70 14.8 13.6 – 15.9
T3 Uptake/T Uptake (%, TU) % Uptake 34.1 28.1 – 40.0 41.2 33.9 – 48.4 45.2 37.2 – 53.1
T4 (Free) (FT4) ng/dL 0.989 0.811 – 1.17 2.25 1.87 – 2.62 5.45 4.58 – 6.31
T4 (Total) (T4) µg/dL 7.35 5.20 – 9.51 12.6 9.95 – 15.3 17.9 14.6 – 21.1
Theophylline (THEO) µg/mL 4.53 3.58 – 5.48 14.1 11.6 – 16.6 26.6 22.1 – 31.1
Thyroid Stimulating Hormone (TSH) µIU/mL 0.414 0.299 – 0.528 5.64 4.64 – 6.64 35.7 29.2 – 42.3
Tobramycin (TOBR) µg/mL 0.775 0.446 – 1.10 3.07 2.46 – 3.68 8.50 7.49 – 9.50
Valproic Acid (VALP) µg/mL 38.0 30.6 – 45.4 79.0 65.9 – 92.0 106 88.7 – 122
Vancomycin (VANC) µg/mL 7.15 5.43 – 8.87 17.8 14.7 – 20.8 30.9 26.2 – 35.6
Vitamin B12 (VB12) pg/mL 352 266 – 439 526 434 – 617 681 577 – 785
SIEMENS IMMULITE / IMMULITE 1000
AFP ng/mL 17.8 11.7 – 23.8 96.5 62.5 – 131 216 146 – 286
Androstenedione ng/mL 1.06 0.616 – 1.50 2.79 1.34 – 4.24 5.92 3.39 – 8.45
Carcinoembryonic Antigen (Rgt. Lot 407 and above) (2) ng/mL 1.89 1.50 – 2.28 20.5 16.8 – 24.2 43.6 34.5 – 52.8
CEA ng/mL 2.43 1.58 – 3.27 21.9 16.5 – 27.4 49.7 37.7 – 61.6
Cortisol µg/dL 4.27 2.91 – 5.63 19.9 14.5 – 25.4 29.3 21.4 – 37.2
Cortisol (Rgt. Lots 550 and above) (2) µg/dL 3.15 2.19 – 4.11 16.3 11.4 – 21.2 24.6 17.2 – 32.0
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) µg/dL 52.6 34.4 – 70.8 144 102 – 187 465 335 – 596
Estradiol pg/mL 94.8 65.8 – 124 274 196 – 353 573 413 – 732
Estriol (Free) (UE3) ng/mL 1.04 0.321 – 1.76 4.74 3.03 – 6.44 10.8 7.40 – >11.2
Ferritin ng/mL 55.5 40.9 – 70.2 121 88.1 – 153 257 187 – 327
Follicle Stimulating Hormone (FSH) mIU/mL 5.60 4.25 – 6.95 23.6 18.3 – 28.8 45.5 35.3 – 55.8
Gastrin (2) pg/mL 121 82.9 – 159 578 363 – 793 1233 982 – 1484
hCG mIU/mL 10.8 5.99 – 15.7 33.7 21.4 – 46.0 238 159 – 317
hCG (Turbo) (2) mIU/mL 10.8 8.09 – 13.5 36.8 28.0 – 45.6 249 197 – 301
Human Growth Hormone (hGH) (LKGRH) ng/mL 3.60 1.88 – 5.31 8.28 4.94 – 11.6 14.2 8.81 – 19.7
Immunoglobulin E (IgE) (Rgt. Lots 401+) IU/mL 377 258 – 496 134 93.4 – 175 85.7 60.4 – 111
Luteinizing Hormone (LH) mIU/mL 1.42 1.08 – 1.76 21.4 15.6 – 27.2 61.8 44.8 – 78.8
Progesterone (LKPW1) ng/mL 0.769 0.479 – 1.06 10.1 6.81 – 13.3 25.4 17.4 – 33.3
Prolactin ng/mL 7.60 5.55 – 9.65 20.2 15.2 – 25.3 43.5 33.8 – 53.3
PSA (Free) (2) ng/mL 0.245 0.188 – 0.302 1.38 1.14 – 1.62 9.92 7.94 – 11.9
PSA (Total) ng/mL 0.798 0.263 – 1.33 3.30 1.99 – 4.61 20.7 13.7 – 27.7
PSA (Total) (Gen. 3) ng/mL 0.678 0.143 – 1.21 2.27 1.30 – 3.25 16.0 10.5 – >20.0
T3 (Free) pg/mL 2.77 1.65 – 3.88 6.15 4.44 – 7.87 9.50 7.19 – 11.8

