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Dimension® Clinical Chemistry System Method Specifics

FAST FACTS
Precision Guidelines
Total Reduced AutoDilute
Sample Sample Sample
Cat. Assay Reference Recommended Volume Volume Recommended Volume
1 1
Method No. Units Range Interval Specimens (µL) (µL) Manual Diluent (µL) Concentration 5-Test SD
ABS DF79 mAU N/A N/A ABS soln 5 N/A N/A N/A N/A N/A
1
ACP DF11 U/L 0.00 – 25.00 0 – 0.80 S, P 2 x 24 N/A Acidified Enzyme Diluent 5 0.76 0.3
10.5 0.3
1
ACTM DF88 µg/mL 0.0 – 300.0 10.0 – 30.0 S, P 2x4 N/A Acetaminophen Free Serum 2 16.2 1.93
Drug Calibrator II Level 1 75.0 2.35
2
AHDL DF48A mg/dL 10 – 150 < 40 Low HDL S, P 3 N/A Water 2 30 2
> 60 High HDL 50 2

2
ALB DF13 g/dL 0.6 – 8.0 3.4 – 5.0 S, P 5 N/A Water 2 0.69 0.10
3.84 0.12
3 2
ALC DF18 mg/dL 0.0 – 300.0 (S,ppWB) Negative S, ppWB, U 3 N/A Water 2 100 3
(U) - 50.0 300 6
2
ALDL DF131 mg/dL 5 - 300 <100 S, P 3 N/A Water 2 130 2
315 5
ALP DF15A U/L 0 – 1000 50 – 136 S, P 7 N/A Enzyme Diluent 3 150 6
700 15
ALT (GPT) DF43A U/L 0 – 1000 30 – 65 S, P 35 20 Enzyme Diluent 10 50 3
470 7
870 11
AMON 1 DF19 µmol/L 0 – 1000 11 – 32 P 53 N/A Water 2 26 25 5.5
500 17.5
AMY DF17A U/L 0 – 650 (serum) 25 – 115 S, P, U 14 10 Enzyme Diluent 7 50 4
(urine) 59 – 401 U/24 hr 600 10
AST (GOT) DF41A U/L 0 – 1000 15 – 37 S, P 40 20 Enzyme Diluent 20 40 2.5
440 8
830 15
BUN DF21 mg/dL 0 – 150 (S,P) 7 – 18 S, P, U 3 N/A Water 2 2 16 1.1
(U) 7 – 20 g/24 hr 135 9
C3 DF101 mg/dL 10 – 350 90 – 207 S 2 N/A Saline N/A 75 4
200 8
C4 DF102 mg/dL 5.0 – 140.0 17.4 – 52.2 S 3 N/A Saline N/A 15 0.8
40 2
CA DF23A mg/dL 5.0 – 15.0 (S,P) 8.5 – 10.1 S, P, U 5 N/A Water 2 3 7 0.17
(U) 42.0 – 353.0 mg/24 hr 13.5 0.23
CCRP (HM) RF434 mg/L 0.1 - 15.0 <3 S,P 12 N/A Water 2 2 6 0.31
12 0.58
CHOL DF27 mg/dL 50 – 600 < 200 S, P 3 N/A Water 2 2 220 5
400 7
CK DF29A U/L 0 – 800 35 – 232 male S, P 14 N/A Enzyme Diluent 7 150 6
21 - 215 female 700 15

CKMB DF31 U/L 0 – 125 0–6 S, P 20 N/A Enzyme Diluent N/A 10 1.5
50 2.0
CRBM DF87 µg/mL 0.0 – 20.0 4.0 – 12.0 S, P 3 N/A Carbamazepine Free Serum 2 5 0.20
Drug Calibrator II Level 1 10 0.48

CREA DF33A mg/dL 0.0 – 20.0 (S,P) 0.6 – 1.3 S, P, U 20 15 Water 2 (S,P) 10 1 0.1
(U) 0.6 – 2.5 g/24 hr Enzyme Diluent (U) 18.6 0.5

CRP DF37 mg/dL 0.2 – 12.0 < 0.9 S, P 3 N/A Water 2 2 2.0 0.14
8.0 0.28
4
CSA DF89 ng/mL 25 - 500 see IFU WB 5 NA Level 1 Calibrator N/A 180 20.4
330 35.2
Dimension® Clinical Chemistry System Method Specifics
FAST FACTS
Precision Guidelines
Total Reduced AutoDilute
Sample Sample Sample
Cat. Assay Reference Recommended Volume Volume Recommended Volume
1 1
Method No. Units Range Interval Specimens (µL) (µL) Manual Diluent (µL) Concentration 5-Test SD
4
CSAE DF108 ng/mL 350 - 2000 see IFU WB 3 NA Level 0 Calibrator N/A 800 87.5
1400 127.4
2
CTNI (HM) RF421C ng/mL 0.04 – 40.00 0.00 – 0.05 S, P 50 N/A Water 20 2.0 0.20
25 1.50
DBIL DF25A mg/dL 0.00 – 20.00 0.00 – 0.30 S, P 31 13 Water 2 10 0.6 0.06
16.8 0.34
DBI DF125 mg/dL 0.05 - 16.0 0.0 - 0.2 S, P 10 NA Water 2 5 0.6 0.06
16 0.34
DGNA DF35A ng/mL 0.06 – 5.00 0.90 – 2.00 S, P 30 N/A Digoxin Free Serum N/A 0.6 0.06
2.4 0.09
DGTX DF36 ng/mL 2.0 – 80.0 14 – 26 S, P 20 N/A Digitoxin Free Serum N/A 10 1.0
40 4.0
2
ECO2 DF137 mmol/L 5 – 45 21 – 32 S, P 5 N/A Water N/A 25 1.2
50 2
5
FERR (HM) RF440 ng/mL 1 - 1000 3 – 388 S, P 40 N/A Sample Diluent 2 25 1.4
FERR Calibrator Level 1 150 5.1
500 18.2
FPSA (HM) RF452 ng/mL 0.05 - 45.00 < 4.00 S, P 60 N/A N/A 4.00 0.27
10.00 0.7
FT4 (HM) RF410 ng/dL 0.20 – 6.50 0.77 – 1.61 S, P 50 N/A Do Not Dilute N/A 0.70 0.10
3.00 0.25
GENT DF12 µg/mL 0.0 – 12.0 4.0 – 8.0 S, P 3 N/A Gentamicin Free Serum 2 1.5 0.17
Drug Calibrator II Level 0 6.0 0.21
GGT DF45A U/L 0 – 800 5 – 85 S, P 32 15 Enzyme Diluent 16 80 3
400 7
GLU DF39A mg/dL 0 – 500 (S,P) 70 – 110 S, P, U, CSF 3 N/A Water 2 2 78 4.7
(CSF) 40 – 75 264 12.0
(U) <0.5 g/24 hr
GLUC DF40 mg/dL 0 - 500 (S,P) 74 - 106 S, P, U, CSF 3 N/A Water 2 2 78 4.7
(CSF) 40 – 70 264 12.0
(U) <0.5 g/24 hr
HA1C DF105 % Hb 1 – 30 g/dL 4.8 – 6.0 % Whole blood 3 N/A Normal Saline N/A 6% 0.33
HbA1c 0.2 – 2.9 g/dL 9% 0.69

HCG (HM) RF430 mIU/mL 1 - 1000 0 - 6 NPF S, P 40 N/A Sample Diluent 5 26 25 2.5
0 - 2 Males 150 11
500 37
IBCT DF84 µg/dL 0 – 1000 250 – 450 S, P 25 N/A Water 2 12 550 9.5
1000 22.1
IGA1 DF74 mg/dL 10 – 1000 87 – 474 S, P 10 N/A Saline 2 86 7.4
298 10.9
IGG1 DF76 mg/dL 50 – 4500 681 – 1648 S, P 10 N/A Saline 2 383 28.2
1303 70
1
IGM DF81 mg/dL 10 – 450 48 – 312 S, P 10 N/A Saline 2 40 6.9
135 10.1
IRON DF85 µg/dL 5 - 1000 M 65 - 175 S, P 40 25 Water 2 20 50 5.1
F 50-170 1000 22.1

IRN DF49A µg/dL 0 – 1000 35 – 150 S 50 25 Water 2 N/A 50 7.5


1000 30.0
LA DF16 mmol/L 0.3 – 15 (P) 0.4 – 2.0 P, CSF 4 N/A Water 2 2 2.0 0.15
(CSF) 0.6 – 2.2 8.0 0.40
LDH DF53A U/L 0 – 600 100 – 190 S, P 14 N/A Enzyme Diluent 7 170 7
Dimension® Clinical Chemistry System Method Specifics
FAST FACTS
Precision Guidelines
Total Reduced AutoDilute
Sample Sample Sample
Cat. Assay Reference Recommended Volume Volume Recommended Volume
1 1
Method No. Units Range Interval Specimens (µL) (µL) Manual Diluent (µL) Concentration 5-Test SD
306 10
7 5 6
LHCG (HM) RF530 mIU/mL 1 - 1000 0 - 6 NPF S, P 40 N/A Sample Diluent 2 25 2.5
0 - 2 Males 150 11
500 37
1
LI DF132 mmol/L 0.20 – 5.00 0.60 – 1.20 S, P 20 N/A Lithium-Free Serum N/A 0.90 0.06
1.80 0.08
2
LIDO DF113 µg/mL 0.5 - 12.0 1.5 - 5.0 S, P 6 N/A Water 2 3.0 0.17
6.0 0.26
2
LIP DF55A U/L 50 – 1500 114 – 286 S, P 4 N/A Water 2 148 7
802 20
LMMB (HM) 7 RF520 ng/mL 0.5 – 300.0 0.0 – 3.6 S, P 60 N/A Sample Diluent 5 30 0 1.0
10 1.1
300 20
LPBN (HM) 7 RF523 pg/mL 10 - 20,000 (<75 years) 125 P 50 N/A Sample Diluent 5 N/A 150 15
(>75 years) 450 PBNP Calibrator Level 1 450 45
LTNI (HM) 7 RF521 ng/mL 0.04 – 40.00 0.00 – 0.05 S, P 50 N/A Water 2 20 2.0 0.20
25.0 1.50
MALB DF114 mg/L 1.3 - 100 <30 mg/24hr U 17 N/A Water 2 2 12.5 1.9
<20 µg/min L1 MALB Cal 50 2.5
MG 1 DF57 mg/dL 0.0 – 20.0 (S,P) 1.8 – 2.4 S, P, U 2x2 N/A Water 2 N/A 1.0 0.11
(U) 24.0 – 255.0 mg/24 hr 9.0 0.56
MMB (HM) RF420 ng/mL 0.5 – 300.0 0.0 – 3.6 S, P 60 N/A Sample Diluent 5 30 0 1
10 1.1
300 20
MYO (HM) RF422A ng/mL 1 - 1000 10 to 92 S, P 20 N/A Sample Diluent 5 2 170 8.5
450 22.5
NAPA DF111 µg/mL 0.5 - 30.0 10 to 30 S, P 2 N/A Drug free serum N/A 6.6 0.35
Drug II Calibrator Level 1 13.8 0.67

PALB DF80 mg/dL 2.0 – 50.0 18.0 – 35.7 S, P 2 N/A Water 2 N/A 8.8 0.70
Normal Saline 34.9 1.42
PALB Calibrator Level 1

PBNP RF423 pg/mL 10 - 30,000 (<75 years) 125 P 50 N/A Sample Diluent 5 N/A 150 15
(>75 years) 450 PBNP Calibrator Level 1 450 45

PCHE DF51 U/mL 0 – 14 7 – 19 S, P 2 N/A Enzyme Diluent N/A 4.0 0.1


10.1 0.3
2
PHNO DF60 µg/mL 0.0 – 80.0 15.0 – 40.0 S, P 4 N/A Water 2 10 1
Phenobarbital Free Serum 40 2.5
Drug Calibrator Level 1

PHOS DF61 mg/dL 0.0 – 9.0 (S,P) 2.5 – 4.9 S, P, U 3 N/A Water 2 2 2.0 0.15
(U) 0.4 – 1.3 g/24 hr 8.0 0.40
PROC DF110 µg/mL 0.5 - 20.0 4.0 to 12.0 S, P 2 N/A Drug free serum N/A 4.7 0.20
Drug II Calibrator Level 1 9.5 0.29

