Reagents on COBAS INTEGRA Systems

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within specification within specification Lipemia AAGP α1-acid Glycoprotein X X no no no no no no no AAGP2 α1-acid Glycoprotein Gen.2 X X X 60 60 1000 1026 1026 621 700 AAT2 α1-antitrypsin ver.2 X X X no no no no no no 1200 Acetaminophen 5µg/mL X X <1 12 10 <17 210 6.2 1000 ACETA Acetaminophen 30µg/mL X X 9 no 200 154 no 124 1800 Acetaminophen 50µg/mL X X 12 no 350 205 no 217 2000 ACPP Acid/Prostatic Phosphatase X 0.7 0.7 10 12 12 6 270 ALB2 Albumin Gen.2 X X X no no 420 no no 261 no ALBS ALBS2 Albumin (Turbidimetric) Application Albumin (Tina Quant) Gen.2 Application X no no no no no no no X X X 60 60 1000 1026 1026 621 1000 ALP2 ALP IFCC Gen.2 X X 42 42 250 718 718 155 no ALTL Alanine Aminotransferase X X X no no 130 no no 81 150 ALTPL Alanine Aminotransferase Pyridoxal Phosphate Activated X X X no no 130 no no 81 no AMIKM 3 Amikacin X X n/a 18 18 1000 308 308 621-1 -

within specification within specification Lipemia AMYL2 α-amylase EPS ver.2 X X X 52 no 260 889 no 161 no AMY-P α-amylase EPS Pancreatic X X 17 17 100 300 300 62 no AP2P ALP IFCC Gen.2 Primary Tube X X no no 250 no no 155 no APOAT Apolipoprotein A-1 ver.2 X X X no no no no no no 1000 APOBT Apolipoprotein B ver.2 X X X no no no no no no 1000 ASO2 ASTL ASTPL Antistreptolysin O Application for C.f.a.s. PAC Aspartate Aminotransferase Pyridoxal Phosphate Activated Aspartate Aminotransferase Pyridoxal Phosphate Activated X no no no no no no 1500 X X X no no 25 no no 16 150 X X X no no 25 no no 16 no AT Antithrombin X no no no no no no no BIL-D Bilirubin Direct X X n/a n/a n/a n/a 10 n/a n/a 6 270 BIL-D Gen. 2 X X X n/a n/a n/a n/a 25 n/a n/a 16 750 BILT2 Bilirubin Total DPD X X X n/a n/a n/a n/a 140 n/a n/a 87 1300 BILT3 Bilirubin Total Gen. 3 X X 4) X 8) n/a n/a n/a n/a 800 n/a n/a 497 1000 BILT3 Bilirubin Total Gen. 3 for Neonates X X 4) X 8) n/a n/a n/a n/a 1000 n/a n/a 621 1000-2 -

within specification within specification Lipemia BIL-T Bilirubin Total X n/a n/a n/a n/a 10 n/a n/a 6 9 BILTS Total Bilirubin Special X X X n/a n/a n/a n/a 1000 n/a n/a 621 1400 C3C-2 Complement C3c ver.2 X X no no no no no no no C4-2 Complement C4 ver.2 X X X no no no no no no no CA Calcium X X *4 no no no no no no no CA2 Calcium Gen. 2 X X *4 60 60 1000 1026 1026 621 1000 CAB 3 Carbamazepine X X n/a n/a 20 20 750 342 342 466 CEU Ceruloplasmin X X no no no no no no 50 CEU2 CEU3 Ceruloplasmin Application for C.f.a.s. Proteins Ceruloplasmin Application for C.f.a.s. PAC X X no no no no no no 50 X X no no no no no no 50 CHE Cholinesterase X X X no no no no no no no CHE2 Cholinesterase Gen.2 X X X no no 350 no no 217 1000 CHET2 Cholinesterase Total Gen.2 X X X no no 350 no no 217 1000 CHE-D Cholinesterase/Dibucaine X X X no no no no no no no - 3 -