Page 15 English • 2019-10 • 1536-00

7
Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
SIEMENS IMMULITE / IMMULITE 1000 (continued)
T3 (Total) ng/dL 52.1 <40.0 – 73.3 186 139 – 233 344 265 – 422
T3 Uptake/T Uptake % Uptake 29.8 24.3 – 35.4 36.4 29.4 – 43.4 45.1 35.1 – 55.0
T4 (Free) ng/dL 1.26 0.970 – 1.55 2.77 2.18 – 3.35 5.48 4.36 – >6.00
T4 (Total) µg/dL 5.66 4.00 – 7.32 10.4 7.60 – 13.2 14.5 10.7 – 18.3
Testosterone ng/dL 115 58.6 – 171 540 317 – 763 1343 809 – >1600
Thyroglobulin (Tg) ng/mL
Thyroid Stimulating Hormone (TSH) (Gen. 3) µIU/mL 0.465 0.353 – 0.577 5.90 4.28 – 7.52 31.6 22.6 – 40.7
Thyroid Stimulating Hormone (TSH) (Rapid) µIU/mL 0.425 0.313 – 0.537 5.93 4.31 – 7.56 30.7 21.9 – 39.4
Vitamin B12 pg/mL 363 268 – 458 569 408 – 731 757 519 – 996
SIEMENS IMMULITE 2000 / 2000 XPi
ACTH pg/mL 31.9 13.5 – 50.3 225 86.2 – 364 342 130 – 555
AFP ng/mL 16.5 10.9 – 22.0 84.8 54.9 – 115 197 127 – 266
Androstenedione ng/mL 0.894 0.421 – 1.37 2.97 1.63 – 4.31 5.56 2.73 – 8.38
Androstenedione (Rgt. Lots 450 and above) ng/mL 1.20 0.570 – 1.83 3.28 2.17 – 4.39 6.45 4.50 – 8.40
Calcitonin pg/mL 18.5 13.4 – 23.6 <2.00 <2.00
Carbamazepine µg/mL 2.40 1.62 – 3.18 7.11 5.45 – 8.77 11.4 8.94 – 13.9
CEA ng/mL 2.36 1.49 – 3.23 21.7 16.3 – 27.1 45.7 39.4 – 52.0
Cortisol µg/dL 3.70 2.62 – 4.78 18.2 13.9 – 22.5 27.2 20.6 – 33.8
Cortisol (Rgt. Lots 550 and above) (2) µg/dL 2.95 2.08 – 3.82 15.7 12.2 – 19.2 23.3 18.1 – 28.5
C-Peptide ng/mL 1.18 0.861 – 1.50 5.38 4.17 – 6.59 7.59 5.92 – 9.27
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 50.9 32.4 – 69.4 128 90.7 – 165 446 327 – 565
Digoxin ng/mL 0.907 0.597 – 1.22 2.13 1.63 – 2.63 3.39 2.69 – 4.08
Estradiol pg/mL 90.7 60.4 – 121 302 231 – 374 663 521 – 804
Estriol (Free) ng/mL 0.965 0.369 – 1.56 4.25 2.93 – 5.57 8.82 6.41 – 11.2
Ferritin ng/mL 58.1 43.5 – 72.6 129 96.3 – 162 295 220 – 370
Folate ng/mL 3.45 2.31 – 4.58 8.77 5.94 – 11.6 15.2 10.5 – 19.9
Follicle Stimulating Hormone (FSH) mIU/mL 5.71 4.37 – 7.04 24.1 18.6 – 29.7 46.6 35.7 – 57.5
