Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit ACP2 Acid phosphatase total 1-naphthyl phosphate Gen.2 24.0 0.401 0.279 0.00466 ACP2 Acid phosphatase, non-postatic 1-naphthyl phosphate (Inhib.:tatate) Gen.2 11.7 0.195 0.233 0.00389 ACP2 Acid phosphatase, postatic 1-naphthyl phosphate (Inhib.:tatate) calculated 12.3 0.205 0.363 0.00607 ALB2 Albumin BCG Gen.2 ERM-DA470k/IFCC 6 4.70 47.0 0.0558 0.558 g/dl ALBP Albumin BCP CRM 470 2 3.75 37.5 0.0425 0.425 g/dl ALP2S Alkaline phosphatase IFCC Gen.2 Oiginal fomulation IFCC 5 (1983), manual 71.9 1.20 0.690 0.0115 ALP2L Alkaline phosphatase IFCC Gen.2 Oiginal fomulation IFCC 5 (1983), manual 71.9 1.20 0.690 0.0115 ALTLP Alanine aminotansfease IFCC with pyidoxal phosphate Oiginal fomulation IFCC 5 44.8 0.748 0.470 0.00785 cobas c systems_pecinom U_Ve 14 Page 1 of 13
Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit ALTL Alanine aminotansfease IFCC without pyidoxal phosphate Oiginal fomulation IFCC 5 (2002) modified, manual 44.8 0.748 0.470 0.00785 AMYL2 Amylase alpha IFCC liquid ve. 2 Roche eagent accoding to IFCC 5 (1998), manual 79.5 1.33 0.817 0.0136 AMYL2 Amylase alpha IFCC liquid ve. 2 STAT Roche eagent accoding to IFCC 5 (1998), manual 79.5 1.33 0.817 0.0136 AMY-P Amylase panceatic alpha EPS ve. 2 40.0 0.668 0.358 0.00598 ASTLP Aspatate aminotansfease IFCC with pyidoxal phosphate Oiginal fomulation IFCC 5 44.2 0.738 0.548 0.00915 ASTL Aspatate aminotansfease IFCC without pyidoxal phosphate Oiginal fomulation IFCC 5 (2002) modified, manual 44.2 0.738 0.548 0.00915 ASTL Aspatate aminotansfease IFCC without pyidoxal phosphate STAT Oiginal fomulation IFCC 5 (2002) modified, manual 44.2 0.738 0.548 0.00915 D-BIL Biliubin diect Jendassik-Gof c 501 only 0.831 14.2 0.0165 0.282 cobas c systems_pecinom U_Ve 14 Page 2 of 13
Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit BILD2 Biliubin diect Gen.2 Jendassik-Gof 0.936 16.0 0.00429 0.0733 BILD2 Biliubin diect Gen.2 Jendassik-Gof 0.918 15.7 0.00696 0.119 BILTS Biliubin total Diazo special acc. to Doumas 1.14 19.5 0.0274 0.469 BILTS Biliubin total Diazo special STAT acc. to Doumas 1.14 19.5 0.0274 0.469 BILTS Biliubin total Diazo special acc. to Doumas 0.942 16.1 0.0353 0.603 BILTS Biliubin total Diazo special STAT acc. to Doumas 0.942 16.1 0.0353 0.603 cobas c systems_pecinom U_Ve 14 Page 3 of 13
Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit BILT2 Biliubin total DPD Gen. 2 acc. to Doumas 1.04 17.8 0.0187 0.319 BILT2 Biliubin total DPD Gen. 2 STAT acc. to Doumas 1.04 17.8 0.0187 0.319 BILT2 Biliubin total DPD Gen. 2 acc. to Doumas 0.948 16.2 0.0153 0.262 BILT3 Biliubin total Gen. 3 DPD acc. to Doumas 1.10 18.8 0.0182 0.311 BILT3 Biliubin total Gen. 3 DPD acc. to Doumas 1.00 17.1 0.0189 0.323 BUN Blood Uea nitogen Uease/GLDH SRM 909b 3 calculated 19.5 6.97 0.209 0.0747 BUN Blood Uea nitogen Uease/GLDH STAT SRM 909b 3 calculated 19.5 6.97 0.209 0.0747 cobas c systems_pecinom U_Ve 14 Page 4 of 13
Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit CA o-cesolphthaleine complexone SRM 956c L3 3 2.17 8.70 0.0197 0.0790 CA o-cesolphthaleine complexone STAT SRM 956c L3 3 2.17 8.70 0.0197 0.0790 CA o-cesolphthaleine complexone SRM 956c L3 3 2.21 8.86 0.0146 0.0585 CA o-cesolphthaleine complexone STAT SRM 956c L3 3 2.21 8.86 0.0146 0.0585 CA2 nm-bapta SRM 956c L2 3 2.23 8.94 0.0167 0.0670 cobas c systems_pecinom U_Ve 14 Page 5 of 13
Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit CA2 nm-bapta STAT SRM 956c L2 3 2.23 8.94 0.0167 0.0670 CA2 nm-bapta SRM 956c L2 3 2.30 9.22 0.0125 0.0501 CA2 nm-bapta STAT SRM 956c L2 3 2.30 9.22 0.0125 0.0501 CHE Cholinestease acethylthiocholine 2930 48.9 26.2 0.438 CHE2 Cholinestease butyylthiocholine Gen. 2 5400 90.2 62.0 1.04 CHED2 Cholinestease butyylthiocholine Gen. 2 5400 90.2 62.0 1.04 CHOL2 Cholesteol CHOD-PAP Gen. 2 stand. ID/MS ID-MS 4 94.3 2.44 0.974 0.0252 cobas c systems_pecinom U_Ve 14 Page 6 of 13
Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit CHOL2 Cholesteol CHOD-PAP Gen. 2 stand. Abell-Kendall CKL Ceatine kinase IFCC liquid cobas c 501/ c 502 / c 311 CK Ceatine kinase IFCC liquid cobas c 701 / c 702 CREP2 Ceatinine plus ve. 2 Abell-Kendall 96.3 Oiginal fomulation IFCC 5 Oiginal fomulation IFCC 5 ID-MS 4 1.01 2.49 163 2.72 148 2.47 89.1 1.71 0.0442 1.36 0.0227 0.900 0.0150 0.0166 1.47 CREJ2 Ceatinine Jaffé compensated Gen. 2 STAT seum, plasma ID-MS 4 1.06 93.4 0.0318 2.81 CREJ2 Ceatinine Jaffé ate-blanked and compensated Gen. 2 seum,plasma ID-MS 4 1.18 104 0.0324 2.87 GGT-2 Glutamyltansfease gamma liquid stand. Szasz Oiginal fomulation Pesijn/v.d. Slik (1976), manual 40.7 0.680 0.704 0.0118 cobas c systems_pecinom U_Ve 14 Page 7 of 13
Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit GGT-2 Glutamyltansfease gamma liquid stand. IFCC Oiginal fomulation IFCC 5 46.4 0.775 0.436 0.00728 GLDH3 Glutamate dehydogenase opt. (DGKC) Gen.3 23.7 0.396 0.436 0.00728 GLUC2 Glucose HK ID-MS 4 91.7 5.09 1.44 0.0801 GLUC2 Glucose HK STAT ID-MS 4 91.7 5.09 1.44 0.0801 GLUC2 Glucose HK hemolysate Gen. 2 ID-MS 4 91.7 5.09 1.44 0.0801 GLUC2 Glucose HK hemolysate Gen. 2 STAT ID-MS 4 91.7 5.09 1.44 0.0801 GLUC3 Glucose HK ID-MS 4 91.7 5.09 1.44 0.0801 GLUC3 Glucose HK STAT ID-MS 4 91.7 5.09 1.44 0.0801 cobas c systems_pecinom U_Ve 14 Page 8 of 13
Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit HBDH2 Hydoxybutyate dehydogenase alpha opt. (DGKC) Gen. 2 161 2.69 2.32 0.0387 IGA-2 Immunoglobulin A immunotubidimetic Gen. 2 standad CRM 470 2 130 1.30 1.37 0.0137 IGG-2 Immunoglobulin G immunotubidimetic Gen. 2 standad seum, plasma ERM-DA470k/IFCC 6 753 7.53 9.67 0.0967 IGM-2 Immunoglobulin M immunotubidimetic Gen. 2 standad CRM 470 2 65.6 0.656 1.51 0.0151 IRON2 Ion FeoZine Gen. 2 SRM 937 3 20.0 112 0.249 1.39 μg/dl LACT2 Lactate enzymatic coloimetic test Gen. 2 Pimay efeence mateial (weighed in puified mateial) 14.6 1.62 0.192 0.0213 LACT2 Lactate enzymatic coloimetic test Gen. 2 STAT Pimay efeence mateial (weighed in puified mateial) 14.6 1.62 0.192 0.0213 cobas c systems_pecinom U_Ve 14 Page 9 of 13
Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit LDHI2 Lactate dehydogenase IFCC liquid ve. 2 Oiginal fomulation IFCC 5 160 2.67 1.77 0.0296 LDHI2 Lactate dehydogenase IFCC liquid ve. 2 sample pe-dilution Oiginal fomulation IFCC 5 160 2.67 1.77 0.0296 LDHL Lactate dehydogenase opt. (DGKC) 318 5.31 2.53 0.0423 LIPC Lipase enzymatic coloimetic test 55.4 0.925 0.638 0.0107 LIPC Lipase enzymatic coloimetic test STAT 55.4 0.925 0.638 0.0107 LI Lithium coloimetic test Flame photomety 0.927 0.640 0.0123 0.00849 MG Magnesium Chloophosphonazo III seum,plasma Atomic absoption 0.740 1.80 0.00614 0.0149 cobas c systems_pecinom U_Ve 14 Page 10 of 13
Roche Diagnostics GmbH Novembe 2012 MG Magnesium Chloophosphonazo III seum,plasma STAT MG2 Magnesium Gen. 2 MG2 Magnesium xylidyl blue method MG2 Magnesium xylidyl blue method STAT PHOS2 Phospahte (inoganic) molybdate UV ve. 2 Refeence Method Refeence Mateial Selected Measuement Pocedue Atomic absoption 0.704 Atomic absoption 0.787 Atomic absoption 0.851 Atomic absoption 0.851 Pimay efeence mateial (NERL) (weighed in puified mateial) 1.80 1.91 2.07 2.07 1.29 4.00 Assigned Value Uncetainty 1 Unit 0.00614 0.0149 0.00507 0.0123 0.00461 0.0112 0.00461 0.0112 0.0173 0.0536 PHOS2 Phospahte (inoganic) molybdate UV ve. 2 STAT Pimay efeence mateial (NERL) (weighed in puified mateial) 1.29 4.00 0.0173 0.0536 cobas c systems_pecinom U_Ve 14 Page 11 of 13
Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit TRIGL Tiglyceides GPO-PAP ID-MS 4 100 1.13 1.33 0.0150 TRIGB Tiglyceides/Glyceol Blanked glyceol blanked SRM 909b 3 44.3 0.501 0.726 0.00820 TP2 Total potein Biuet Gen. 2 SRM 927d 3 6.20 62.0 0.0384 0.384 g/dl TP2 Total potein Biuet Gen. 2 STAT SRM 927d 3 6.20 62.0 0.0384 0.384 g/dl TRSF2 Tansfein immunotubidimetic ve. 2 CRM 470 2 1.99 0.251 0.0119 0.00150 UA2 Uic acid enzymatic coloimetc test ve. 2 ID-MS 4 4.43 265 0.0302 1.81 cobas c systems_pecinom U_Ve 14 Page 12 of 13
Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit UIBC Unsatuated ion-binding capacity FeoZine Pimay efeence mateial (ion) (weighed in puified mateial) 27.2 152 0.790 4.42 μg/dl UIBC Unsatuated ion-binding capacity FeoZine Pimay efeence mateial (ion) (weighed in puified mateial) 27.4 153 0.570 3.19 μg/dl UREAL Uea Uease/GLDH SRM 909b 3 41.9 6.97 0.449 0.0747 UREAL Uea Uease/GLDH STAT SRM 909b 3 41.9 6.97 0.449 0.0747 1 This uncetainty (expanded uncetainty; k = 2) was calculated in accodance with the Guide to the expession of uncetainty in (GUM:1993). Fo the estimation of the single standad uncetainties nomal distibution of the esults is assumed; the level of confidence of the expanded uncetainty is about 95% with the coveage facto k=2 (analogue to the 2sd of the standad uncetainty). 2 CRM = Cetified Refeence Mateial, Euopean 3 SRM = Standad Refeence Mateial 4 ID-MS = Isotope Dilution - Mass Spectomety 5 IFCC = Intenational Fedeationof clinical chemisty and laboatoy medicine 6 ERM = Euopean Refeence Mateials 7 Unless othewise noted, the assigned values and uncetainties ae valid fo cobas c 501, cobas c 502, cobas c 311 cobas c 701 and cobas c 702 povided that the method is available on that analyze. cobas c systems_pecinom U_Ve 14 Page 13 of 13