within specification within specification CHED2 CHED2 Cholinesterase/Dibucaine Gen.2 (decision level 5000 U/L) Cholinesterase/Dibucaine Gen.2 (decision level 1250 U/L) Lipemia X X X no 50 150 no 50 93 400 X X X no 50 150 no 50 93 400 CHOL2 Cholesterol Gen.2 X X X 16 11 810 274 188 503 no CKL Creatine Kinase X X 15 15 100 255 255 62 no CKMBL Creatine Kinase-MB X X 20 20 10 340 340 6 500 Cl Chloride (03003523001) X X *4 no no 1000 no no 621 no Cl Chloride Gen. 2 (04581008) X X *4 no no 1000 no no 621 no CO2-L Bicarbonate liquid X X no no no no no no no CEJC CEJC Creatinine Jaffé Integra 400 Comp. Method for and Plasma Creatinine Jaffé Integra 700/800 Comp. Method for and Plasma X X X 5 5 800 85 85 497 250 X X X 5 5 400 85 85 248 250 CEP2 Creatinine plus ver.2 X X X 20 20 800 340 340 497 1000 CPL2 C-eactive Protein (Latex) Integra 400 Application for C.f.a.s. Proteins X X X no no no no no no 1500 (3 mg/l) - 4 -

within specification within specification CPL2 CPL2 C-eactive Protein (Latex) Integra 400 Application for C.f.a.s. Proteins C-eactive Protein (Latex) Integra 700/800 Application for C.f.a.s. Proteins Lipemia X X X no no no no no no 623 (80 mg/l) X X X no no no no no no 1094 (3 mg/l) CPHS C-eactive Protein High Sensitive X X X 60 60 1000 1026 1026 621 500 CPL2 C-eactive Protein (Latex) Integra 700/800 Application for C.f.a.s. Proteins X X X no no no no no no 797 (80 mg/l) CSAII Cyclosporine X 5) no 6) 50 50 no 6) 855 855 no 6) 1500 D-DI D-Dimer X X no no 300 no no 186 600 DIG 3 Digoxin X X n/a 25 25 2000 428 428 1242 DIGIT 3 Digitoxin X X n/a 19 19 1000 325 325 621 ETOH2 Ethanol Gen.2 X X X no no no no no no no FE2 Ferritin Gen.2 X X no no 960 no no 596 160 FPHNY 3 Free Phenytoin X X n/a 26 26 1000 445 445 621 FA Fructosamine X X X 5 5 50 85 85 31 no FVALP 3 Free Valproic Acid X X n/a 27 27 1000 462 462 621-5 -

within specification within specification GENT 3 Gentamicin X X n/a 15 15 1000 257 257 621 GGTI2 γ-glutamyltransferase ver.2 Standardized against IFCC X X X no 48 550 no 821 342 no GGTS2 γ-glutamyltransferase ver.2 Standardized against Szasz X X X no 48 550 no 821 342 no GLDH3 GLDH Gen.3 Utility Cassette Set X X X n/a 22 54 10 376 923 6 under evaluation GLUC2 Glucose HK X X X X no no no no no no no Lipemia GLUC3 Glucose HK Gen.3 X X X X 60 60 1200 1026 1026 745 1900 GLUCL Glucose HK Liquid X X X X no no no no no no no HAPT2 Haptoglobin ver.2 X X X n/a no no n/a no no n/a 1600 HBDH2 HBDH Gen.2 Utility Cassette Set X X X no no 25 no no 16 700 HDL_C HDL-Cholesterol plus 2nd generation X X X 24 24 1500 410 410 932 no HDLC3 HDL-Cholesterol plus 3rd generation X X X 47 60 1200 804 1026 745 2000 IGA Immunoglobulin A X X X no no no no no no 750 IGGT Immunoglobulin G (Turbidimetric) X X X X no no no no no no no IGM Immunoglobulin M X X no no no no no no 150-6 -

within specification within specification Lipemia ION Iron X X 40 40 500 684 684 311 120 K Potassium X X *4 no no 100 no no 62 no LACT2 Lactate Gen.2 X 18 no no 308 no no no LDHI2 Lactate Dehydrogenase acc. IFCC ver.2 X X no no 10 no no 6 no LDHL Lactate Dehydrogenase (P-L) X X no no 10 no no 6 120 LDHPL LDIP2 Lactate Dehydrogenase (P-L) Primary Tube Lactate Dehydrogenase acc. IFCC ver.2 Primary Tube X X no no 10 no no 6 120 X X no no 10 no no 6 no LDL-C LDL-Cholesterol plus 2nd generation X X X 40 40 1000 684 684 621 400 Li Lithium X X *4 no no 100 no no 62 no LIDO 3 Lidocaine X X n/a 18 18 1000 308 308 621 LIPC Lipase colorimetric X X no no no no no no no LPALX Lipoprotein (a) (Latex) X X X no no no no no no no LPA2 Lipoprotein (a) (Latex) Gen. 2 X X *9) X *9) 60 60 1000 1026 1026 621 2000 MG Magnesium X X 4) no no 550 no no 342 no - 7 -