PTN DF64 µg/mL 0.5 – 40.0 10.0 – 20.0 S, P 4 N/A Phenytoin Free Serum 2 10 1.0
Drug Calibrator I Level 1 20 1.7

RCRP 1 DF34 mg/dL 0.05 – 25.00 < 0.3 S, P 2X8 N/A Water 2 N/A 2.00 0.10
RCRP Calibrator Level 1 12.00 0.40
Dimension® Clinical Chemistry System Method Specifics
FAST FACTS
Precision Guidelines
Total Reduced AutoDilute
Sample Sample Sample
Cat. Assay Reference Recommended Volume Volume Recommended Volume
1 1
Method No. Units Range Interval Specimens (µL) (µL) Manual Diluent (µL) Concentration 5-Test SD
2
SAL DF20 mg/dL 0.0 – 100.0 2.8 – 20.0 S 15 N/A Water 5 20 1.0
100 2.0
T3 (HM) RF414 ng/mL 0.20 - 6.00 0.7 - 1.9 S, P 20 N/A T3 Calibrator Level 1 N/A 1 0.11
4 0.25
2
T4 DF65 µg/dL 0.5 – 24.0 4.7 – 13.3 S, P 16 N/A Water 4 5.1 0.8
13.9 1
4
TACR DF107 ng/mL 1.2 - 30.0 see IFU WB 20 N/A TACR Calibrator Level 1 N/A 6 0.76
12 1.04
2
TBI DF167 mg/dL 0.1 - 25.0 0.2 - 1.0 S, P 10 N/A Water 5 1.1 0.03
18.8 0.56
TBIL DF67A mg/dL 0.00 – 25.00 <1.00 S, P 28 12 Water 2 14 1.1 0.03
18.8 0.56
2
TGL DF69A mg/dL 15 – 1000 <150 S, P 4 N/A Water 2 100 5
400 16
THEO DF71 µg/mL 2.0 – 40.0 10.0 – 20.0 S, P 4 N/A Water 2 2 10 0.6
Theophylline Free Serum 20 1.0

TOBR DF14 µg/mL 0.0 – 12.0 4.0 – 8.0 S, P 3 N/A Drug II Calibrator Level 1 2 1.5 0.17
Tobramycin Free Serum 6.0 0.28

TP DF73 g/dL 2.0 – 12.0 6.4 – 8.2 S, P 15 10 Water 2 8 6.8 0.12

2
TPSA (HM) RF451 ng/mL 0.05 - 100.0 <4 S, P 40 N/A Water 2 4 0.22
50 2.63
TRNF DF103 mg/dL 40 – 750 202 – 364 S, P 2 N/A Saline N/A 140 6
300 12
5
TSH (HM) RF412 µIU/mL 0.01 – 50.00 0.34 – 4.82 S, P 60 N/A Sample Diluent 30 0.97 0.05
3.98 0.16
TU DF75A % 15 – 68 31 – 39 S, P 20 N/A Do Not Dilute N/A 25% 2.5%
48% 2.8%
UCFP DF26 mg/dL 6.0 – 250.0 (CSF)15.0 – 45.0 CSF, U 10 N/A Water 2 5 32 1.2
(U) <149.1 mg/day 142 2.0
URCA DF77 mg/dL 0.0 – 20.0 (S,P) 2.6 – 7.2 S, P, U 17 10 Water 2 5 4.9 0.2
(U) 150.0 – 990.0 mg/24 hr 17.7 0.4
VALP DF78 µg/mL 3.0 – 150.0 50.0 – 100.0 S, P 3 N/A Water 2 2 40 2.3
Drug Calibrator II Level 1 75 2.5
Valproic Acid Free Serum

VANC DF86 µg/mL 0.0 – 50.0 18.0 – 26.0 Peak S, P 2 N/A Drug Calibrator II Level 1 N/A 6 0.42
5.0 - 10.0 Trough Vancomycin Free Serum 25 1.69

1 Two cuvettes S : Serum


2 Type II Laboratory Grade Water Required U : Urine
3 Normal cut-off to be determined by each laboratory. CSF : Cerebrospinal Fluid
4 Instructions for Use (Flex® reagent cartridge insert sheet). ppWB : protein procipitate from Whole Blood
5 Use Sample Diluent (Cat. No. 791092901) WB : Whole Blood
6 HCG uses an addiitonal 10-fold dulution prior to taking the autodilute sample. P : Plasma
7 For use on the Dimension® Expand® System only. M : adult males
8 Mean (if 0 or greater) + 2SD (n=20) NPF : non-pregnant females
If mean is negative 2SD (n=20) used. N/A : Not Applicable
HM : Heterogeneous Immunoassay Module Issued 9/07
Dimension® Clinical Chemistry System SI Method Specifics
FAST FACTS
Precision Guidelines
Total Reduced
Sample Sample AutoDilute
Assay Recommended Volume Volume Recommended Sample
1 1
Method Cat. No. Units Range Reference Interval Specimens (µL) (µL) Manual Diluent Volume (µL) Concentration 5-Test SD
ABS DF79 mAU N/A N/A ABS soln 5 N/A N/A N/A N/A N/A
1
ACP DF11 U/L 0.00 – 25.00 0 – 0.80 S, P 2 x 24 N/A Acidified Enzyme Diluent 5 0.76 0.3
10.5 0.3
ACTM 1 DF88 µmol/L 0.0 – 1985.4 66.2 - 198.5 S, P 2x4 N/A Acetaminophen Free Serum 2 107.2 12.78
Drug Calibrator II Level 1 496.4 15.56
AHDL DF48A mmol/L 0.26 - 3.89 < 1.04 Low HDL S, P 3 N/A Water 2 2 0.78 0.05
> 1.55 High HDL 1.30 0.05

ALB DF13 g/L 6 – 80 34 – 50 S, P 5 N/A Water 2 2 7 1.0


38 1.2
3 2
ALC DF18 mmol/L 0.0 - 65.0 (S,ppWB) Negative S, ppWB, U 3 N/A Water 2 100 3
(U) - 50.0 300 6
2
ALDL DF131 mmol/L 0.13 - 7.8 <2.6 S, P 3 N/A Water 2 3.4 0.05
8.1 0.13
ALP DF15A U/L 0 – 1000 50 – 136 S, P 7 N/A Enzyme Diluent 3 150 6
700 15
ALT (GPT) DF43A U/L 0 – 1000 30 – 65 S, P 35 20 Enzyme Diluent 10 50 3
470 7
870 11
AMON 1 DF19 µmol/L 0 – 1000 11 – 32 P 53 N/A Water 2 26 25 5.5
500 17.5
AMY DF17A U/L 0 – 650 (serum) 25 – 115 S, P, U 14 10 Enzyme Diluent 7 50 4
(urine) 59 – 401 U/24 hr 600 10
AST (GOT) DF41A U/L 0 – 1000 15 – 37 S, P 40 20 Enzyme Diluent 20 40 2.5
440 8
830 15
BUN DF21 mmol/L 0.0 - 53.5 (S,P) 2.5 - 6.4 S, P, U 3 N/A Water 2 2 5.7 0.4
(U) 249 - 714 mmol/24 hr 48.2 3.2
C3 DF101 g/L 0.10 - 3.50 0.90 - 2.07 S 2 N/A Saline N/A 0.75 0.04
2.00 0.08
C4 DF102 g/L 0.05 - 1.40 0.174 - 0.522 S 3 N/A Saline N/A 0.150 0.008
0.400 0.020
2
CA DF23A mmol/L 1.25 - 3.74 (S,P) 2.12 - 2.52 S, P, U 5 N/A Water 3 1.75 0.04
(U) 1.0 - 8.8 mmol/24 hr 3.37 0.06
CCRP (HM) RF434 mg/L 0.1 - 15.0 <3 S,P 12 NA Water 2 2 6 0.31
12 0.58
CHOL DF27 mmol/L 1.3 - 15.5 < 5.2 S, P 3 N/A Water 2 2 5.7 0.13
10.3 0.18
CK DF29A U/L 0 – 800 21 – 232 S, P 14 N/A Enzyme Diluent 7 150 6
700 15
CKMB DF31 U/L 0 – 125 0–6 S, P 20 N/A Enzyme Diluent N/A 10 1.5
50 2.0
CRBM DF87 µmol/L 0.0 - 85.0 16.9 - 50.8 S, P 3 N/A Carbamazepine Free Serum 2 21.1 0.85
Drug Calibrator II Level 1 42.3 2.03

CREA DF33A µmol/L 0 - 1768 (S,P) 53 - 115 S, P, U 20 15 Water 2 (S,P) 10 88 9


(U) 5.3 - 22.1 mmol/24 hr Enzyme Diluent (U) 1644 44

CRP DF37 mg/L 2 – 120 <9 S, P 3 N/A Water 2 2 20 1.4


80 2.8
CSA DF89 nmol/L 20.8 - 416.3 see IFU 4 WB 5 NA Level 1 Calibrator N/A 149.9 17.0
274.8 29.3
4
CSAE DF108 ng/mL 350 - 2000 see IFU WB 3 NA Level 0 Calibrator N/A 665.6 72.8
Dimension® Clinical Chemistry System SI Method Specifics
FAST FACTS
Precision Guidelines
Total Reduced
Sample Sample AutoDilute
Assay Recommended Volume Volume Recommended Sample
1 1
Method Cat. No. Units Range Reference Interval Specimens (µL) (µL) Manual Diluent Volume (µL) Concentration 5-Test SD
1164.8 106.0
2
CTNI (HM) RF421C µg/L 0.04 – 40.00 0.00 – 0.05 S, P 50 N/A Water 20 2.0 0.20
25 1.50
2
DBIL DF25A µmol/L 0 – 342 0-5 S, P 31 13 Water 10 10.3 1.03
287 5.8
2
DBI DF125 µmol/L 0.9 - 274 0-3 S, P 10 NA Water 5 10.3 1.0
287 5.8
DGNA DF35A nmol/L 0.08 - 6.41 1.15 - 2.56 S, P 30 N/A Digoxin Free Serum N/A 0.77 0.08
3.07 0.12
DGTX DF36 nmol/L 2.6 - 104.6 18.3 - 34.0 S, P 20 N/A Digitoxin Free Serum N/A 13.1 1.3
52.4 5.2
ECO2 DF137 mmol/L 5 – 45 21 – 32 S, P 5 N/A Water 2 N/A 25 1.2
50 2
5
FERR (HM) RF440 µg/L 1 – 1000 8 – 388 S, P 40 N/A Sample Diluent 2 25 1.4
FERR Calibrator Level 1 150 5.1
500 18.2
FPSA (HM) RF452 µg/L 0.05 - 45.00 < 4.00 S, P 60 N/A N/A 4.00 0.27
10.00 0.7
FT4 (HM) RF410 pmol/L 2.57 - 83.7 9.9 - 20.7 S, P 50 N/A Do Not Dilute N/A 9.01 1.29
38.61 3.22
GENT DF12 µmol/L 0.0 - 25.92 8.64 - 17.28 S, P 3 N/A Gentamicin Free Serum 2 3.24 0.37
Drug Calibrator II Level 0 12.96 0.45
GGT DF45A U/L 0 – 800 5 – 85 S, P 32 15 Enzyme Diluent 16 80 3
400 7
GLU DF39A mmol/L 0 - 27.8 (S,P) 3.6 - 6.1 S, P, U, CSF 3 N/A Water 2 2 4.3 0.3
(CSF) 2.3 - 4.1 14.6 0.7
(U) <2.8 mmol/24 hr
GLUC DF40 mmol/L 0 - 27.8 (S,P) 4.1 - 5.9 S, P, U, CSF 3 N/A Water 2 2 4.3 0.3
(CSF) 2.2 - 3.9 14.6 0.7
(U) <2.8 mmol/24 hr
HA1C DF105 % Hb 1 – 30 g/dL 4.8 – 6.0 % Whole blood 3 N/A Normal Saline N/A 6% 0.33
HbA1c 0.2 – 2.9 g/dL 9% 0.69

