Dimension Clinical Chemistry System Method Specifics ......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 –

Dimension® Clinical Chemistry System Method Specifics FAST FACTS

Precision Guidelines

MethodCat. No. Units

Assay Range

Reference Interval

Recommended Specimens

Total Sample Volume

(µL)

Reduced Sample Volume

(µL)1Recommended Manual Diluent

AutoDilute Sample Volume

(µL)1 Concentration 5-Test SDABS DF79 mAU N/A N/A ABS soln 5 N/A N/A N/A N/A N/AACP 1 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 0.3ACTM 1 DF88 µg/mL 0.0 – 300.0 10.0 – 30.0 S, P 2 x 4 N/A Acetaminophen Free Serum 2 16.2 1.93

Drug Calibrator II Level 1 75.0 2.35AHDL DF48A mg/dL 10 – 150 < 40 Low HDL S, P 3 N/A Water 2 2 30 2

> 60 High HDL 50 2

ALB DF13 g/dL 0.6 – 8.0 3.4 – 5.0 S, P 5 N/A Water 2 2 0.69 0.103.84 0.12

ALC DF18 mg/dL 0.0 – 300.0 (S,ppWB) Negative3 S, ppWB, U 3 N/A Water 2 2 100 3(U) - 50.0 300 6

ALDL DF131 mg/dL 5 - 300




Assay Range

Reference Interval


Total Sample Volume

(µL)




(µL)1 Concentration 5-Test SDCSAE DF108 ng/mL 350 - 2000 see IFU4 WB 3 NA Level 0 Calibrator N/A 800 87.5

1400 127.4CTNI (HM) RF421C ng/mL 0.04 – 40.00 0.00 – 0.05 S, P 50 N/A Water 2 20 2.0 0.20

25 1.50DBIL DF25A mg/dL 0.00 – 20.00 0.00 – 0.30 S, P 31 13 Water 2 10 0.6 0.06

16.8 0.34DBI DF125 mg/dL 0.05 - 16.0 0.0 - 0.2 S, P 10 NA Water 2 5 0.6 0.06

16 0.34DGNA 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 0.09DGTX DF36 ng/mL 2.0 – 80.0 14 – 26 S, P 20 N/A Digitoxin Free Serum N/A 10 1.0

40 4.0ECO2 DF137 mmol/L 5 – 45 21 – 32 S, P 5 N/A Water 2 N/A 25 1.2

50 2FERR (HM) RF440 ng/mL 1 - 1000 3 – 388 S, P 40 N/A Sample Diluent 5 2 25 1.4

FERR Calibrator Level 1 150 5.1500 18.2

FPSA (HM) RF452 ng/mL 0.05 - 45.00 < 4.00 S, P 60 N/A N/A 4.00 0.2710.00 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 0.103.00 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 0.17Drug Calibrator II Level 0 6.0 0.21

GGT DF45A U/L 0 – 800 5 – 85 S, P 32 15 Enzyme Diluent 16 80 3400 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)




Assay Range

Reference Interval


Total Sample Volume

(µL)




(µL)1 Concentration 5-Test SD306 10

LHCG (HM) 7 RF530 mIU/mL 1 - 1000 0 - 6 NPF S, P 40 N/A Sample Diluent 5 2 6 25 2.50 - 2 Males 150 11

500 37LI1 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 0.08LIDO DF113 µg/mL 0.5 - 12.0 1.5 - 5.0 S, P 6 N/A Water 2 2 3.0 0.17

6.0 0.26LIP DF55A U/L 50 – 1500 114 – 286 S, P 4 N/A Water 2 2 148 7

802 20LMMB (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 1.1300 20

LPBN (HM) 7 RF523 pg/mL 10 - 20,000 (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 0.2025.0 1.50

MALB DF114 mg/L 1.3 - 100




Assay Range

Reference Interval


Total Sample Volume

(µL)




(µL)1 Concentration 5-Test SDSAL DF20 mg/dL 0.0 – 100.0 2.8 – 20.0 S 15 N/A Water 2 5 20 1.0

100 2.0T3 (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 0.25T4 DF65 µg/dL 0.5 – 24.0 4.7 – 13.3 S, P 16 N/A Water 2 4 5.1 0.8

13.9 1TACR DF107 ng/mL 1.2 - 30.0 see IFU4 WB 20 N/A TACR Calibrator Level 1 N/A 6 0.76

12 1.04TBI DF167 mg/dL 0.1 - 25.0 0.2 - 1.0 S, P 10 N/A Water 2 5 1.1 0.03

18.8 0.56TBIL DF67A mg/dL 0.00 – 25.00

Dimension® Clinical Chemistry System SI Method Specifics FAST FACTS


Method Cat. No. UnitsAssay Range Reference Interval


Total Sample Volume

(µL)



AutoDilute Sample

Volume (µL)1 Concentration 5-Test SDABS DF79 mAU N/A N/A ABS soln 5 N/A N/A N/A N/A N/AACP 1 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 0.3ACTM 1 DF88 µmol/L 0.0 – 1985.4 66.2 - 198.5 S, P 2 x 4 N/A Acetaminophen Free Serum 2 107.2 12.78

Drug Calibrator II Level 1 496.4 15.56AHDL 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 1.038 1.2

ALC DF18 mmol/L 0.0 - 65.0 (S,ppWB) Negative 3 S, ppWB, U 3 N/A Water 2 2 100 3(U) - 50.0 300 6

ALDL DF131 mmol/L 0.13 - 7.8





Total Sample Volume

(µL)



AutoDilute Sample

Volume (µL)1 Concentration 5-Test SD1164.8 106.0

CTNI (HM) RF421C µg/L 0.04 – 40.00 0.00 – 0.05 S, P 50 N/A Water 2 20 2.0 0.2025 1.50

DBIL DF25A µmol/L 0 – 342 0 - 5 S, P 31 13 Water 2 10 10.3 1.03287 5.8

DBI DF125 µmol/L 0.9 - 274 0 - 3 S, P 10 NA Water 2 5 10.3 1.0287 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 0.083.07 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 1.352.4 5.2