Gastrin (2) pg/mL 130 86.2 – 174 564 354 – 774 1147 883 – 1411
hCG mIU/mL 10.8 5.59 – 16.1 36.5 25.3 – 47.6 220 165 – 275
Human Growth Hormone (hGH) (L2KGRH/L5KGRH) ng/mL 3.97 2.00 – 5.94 8.30 4.61 – 12.0 13.3 7.60 – 18.9
IGF-1/Somatomedin C ng/mL 94.7 71.7 – 118 109 83.3 – 135 94.6 71.7 – 118
Immunoglobulin E (IgE) IU/mL 400 284 – 517 137 95.0 – 178 87.4 61.6 – 113
Luteinizing Hormone (LH) mIU/mL 1.28 0.937 – 1.62 19.0 14.0 – 24.0 56.8 41.7 – 71.8
Phenobarbital µg/mL 10.0 8.34 – 11.7 24.4 20.4 – 28.3 49.1 41.3 – 57.0
Phenytoin µg/mL 7.02 4.53 – 9.51 12.7 8.87 – 16.5 21.8 15.8 – 27.7
Progesterone ng/mL 0.700 0.415 – 0.985 8.86 6.17 – 11.6 23.6 16.5 – 30.7
Prolactin ng/mL 6.59 5.27 – 7.91 17.4 13.8 – 21.0 38.4 30.4 – 46.3
Prostatic Acid Phosphatase (PAP) ng/mL 1.49 1.14 – 1.84 22.6 17.3 – 27.9 49.4 37.8 – 61.0
PSA (Free) ng/mL 0.255 0.151 – 0.359 1.42 1.07 – 1.77 10.2 7.86 – 12.4
PSA (Total) ng/mL 0.747 0.298 – 1.20 2.88 1.70 – 4.05 18.4 11.5 – 25.2
T3 (Free) pg/mL 2.54 1.83 – 3.24 6.51 4.99 – 8.03 9.69 7.51 – 11.9
T3 (Total) ng/dL 59.2 38.1 – 80.3 202 161 – 243 336 268 – 404
T3 Uptake/T Uptake (2) % Uptake 30.6 25.5 – 35.7 33.7 27.8 – 39.6 39.2 31.0 – 47.4
T4 (Free) (L2KFT4/L5KFT4) ng/dL 1.21 0.994 – 1.42 2.63 2.19 – 3.06 4.92 4.13 – 5.71
T4 (Total) µg/dL 5.41 4.03 – 6.78 9.82 7.49 – 12.1 13.7 10.6 – 16.9
Testosterone ng/dL 127 76.3 – 178 475 306 – 643 1077 705 – 1450
Theophylline µg/mL 4.29 2.57 – 6.02 13.9 9.80 – 17.9 27.9 20.4 – 35.4
Thyroglobulin (Tg) ng/mL 2.39 1.29 – 3.49 2.58 1.48 – 3.68 0.200 <0.200 – 1.22
Thyroid Stimulating Hormone (TSH) (Gen. 3) µIU/mL 0.452 0.351 – 0.552 5.85 4.33 – 7.37 30.2 22.0 – 38.5
Thyroid Stimulating Hormone (TSH) (Rapid) µIU/mL 0.498 0.398 – 0.599 6.04 4.47 – 7.61 29.2 21.3 – 37.2
Thyroxine Binding Globulin (TBG) µg/mL 16.4 12.1 – 20.6 14.6 10.7 – 18.6 14.3 10.5 – 18.2
Valproic Acid µg/mL 30.1 23.1 – 37.1 70.1 56.9 – 83.4 107 87.6 – 126
Vitamin B12 pg/mL 325 224 – 427 558 393 – 723 776 534 – >1000
SIEMENS STRATUS CS
hCG mIU/mL § § §