HCG (HM) RF430 IU/L 1 - 1000 0 - 6 NPF S, P 40 N/A Sample Diluent 5 26 25 2.5
0 - 2 Males 150 11
500 37
IBCT DF84 µmol/L 0 - 179.1 44.8 - 80.6 S, P 25 N/A Water 2 12 98.5 1.7
179.1 3.96
IGA 1 DF74 g/L 0.1 – 10.0 0.87 – 4.74 S, P 10 N/A Saline 2 0.86 0.074
2.98 0.109
IGG1 DF76 g/L 0.5 – 45.0 6.81 – 16.48 S, P 10 N/A Saline 2 3.83 0.282
13.03 0.7
IGM 1 DF81 g/L 0.10 – 4.50 0.48 – 3.12 S, P 10 N/A Saline 2 0.4 0.069
1.35 0.101
IRON DF85 µmol/L 0.9 - 179.0 M 11.6 - 31.3 S, P 40 25 Water 2 20 9 0.91
F 9.0 - 30.4 179 4.0

IRN DF49A µmol/L 0 – 179 6 - 27 S 50 25 Water 2 N/A 8.95 1.34


179 5.37
LA DF16 mmol/L 0.3 – 15.0 (P) 0.4 – 2.0 P, CSF 4 N/A Water 2 2 2.0 0.15
(CSF) 0.6 – 2.2 8.0 0.40
LDH DF53A U/L 0 – 600 100 – 190 S, P 14 N/A Enzyme Diluent 7 170 7
306 10
Dimension® Clinical Chemistry System SI Method Specifics
FAST FACTS
Precision Guidelines
Total Reduced
Sample Sample AutoDilute
Assay Recommended Volume Volume Recommended Sample
1 1
Method Cat. No. Units Range Reference Interval Specimens (µL) (µL) Manual Diluent Volume (µL) Concentration 5-Test SD
LHCG (HM) 7 RF530 IU/L 1 - 1000 0 - 6 NPF S, P 40 N/A Sample Diluent 5 26 25 2.5
0 - 2 Males 150 11
500 37
LI1 DF132 mmol/L 0.20 – 5.00 0.60 – 1.20 S, P 20 N/A Lithium-Free Serum N/A 0.9 0.06
1.8 0.08
LIDO DF113 µmol/L 2.14 - 51.2 6.4 - 21.3 S, P 6 N/A Water 2 2 12.8 0.73
25.6 1.11
2
LIP DF55A U/L 50 – 1500 114 – 286 S, P 4 N/A Water 2 148 7
802 20
7 5
LMMB (HM) RF520 µg/L 0.5 – 300.0 0.0 – 3.6 S, P 60 N/A Sample Diluent 30 0 1.0
10 1.1
300 20
7 5
LPBN (HM) RF523 pg/mL 10 - 20,000 (<75 years) 125 P 50 N/A Sample Diluent N/A 150 15
(>75 years) 450 PBNP Calibrator Level 1 450 45
7 2
LTNI (HM) RF521 µg/L 0.04 – 40.00 0.00 – 0.05 S, P 50 N/A Water 20 2.0 0.20
25.0 1.50
MALB DF114 mg/L 1.3 - 100 <30 mg/24hr U 17 N/A Water 2 2 12.5 1.9
<20 µg/min L1 MALB Cal 50 2.5
MG 1 DF57 mmol/L 0.0 - 8.22 (S,P) 0.74 - 0.99 S, P, U 2x2 N/A Water 2 N/A 0.41 0.05
(U) 0.99 - 10.5 mmol/24 hr 3.7 0.23
MMB (HM) RF420 µg/L 0.5 – 300.0 0.0 – 3.6 S, P 60 N/A Sample Diluent 5 30 0 1
10 1.1
300 20
MYO (HM) RF422A µg/L 1 - 1000 10 to 92 S, P 20 N/A Sample Diluent 5 2 170 8.5
450 22.5
NAPA DF111 µmol/L 1.8 - 108.3 10.0 - 30.0 S, P 2 N/A Drug free serum N/A 23.8 1.27
Drug II Calibrator Level 1 49.8 2.43
PALB DF80 mg/L 20 – 500 180 – 357 S, P 2 N/A Water 2 N/A 88 7.00
Normal Saline 349 14.2
PALB Calibrator Level 1
PBNP RF423 pg/mL 10 - 30,000 (<75 years) 125 P 50 N/A Sample Diluent 5 N/A 150 15
(>75 years) 450 PBNP Calibrator Level 1 450 45
PCHE DF51 U/L 0 – 14,000 7000 – 19,000 S, P 2 N/A Enzyme Diluent N/A 4000 100
10100 300
PHNO DF60 µmol/L 0 – 344 64 – 172 S, P 4 N/A Water 2 2 44 4.3
Drug Calibrator I Level 1 176 10.8
Phenobarbital Free Serum
PHOS DF61 mmol/L 0.00 – 3.00 (S,P) 0.81 – 1.58 S, P, U 3 N/A Water 2 2 0.65 0.05
(U) 12.00 – 42.00 mmol/24hr 2.58 0.13
PROC DF110 µmol/L 2.1 - 85.0 17 - 51 S, P 2 N/A Drug free serum N/A 20 0.85
Drug II Calibrator Level 1 40.4 1.25
PTN DF64 µmol/L 2.0 – 158.4 39.6 – 79.2 S, P 4 N/A Phenytoin Free Serum 2 39.6 3.96
Drug Calibrator I Level 1 79.2 6.7
RCRP 1 DF34 mg/L 0.5 – 250.0 <3 S, P 10 N/A Water 2 N/A 20 1.0
RCRP Calibrator Level 1 120 4.0
SAL DF20 mmol/L 0.00 – 7.24 0.20 – 1.45 S 15 N/A Water 2 5 1.45 0.07
7.24 0.14
T3 (HM) RF414 nmol/L 0.3 - 9.2 1.1 - 2.9 S, P 20 N/A T3 Calibrator Level 1 N/A 1.5 0.2
6.1 0.4

T4 DF65 nmol/L 6.4 – 309 60 – 171 S, P 16 N/A Water 2 4 66 10


179 13
Dimension® Clinical Chemistry System SI Method Specifics
FAST FACTS
Precision Guidelines
Total Reduced
Sample Sample AutoDilute
Assay Recommended Volume Volume Recommended Sample
1 1
Method Cat. No. Units Range Reference Interval Specimens (µL) (µL) Manual Diluent Volume (µL) Concentration 5-Test SD
TACR DF107 nmol/L 1.6 - 39.0 see IFU4 WB 20 N/A TACR Calibrator Level 1 N/A 7.8 0.99
15.60 1.35
TBI DF167 µmol/L 2 - 428 3 to 17 S, P 10 N/A Water 2 5 19 0.5
322 10
2
TBIL DF67A µmol/L 0 – 428 < 17.10 S, P 28 12 Water 14 18.8 0.51
321.5 9.58
2
TGL DF69A mmol/L 0.17 – 11.3 <1.70 S, P 4 N/A Water 2 1.13 0.06
4.53 0.18
2
THEO DF71 µmol/L 11 – 222 56 – 111 S, P 4 N/A Water 2 56 3.3
Theophylline Free Serum 111 5.5
TOBR DF14 µmol/L 0.0 – 25.7 8.6 – 17.3 S, P 3 N/A Tobramycin Free Serum 2 3.21 0.43
Drug Calibrator II Level 1 12.84 0.60
2
TP DF73 g/L 20 – 120 64 – 82 S, P 15 10 Water 8 68 1.2