ECO2 DF137 mmol/L 5 – 45 21 – 32 S, P 5 N/A Water 2 N/A 25 1.250 2

FERR (HM) RF440 µg/L 1 – 1000 8 – 388 S, P 40 N/A Sample Diluent 5 2 25 1.4FERR Calibrator Level 1 150 5.1

500 18.2FPSA (HM) RF452 µg/L 0.05 - 45.00 < 4.00 S, P 60 N/A N/A 4.00 0.27

10.00 0.7FT4 (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 3.22GENT 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 0.45GGT DF45A U/L 0 – 800 5 – 85 S, P 32 15 Enzyme Diluent 16 80 3

400 7GLU 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)





Total Sample Volume

(µL)



AutoDilute Sample

Volume (µL)1 Concentration 5-Test SDLHCG (HM) 7 RF530 IU/L 1 - 1000 0 - 6 NPF S, P 40 N/A Sample Diluent 5 2 6 25 2.5

0 - 2 Males 150 11500 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 0.061.8 0.08

LIDO DF113 µmol/L 2.14 - 51.2 6.4 - 21.3 S, P 6 N/A Water 2 2 12.8 0.7325.6 1.11

LIP DF55A U/L 50 – 1500 114 – 286 S, P 4 N/A Water 2 2 148 7802 20

LMMB (HM) 7 RF520 µg/L 0.5 – 300.0 0.0 – 3.6 S, P 60 N/A Sample Diluent 5 30 0 1.010 1.1300 20

LPBN (HM) 7 RF523 pg/mL 10 - 20,000 (75 years) 450 PBNP Calibrator Level 1 450 45

LTNI (HM) 7 RF521 µg/L 0.04 – 40.00 0.00 – 0.05 S, P 50 N/A Water 2 20 2.0 0.2025.0 1.50

MALB DF114 mg/L 1.3 - 100





Total Sample Volume

(µL)



AutoDilute Sample

Volume (µL)1 Concentration 5-Test SDTACR 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 1.35TBI DF167 µmol/L 2 - 428 3 to 17 S, P 10 N/A Water 2 5 19 0.5

322 10TBIL DF67A µmol/L 0 – 428 < 17.10 S, P 28 12 Water 2 14 18.8 0.51

321.5 9.58TGL DF69A mmol/L 0.17 – 11.3

Dimension® Clinical Chemistry System Method InformationFAST FACTS

Flex® Well Stability on the Instrument

Method

Sample Initiated Reaction Wavelength

Measurement Type Unopened Opened (well #)

Tests/Well

Tests/Flex®

Flex®/Carton

ABS 510/405 End Point 30 days 72 hours 5 30 4ACP4 600/700 Rate 30 days 72 hours 5 15 8ACTM4 600/700 End Point 30 days 72 hours 10 20 4AHDL 600/700 End Point 30 days 3 days (1–3); 10 days (4); 15 days (5–6) 10 30 8ALB X 540/600/700 End Point 30 days 72 hours 20 120 4ALC X 340/383 End Point 30 days 5 days 6 30 4ALDL 540/700 End Point 30 days 5 days 10 30 4ALP 405/510 Rate 30 days 48 hours (1–6); 30 days (8) 30 90 4ALT (GPT) 340/700 Rate 30 days 72 hours 20 60 4AMON4 340/383 Rate 30 days 72 hours 5 15 8AMY X 405/577 Rate 30 days 72 hours 10 60 4AST (GOT) 340/700 Rate 30 days 72 hours 30 90 4BUN X 340/383 Rate 30 days 5 days 40 120 4C3 1 340/700 Turbidimetric – End Point 30 days 4 days 10 30 4C4 1 340/700 Turbidimetric – End Point 30 days 4 days 10 30 4CA X 577/540 End Point 30 days 24 hours (1–6); 10 days (7–8) 10 60 8CCRP 1 X 405/510 Rate 30 days 10 days (1,3); 3 days (4-6) 10 30 4CHOL X 452/540/700 End Point 30 days 5 days 20 60 8CK X 340/405 Rate 30 days 5 days 20 120 4CKMB X 340/405 Rate 30 days 48 hours (1–5); 30 days (6) 6 30 4CRBM 1 340/700 Turbidimetric – Rate 30 days 72 hours 10 20 4CREA X 510/600 Rate 30 days 5 days 40 120 4CRP 1 340/700 Turbidimetric – Rate 30 days 72 hours (1–6); 30 days (7–8) 10 30 4RCRP 1,4 X 340/700 Turbidimetric – Rate 30 days 72 hours 10 30 4CSA 577/700 Rate 30 days 72 hours (1-6); 10 days (7-8) 10 20 4CSAE 577/700 Rate 30 days 72 hours (1-6); 10 days (7-8) 10 20 4CTNI (HM) 510/700 Rate 30 days 3 days 30 30 4DBI 540/700 End Point 30 days 2 days (1-4), 30 days (5-8) 10 40 8DBIL 540/700 End Point 30 days 48 hours 10 40 8DGNA (HM) 577/700 Rate 30 days 72 hours (1–6); 10 days (7) 10 20 4DGTX (HM) 577/700 Rate 30 days 72 hours (1–6); 10 days (7) 10 20 4ECO2 X 405/700 Rate 30 days 2 days 15 90 4FERR (HM) 577/700 Rate 30 days 10 days (1, 3, 7), 3 days (4–6) 10 30 4FPSA 577/700 Rate 30 days 15 days (1-3, 7), 5 days (4–6) 10 30 4FT4 (HM) 510/700 Rate 30 days 3 days (1–4), 6 days (5–8) 15 30 4GENT 1 340/700 Turbidimetric – Rate 30 days 72 hours (1–6); 30 days (8) 10 20 4GGT X 405/600 Rate 30 days 72 hours (1–6); 30 days (7–8) 12 72 4GLU X 340/383 End Point 30 days 5 days 40 240 4GLUC X 340/383 End Point 42 days 7 days 60 360 4HA1C 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 A1CHCG (HM) 577/700 Rate 30 days 5 days (1–2), 3 days (4–6), 10 days (3,8) 10 30 4IBCT 600/700 End Point 30 days 6 days (1–3), 30 days (4–8) 20 60 4IGA 1,4 340/700 Turbidimetric – Rate 30 days 4 days 10 30 4