Page 16 English • 2019-10 • 1536-00

7
Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40381 Level 2 - 40382 Level 3 - 40383
Units Mean Range Mean Range Mean Range
TOSOH AIA SYSTEMS (2)
25-Hydroxy Vitamin D (AIA-PACK) ng/mL 10.6 7.40 – 13.8 15.1 10.6 – 19.6 24.7 17.3 – 32.1
ACTH (ST AIA-PACK) (5) pg/mL 25.3 17.7 – 32.8 123 86.1 – 160 123 86.4 – 161
AFP (ST AIA-PACK) ng/mL 18.0 12.6 – 23.4 91.7 64.2 – 119 195 137 – 254
CEA (ST AIA-PACK) ng/mL 2.70 1.90 – 3.50 18.8 13.2 – 24.4 40.0 28.0 – 52.0
Cortisol (ST AIA-PACK) µg/dL 3.70 2.60 – 4.80 18.5 13.0 – 24.1 28.7 20.1 – 37.3
C-Peptide (II, ST AIA-PACK) ng/mL 1.46 1.02 – 1.90 5.55 3.89 – 7.22 8.05 5.64 – 10.5
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (ST AIA-PACK) µg/dL 70.5 49.4 – 91.7 182 127 – 237 557 390 – 724
Estradiol (REF E2-025274) pg/mL 223 156 – 290 560 392 – 728 1149 804 – 1494
Estradiol (REF HSE2-025225) pg/mL 92.2 64.5 – 120 248 173 – 322 529 370 – 687
Ferritin (ST AIA-PACK) ng/mL 44.2 30.9 – 57.5 98.3 68.8 – 128 223 156 – 290
Folate (AIA-PACK) ng/mL 5.50 2.05 – 8.95 12.3 4.87 – 19.7 17.0 11.9 – >20.0
Follicle Stimulating Hormone (FSH) (ST AIA-PACK) mIU/mL 6.60 4.60 – 8.60 18.1 12.7 – 23.5 36.6 25.6 – 47.6
hCG (Total Beta, ST AIA-PACK) mIU/mL 8.80 6.20 – 11.4 29.8 20.9 – 38.7 187 131 – 243
Human Growth Hormone (hGH) (ST AIA-PACK) ng/mL 4.10 2.87 – 5.33 9.97 6.98 – 13.0 16.7 11.7 – 21.7
Immunoglobulin E (IgE) (II, ST AIA-PACK) IU/mL 343 240 – 446 128 89.5 – 166 78.3 54.8 – 102
Insulin (IRI, ST AIA-PACK) µIU/mL 18.3 12.8 – 23.8 63.6 44.5 – 82.7 186 131 – 242
Luteinizing Hormone (LH) (II, ST AIA-PACK) mIU/mL 1.30 0.900 – 1.70 21.3 14.9 – 27.7 70.9 49.6 – 92.2
Progesterone (ST AIA-PACK, PROGII) ng/mL 0.310 0.220 – 0.400 14.0 9.81 – 18.2 38.3 26.8 – >40.0
Progesterone (ST AIA-PACK, PROGIII) (Cal Lot G33CC359) ng/mL 0.650 0.460 – 0.850 16.0 11.2 – 20.7 >40.0
Prolactin ng/mL 1.20 <1.00 – 1.60 5.80 4.10 – 7.50 5.90 4.10 – 7.70
Prostatic Acid Phosphatase (PAP) (ST AIA-PACK) ng/mL 1.20 0.800 – 1.60 21.3 14.9 – 27.7 39.3 27.5 – >40.0
PSA (Total) (ST AIA-PACK) ng/mL 0.830 0.580 – 1.08 2.82 1.97 – 3.67 16.9 11.8 – 22.0
T3 (Free) (ST AIA-PACK) pg/mL 2.65 1.86 – 3.45 11.1 7.78 – 14.4 24.5 17.2 – >25.0
T3 (Total) (ST AIA-PACK) ng/mL 0.740 0.520 – 0.960 1.98 1.39 – 2.57 3.07 2.15 – 3.99
T3 Uptake/T Uptake (ST AIA-PACK) % Uptake 33.6 23.5 – 43.7 42.8 30.0 – 55.6 47.7 33.4 – >60.0
T4 (Free) (ST AIA-PACK) ng/dL 1.10 0.770 – 1.43 2.75 1.93 – 3.58 5.22 3.65 – 6.79
T4 (Total) (ST AIA-PACK) µg/dL 6.00 4.20 – 7.80 9.90 6.90 – 12.9 14.2 9.90 – 18.5
Testosterone (ST AIA-PACK) ng/dL 109 76.5 – 142 473 331 – 615 1220 854 – 1586
Thyroid Stimulating Hormone (TSH) (ST AIA-PACK) µIU/mL 0.390 0.270 – 0.510 5.45 3.82 – 7.09 28.8 20.2 – 37.4
Thyroid Stimulating Hormone (TSH) (TSH3G, AIA-PACK) µIU/mL 0.410 0.290 – 0.530 5.62 3.93 – 7.31 30.4 21.3 – 39.5
Vitamin B12 (AIA-PACK) pg/mL 410 287 – 533 674 472 – 876 887 621 – 1153

FOOTNOTES
(1) All footnotes may not apply to your custom selected data chart.
(2) The assigned values were determined using the reagent and/or instrument manufacturer’s protocol and may not represent ±3SD ranges.
(3) For the conversion factor, refer to the manufacturer’s instruction for use.
(4) Values are not suitable for the following method/instrument: Mindray CL-900i)
(5) No distinct recovery values may be observed between Levels 2 and 3 on some methods.
Data is not available at this time. Please inquire.
§ The data required to establish the means and acceptable ranges for this assay were not obtained due to limited assignment participation. If your facility is
interested in participating in the Value Assignment Program for this assay, please contact your local Bio-Rad office.
Not applicable

Page 17 English • 2019-10 • 1536-00

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