2
TPSA (HM) RF451 µg/L 0.05 - 100.0 <4 S, P 40 N/A Water 2 4 0.22
50 2.63
TRNF DF103 g/L 0.40 – 7.50 2.02 – 3.64 S, P 2 N/A Saline N/A 1.40 0.06
3.00 0.12
TSH (HM) DF412 mIU/L 0.01 – 50.00 0.34 – 4.82 S, P 60 N/A Sample Diluent 5 30 0.97 0.05
3.98 0.16
TU DF75A % 15 – 68 31 – 39 S, P 20 N/A Do Not Dilute N/A 25% 2.50%
48% 2.80%
UCFP DF26 mg/L 60 – 2500 (CSF) 150 – 450 CSF, U 10 N/A Water 2 5 320 12
(U) <149 mg/day 1420 20
2
URCA DF77 µmol/L 0 – 1190 (S,P) 155–428 S, P, U 17 10 Water 5 291 12
(U) 0.89 – 5.89 mmol/24hr 1053 24
VALP DF78 µmol/L 20.8 – 1040.0 346.0 – 693.0 S, P 3 N/A Water 2 2 277.2 15.9
Drug Calibrator II Level 1 538.7 17.3
Valproic Acid Free Serum
VANC DF86 µmol/L 0.0 – 33.5 12.1 – 17.4 Peak S, P 2 N/A Water 2 N/A 4.02 0.28
3.4 – 6.6 Trough Drug Calibrator II Level 1 16.75 1.13
Vancomycin Free Serum
1 Two cuvettes S : Serum
2 Type II Laboratory Grade Water Required U : Urine
3 Normal cut-off to be determined by each laboratory. CSF : Cerebrospinal Fluid
4 Instructions for Use (Flex® reagent cartridge insert sheet). ppWB : protein procipitate from Whole Blood
5 Use Sample Diluent (Cat. No. 791092901) WB : Whole Blood
6 HCG uses an addiitonal 10-fold dulution prior to taking the autodilute sample. P : Plasma
7 For use on the Dimension® Expand® System only. M : adult males
8 Mean (if 0 or greater) + 2SD (n=20) NPF : non-pregnant females
If mean is negative 2SD (n=20) used. N/A : Not Applicable
HM : Heterogeneous Immunoassay Module Issued 9/07
Dimension® Clinical Chemistry System Method Information
FAST FACTS
Flex® Well Stability on the Instrument
Sample
Initiated Measurement Tests/ Tests/ Flex®/
Method Reaction Wavelength Type Unopened Opened (well #) Well Flex® Carton
ABS 510/405 End Point 30 days 72 hours 5 30 4
ACP4 600/700 Rate 30 days 72 hours 5 15 8
ACTM4 600/700 End Point 30 days 72 hours 10 20 4
AHDL 600/700 End Point 30 days 3 days (1–3); 10 days (4); 15 days (5–6) 10 30 8
ALB X 540/600/700 End Point 30 days 72 hours 20 120 4
ALC X 340/383 End Point 30 days 5 days 6 30 4
ALDL 540/700 End Point 30 days 5 days 10 30 4
ALP 405/510 Rate 30 days 48 hours (1–6); 30 days (8) 30 90 4
ALT (GPT) 340/700 Rate 30 days 72 hours 20 60 4
AMON4 340/383 Rate 30 days 72 hours 5 15 8
AMY X 405/577 Rate 30 days 72 hours 10 60 4
AST (GOT) 340/700 Rate 30 days 72 hours 30 90 4
BUN X 340/383 Rate 30 days 5 days 40 120 4
C3 1 340/700 Turbidimetric – End Point 30 days 4 days 10 30 4
C4 1 340/700 Turbidimetric – End Point 30 days 4 days 10 30 4
CA X 577/540 End Point 30 days 24 hours (1–6); 10 days (7–8) 10 60 8
CCRP 1 X 405/510 Rate 30 days 10 days (1,3); 3 days (4-6) 10 30 4
CHOL X 452/540/700 End Point 30 days 5 days 20 60 8
CK X 340/405 Rate 30 days 5 days 20 120 4
CKMB X 340/405 Rate 30 days 48 hours (1–5); 30 days (6) 6 30 4
CRBM 1 340/700 Turbidimetric – Rate 30 days 72 hours 10 20 4
CREA X 510/600 Rate 30 days 5 days 40 120 4
CRP 1 340/700 Turbidimetric – Rate 30 days 72 hours (1–6); 30 days (7–8) 10 30 4
RCRP 1,4 X 340/700 Turbidimetric – Rate 30 days 72 hours 10 30 4
CSA 577/700 Rate 30 days 72 hours (1-6); 10 days (7-8) 10 20 4
CSAE 577/700 Rate 30 days 72 hours (1-6); 10 days (7-8) 10 20 4
CTNI (HM) 510/700 Rate 30 days 3 days 30 30 4
DBI 540/700 End Point 30 days 2 days (1-4), 30 days (5-8) 10 40 8
DBIL 540/700 End Point 30 days 48 hours 10 40 8
DGNA (HM) 577/700 Rate 30 days 72 hours (1–6); 10 days (7) 10 20 4
DGTX (HM) 577/700 Rate 30 days 72 hours (1–6); 10 days (7) 10 20 4
ECO2 X 405/700 Rate 30 days 2 days 15 90 4
FERR (HM) 577/700 Rate 30 days 10 days (1, 3, 7), 3 days (4–6) 10 30 4
FPSA 577/700 Rate 30 days 15 days (1-3, 7), 5 days (4–6) 10 30 4
FT4 (HM) 510/700 Rate 30 days 3 days (1–4), 6 days (5–8) 15 30 4
GENT 1 340/700 Turbidimetric – Rate 30 days 72 hours (1–6); 30 days (8) 10 20 4
GGT X 405/600 Rate 30 days 72 hours (1–6); 30 days (7–8) 12 72 4
GLU X 340/383 End Point 30 days 5 days 40 240 4
GLUC X 340/383 End Point 42 days 7 days 60 360 4
HA1C 1 405/700 for hgb Colorimetric/Turbidimetric 30 days 5 days (1-2); 10 days (3); 10 days (4-6) 10 20 6
340/700 for hgb A1C
HCG (HM) 577/700 Rate 30 days 5 days (1–2), 3 days (4–6), 10 days (3,8) 10 30 4
IBCT 600/700 End Point 30 days 6 days (1–3), 30 days (4–8) 20 60 4
IGA 1,4 340/700 Turbidimetric – Rate 30 days 4 days 10 30 4
Dimension® Clinical Chemistry System Method Information
FAST FACTS
Flex® Well Stability on the Instrument
Sample
Initiated Measurement Tests/ Tests/ Flex®/
Method Reaction Wavelength Type Unopened Opened (well #) Well Flex® Carton
IGG 1,4 340/700 Turbidimetric – Rate 30 days 4 days 10 30 4
IGM 1,4 340/700 Turbidimetric – Rate 30 days 4 days 10 30 4
IRN 600/700 End Point 30 days 72 hours (1–5); 30 days (6–8) 12 60 4
IRON 600/700 End Point 30 days 3 days (1-4), 14 days (5-6) 15 60 4
LA 340/383 End Point 30 days 5 days 15 30 4
LDH X 340/383 Rate 30 days 72 hours (1–6); 30 days (7) 20 120 4
LHCG (HM) 2 577/700 Rate 30 days 5 days (1–2), 3 days (4–6), 10 days (3,8) 10 30 4
LI4 X 540/700 Endpoint 30 days 5 days 10 20 4
LIDO 1 340/700 Turbidimetric – Rate 30 days 72 hours 10 20 4
LIP (Cal) X 577/700 Rate 30 days 48 hours (1–6); 30 days (7–8) 10 30 4
LMMB (HM) 2 577/700 Rate 30 days 3 days (1–6), 10 days (7–8) 10 20 4
LPBN (HM) 2 X 510/700 Rate 30 days 3 days (1-4), 6 days (6-8) 9 18 4
LTNI (HM) 2 510/700 Rate 30 days 3 days 18 18 4
MALB 340/700 Turbidimetric – Rate 30 days 3 days 10 20 4
MG4 X 600/510 End Point 30 days 48 hours 10 30 4
MMB (HM) 577/700 Rate 30 days 3 days (1–6), 10 days (7–8) 20 40 4
MYO (HM) 577/700 Rate 30 days 5 days (4–6), 10 days (1, 3, 7,8) 10 30 4
NAPA 1 340/700 Turbidimetric – Rate 30 days 72 hours 10 20 4
PALB 1 X 383/700 Turbidimetric – Rate 30 days 72 hours 10 30 4
PBNP (HM) 510/700 Rate 30 days 3 days (1-4), 6 days (6-8) 15 30 4
PCHE 600/700 Rate 30 days 72 hours 10 30 4
PHNO 1 340/700 Turbidimetric – Rate 30 days 72 hours 10 20 4
PHOS 340/383 or 340/700 3 End Point 30 days 72 hours (1–6); 30 days (7–8) 20 120 4
PROC 1 340/700 Turbidimetric – Rate 30 days 72 hours 10 20 4
PTN 1 340/700 Turbidimetric – Rate 30 days 72 hours (1–6); 7 days (7– 8) 7 28 4
SAL 510/700 End Point 30 days 5 days 10 30 4
T3 577/700 Rate 30 days 3 days (1-6), 10 days (7-8) 10 20 4
T4 340/383 Rate 30 days 72 hours (1–6); 15 days (7–8) 15 30 4
TACR 577/700 Rate 30 days 48 hours (1-8), 6 days (7-8) 10 20 4
TBI 540/700 End Point 30 days 5 days (1-4,6), 12 days (2) 15 60 8
TBIL 540/700 End Point 30 days 5 days (1,4–6); 15 days (2), 72 hours (3) 15 60 8
TGL X 510/700 Endpoint 30 days 10 days 20 120 4
THEO 1 340 Turbidimetric – Rate 30 days 72 hours (1–5); 30 days (7) 10 20 4
TOBR 1 340/700 Turbidimetric – Rate 30 days 72 hours (1–6); 30 days (8) 10 20 4
TP 540/700 End Point 30 days 5 days 40 120 4
TPSA (HM) 577/700 Rate 30 days 15 days (1, 3, 7), 5 days (4–6) 10 30 4
TRNF 1 340/700 Turbidimetric – End Point 30 days 4 days 10 30 4
TSH (HM) 510/700 Rate 30 days 3 days (1–4), 7 days (6–8) 25 50 4
TU 340/383 Rate 30 days 48 hours (1–6); 15 days (7–8) 10 20 8
UCFP X 600/700 End Point 30 days 5 days 4 20 4
URCA X 293/700 End Point 30 days 72 hours (1–3, 7); 30 days (8) 20 60 8
VALP 1 340/700 Turbidimetric – Rate 30 days 72 hours 10 20 4
VANC 1 340/700 Turbidimetric – Rate 30 days 72 hours (1–6); 30 days (8) 10 20 4
Dimension® Clinical Chemistry System Method Information
FAST FACTS
Flex® Well Stability on the Instrument
Sample
Initiated Measurement Tests/ Tests/ Flex®/
Method Reaction Wavelength Type Unopened Opened (well #) Well Flex® Carton

*two cuvette method

1 : Recalibration is required after the source lamp is replaced in the instrument


2 : For use on Dimension® Xpand® system only.
3 : Dimension® Systems other than AR using software 5.0 or higher or AR 4.5 or higher.
4: Two cuvette methods
HM : Heterogeneous Immunoassay Module

Issued 9/07
Dimension® Clinical Chemistry System Urine Drugs of Abuse Method Specifics
FAST FACTS Recommended
Autodilute Cut-Off Precision Guidelines*
Assay Range Recommended Sample Recommended Sample Volume Concentration
Method Cat. No. Units Semi-Quantitative Specimens Volume (µL) Manual Diluent (µL) ng/mL 5-Test SD %CV (NQU)
AMPH (300 ng/mL cutoff) DF91B ng/mL semi-quantitative 95-900 Urine 6 Water f 2 300 21 7
QUAL qualitative N/A 300 19 1.9
AMPH (500 ng/mL cutoff) DF91B ng/mL semi-quantitative 95-900 Urine 6 Water f 2 500 24 4.8
QUAL qualitative N/A 500 17 1.7
AMPH (1000 ng/mL cutoff) DF91B ng/mL semi-quantitative 125-1800 Urine 3 Water f 2 1000 52 5.2
QUAL qualitative N/A 1000 18 1.8
BARB DF96A ng/mL semi-quantitative 20 - 720 Urine 10 Water f 2 200 18 9
QUAL qualitative N/A N/A N/A 200 19 1.9
BENZ DF97A ng/mL semi-quantitative 30 - 900 Urine 10 Water f 2 200 18 9
QUAL qualitative N/A N/A N/A 200 20 2
COC (300 ng/mL cutoff) DF92A ng/mL semi-quantitative 35 - 900 Urine 12 Water f 2 300 50 16.7
QUAL qualitative N/A N/A N/A 300 20 2
COC (150 ng/mL cutoff) DF92A ng/mL semi-quantitative 35 - 900 Urine 12 Water f 2 150 30 20
QUAL qualitative N/A N/A N/A 150 30 3
EXTC (300 ng/mL cutoff) DF109 ng/mL semi-quantitative 25 - 450 Urine 13 Water f 2 300 20 6.8
QUAL qualitative N/A N/A N/A 300 16 1.6
EXTC (500 ng/mL cutoff) DF109 ng/mL semi-quantitative 75 - 900 Urine 8 Water f 2 500 33 6.6
QUAL qualitative N/A N/A N/A 500 16 1.6
METH DF90A ng/mL semi-quantitative 107 - 900 Urine 6 Water f 2 300 15 5
QUAL qualitative N/A N/A N/A 300 27 2.7
OPI (2000 ng/mL cutoff) DF93A ng/mL semi-quantitative 140 - 3800 Urine 3 Water f 2 2000 200 10
QUAL qualitative N/A N/A N/A 2000 30 3
OPI (300 ng/mL cutoff) DF93A ng/mL semi-quantitative 50 - 1800 Urine 12 Water f 3 or 6 300 N/A N/A
QUAL qualitative N/A N/A N/A 300 N/A N/A
PCP DF94A ng/mL semi-quantitative 5 - 75 Urine 14 Water f 2 25 2.5 10
QUAL qualitative N/A N/A N/A 25 20 2
THC DF95A ng/mL semi-quantitative 15 - 85 Urine 13 Water f 3 50 4.5 9
QUAL qualitative N/A N/A N/A 50 24 2.4
Dimension® Clinical Chemistry System Urine Drugs of Abuse Method Specifics (cont 2)
FAST FACTS

Flex® Well Stability on the Instrument


Number of
Reagent
Number of Deliveries to
Method Wavelength Measurement Type Reagents in Flex® Cuvette Tests/Well Tests/Flex® Flex®/Carton Unopened Opened
AMPH 340/600 Rate 2 2 10 20 4 30 days 2 days

BARB 340/600 Rate 2 2 10 20 4 30 days 2 days

BENZ 340/600 Rate 2 2 10 20 4 30 days 2 days

COC 340/600 Rate 2 2 10 20 4 30 days 2 days

EXTC 340/600 Rate 2 2 10 20 4 30 days 2 days

METH 340/600 Rate 2 2 10 20 4 30 days 2 days

OPI 340/600 Rate 2 2 10 20 4 30 days 2 days

PCP 340/600 Rate 2 2 10 20 4 30 days 2 days

THC 340/600 Rate 2 2 10 20 4 30 days 2 days

Issued 9/07
Dimension® Clinical Chemistry System Interference Table for Urine Drugs of Abuse
FAST FACTS
Human
Ascorbic Gamma- Serum Oxalic Sodium
Method Acetone Acid Bilirubin Creatinine Ethanol Globulin Glucose Hemoglobin Albumin Acid Chloride Urea Riboflavin
1.0 g/dL 1.5 g/dL 0.25 mg/dL 0.5 g/dL 1.0 g/dL 0.5 g/dL 2.0 g/dL 115 mg/dL 0.5 g/dL 0.1 g/dL 6.0 g/dL 6.0 g/dL 7.5 mg/dL

AMPH None None None None None None None None None None None None None
BARB None None None None None None None None None None None None None
None
BENZ None None None None None None None None None None @3.0 g/dL None None
None None
COC @0.5 g/dL None None None @0.5 g/dL None None None None None None None None
None
EXTC None None @2.0 mg/dL None None None None None None None None None None
METH None None None None None None None None None None None None None
OPI None None None None None None None None None None None None None
None
PCP None None None None None None None None None None @1.0 g/dL None None
THC None None None None None None None None None None None None None