Method



Tests/Well

Tests/Flex®

Flex®/Carton

IGG 1,4 340/700 Turbidimetric – Rate 30 days 4 days 10 30 4IGM 1,4 340/700 Turbidimetric – Rate 30 days 4 days 10 30 4IRN 600/700 End Point 30 days 72 hours (1–5); 30 days (6–8) 12 60 4IRON 600/700 End Point 30 days 3 days (1-4), 14 days (5-6) 15 60 4LA 340/383 End Point 30 days 5 days 15 30 4LDH X 340/383 Rate 30 days 72 hours (1–6); 30 days (7) 20 120 4LHCG (HM) 2 577/700 Rate 30 days 5 days (1–2), 3 days (4–6), 10 days (3,8) 10 30 4LI4 X 540/700 Endpoint 30 days 5 days 10 20 4LIDO 1 340/700 Turbidimetric – Rate 30 days 72 hours 10 20 4LIP (Cal) X 577/700 Rate 30 days 48 hours (1–6); 30 days (7–8) 10 30 4LMMB (HM) 2 577/700 Rate 30 days 3 days (1–6), 10 days (7–8) 10 20 4LPBN (HM) 2 X 510/700 Rate 30 days 3 days (1-4), 6 days (6-8) 9 18 4LTNI (HM) 2 510/700 Rate 30 days 3 days 18 18 4MALB 340/700 Turbidimetric – Rate 30 days 3 days 10 20 4MG4 X 600/510 End Point 30 days 48 hours 10 30 4MMB (HM) 577/700 Rate 30 days 3 days (1–6), 10 days (7–8) 20 40 4MYO (HM) 577/700 Rate 30 days 5 days (4–6), 10 days (1, 3, 7,8) 10 30 4NAPA 1 340/700 Turbidimetric – Rate 30 days 72 hours 10 20 4PALB 1 X 383/700 Turbidimetric – Rate 30 days 72 hours 10 30 4PBNP (HM) 510/700 Rate 30 days 3 days (1-4), 6 days (6-8) 15 30 4PCHE 600/700 Rate 30 days 72 hours 10 30 4PHNO 1 340/700 Turbidimetric – Rate 30 days 72 hours 10 20 4PHOS 340/383 or 340/700 3 End Point 30 days 72 hours (1–6); 30 days (7–8) 20 120 4PROC 1 340/700 Turbidimetric – Rate 30 days 72 hours 10 20 4PTN 1 340/700 Turbidimetric – Rate 30 days 72 hours (1–6); 7 days (7– 8) 7 28 4SAL 510/700 End Point 30 days 5 days 10 30 4T3 577/700 Rate 30 days 3 days (1-6), 10 days (7-8) 10 20 4T4 340/383 Rate 30 days 72 hours (1–6); 15 days (7–8) 15 30 4TACR 577/700 Rate 30 days 48 hours (1-8), 6 days (7-8) 10 20 4TBI 540/700 End Point 30 days 5 days (1-4,6), 12 days (2) 15 60 8TBIL 540/700 End Point 30 days 5 days (1,4–6); 15 days (2), 72 hours (3) 15 60 8TGL X 510/700 Endpoint 30 days 10 days 20 120 4THEO 1 340 Turbidimetric – Rate 30 days 72 hours (1–5); 30 days (7) 10 20 4TOBR 1 340/700 Turbidimetric – Rate 30 days 72 hours (1–6); 30 days (8) 10 20 4TP 540/700 End Point 30 days 5 days 40 120 4TPSA (HM) 577/700 Rate 30 days 15 days (1, 3, 7), 5 days (4–6) 10 30 4TRNF 1 340/700 Turbidimetric – End Point 30 days 4 days 10 30 4TSH (HM) 510/700 Rate 30 days 3 days (1–4), 7 days (6–8) 25 50 4TU 340/383 Rate 30 days 48 hours (1–6); 15 days (7–8) 10 20 8UCFP X 600/700 End Point 30 days 5 days 4 20 4URCA X 293/700 End Point 30 days 72 hours (1–3, 7); 30 days (8) 20 60 8VALP 1 340/700 Turbidimetric – Rate 30 days 72 hours 10 20 4VANC 1 340/700 Turbidimetric – Rate 30 days 72 hours (1–6); 30 days (8) 10 20 4



Method



Tests/Well

Tests/Flex®

Flex®/Carton

*two cuvette method

1 : Recalibration is required after the source lamp is replaced in the instrument2 : 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 methodsHM : Heterogeneous Immunoassay Module

Issued 9/07

Dimension® Clinical Chemistry System Urine Drugs of Abuse Method SpecificsFAST FACTS Recommended

Autodilute Cut-Off Precision Guidelines*

Method Cat. No. UnitsAssay Range Semi-Quantitative


Sample Volume (µL)

Recommended Manual Diluent

Sample Volume (µL)

Concentration 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 7QUAL 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 4.8QUAL 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 5.2QUAL qualitative N/A 1000 18 1.8

BARB DF96A ng/mL semi-quantitative 20 - 720 Urine 10 Water f 2 200 18 9QUAL 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 9QUAL 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 16.7QUAL 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 20QUAL 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 6.8QUAL 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 6.6QUAL 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 5QUAL 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 10QUAL 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/AQUAL 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 10QUAL 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 9QUAL 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


Method Wavelength Measurement TypeNumber of

Reagents in Flex®

Number of Reagent Deliveries to 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 AbuseFAST FACTS

Method AcetoneAscorbic

Acid Bilirubin Creatinine EthanolGamma-Globulin Glucose Hemoglobin

Human Serum

Albumin Oxalic Acid

Sodium 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 NoneBARB None None None None None None None None None None None None None