within specification within specification Lipemia MYO Myoglobin X X X no no no no no no 100 MYO2 Myoglobin Gen.2 (Integra 800) X X X 60 60 500 1026 1026 311 499 MYO2 Myoglobin Gen.2 (Integra 400) X X X 60 60 500 1026 1026 311 500 Na Sodium X X *4 no no 1000 no no 621 no NAPA 3 N-Acetyl-Procainamide X X n/a 28 28 1000 479 479 621 NH3L Ammonia X 11 11 100 188 188 62 80 PHNO 3 Phenobarbital X X n/a 38 38 1000 650 650 621 PHNY 3 Phenytoin X X n/a 29 29 1000 496 496 621 PHNY 3 Phenytoin free X X n/a 25 25 1000 428 428 621 PHOS2 Phosphate (Inorganic) ver.2 X X X 51 no 420 872 no 261 1000 PEA3 PEA3 Prealbumin Integra 400 Application for C.f.a.s. PAC Prealbumin Integra 700/800 Application for C.f.a.s. PAC X no no no no no no 120 X no no no no no no 169 PIM 3 Primidone X X n/a 18 18 1000 308 308 621 POC 3 Procainamide X X n/a 19 19 1000 325 325 621-8 -

within specification within specification QUIN 3 Quinidine X X n/a 24 24 1000 410 410 621 F-II heumatoid Factors II X X X no no no no no no no Lipemia Salicylate 20µg/mL X X n/a 23 23 600 393 393 373 n/a Salicylate 40µg/mL X X n/a n/a n/a n/a n/a n/a n/a n/a n/a 500 Salicylate Salicylate 200µg/mL X X 23 23 1000 393 393 621 1000 Salicylate 300µg/mL 3 X X n/a 23 23 1000 393 393 621 SBAB 3 Barbiturates X X n/a 24 24 1000 410 410 621 SBENZ 3 Benzodiazepines X X n/a 23 23 1000 393 393 621 STF Soluble Transferrin eceptor X X no no no no no no no T4 3 Total T4 (Thyroxine) X X n/a 15 15 1000 257 257 621 THEO 3 Theophylline X X n/a 29 29 1000 496 496 621 TOB 3 Tobramycin X X n/a 13 13 1000 222 222 621 TMPA Total Mycrophenolic Acid X X 66 17 1000 1129 291 621 93 7) TP2 Total Protein X X X no no 500 no no 311 no - 9 -

within specification within specification Lipemia TIGL Triglycerides X X X n/a 5 5 600 86 86 373 n/a TSF2 Transferrin ver.2 X X no no no no no no 1500 T-UP 3 T-Uptake X X n/a 33 33 1000 564 564 621 UA2 Uric Acid ver.2 X X X 39 35 no 667 599 no no UIBC Unsaturated Iron-Binding Capacity X X no no 100 no no 62 200 UEAL Urea/BUN X X X no no no no no no no VALP 3 Valproic Acid X X n/a 38 38 1000 650 650 621 VALP 3 Valproic Acid free X X n/a 27 27 1000 462 462 621 VANC 3 Vancomycin X X n/a 17 17 1000 291 291 621 n/a = not applicable no = no significant interference up to the highest tested level 1 s were tested with the following substances added to samples: I Hemolysate up to 621 µmol/l (1000 mg/dl) hemoglobin Bilirubin up to 1026 µmol/l (60 mg/dl) Lipemia up to 20 g/l Intralipid (2000 mg/dl). Lipemia has no units as it is a measure of turbidity. Only significant interferences (>10%) are listed in the method sheets - 10 -

within specification within specification eference: Glick M, yder KW, Jackson SA. Graphical Comparisons of s in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470 474. Lipemia 2 L index not measured with Intralipid, interference measured as Triglycerides (see Method Sheet) 3 Endogenous bilirubin samples were used, total bilirubin was measured 4 only Lithium- 5 whole blood sample 6 No significant interference over a hematocrit range from 15-54 % 7 No significant interference up to a triglycerides level of 500 mg/dl (5.65 mmol/l) with a recovery specification of ± 10 % or 600 mg/dl (6.78 mmol/l) with a recovery specification of ± 15 %. 8 K2-EDTA / K3-EDTA / the use of EDTA-plasma may lead to slightly lower values 9 K2-EDTA / K3-EDTA / Li-Heparin - 11 -