Issued 9/07
Dimension® Clinical Chemistry System Urine Test Method Specifics
FAST FACTS
Dilution Recommended Recommended
Sample Sample Factors Autodilute Manual Dilute 24 hour
24 hr Collection Volume Dilution (Number ) Sample Sample Units Assay Reference Units Random Reference
AMY a refrigerate b 14 1:2c 2 N/A Enzyme U/L 0 – 650 59 – 401 U/24 hr 30 – 200
Diluent
ALC h refrigerate 3 none none N/A Water f mg/dL 0 – 300 N/A N/A 0.0 – 50.0
[mmol/L] [0 – 65] [0 – 11]
BUN g refrigerate 3 1 : 10 d 10 d N/A Water f mg/dL 0 – 150 7.0 – 20.0 g/24 hr 350 – 1000
[mmol/L] [0 – 53.5] [249– 714] [mmol/24 hr] [125 – 357]
CA 10–20 mL 6M HCl/ 5 none none 2 Water f mg/dL 5 – 15 42 – 353 mg/24 hr 2.0 – 17.5
24 hr collection [mmol/L] [1.25 – 3.74] [1.0 – 8.8] [mmol/24 hr] [0.5 – 4.37]
CREA g refrigerate 20 1 : 10 e 10 e N/A Enzyme mg/dL 0 – 20 0.6 – 2.5 g/24 hr 30 – 125
Diluent [µmoI/L] [0 – 1768] [5.3 – 22.1] [mmol/24 hr] [2652 – 11050]
GLU refrigerate 3 none none 2 Water f mg/dL 0 – 500 < 0.5 g/24 hr 0 – 30
[mmol/L] [0 – 27.8] [< 2.8] [mmol/24 hr] [0 – 1.7]
GLUC refrigerate 3 none none 2 Water f mg/dL 0 – 500 < 0.5 g/24 hr 1– 15
[mmol/L] [0 – 27.8] [< 2.8] [mmol/24 hr] [0.1 - 0.8 ]
MALB 24 hr collection 17 none none N/A Waterf mg/L 1.3 - 100 <30 mg/24 hr Not used
L1 MALB CAL <20 µg/min Not used
MG 10 mL 12M HCl/ 4 none none N/A Water f mg/dL 0 – 20 24 – 255 mg/24 hr 1– 13
24 hr collection [mmol/L] [0 – 8.22] [0.99 – 10.5] [mmol/24 hr] [0.41 – 5.30]
PHOS g 10–20 mL 6M HCl/ 3 1 : 10 d 10 d N/A Water f mg/dL 0–9 0.4 – 1.3 g/24 hr 20 – 60
24 hr collection [mmol/L] [0 – 3.0] [12 – 42] [mmol/24 hr] [6.5 – 19.4]
UCFP refrigerate 10 none none 5 Water f mg/dL 6 – 250 <149.1 mg/dL mg/24 hr < 11.9
[mg/L] [60 – 2500] [<1491] [mg/24 hr] [< 119]
URCA g 10 m 5% (w/v) NaOH/ 17 1 : 10 d 10 d N/A Water f mg/dL 0 – 20 150 – 990 mg/24 hr 7.5 – 49.5
24 hr collection [µmol/L] [0 – 1190] [0.89 – 5.89] [mmol/24 hr] [446 – 2944]

a Albumin must be added to all urine specimens to maximize amylase activity.


b Adjust to pH of 7.0 before storage.
c For urine AMY, dilute 1 part sample with 1 part Enzyme Diluent for a 1:2 dilution.
d For urine BUN, PHOS and URCA on AR instruments only, dilute 1 part of sample with 9 parts Purified Water Diluent (Cat. No. 710615901) or reagent grade water
for a 1:10 dilution.
e For urine CREA on the AR instruments only, dilute 1 part sample with 9 part Enzyme Diluent for a 1:10 dilution.
f Purified water Diluent (Cat. No. 710615901) or reagent grade water.
g Auto Urine Dilution (AUD). On Dimension® XL/RxL/ARx/Xpand® systems. The AUD methods are BUN, CREA, PHOS and URCA. Samples are automatically diluted
1:10 by the instrument with system reagent grade water.
h Urinary ALC is reported NEGATIVE if < 50 mg/dL and POSITIVE is > 50 mg/dL. All positive results should be confirmed by alternate method such as QC Chromatography.
N/A Not Applicable

Issued 9/07
Dimension® Clinical Chemistry System ELECTROLYTES MultiPLY®
FAST FACTS Integrated Multisensor (IMT)
for Dimension® AR systems

Test Specifications
Direct Indirect
Assigned Assigned Precision Guidelines
Recommended Sample Units Assay Reference Decimal Calibration Measurement Concentrationo
Method Specimens Volume (µL) [SI] Range Interval Place Material Type Coefficients Coefficients f Sample 5 Test SD
C0 C1 C0 C1
IMT
Standard A, Direct 120 2.0
a
Na S, P, U mmol/L 50 – 200 140 – 148 0 B Potentiometric 0 0.96 0 0.93 160 2.0

IMT
Standard A, Direct 0.15
a
K S, P, U mmol/L 1.0 – 10.0 3.6 – 5.2 1 B Potentiometric 0 0.96 0 0.93 2.0 6.0 0.15

IMT
Standard A, Direct 2.0
a
Cl S, P, U mmol/L 50 – 200 100 – 108 0 B Potentiometric 0 0.96 0 0.96 95 128 2.0

IMT
Standard A, Indirect 20 2.0
a
TCO2 S, P mmol/L 5.0 – 45.0 21 – 32 1 B Potentiometric -6.25 1.25 -6.25 1.25 30 2.0

Urine Test Specifications


Dilution
24 hr Factors Random 24 hr
Collection Sample (Number to Assay Reference Reference
Method (Additive) Dilution Enter) d Range Interval Units [SI] Interval
Na b refrigerate 1:3c none 2 – 300 20 – 110 mmol/24 hr 40 – 220
Kb refrigerate 1:3c none 1 – 100 12 – 75 mmol/24 hr 25 – 125
Cl b refrigerate 1:3c none 10 – 330 55 – 125 mmol/24 hr 110 – 250

a: AR - 80 µL (Na, K, Cl, CO2) or 60 µL (Na, K)


b: Acidified samples are unacceptable
c: Dilute 1 part sample with 2 parts MultiPLY® Urine Diluent for a 1:3 dilution
d: Dilution factor is calculated automatically by the Dimension® system
Issued 9/07
Dimension® Clinical Chemistry System ELECTROLYTES QuikLYTE®
FAST FACTS Indirect Integrated Multisensor (IMT)
for Dimension® XL, RxL, ARx, Xpand®
and RxL Max® systems

Test Specifications
Precision Guidelines
Assigned Concentration
Recommended Assay Reference Decimal Sample Calibration Measurement Coefficients of Sample 5 Test SD
Method Specimens Volume (µL) Units [SI] Range Interval Place Dilution Material Type C0 C1
45 µL a Indirect IMT
Na S, P, U (XL, RxL, ARx) mmol/L 50 – 200 136 – 145 0 1:10 Standard A, B Potentiometric 1.5 1.01 120 2.0
40 µL (Xpand®) 160 2.0
Indirect IMT
a
K S, P, U mmol/L 1.0 – 10.0 3.5 – 5.1 1 1:10 Standard A, B Potentiometric -0.2 1.05 2.0 0.15
6.0 0.15
Indirect IMT
a
Cl S, P, U mmol/L 50 – 200 98 – 107 0 1:10 Standard A, B Potentiometric -10 1.09 95 2.0
128 2.0
Indirect IMT
a
TCO2 S, P mmol/L 5.0 – 45.0 21 – 32 1 1:10 Standard A, B Potentiometric -6 1.15 20 2.0
30 2.0

Urine Test Specifications

Dilution
24 hr Factors Random 24 hr
24 hr Collection Sample (Number to Assay Reference Units [S. Reference
Method (Additive) Dilution Enter) Range Interval I.] Interval
b
Na refrigerate 1 : 10 c none 5 – 300 20 – 110 mmol/24 hr 40 – 220

b
K refrigerate 1 : 10 c none 1 – 300 12 – 62 mmol/24 hr 25 – 125

b c
Cl refrigerate 1 : 10 none 10 – 330 55 – 125 mmol/24 hr 110 – 250

a: Volume used for all four electrolytes


b: Acidified samples are unacceptable
c: XL/RxL/Arx/Xpand®/RxL Max® systems automatically dilute urine Na, K, Cl

Issued 9/07
Dimension® Clinical Chemistry System Interference Table
FAST FACTS
Method Bilirubin Hemoglobin (monomer) Lipemia EDTA Li+ Heparin K+ Oxalate Na+ Fluoride Na+ Heparin
2
20 mg/dL 500 mg/dL 600 mg/dL triglyceride 200 mg/dL 280 U/mL 500 mg/dL 400 mg/dL 8000 U/L
ACP None None None Do Not Use None None None Not Tested
ACTM -21% None @1000 mg/dL Hemoglobin None @3000 mg/dL triglyceride None None None None Not Tested
None @ 5 mg/dL Bilirubin
AHDL None @80 mg/dL Bilirubin None @1000 mg/dL Hemoglobin None @3000 mg/dL triglyceride None None Not Tested Not Tested None
-2.4 g/dL@4.1 g/dL None @14.3 U/mL
ALB None None None None ALB None None Na Heparin1

3
ALC None None @ 1000 mg/dL Hemoglobin None @ 1000 mg/dL triglyceride Not Tested None None See IFU Not Tested
-11% @ 40 mg/dL Bilirubin +16% @ 3000 mg/dL triglyceride
ALDL None @ 60 mg/dL None @1000 mg/dL Hemoglobin None @ 1000 mg/dL Not Tested Not Tested Not Tested Not Tested None
ALP None None None Do Not Use None None None Not Tested
ALT (GPT) None None None @800 mg/dL triglyceride None None None None Not Tested
AMON None Do Not Use None None None None None Not Tested
AMY None None None @1000 mg/dL triglyceride Do Not Use Not Tested Do Not Use None @1 mg/dL Not Tested
Na+F
AST (GOT) None +47 U/L@73 U/L AST None @ 800 mg/dL triglyceride None None None None Not Tested
BUN None None None None None None None Not Tested
C3 None@50 mg/dL Bilirubin None@1300 mg/dL Hemoglobin None@750 mg/dL triglyceride Do Not Use Do Not Use Do Not Use Do Not Use Not Tested
C4 None@50 mg/dL Bilirubin None@1300 mg/dL Hemoglobin None@750 mg/dL triglyceride Do Not Use Do Not Use Do Not Use Do Not Use Not Tested
CA None None None Do Not Use None Do Not Use None Not Tested
-4mg/dL @200
CHOL -15 mg/dL @ 8.1 mg/dL (conj) None None None mg/dL CHOL -12% -12% Not Tested
& 9.4 (unconj) Bilirubin @ 150 CHOL
-25 mg/dL @ 12.8 mg/dL (conj)
& 14.7 (unconj) Bilirubin @ 250 CHOL
CK -10 U/L @ 58 U/L CK +10 U/L @ 50 U/L CK with 250 mg/dL Hgb None Do Not Use None Do Not Use Do Not Use Not Tested
CKMB +20 U/L@28 U/L CKMB +7 U/L@21 U/L CKMB None Do Not Use None Do Not Use Do Not Use Not Tested
CL None@94 mg/dL Bilirubin None None@1000 mg/dL triglyceride Not Tested None Not Tested Not Tested Not Tested
CRBM None None None@1000 mg/dL triglyceride None None Not Tested Not Tested Not Tested
CREA None @ 60 mg/dL Bilirubin None None None None None None Not Tested
-15% at 3 mg/L
CCRP None @ 80 mg/dL Bilirubin None @ 1000 mg/dL Hemoglobin None @ 3000 mg/dL triglyceride CRP None Not Tested Not Tested None
CRP None None None @900 mg/mL TRIG None None None None Not Tested
CSA None @ 60 mg/dL Bilirubin N/A None @ 1500 mg/dL triglyceride None Do Not Use Do Not Use Do Not Use Do Not Use
CSAE None @ 60 mg/dL Bilirubin N/A None @ 1500 mg/dL triglyceride None Do Not Use Do Not Use Do Not Use Do Not Use
CTNI (HM) None None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride Do Not Use Not Tested Do not Use Not Tested None
DBI N/A See IFU3 -22% @ 200 mg/dL triglyceride None None Not Tested Not Tested Not Tested
DBIL N/A -0.2 mg/dL @0.3 mg/dL DBIL None None None None None Not Tested
-1.5 mg/dL @4.3 mg/dL DBIL
DGNA None None None@1000 mg/dL triglyceride None None None None@1 mg/dL Na+F Not Tested
DGTX None@60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride None None Not Tested Not Tested None
ECO2 <5%@60 mg/dL Bilirubin <5%@1000 mg/dL Hemoglobin <5%@3000 mg/dL triglyceride Not Tested Not Tested Not Tested Not Tested None
FERR (HM) None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride Not Tested None Do Not Use Not Tested None
FPSA None @ 40 mg/dL Bilirubin None @1000 mg/dL Hemoglobin None @ 3000 mg/dL triglyceride Not Tested None Not Tested Not Tested Not Tested
FT4 (HM) None None@1000 mg/dL Hemoglobin None@500 mg/dL triglyceride Not Tested None Do Not Use Not Tested None
GENT None @ 80 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@1000 mg/dL triglyceride None None Not Tested Not Tested Not Tested
-12%@ 3000 mg/dL triglyceride
GGT None None None None None None None Not Tested
GLU -12 mg/dL@124 mg/dL GLU -20 mg/dL@131 mg/dL GLU +10 mg/dL@129 mg/dL GLU None None None None Not Tested