BENZ None None None None None None None None None NoneNone

@3.0 g/dL None None

COCNone

@0.5 g/dL None None NoneNone

@0.5 g/dL None None None None None None None None

EXTC None NoneNone

@2.0 mg/dL None None None None None None None None None NoneMETH None None None None None None None None None None None None NoneOPI None None None None None None None None None None None None None

PCP None None None None None None None None None NoneNone

@1.0 g/dL None NoneTHC None None None None None None None None None None None None None

Issued 9/07

Dimension® Clinical Chemistry System Urine Test Method SpecificsFAST FACTS

Dilution Recommended Recommended

24 hr CollectionSample Volume

Sample Dilution

Factors (Number )

Autodilute Sample

Manual Dilute Sample Units Assay

24 hour Reference Units Random Reference

AMY a refrigerate b 14 1 : 2 c 2 N/A Enzyme U/L 0 – 650 59 – 401 U/24 hr 30 – 200Diluent

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 – 17.524 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 – 125Diluent [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

Dimension® Clinical Chemistry System ELECTROLYTES MultiPLY® FAST FACTS Integrated Multisensor (IMT)

for Dimension® AR systems

Test SpecificationsDirect IndirectAssigned Assigned Precision Guidelines

MethodRecommended

SpecimensSample

Volume (µL)Units [SI]

Assay Range

Reference Interval

Decimal Place

Calibration Material

Measurement Type Coefficients Coefficients

Concentrationof Sample 5 Test SD

C0 C1 C0 C1

Na S, P, U a mmol/L 50 – 200 140 – 148 0

IMT Standard A,

BDirect

Potentiometric 0 0.96 0 0.93120 160

2.0 2.0

K S, P, U a mmol/L 1.0 – 10.0 3.6 – 5.2 1

IMT Standard A,

BDirect

Potentiometric 0 0.96 0 0.93 2.0 6.00.15 0.15

Cl S, P, U a mmol/L 50 – 200 100 – 108 0

IMT Standard A,

BDirect

Potentiometric 0 0.96 0 0.96 95 1282.0 2.0

TCO2 S, P a mmol/L 5.0 – 45.0 21 – 32 1

IMT Standard A,

BIndirect

Potentiometric -6.25 1.25 -6.25 1.2520 30

2.0 2.0

Urine Test Specifications

24 hr Dilution Factors Random 24 hr

MethodCollection (Additive)

Sample Dilution

(Number to Enter) d

Assay Range

Reference Interval Units [SI]

Reference Interval

Na b refrigerate 1 : 3 c none 2 – 300 20 – 110 mmol/24 hr 40 – 220K b refrigerate 1 : 3 c none 1 – 100 12 – 75 mmol/24 hr 25 – 125Cl b refrigerate 1 : 3 c 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 unacceptablec: Dilute 1 part sample with 2 parts MultiPLY® Urine Diluent for a 1:3 dilutiond: 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 ConcentrationAssay Reference Decimal Sample Calibration Measurement Coefficients of Sample 5 Test SD

Method Specimens Volume (µL) Units [SI] Range Interval Place Dilution Material Type C 0 C 1

Na S, P, U45 µL a

(XL, RxL, ARx) mmol/L 50 – 200 136 – 145 0 1:10Indirect IMT

Standard A, B Potentiometric 1.5 1.01 120 2.040 µL (Xpand®) 160 2.0

K S, P, U a mmol/L 1.0 – 10.0 3.5 – 5.1 1 1:10Indirect IMT

Standard A, B Potentiometric -0.2 1.05 2.0 0.156.0 0.15

Cl S, P, U a mmol/L 50 – 200 98 – 107 0 1:10Indirect IMT

Standard A, B Potentiometric -10 1.09 95 2.0128 2.0

TCO2 S, P a mmol/L 5.0 – 45.0 21 – 32 1 1:10Indirect IMT

Standard A, B Potentiometric -6 1.15 20 2.030 2.0

Urine Test Specifications

24 hr Dilution Factors Random 24 hr

Method24 hr Collection

(Additive)Sample Dilution

(Number to Enter)

Assay Range

Reference Interval

Units [S. I.]

Reference Interval

Na b refrigerate 1 : 10 c none 5 – 300 20 – 110 mmol/24 hr 40 – 220

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

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

a: Volume used for all four electrolytesb: Acidified samples are unacceptablec: XL/RxL/Arx/Xpand®/RxL Max® systems automatically dilute urine Na, K, Cl

Issued 9/07

Recommended

Dimension® Clinical Chemistry System Interference TableFAST FACTSMethod Bilirubin Hemoglobin (monomer) Lipemia EDTA Li+ Heparin K+ Oxalate Na+ Fluoride Na+ Heparin

20 mg/dL 500 mg/dL 600 mg/dL triglyceride2 200 mg/dL 280 U/mL 500 mg/dL 400 mg/dL 8000 U/LACP None None None Do Not Use None None None Not TestedACTM -21% None @1000 mg/dL Hemoglobin None @3000 mg/dL triglyceride None None None None Not Tested

None @ 5 mg/dL BilirubinAHDL None @80 mg/dL Bilirubin None @1000 mg/dL Hemoglobin None @3000 mg/dL triglyceride None None Not Tested Not Tested None

ALB None None None None-2.4 g/[email protected] g/dL

ALB None NoneNone @14.3 U/mL

Na Heparin1

ALC None None @ 1000 mg/dL Hemoglobin None @ 1000 mg/dL triglyceride Not Tested None None See IFU3 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 NoneALP None None None Do Not Use None None None Not TestedALT (GPT) None None None @800 mg/dL triglyceride None None None None Not TestedAMON None Do Not Use None None None None None Not TestedAMY None None None @1000 mg/dL triglyceride Do Not Use Not Tested Do Not Use None @1 mg/dL Not Tested

Na+FAST (GOT) None +47 U/L@73 U/L AST None @ 800 mg/dL triglyceride None None None None Not TestedBUN None None None None None None None Not TestedC3 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 TestedC4 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 TestedCA None None None Do Not Use None Do Not Use None Not Tested

CHOL -15 mg/dL @ 8.1 mg/dL (conj) None None None-4mg/dL @200 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 CHOLCK -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 TestedCKMB +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 TestedCL None@94 mg/dL Bilirubin None None@1000 mg/dL triglyceride Not Tested None Not Tested Not Tested Not TestedCRBM None None None@1000 mg/dL triglyceride None None Not Tested Not Tested Not TestedCREA None @ 60 mg/dL Bilirubin None None None None None None Not Tested

CCRP None @ 80 mg/dL Bilirubin None @ 1000 mg/dL Hemoglobin None @ 3000 mg/dL triglyceride-15% at 3 mg/L

CRP None Not Tested Not Tested NoneCRP None None None @900 mg/mL TRIG None None None None Not TestedCSA None @ 60 mg/dL Bilirubin N/A None @ 1500 mg/dL triglyceride None Do Not Use Do Not Use Do Not Use Do Not UseCSAE None @ 60 mg/dL Bilirubin N/A None @ 1500 mg/dL triglyceride None Do Not Use Do Not Use Do Not Use Do Not UseCTNI (HM) None None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride Do Not Use Not Tested Do not Use Not Tested NoneDBI N/A See IFU3 -22% @ 200 mg/dL triglyceride None None Not Tested Not Tested Not TestedDBIL 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 DBILDGNA None None None@1000 mg/dL triglyceride None None None None@1 mg/dL Na+F Not TestedDGTX None@60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride None None Not Tested Not Tested NoneECO2


20 mg/dL 500 mg/dL 600 mg/dL triglyceride2 200 mg/dL 280 U/mL 500 mg/dL 400 mg/dL 8000 U/LNone @ 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 NoneHCG (HM) None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride None None Do Not Use Not Tested NoneIBCT None @ 60 mg/dL Bilirubin None@250 mg/dL Hemoglobin None Not Tested None Not Tested Not Tested NoneIGA None@40 mg/dL Bilirubin None None@750 mg/dL triglyceride Not Tested Not Tested Not Tested Not Tested NoneIGG None@40 mg/dL Bilirubin None None@750 mg/dL triglyceride Not Tested Not Tested Not Tested Not Tested NoneIGM None@40 mg/dL Bilirubin None None@750 mg/dL triglyceride Not Tested Not Tested Not Tested Not Tested NoneIRN -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 TestedIRON 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 IRONK None@94 mg/dL Bilirubin None None@1000 mg/dL triglyceride Not Tested None Not Tested Not Tested Not TestedLA None Gross hemolysis elevates LA None @1000 mg/dL triglyceride Not Tested Do Not Use None None Do Not UseLDH None +50 U/L@131 U/L LDH None Do Not Use None Do Not Use Do Not Use Not TestedLHCG None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride None None Do Not Use Not Tested NoneLI 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 NoneLIDO None @ 40 mg/dL Bilirubin None None@1000 mg/dL triglyceride None Not Tested NotTested Not Tested NoneLIP None +30 U/L@143 U/L LIP None@1000 mg/dL triglyceride Do Not Use None Do Not Use Do Not Use NoneLMMB 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 NoneLTNI None None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride Do Not Use Not Tested Do not Use Not Tested NoneMALB None None @ 10 mg/dL Hemoglobin Not Tested Do Not Use Not Tested Not Tested Not Tested Not Tested

MG None @ 60 mg/dL Bilirubin spuriously elevated results None at 2.0 mg/dL Mg -0.4 mg/dL

@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 NoneNA None@94 mg/dL Bilirubin None None@1000 mg/dL triglyceride Not Tested None Not Tested Not Tested Not TestedNAPA None @ 60 mg/dL Bilirubin None None@1000 mg/dL triglyceride None None Not Tested Not Tested NonePALB None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None @1000 mg/dL triglyceride None None Not Tested Not Tested NonePBNP None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None @3000 mg/dL triglyceride Not Tested None Not Tested Not Tested NonePCHE None None None None None Do Not Use Do Not Use Not TestedPHNO 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 triglyceridePHOS +0.26 mg/[email protected] mg/dL PHOS None@1000 mg/dL Hemoglobin +0.06 mg/[email protected] mg/dL PHOS None None None None Not TestedPROC None @ 60 mg/dL Bilirubin None None @1000 mg/dL triglyceride None None Not Tested Not Tested NonePTN 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 triglycerideRCRP 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 triglycerideSAL -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 NoneT4 None None None Do Not Use None None None Not TestedTACR None @ 60 mg/dL Bilirubin None None@1000 mg/dL triglyceride None Not Tested Not Tested Not Tested Not TestedTBI N/A None + 18% @ 1.1 mg/dL total bilirubin None None Not Tested Not Tested Not TestedTBIL N/A None None None None None None Not TestedTCO2 None@94 mg/dL Bilirubin None None@1000 mg/dL triglyceride Not Tested None Not Tested Not Tested Not TestedTGL None @ 60 mg/dL Bilirubin None Not Tested Not Tested Not Tested Not Tested Not Tested NoneTHEO None None None None None None None Not TestedTOBR None None None@1000 mg/dL triglyceride None None Not Tested Not Tested Not Tested


20 mg/dL 500 mg/dL 600 mg/dL triglyceride2 200 mg/dL 280 U/mL 500 mg/dL 400 mg/dL 8000 U/LTP -0.6 g/[email protected] g/dL TP +0.5 g/dL @ 6.5 g/dL TP None None None None None Not TestedTPSA (HM) None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None @3000 mg/dL triglyceride Not Tested None Not Tested Not Tested Not TestedTRNF None@50 mg/dL Bilirubin None@1300 mg/dL Hemoglobin None@750 mg/dL triglyceride Do Not Use None Not Tested Not Tested NoneTSH (HM) None None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride Not Tested None Do Not Use Not Tested NoneTU None None None None None None None Not Tested