GLUC None @ 60 mg/dL Bilirubin None @ 1000mg/dL Hemoglobin None @ 400 mg/dL triglyceride Not Tested None Not Tested None None
Dimension® Clinical Chemistry System Interference Table
FAST FACTS
Method Bilirubin Hemoglobin (monomer) Lipemia EDTA Li+ Heparin K+ Oxalate Na+ Fluoride Na+ Heparin
2
20 mg/dL 500 mg/dL 600 mg/dL triglyceride 200 mg/dL 280 U/mL 500 mg/dL 400 mg/dL 8000 U/L
None @ 4000 mg/dL of native
triglyceride @ 50 mg/dL Gluc
HA1C None @ 60 mg/dL Bilirubin None None@3000 mg/dL triglyceride None None Not Tested None None
HCG (HM) None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride None None Do Not Use Not Tested None
IBCT None @ 60 mg/dL Bilirubin None@250 mg/dL Hemoglobin None Not Tested None Not Tested Not Tested None
IGA None@40 mg/dL Bilirubin None None@750 mg/dL triglyceride Not Tested Not Tested Not Tested Not Tested None
IGG None@40 mg/dL Bilirubin None None@750 mg/dL triglyceride Not Tested Not Tested Not Tested Not Tested None
IGM None@40 mg/dL Bilirubin None None@750 mg/dL triglyceride Not Tested Not Tested Not Tested Not Tested None
IRN -14 µg/dL @102 µg/dL IRN + 20 µg/dL at 50 mg/dL Hgb @ 88 µg/dL IRN None Do Not Use Do Not Use Do Not Use Do Not Use Not Tested
IRON None @ 80 mg/dL Bilirubin 200 mg/dL Hgb + 22% @55 µg/dL IRON None@3000 mg/dL triglyceride Do Not Use None Do Not Use Do Not Use None
200 mg/dL Hgb + 10% @107 µg/dL IRON
K None@94 mg/dL Bilirubin None None@1000 mg/dL triglyceride Not Tested None Not Tested Not Tested Not Tested
LA None Gross hemolysis elevates LA None @1000 mg/dL triglyceride Not Tested Do Not Use None None Do Not Use
LDH None +50 U/L@131 U/L LDH None Do Not Use None Do Not Use Do Not Use Not Tested
LHCG None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride None None Do Not Use Not Tested None
LI None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@3250 mg/dL triglyceride Do Not Use Do Not Use Do Not Use Not Tested None
LIDO None @ 40 mg/dL Bilirubin None None@1000 mg/dL triglyceride None Not Tested NotTested Not Tested None
LIP None +30 U/L@143 U/L LIP None@1000 mg/dL triglyceride Do Not Use None Do Not Use Do Not Use None
LMMB None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@1500 mg/dL triglyceride None None Do Not Use Not Tested None
LPBN None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None @3000 mg/dL triglyceride Not Tested None Not Tested Not Tested None
LTNI None None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride Do Not Use Not Tested Do not Use Not Tested None
MALB None None @ 10 mg/dL Hemoglobin Not Tested Do Not Use Not Tested Not Tested Not Tested Not Tested
-0.4 mg/dL
MG None @ 60 mg/dL Bilirubin spuriously elevated results None at 2.0 mg/dL Mg @1.8 mg/dL MG None None None Not Tested
-1.0 mg/dL @ 1.8 mg/dL Mg -0.6 mgdL @ 1.8 mg/dL Mg
MMB (HM) None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@1500 mg/dL triglyceride None None Do Not Use Not Tested None
MYO (HM) None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@1500 mg/dL triglyceride Not Tested None Do Not Use Not Tested None
NA None@94 mg/dL Bilirubin None None@1000 mg/dL triglyceride Not Tested None Not Tested Not Tested Not Tested
NAPA None @ 60 mg/dL Bilirubin None None@1000 mg/dL triglyceride None None Not Tested Not Tested None
PALB None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None @1000 mg/dL triglyceride None None Not Tested Not Tested None
PBNP None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None @3000 mg/dL triglyceride Not Tested None Not Tested Not Tested None
PCHE None None None None None Do Not Use Do Not Use Not Tested
PHNO None @ 80 mg/dL Bilirubin None @ 1000 mg/dL Hemoglobin None @200 mg/dL triglyceride None None Not Tested Not Tested Not Tested
-11% @ 600 mg/dL triglyceride
PHOS +0.26 mg/dL@2.23 mg/dL PHOS None@1000 mg/dL Hemoglobin +0.06 mg/dL@2.23 mg/dL PHOS None None None None Not Tested
PROC None @ 60 mg/dL Bilirubin None None @1000 mg/dL triglyceride None None Not Tested Not Tested None
PTN None @ 80 mg/dL Bilirubin None @ 1000 mg/dL Hemoglobin None @1000 mg/dL triglyceride None None Not Tested Not Tested Not Tested
-18% @ 3000 mg/dL triglyceride
RCRP None @ 40 mg/dL Bilirubin None None @ 1000 mg/dL triglyceride None None @ 8000 U/L Not Tested Not Tested Not Tested
+30% @ 60 mg/dL Bilirubin +35% @ 1000 mg/dL Hemoglobin -69% @ 3000 mg/dL triglyceride
SAL -15% @ 20 mg/dL Bilirubin None @ 1000 mg/dL Hemoglobin None@1000 mg/dL triglyceride None None Not Tested Not Tested Not Tested
-7% @ 5 mg/dL Bilirubin +96% @ 3000 mg/dL triglyceride
-11% @ 2 mg/dL Bilirubin
T3 None @ 60 mg/dL Bilirubin None @ 1000 mg/dL Hemoglobin None @ 3000 mg/dL triglyceride None None Not Tested Not Tested None
T4 None None None Do Not Use None None None Not Tested
TACR None @ 60 mg/dL Bilirubin None None@1000 mg/dL triglyceride None Not Tested Not Tested Not Tested Not Tested
TBI N/A None + 18% @ 1.1 mg/dL total bilirubin None None Not Tested Not Tested Not Tested
TBIL N/A None None None None None None Not Tested
TCO2 None@94 mg/dL Bilirubin None None@1000 mg/dL triglyceride Not Tested None Not Tested Not Tested Not Tested
TGL None @ 60 mg/dL Bilirubin None Not Tested Not Tested Not Tested Not Tested Not Tested None
THEO None None None None None None None Not Tested
TOBR None None None@1000 mg/dL triglyceride None None Not Tested Not Tested Not Tested
Dimension® Clinical Chemistry System Interference Table
FAST FACTS
Method Bilirubin Hemoglobin (monomer) Lipemia EDTA Li+ Heparin K+ Oxalate Na+ Fluoride Na+ Heparin
2
20 mg/dL 500 mg/dL 600 mg/dL triglyceride 200 mg/dL 280 U/mL 500 mg/dL 400 mg/dL 8000 U/L
TP -0.6 g/dL@6.1 g/dL TP +0.5 g/dL @ 6.5 g/dL TP None None None None None Not Tested
TPSA (HM) None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None @3000 mg/dL triglyceride Not Tested None Not Tested Not Tested Not Tested
TRNF None@50 mg/dL Bilirubin None@1300 mg/dL Hemoglobin None@750 mg/dL triglyceride Do Not Use None Not Tested Not Tested None
TSH (HM) None None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride Not Tested None Do Not Use Not Tested None
TU None None None None None None None Not Tested
Do not use hemolyzed samples None @1 g/L
UCFP None results are increased Not Tested EDTA None Not Tested None @1 mg/dL Na+F Not Tested
URCA None None -0.2 mg/dL @ 4.3 mg/dL URCA None None None None Not Tested
VALP None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride Not Tested None Not Tested Not Tested Not Tested
VANC None None None@1000 mg/dL triglyceride None None None None@1 mg/dL Na+F Not Tested

1. Sodium heparin concentration routinely found in blood collection tubes.


2. Triglyceride testing was done using Intralipid®.
3. IFU - Instructions for Use (insert sheet).

NOTE: * The word “None” indicates that no significant interference was observed; please refer to the
method-specific insert sheet for additional detail.
* See the method-specific insert sheet for information on interference from commonly administered
drugs, metabolites, etc.
HM Heterogeneous Immunoassay Module

Issued 9/07
Dimension® Clinical Chemistry System Interference Table - SI Units
FAST FACTS
Method Bilirubin Hemoglobin (monomer) Lipemia EDTA Li+ Heparin K+ Oxalate Na+ Fluoride Na+ Heparin
2
342 µmol/L 0.31 mmol/L 6.86 mmol/L triglyceride 2 gm/L 280000 U/L 5g/L 4g/L 8000 U/L
ACP None None None Do Not Use None None None Not Tested
ACTM -21% None @0.62 mmol/L Hemoglobin None @34.29 mmol/L triglyceride None None None None Not Tested
None @ 86 µmol/L Bilirubin
AHDL None @1368 µmol/L Bilirubin None @0.62 mmol/L Hemoglobin None @34.29 mmol/L triglyceride None None Not Tested Not Tested None
-24 g/dL@41 None @14.3 U/mL
1
ALB None None None None g/dL ALB None None Na Heparin

ALC None None @ 0.62 mmol/L Hemoglobin None @ 11.43 µmol/L triglyceride Not Tested None None See IFU Not Tested
-11% @ 384 µmol/L Bilirubin +16% @ 34.29 µmol/L triglyceride
ALDL None @ 1026 µmol/L Bilirubin None @0.62 mmol/L Hemoglobin None @ 11.3 mmol/L Not Tested Not Tested Not Tested Not Tested None
ALP None None None Do Not Use None None None Not Tested
ALT (GPT) None None None @9.12 mmol/L triglyceride None None None None Not Tested
AMON None Do Not Use None None None None None Not Tested
AMY None None None @11.4 mmol/L triglyceride Do Not Use Not Tested Do Not Use None @238 µmol/L Not Tested
Na+F
AST (GOT) None +47 U/L@73 U/L AST None @ 9.03 mmol/L triglyceride None None None None Not Tested
BUN None None None None None None None Not Tested
C3 None@855 mmol/L Bilirubin None @ 0.78 mmol/L Hemoglobin None @ 8.5 mmol/L triglyceride Do Not Use Do Not Use Do Not Use Do Not Use Not Tested
C4 None@855 mmol/L Bilirubin None @ 0.78 mmol/L Hemoglobin None @ 8.5 mmol/L triglyceride Do Not Use Do Not Use Do Not Use Do Not Use Not Tested
CA None None None Do Not Use None Do Not Use None Not Tested
-0.1 mmol/L
- 0.4 mmol/L @ 139 µmol/L (conj) & 161 µmol @5.2 mmol/L
CHOL (unconj) Bilirubin @ 3.9 mmol/L CHOL None None None CHOL -12% -12% Not Tested
-0.7 mmol/L @ 219 µmol/L (conj) & 251 µmol
(unconj) Bilirubin @ 6.5 mmol/L CHOL
+10 U/L @ 50 U/L CK with
CK -10 U/L @ 58 U/L CK 0.15 mmol/L Hgb None Do Not Use None Do Not Use Do Not Use Not Tested