UCFP NoneDo not use hemolyzed samples

results are increased Not TestedNone @1 g/L

EDTA None Not Tested None @1 mg/dL Na+F Not TestedURCA None None -0.2 mg/dL @ 4.3 mg/dL URCA None None None None Not TestedVALP None @ 60 mg/dL Bilirubin None@1000 mg/dL Hemoglobin None@3000 mg/dL triglyceride Not Tested None Not Tested Not Tested Not TestedVANC 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 UnitsFAST FACTSMethod Bilirubin Hemoglobin (monomer) Lipemia EDTA Li+ Heparin K+ Oxalate Na+ Fluoride Na+ Heparin

342 µmol/L 0.31 mmol/L 6.86 mmol/L triglyceride2 2 gm/L 280000 U/L 5g/L 4g/L 8000 U/LACP None None None Do Not Use None None None Not TestedACTM -21% None @0.62 mmol/L Hemoglobin None @34.29 mmol/L triglyceride None None None None Not Tested

None @ 86 µmol/L BilirubinAHDL None @1368 µmol/L Bilirubin None @0.62 mmol/L Hemoglobin None @34.29 mmol/L triglyceride None None Not Tested Not Tested None

ALB None None None None-24 g/dL@41

g/dL ALB None NoneNone @14.3 U/mL

Na Heparin1

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 NoneALP None None None Do Not Use None None None Not TestedALT (GPT) None None None @9.12 mmol/L triglyceride None None None None Not TestedAMON None Do Not Use None None None None None Not TestedAMY None None None @11.4 mmol/L triglyceride Do Not Use Not Tested Do Not Use None @238 µmol/L Not Tested

Na+FAST (GOT) None +47 U/L@73 U/L AST None @ 9.03 mmol/L triglyceride None None None None Not TestedBUN None None None None None None None Not TestedC3 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 TestedC4 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 TestedCA None None None Do Not Use None Do Not Use None Not Tested

CHOL- 0.4 mmol/L @ 139 µmol/L (conj) & 161 µmol

(unconj) Bilirubin @ 3.9 mmol/L CHOL None None None

-0.1 mmol/L @5.2 mmol/L

CHOL -12% -12% Not Tested-0.7 mmol/L @ 219 µmol/L (conj) & 251 µmol

(unconj) Bilirubin @ 6.5 mmol/L CHOL

CK -10 U/L @ 58 U/L CK+10 U/L @ 50 U/L CK with

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 [email protected] mmol/L triglyceride Not Tested None Not Tested Not Tested Not TestedCRBM None None [email protected] mmol/L triglyceride None None Not Tested Not Tested Not TestedCREA None@1026 µmol/L Bilirubin None None None None None None Not Tested

CCRP None @ 1368 µmol/L Bilirubin None @ 0.62 mmol/L Hemoglobin None @ 33.9 mmol/L triglyceride-15% at 3 mg/L

CRP None Not Tested Not Tested NoneCRP None None None @ > 10.2 mmol/L triglyceride None None None None Not TestedCSA 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 UseCSAE 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 UseCTNI (HM) None [email protected] mmol/L Hemoglobin [email protected] mmol/L triglyceride Do Not Use Not Tested Do not Use Not Tested NoneDBI N/A See IFU3 - 22% @ 2.29 mmol/L triglyceride None None Not Tested Not Tested Not TestedDBIL N/A -3 µmol/L @ 5 µmol/L DBIL None None None None None Not Tested

-26 µmol/L @ 74 µmol/L DBIL

DGNA None None [email protected] mmol/L triglyceride None None [email protected] g/L

Na+F Not TestedDGTX None@1026 µmol/L Bilirubin [email protected] mmol/L Hemoglobin [email protected] mmol/L triglyceride None None Not Tested Not Tested NoneECO2

Dimension® Clinical Chemistry System Interference Table - SI Units (cont. 2)FAST FACTSMethod Bilirubin Hemoglobin (monomer) Lipemia EDTA Li+ Heparin K+ Oxalate Na+ Fluoride Na+ Heparin

342 µmol/L 0.31 mmol/L 6.86 mmol/L triglyceride2 2 gm/L 280000 U/L 5g/L 4g/L 8000 U/LGLUC 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 [email protected] mmol/L triglyceride None None Do Not Use None NoneHCG (HM) None@1026 µmol/L Bilirubin [email protected] mmol/L Hemoglobin [email protected] mmol/L triglyceride None None Do Not Use Not Tested NoneIBCT None@1026 µmol/L Bilirubin [email protected] mmol/L Hemoglobin None None None Not Tested Not Tested Not TestedIGA None@684 mmol/L Bilirubin None [email protected] mmol/L triglyceride Not Tested Not Tested Not Tested Not Tested NoneIGG None@684 mmol/L Bilirubin None [email protected] mmol/L triglyceride Not Tested Not Tested Not Tested Not Tested NoneIGM None@684 mmol/L Bilirubin None [email protected] mmol/L triglyceride Not Tested Not Tested Not Tested Not Tested None

IRN -2.5 µmol/L @18.3 µmol/L IRN+3.6 µmol/L at 0.03 mmol/L Hgb @ 15.8

µmol/L IRN None Do Not Use Do Not Use Do Not Use Do Not Use Not Tested

IRON None @1368 µmol/L Bilirubin0.12 mmol/L Hgb + 22% @9.8 µmol/L

IRON None @ 34.29 mmol/L triglyceride Do Not Use None Do Not Use Do Not Use None0.12 mmol/L Hgb + 10% @19.2 µmol/L

IRONK None@1642 mmol/L Bilirubin None None @11.3 mmol/L triglyceride Not Tested None Not Tested Not Tested Not TestedLA None None None @11.29 mmol/L triglyceride Not Tested Do Not Use None None Do Not UseLDH None +50 U/L@131 U/L LDH None Do Not Use None Do Not Use Do Not Use Not TestedLHCG None@1026 µmol/L Bilirubin [email protected] mmol/L Hemoglobin [email protected] mmol/L triglyceride None None Do Not Use Not Tested NoneLI None@1026 µmol/L Bilirubin [email protected] mmol/L Hemoglobin None @36.7 mmol/L triglyceride Do Not Use Do Not Use Do Not Use Not Tested NoneLIDO None @ 684 µmol/L Bilirubin None [email protected] mmol/L triglyceride None Not Tested NotTested Not Tested NoneLIP None +30 U/L@143 U/L LIP [email protected] mmol/L triglyceride Do Not Use None Do Not Use Do Not Use NoneLMMB None@1026 µmol/L Bilirubin [email protected] mmol/L Hemoglobin [email protected] 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 NoneLTNI None None@ 0.62 mmol/L Hemoglobin [email protected] mmol/L triglyceride Do Not Use Not Tested Do not Use Not Tested NoneMALB None None @ 0.06 mmol/L Hemoglobin Not Tested Do Not Use Not Tested Not Tested Not Tested Not Tested

MG None @ 1026 µmol/L Bilirubin spuriously elevated results None @ 0.82 mmol/L of Mg -0.16 mmol/L @ 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 MGMMB (HM) None@1026 µmol/L Bilirubin [email protected] mmol/L Hemoglobin [email protected] mmol/L triglyceride None None Do Not Use Not Tested None MYO (HM) None@1026 µmol/L Bilirubin None@ 0.62 mmol/L Hemoglobin [email protected] mmol/L triglyceride Not Tested None Do Not Use Not Tested NoneNA None@1642 mmol/L Bilirubin None None @ 11.4 mmol/L triglyceride Not Tested None Not Tested Not Tested Not TestedNAPA None @ 1026 µmol/L Bilirubin None [email protected] mmol/L triglyceride None None Not Tested Not Tested NonePALB None@1026 µmol/L Bilirubin None@ 0.62 mmol/L Hemoglobin None @ 11.4 mmol/L triglyceride None None Not Tested Not Tested NonePBNP None@1026 µmol/L Bilirubin None@ 0.62 mmol/L Hemoglobin None @33.9 mmol/L triglyceride Not Tested None Not Tested Not Tested NonePCHE None None None None None Do Not Use Do Not Use Not TestedPHNO 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 triglyceridePHOS +0.26 mmol/[email protected] mmol/L PHOS None@ 0.62 mmol/L Hemoglobin +0.06 mmol/[email protected] mmol/L PHOS None None None None Not TestedPROC None @ 1026 µmol/L Bilirubin None [email protected] mmol/L triglyceride None None Not Tested Not Tested NonePTN 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 triglycerideRCRP 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 triglycerideSAL -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 NoneT4 None None None Do Not Use None None None Not TestedTACR None@1026 µmol/L Bilirubin None None @11.30 mmol/L triglyceride None Not Tested Not Tested Not Tested Not TestedTBI N/A None +18% @ 19 µmol/L total bilirubin None None Not Tested Not Tested Not TestedTBIL N/A None None None None None None Not TestedTCO2 None@1642 mmol/L Bilirubin None None @11.4 mmol/L triglyceride Not Tested None Not Tested Not Tested Not TestedTGL None@1026 µmol/L Bilirubin None Not Tested Not Tested Not Tested Not Tested Not Tested NoneTHEO None None None None None None None Not TestedTOBR None None [email protected] mmol/L triglyceride None None Not Tested Not Tested Not Tested

Dimension® Clinical Chemistry System Interference Table - SI Units (cont. 3)FAST FACTSMethod Bilirubin Hemoglobin (monomer) Lipemia EDTA Li+ Heparin K+ Oxalate Na+ Fluoride Na+ Heparin

342 µmol/L 0.31 mmol/L 6.86 mmol/L triglyceride2 2 gm/L 280000 U/L 5g/L 4g/L 8000 U/LTP -6 g/L @ 61 g/L TP +5 g/L @ 65 g/L TP None None None None None Not TestedTPSA (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 TestedTRNF 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 NoneTSH (HM) None None@ 0.62 mmol/L Hemoglobin None @ 33.9 mmol/L triglyceride Not Tested None Do Not Use Not Tested NoneTU None None None None None None None Not Tested

UCFP NoneDo not use hemolyzed samples

results are increased Not TestedNone @1 g/L

EDTA Not Tested Not TestedNone@1 mg/dL

Na+F Not TestedURCA None None -12 µmol/L @ 256 µmol/L URCA None None None None Not TestedVALP 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 TestedVANC 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 InformationFAST FACTSCalibrator/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 FrequencyACP Verifier DC23 ACP 3 H 1.0 – 8 hours @ 2-8°C Verify 3 monthsAHDL Calibrator DC48A AHDL 3 L – 1.0 7 days @ 2-8°C Linear 3 monthsALC Calibrator DC 37 ALC 3 L – 1.0 Use immediately Linear 3 monthsALDL DC131 ALDL 3 H 2.0 – 24 hours @ 2-8°C Linear 60 daysAMON Calibrator DC25 AMON 3 L – 2.0 Use immediately Linear 3 monthsCCRP RC434 CCRP 5 L – 1.0 24 hours @ 2-8°C Logit 3 monthsCHEM 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 monthsCREA 3 H 2.0 – 24 hours @ 2-8°C Linear 3 monthsGLU/GLUC 3 H 2.0 – 24 hours @ 2-8°C Linear 3 monthsLA 3 H 2.0 – 24 hours @ 2-8°C Linear 3 monthsURCA 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 monthsPHOS 3 L – 1.2 Use immediately Linear 3 monthsTGL 3 L – 1.2 Use immediately Linear 3 months