CKMB +20 U/L@28 U/L CKMB +7 U/L@21 U/L CKMB None Do Not Use None Do Not Use Do Not Use Not Tested

CL None@1642 mmol/L Bilirubin None None@11.3 mmol/L triglyceride Not Tested None Not Tested Not Tested Not Tested
CRBM None None None@11.4 mmol/L triglyceride None None Not Tested Not Tested Not Tested
CREA None@1026 µmol/L Bilirubin None None None None None None Not Tested
-15% at 3 mg/L
CCRP None @ 1368 µmol/L Bilirubin None @ 0.62 mmol/L Hemoglobin None @ 33.9 mmol/L triglyceride CRP None Not Tested Not Tested None
CRP None None None @ > 10.2 mmol/L triglyceride None None None None Not Tested
CSA None @1026 µmol/L Bilirubin N/A None @ 16.95 mmol/L triglyceride None Do Not Use Do Not Use Do Not Use Do Not Use
CSAE None @1026 µmol/L Bilirubin N/A None @ 16.95 mmol/L triglyceride None Do Not Use Do Not Use Do Not Use Do Not Use
CTNI (HM) None None@0.62 mmol/L Hemoglobin None@33.9 mmol/L triglyceride Do Not Use Not Tested Do not Use Not Tested None
DBI N/A See IFU3 - 22% @ 2.29 mmol/L triglyceride None None Not Tested Not Tested Not Tested
DBIL N/A -3 µmol/L @ 5 µmol/L DBIL None None None None None Not Tested
-26 µmol/L @ 74 µmol/L DBIL
None@0.01 g/L
DGNA None None None@11.4 mmol/L triglyceride None None None Na+F Not Tested
DGTX None@1026 µmol/L Bilirubin None@0.62 mmol/L Hemoglobin None@33.9 mmol/L triglyceride None None Not Tested Not Tested None
ECO2 <5%@1026 µmol/L Bilirubin <5%@0.62 mmol/L Hemoglobin <5%@33.9 mmol/L triglyceride Not Tested Not Tested Not Tested Not Tested None
FERR (HM) None@1026 µmol/L Bilirubin None@0.62 mmol/L Hemoglobin None@33.9 mmol/L triglyceride Not Tested None Do Not Use Not Tested None
FPSA None@1026 µmol/L Bilirubin None@0.62 mmol/L Hemoglobin None@33.9 mmol/L triglyceride Not Tested None Not Tested Not Tested Not Tested
FT4 (HM) None None@0.62 mmol/L Hemoglobin None@5.6 mmol/L triglyceride Not Tested None Do Not Use Not Tested None
GENT None @ 1368 µmol/L Bilirubin None@0.62 mmol/L Hemoglobin None@11.43 mmol/L triglyceride None None Not Tested Not Tested Not Tested
-12%@ 34.29 mmol/L triglyceride
GGT None None None None None None None Not Tested
GLU -0.7 mmol/L @6.9 mmol/L GLU -1.12 mmol/L@7.27 mmol/L GLU +0.56 mmol/L@ 7.16 mmol/L GLU None None None None Not Tested
Dimension® Clinical Chemistry System Interference Table - SI Units (cont. 2)
FAST FACTS
Method Bilirubin Hemoglobin (monomer) Lipemia EDTA Li+ Heparin K+ Oxalate Na+ Fluoride Na+ Heparin
2
342 µmol/L 0.31 mmol/L 6.86 mmol/L triglyceride 2 gm/L 280000 U/L 5g/L 4g/L 8000 U/L
GLUC None @ 1026 µmol/L Bilirubin None @ 0.62 mmol/L Hemoglobin None @ 4.52 mmol/L triglyceride Not Tested None Not Tested None None
None @ 45.2 mmol/L of native
triglyceride @ 2.78 mmol/L Gluc
HA1C None@1026 µmol/L Bilirubin None None@33.9 mmol/L triglyceride None None Do Not Use None None
HCG (HM) None@1026 µmol/L Bilirubin None@0.62 mmol/L Hemoglobin None@33.9 mmol/L triglyceride None None Do Not Use Not Tested None
IBCT None@1026 µmol/L Bilirubin None@0.16 mmol/L Hemoglobin None None None Not Tested Not Tested Not Tested
IGA None@684 mmol/L Bilirubin None None@8.5 mmol/L triglyceride Not Tested Not Tested Not Tested Not Tested None
IGG None@684 mmol/L Bilirubin None None@8.5 mmol/L triglyceride Not Tested Not Tested Not Tested Not Tested None
IGM None@684 mmol/L Bilirubin None None@8.5 mmol/L triglyceride Not Tested Not Tested Not Tested Not Tested None
+3.6 µmol/L at 0.03 mmol/L Hgb @ 15.8
IRN -2.5 µmol/L @18.3 µmol/L IRN µmol/L IRN None Do Not Use Do Not Use Do Not Use Do Not Use Not Tested
0.12 mmol/L Hgb + 22% @9.8 µmol/L
IRON None @1368 µmol/L Bilirubin IRON None @ 34.29 mmol/L triglyceride Do Not Use None Do Not Use Do Not Use None
0.12 mmol/L Hgb + 10% @19.2 µmol/L
IRON
K None@1642 mmol/L Bilirubin None None @11.3 mmol/L triglyceride Not Tested None Not Tested Not Tested Not Tested
LA None None None @11.29 mmol/L triglyceride Not Tested Do Not Use None None Do Not Use
LDH None +50 U/L@131 U/L LDH None Do Not Use None Do Not Use Do Not Use Not Tested
LHCG None@1026 µmol/L Bilirubin None@0.62 mmol/L Hemoglobin None@33.9 mmol/L triglyceride None None Do Not Use Not Tested None
LI None@1026 µmol/L Bilirubin None@0.62 mmol/L Hemoglobin None @36.7 mmol/L triglyceride Do Not Use Do Not Use Do Not Use Not Tested None
LIDO None @ 684 µmol/L Bilirubin None None@11.40 mmol/L triglyceride None Not Tested NotTested Not Tested None
LIP None +30 U/L@143 U/L LIP None@11.4 mmol/L triglyceride Do Not Use None Do Not Use Do Not Use None
LMMB None@1026 µmol/L Bilirubin None@0.62 mmol/L Hemoglobin None@16.93 mmol/L triglyceride None None Do Not Use Not Tested None
LPBN None@1026 µmol/L Bilirubin None@ 0.62 mmol/L Hemoglobin None @33.9 mmol/L triglyceride Not Tested None Not Tested Not Tested None
LTNI None None@ 0.62 mmol/L Hemoglobin None@33.9 mmol/L triglyceride Do Not Use Not Tested Do not Use Not Tested None
MALB None None @ 0.06 mmol/L Hemoglobin Not Tested Do Not Use Not Tested Not Tested Not Tested Not Tested
-0.16 mmol/L @
MG None @ 1026 µmol/L Bilirubin spuriously elevated results None @ 0.82 mmol/L of Mg 0.74 mg/dL MG None None None Not Tested
-0.41 mmol/L @ 0.74 mmol/L Mg -0.25 mmol/L @ 0.74 mmol/L MG
MMB (HM) None@1026 µmol/L Bilirubin None@0.62 mmol/L Hemoglobin None@16.93 mmol/L triglyceride None None Do Not Use Not Tested None
MYO (HM) None@1026 µmol/L Bilirubin None@ 0.62 mmol/L Hemoglobin None@16.93 mmol/L triglyceride Not Tested None Do Not Use Not Tested None
NA None@1642 mmol/L Bilirubin None None @ 11.4 mmol/L triglyceride Not Tested None Not Tested Not Tested Not Tested
NAPA None @ 1026 µmol/L Bilirubin None None@11.4 mmol/L triglyceride None None Not Tested Not Tested None
PALB None@1026 µmol/L Bilirubin None@ 0.62 mmol/L Hemoglobin None @ 11.4 mmol/L triglyceride None None Not Tested Not Tested None
PBNP None@1026 µmol/L Bilirubin None@ 0.62 mmol/L Hemoglobin None @33.9 mmol/L triglyceride Not Tested None Not Tested Not Tested None
PCHE None None None None None Do Not Use Do Not Use Not Tested
PHNO None @ 1368 µmol/L Bilirubin None@ 0.62 mmol/L Hemoglobin None @2.29 mmol/L triglyceride None None Not Tested Not Tested Not Tested
-11% @ 6.86 mmol/L triglyceride
PHOS +0.26 mmol/L@2.23 mmol/L PHOS None@ 0.62 mmol/L Hemoglobin +0.06 mmol/L@2.23 mmol/L PHOS None None None None Not Tested
PROC None @ 1026 µmol/L Bilirubin None None@11.4 mmol/L triglyceride None None Not Tested Not Tested None
PTN None @ 13680 µmol/L Bilirubin None@ 0.62 mmol/L Hemoglobin None @11.43 mmol/L triglyceride None None Not Tested Not Tested Not Tested
-18% @ 34.29 mmol/L triglyceride
RCRP None @ 684 µmol/L Bilirubin None None @ 11.43 mmol/L triglyceride None None @ 8000 U/L Not Tested Not Tested Not Tested
+30% @ 1026 µmol/L Bilirubin +35% @ 0.62 mmol/L Hemoglobin -69% @ 34.29 mmol/L triglyceride
SAL -15% @ 342 µmol/L Bilirubin None@ 0.62 mmol/L Hemoglobin None @11.43 mmol/L triglyceride None None Not Tested Not Tested Not Tested
-7@ at 86 µmol/L Bilirubin +96% @ 34.29 mmol/L triglyceride
-11 @ 34 µmol/L Bilirubin
T3 None@1026 µmol/L Bilirubin None @ 0.62 mmol/L Hemoglobin None @ 33.9 mmol/L triglyceride None None Not Tested Not Tested None
T4 None None None Do Not Use None None None Not Tested
TACR None@1026 µmol/L Bilirubin None None @11.30 mmol/L triglyceride None Not Tested Not Tested Not Tested Not Tested
TBI N/A None +18% @ 19 µmol/L total bilirubin None None Not Tested Not Tested Not Tested
TBIL N/A None None None None None None Not Tested
TCO2 None@1642 mmol/L Bilirubin None None @11.4 mmol/L triglyceride Not Tested None Not Tested Not Tested Not Tested
TGL None@1026 µmol/L Bilirubin None Not Tested Not Tested Not Tested Not Tested Not Tested None
THEO None None None None None None None Not Tested
TOBR None None None@11.4 mmol/L triglyceride None None Not Tested Not Tested Not Tested
Dimension® Clinical Chemistry System Interference Table - SI Units (cont. 3)
FAST FACTS
Method Bilirubin Hemoglobin (monomer) Lipemia EDTA Li+ Heparin K+ Oxalate Na+ Fluoride Na+ Heparin
2
342 µmol/L 0.31 mmol/L 6.86 mmol/L triglyceride 2 gm/L 280000 U/L 5g/L 4g/L 8000 U/L
TP -6 g/L @ 61 g/L TP +5 g/L @ 65 g/L TP None None None None None Not Tested
TPSA (HM) None@1026 µmol/L Bilirubin None@ 0.62 mmol/L Hemoglobin None @ 33.9 mmol/L triglyceride Not Tested None Not Tested Not Tested Not Tested
TRNF None @ 855 mmol/L Bilirubin None @ 0.78 mmol/L Hemoglobin None @ 8.5 mmol/L triglyceride Do Not Use None Not Tested Not Tested None
TSH (HM) None None@ 0.62 mmol/L Hemoglobin None @ 33.9 mmol/L triglyceride Not Tested None Do Not Use Not Tested None
TU None None None None None None None Not Tested
Do not use hemolyzed samples None @1 g/L None@1 mg/dL
UCFP None results are increased Not Tested EDTA Not Tested Not Tested Na+F Not Tested
URCA None None -12 µmol/L @ 256 µmol/L URCA None None None None Not Tested
VALP None @ 1026 µmol/L Bilirubin None @ 0.62 mmol/L Hemoglobin None @ 33.9 mmol/L triglyceride Not Tested None Not Tested Not Tested Not Tested
VANC None None None @11.4 mmol/L triglyceride None None None None @0.24 mmol/L Not Tested