CHOL Calibrator DC16 CHOL 3 H 1.0 – 24 hours @ 2-8°C Linear 3 monthsCK Verifier DC26 CK 3 H 1.0 – 8 hours @ 2-8°C Verify 3 monthsCKMB Verifier DC27 CKMB 3 H 1.0 – 8 hours @ 2-8°C Verify 3 monthsCRP Calibrator DC30 CRP 2 5 L – 1.0 24 hours @ 2-8°C Logit 2 monthsCSA 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 daysCTNI Calibrator RC421C CTNI / LTNI 4 (HM) 5 L – 2.0 24 hours @ 2-8°C Logit 60 daysDrug 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 monthsPHNO 2 5 L – 3.0 3 months @ 2-8°C Logit 1 monthPTN 2 5 L – 3.0 3 months @ 2-8°C Logit 1 monthTHEO 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 monthsCRBM 2 5 L – 5.0 30 days @ 2-8°C Logit 1 monthDGTX 5 L – 5.0 30 days @ 2-8°C Logit 1 monthGENT 2 5 L – 5.0 30 days @ 2-8°C Logit 1 monthLIDO 2 5 L – 5.0 30 days @ 2-8°C Logit 1 monthNAPA 2 5 L – 5.0 30 days @ 2-8°C Logit 1 monthPROC 2 5 L – 5.0 30 days @ 2-8°C Logit 1 monthTOBR 2 5 L – 5.0 30 days @ 2-8°C Logit 1 monthVALP 2 5 L – 5.0 30 days @ 2-8°C Logit 1 monthVANC 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 daysQUAL 1 1 pt at 500 ng/mL QUAL

AMPH Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 daysQUAL 1 1 pt at 1000 ng/mL QUAL

BARB Semi-Quant 5 L – 14.0 2-8°C 3 Logit 30 daysQUAL 1 1 pt at 200 ng/mL QUAL


Cat. No. Method Levels or Liquid (L) Volume (mL) Volume (mL) Open Vial Stability Type FrequencyBENZ Semi-Quant 5 L – 14.0 2-8°C 3 Logit 30 days

QUAL 1 1 pt at 200 ng/mL QUALCOC Semi-Quant 5 L – 14.0 2-8°C 3 Logit 30 days

QUAL 1 1 pt at 150 ng/mL QUALCOC Semi-Quant 5 L – 14.0 2-8°C 3 Logit 30 days

QUAL 1 1 pt at 300 ng/mL QUALEXTC Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 days

QUAL 1 1 pt at 300 ng/mL QUALEXTC Semi-Quant 5 L – 14.0 2-8°C 3 Logit 30 days

QUAL 1 1 pt at 500 ng/mL QUALMETH Semi-Quant 5 L – 14.0 2-8°C 3 Logit 30 days

QUAL 1 1 pt at 300 ng/mL QUALOPI Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 days

QUAL 1 1 pt at 2000 ng/mL QUALOPI Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 days

QUAL 1 1 pt at 300 ng/mL QUALPCP Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 days

QUAL 1 1 pt at 25 ng/mL QUALTHC Semi-Quant 4 L – 14.0 2-8°C 3 Logit 30 days

QUAL 1 L 1 pt at 50 ng/mL QualECO2 Calibrator DC137 ECO2 3 L – 1.2 Use Immediately Linear 90 daysEnzyme 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 monthsAMY 3 H 2.0 – 8 hours @ 2-8°C Verify 3 monthsAST (GOT) 3 H 2.0 – 8 hours @ 2-8°C Verify 3 monthsGGT 3 H 2.0 – 8 hours @ 2-8°C Verify 3 monthsLDH 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 monthsHA1C Calibrator DF105 HA1C 2 4 H 2.0 – 48 hours @ 2-8°C Logit 30 daysHCG Calibrator RC430 HCG / LHCG4 (HM) 5 H 2.0 – 24 hours @ 2-8°C Logit 60 daysIBCT Calibrator DC84 IBCT 3 L – 1.0 30 days @ 2-8°C Linear 3 monthsIRN Calibrator DC21 IRN 3 L – 1.2 Use Immediately Linear 3 monthsIRON Calibrator DC85 IRON 2 L – – Use Immediately Linear 3 monthsLIP Calibrator DC15A LIP 3 H 3.0 – 24 hours @ 2-8°C Linear 45 daysMALB Calibrator DC114 MALB2 5 L – 1.0 30 days @ 2-8°C Logit 30 daysMMB Calibrator RC420 MMB / LMMB 4 (HM) 5 H 2.0 – 24 hours @ 2-8°C Logit 60 daysMYO Calibrator RC422 MYO (HM) 5 L – 1.0 5 days @ 2-8°C Logit 90 daysPALB Calibrator DC50 PALB 2 5 L – 1.0 30 days @ 2-8°C Logit 2 monthsPBNP Calibrator RC423 PBNP / LPBN 4 (HM) 5 L – 1.0 7 days @ 2-8°C Logit 30 daysPCHE Verified DC28 PCHE 3 H 2.0 – 24 hours @ 2-8°C Verify 3 monthsRCRP Calibrator DC34 RCRP 2 5 L – 1.0 24 hours @ 2-8°C Logit 60 daysSAL Calibrator DC38 SAL 3 L – 4.0 3 months @ 2-8°C Linear 3 monthsSpecial 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 daysIGA 2 5 L – 1.5 7 days @ 2-8°C Logit 60 days


Cat. No. Method Levels or Liquid (L) Volume (mL) Volume (mL) Open Vial Stability Type FrequencyIGG 2 5 L – 1.5 7 days @ 2-8°C Logit 60 daysIGM 2 5 L – 1.5 7 days @ 2-8°C Logit 60 daysTRNF 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 daysL2-5 - 1 mL

T4 Calibrator DC13 T4 5 H 1.0 – 8 hours @ 2-8°C Logit 2 monthsTACR DC107 TACR 5 L (frozen) – L1 - 2 ml 30 days @ 2-8°C Logit 30 days

L2-5 - 1 mLTBIL/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 monthsTBI/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 daysT/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 daysThyroid 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 daysTP/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 monthsTU Calibrator DC14 TU 5 H 2.0 – 8 hours @ 2-8°C Logit 2 monthsUCFP 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 Module2 : Recalibration is required after the source lamp is replaced in the instrument. pt : Point3 : See vial label on the Syva Emit® calibrators for expiration date4 : For use on Dimension® Xpand® system only. EMIT® is a registered trademark of Dade Behring Inc.

Issued 9/07

Fast_Facts_09-2007.xls

Documents

Dimension Clinical Chemistry System Method Specifics ......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 –