1. Sodium heparin concentration routinely found in blood collection tubes.


2. Trigylceride testing was done using Intralipid®.
3. IFU - Instructions for Use (DBI insert sheet).

NOTE: * The word “None” indicates that no significant interference was observed; please refer to the
method-specific insert sheet for additional detail.
* See the method-specific insert sheet for information on interference from commonly administered
drugs, metabolites, etc.
HM Heterogeneous Immunoassay Module

Issued 9/07
Dimension® Clinical Chemistry System Calibration/Verification Information
FAST FACTS
Calibrator/Verifier Number Number of Hydrated (H) Reconstituted Liquid Calibration Calibration
Cat. No. Method Levels or Liquid (L) Volume (mL) Volume (mL) Open Vial Stability Type Frequency
ACP Verifier DC23 ACP 3 H 1.0 – 8 hours @ 2-8°C Verify 3 months
AHDL Calibrator DC48A AHDL 3 L – 1.0 7 days @ 2-8°C Linear 3 months
ALC Calibrator DC 37 ALC 3 L – 1.0 Use immediately Linear 3 months
ALDL DC131 ALDL 3 H 2.0 – 24 hours @ 2-8°C Linear 60 days
AMON Calibrator DC25 AMON 3 L – 2.0 Use immediately Linear 3 months
CCRP RC434 CCRP 5 L – 1.0 24 hours @ 2-8°C Logit 3 months
CHEM I Calibrator DC18A BUN 3 H 2.0 – 24 hours @ 2-8°C Linear 1 month
CA 3 H 2.0 – 24 hours @ 2-8°C Linear 3 months
CREA 3 H 2.0 – 24 hours @ 2-8°C Linear 3 months
GLU/GLUC 3 H 2.0 – 24 hours @ 2-8°C Linear 3 months
LA 3 H 2.0 – 24 hours @ 2-8°C Linear 3 months
URCA 3 H 2.0 – 24 hours @ 2-8°C Linear 3 months
CHEM II Calibrator DC20 MG 3 L – 1.2 Use immediately Linear 3 months
PHOS 3 L – 1.2 Use immediately Linear 3 months
TGL 3 L – 1.2 Use immediately Linear 3 months
CHOL Calibrator DC16 CHOL 3 H 1.0 – 24 hours @ 2-8°C Linear 3 months
CK Verifier DC26 CK 3 H 1.0 – 8 hours @ 2-8°C Verify 3 months
CKMB Verifier DC27 CKMB 3 H 1.0 – 8 hours @ 2-8°C Verify 3 months
CRP Calibrator DC30 CRP 2 5 L – 1.0 24 hours @ 2-8°C Logit 2 months
CSA Calibrator DC89 CSA 5 L (Frozen) – 2.5 (L1) 30 days @ 2-8°C Logit 30 days
2.0 (L2 - L5)
CSAE Calibrator DC108A CSAE 5 L (Frozen) – 2.0 30 days @ 2-8°C Logit 30 days
4
CTNI Calibrator RC421C CTNI / LTNI (HM) 5 L – 2.0 24 hours @ 2-8°C Logit 60 days
Drug Calibrator DC22B DGNA 5 L – 3.0 3 months @ 2-8°C Logit 1 month
LI 5 L – 5.0 3 months @ 2-8°C Logit 2 months
PHNO 2 5 L – 3.0 3 months @ 2-8°C Logit 1 month
PTN 2 5 L – 3.0 3 months @ 2-8°C Logit 1 month
THEO 2 5 L – 3.0 3 months @ 2-8°C Logit 2 months
Drug Calibrator II DC49D ACTM 3 L – 5.0 30 days @ 2-8°C Linear 3 months
CRBM 2 5 L – 5.0 30 days @ 2-8°C Logit 1 month
DGTX 5 L – 5.0 30 days @ 2-8°C Logit 1 month
GENT 2 5 L – 5.0 30 days @ 2-8°C Logit 1 month
LIDO 2 5 L – 5.0 30 days @ 2-8°C Logit 1 month
NAPA 2 5 L – 5.0 30 days @ 2-8°C Logit 1 month
PROC 2 5 L – 5.0 30 days @ 2-8°C Logit 1 month
TOBR 2 5 L – 5.0 30 days @ 2-8°C Logit 1 month
VALP 2 5 L – 5.0 30 days @ 2-8°C Logit 1 month
VANC 2 5 L – 5.0 30 days @ 2-8°C Logit 1 month
Drugs of Abuse Calibrator AMPH Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 days
(Syva Emit® 1) QUAL 1 1 pt at 300 ng/mL QUAL
AMPH Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 days
QUAL 1 1 pt at 500 ng/mL QUAL
AMPH Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 days
QUAL 1 1 pt at 1000 ng/mL QUAL
BARB Semi-Quant 5 L – 14.0 2-8°C 3 Logit 30 days
QUAL 1 1 pt at 200 ng/mL QUAL
Dimension® Clinical Chemistry System Calibration/Verification Information
FAST FACTS
Calibrator/Verifier Number Number of Hydrated (H) Reconstituted Liquid Calibration Calibration
Cat. No. Method Levels or Liquid (L) Volume (mL) Volume (mL) Open Vial Stability Type Frequency
BENZ Semi-Quant 5 L – 14.0 2-8°C 3 Logit 30 days
QUAL 1 1 pt at 200 ng/mL QUAL
COC Semi-Quant 5 L – 14.0 2-8°C 3 Logit 30 days
QUAL 1 1 pt at 150 ng/mL QUAL
COC Semi-Quant 5 L – 14.0 2-8°C 3 Logit 30 days
QUAL 1 1 pt at 300 ng/mL QUAL
EXTC Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 days
QUAL 1 1 pt at 300 ng/mL QUAL
EXTC Semi-Quant 5 L – 14.0 2-8°C 3 Logit 30 days
QUAL 1 1 pt at 500 ng/mL QUAL
METH Semi-Quant 5 L – 14.0 2-8°C 3 Logit 30 days
QUAL 1 1 pt at 300 ng/mL QUAL
OPI Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 days
QUAL 1 1 pt at 2000 ng/mL QUAL
OPI Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 days
QUAL 1 1 pt at 300 ng/mL QUAL
PCP Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 days
QUAL 1 1 pt at 25 ng/mL QUAL
THC Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 days
QUAL 1 L 1 pt at 50 ng/mL Qual
ECO2 Calibrator DC137 ECO2 3 L – 1.2 Use Immediately Linear 90 days
Enzyme Verifier DC19 ALP 3 H 2.0 – 8 hours @ 2-8°C Verify 3 months
ALT (GPT) 3 H 2.0 – 8 hours @ 2-8°C Verify 3 months
AMY 3 H 2.0 – 8 hours @ 2-8°C Verify 3 months
AST (GOT) 3 H 2.0 – 8 hours @ 2-8°C Verify 3 months
GGT 3 H 2.0 – 8 hours @ 2-8°C Verify 3 months
LDH 3 H 2.0 – 8 hours @ 2-8°C Verify 3 months
FERR Calibrator RC440 FERR (HM) 5 L – 1.0 30 days @ 2-8°C Logit 3 months
HA1C Calibrator DF105 HA1C 2 4 H 2.0 – 48 hours @ 2-8°C Logit 30 days
HCG Calibrator RC430 HCG / LHCG4 (HM) 5 H 2.0 – 24 hours @ 2-8°C Logit 60 days
IBCT Calibrator DC84 IBCT 3 L – 1.0 30 days @ 2-8°C Linear 3 months
IRN Calibrator DC21 IRN 3 L – 1.2 Use Immediately Linear 3 months
IRON Calibrator DC85 IRON 2 L – – Use Immediately Linear 3 months
LIP Calibrator DC15A LIP 3 H 3.0 – 24 hours @ 2-8°C Linear 45 days
MALB Calibrator DC114 MALB2 5 L – 1.0 30 days @ 2-8°C Logit 30 days
MMB Calibrator RC420 MMB / LMMB 4 (HM) 5 H 2.0 – 24 hours @ 2-8°C Logit 60 days
MYO Calibrator RC422 MYO (HM) 5 L – 1.0 5 days @ 2-8°C Logit 90 days
PALB Calibrator DC50 PALB 2 5 L – 1.0 30 days @ 2-8°C Logit 2 months
PBNP Calibrator RC423 PBNP / LPBN 4 (HM) 5 L – 1.0 7 days @ 2-8°C Logit 30 days
PCHE Verified DC28 PCHE 3 H 2.0 – 24 hours @ 2-8°C Verify 3 months
RCRP Calibrator DC34 RCRP 2 5 L – 1.0 24 hours @ 2-8°C Logit 60 days
SAL Calibrator DC38 SAL 3 L – 4.0 3 months @ 2-8°C Linear 3 months
Special Protein Calibrator DC51 C3 2 5 L – 1.5 7 days @ 2-8°C Logit 60 days
C4 2 5 L – 1.5 7 days @ 2-8°C Logit 60 days
IGA 2 5 L – 1.5 7 days @ 2-8°C Logit 60 days
Dimension® Clinical Chemistry System Calibration/Verification Information
FAST FACTS
Calibrator/Verifier Number Number of Hydrated (H) Reconstituted Liquid Calibration Calibration
Cat. No. Method Levels or Liquid (L) Volume (mL) Volume (mL) Open Vial Stability Type Frequency
IGG 2 5 L – 1.5 7 days @ 2-8°C Logit 60 days
IGM 2 5 L – 1.5 7 days @ 2-8°C Logit 60 days
TRNF 2 5 L – 1.5 7 days @ 2-8°C Logit 60 days
T3 Calibrator RC414 T3 5 L – L1 - 2 ml 30 days @ 2-8°C Logit 60 days
L2-5 - 1 mL
T4 Calibrator DC13 T4 5 H 1.0 – 8 hours @ 2-8°C Logit 2 months
TACR DC107 TACR 5 L (frozen) – L1 - 2 ml 30 days @ 2-8°C Logit 30 days
L2-5 - 1 mL
TBIL/DBIL Calibrator DC17 DBIL 3 H 1.0 – 24 hours @ 2-8°C Linear 3 months
TBIL 3 H 1.0 – 24 hours @ 2-8°C Linear 3 months
TBI/DBI Calibrator DC167 DBI 3 H 1.0 – 24 hours @ 2-8°C Linear 90 days
TBI 3 H 1.0 24 hours @ 2-8°C Linear 90 days
T/F PSA Calibrator RC452 FPSA (HM) 5 L – 1.0 3 days @ 2-8°C Logit 90 days
TPSA (HM) 5 L – 1.0 3 days @ 2-8°C Logit 90 days
Thyroid Calibrator RC410 FT4 (HM) 5 L – 2.0 3 months @ 2-8°C Logit 30 days
TSH (HM) 5 L – 2.0 3 months @ 2-8°C Logit 60 days
TP/ALB Calibrator DC31 ALB 3 H 2.0 – 8 hours @ 2-8°C Linear 3 months
TP 3 H 2.0 – 8 hours @ 2-8°C Linear 3 months
TU Calibrator DC14 TU 5 H 2.0 – 8 hours @ 2-8°C Logit 2 months
UCFP Calibrator DC45 UCFP 5 L – 4.0 2 months @ 2-8°C Logit 2 months

1 : See Syva Emit® calibrator insert sheet for additional information. HM : Hetergeneous Immunoassay Module
2 : Recalibration is required after the source lamp is replaced in the instrument. pt : Point
3 : See vial label on the Syva Emit® calibrators for expiration date
4 : For use on Dimension® Xpand® system only. EMIT® is a registered trademark of Dade Behring Inc.

Issued 9/07

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