TRACEABILITY and UNCERTAINTY 7 cobas c 501 / c 502 / c 311 / c 701 / c C.f.a.s.
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1 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Calibato Value Uncetainty 1 Unit ACP2 Acid phosphatase total 1-naphthyl phosphate Gen. 2 Roche eagent, manual measuement ACP2 Acid phosphatase, non-postatic 1-naphthyl phosphate (Inhib.:tatate) Gen. 2 Roche eagent, manual measuement ALB2 Albumin BCG Gen. 2 ERM-DA470k/IFCC g/dl g/l ALBP Albumin BCP CRM g/dl g/l ALP2L Alkaline Phosphatase IFCC Gen. 2 Oiginal fomulation IFCC 5 (1983), manual measuement ALP2S Alkaline Phosphatase IFCC Gen. 2 Oiginal fomulation IFCC 5 (1983), manual measuement ALTLP Alanine Aminotansfease IFCC with pyidoxal phosphate Oiginal fomulation measuement ALTL Alanine Aminotansfease IFCC without pyidoxal phosphate Oiginal fomulation IFCC 5 (2002) modified, manual measuement modified cobas c systems_c f a s _Ve 14 Page 1 of 12
2 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Calibato Value Uncetainty 1 Unit AMYL2 Amylase alpha IFCC liquid ve. 2 Roche eagent accoding to IFCC 5 (1998), manual measuement AMYL2 Amylase alpha IFCC liquid ve. 2 STAT Roche eagent accoding to IFCC 5 (1998), manual measuement AMY-P Amylase panceatic alpha EPS ve. 2 Roche eagent, manual measuement ASTLP Aspatate aminotansfease IFCC with pyidoxal phosphate Oiginal fomulation measuement ASTL Aspatate aminotansfease IFCC without pyidoxal phosphate Oiginal fomulation IFCC 5 (2002) modified, manual measuement modified ASTL Aspatate aminotansfease IFCC without pyidoxal phosphate STAT Oiginal fomulation IFCC 5 (2002) modified, manual measuement modified D-BIL Biliubin diect Jendassik-Gof Roche eagent, manual measuement BILD2 Biliubin diect Gen. 2 Jendassik-Gof Roche eagent, manual measuement cobas c systems_c f a s _Ve 14 Page 2 of 12
3 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Calibato Value Uncetainty 1 Unit BILD2 Biliubin diect Gen. 2 Jendassik-Gof Roche eagent, manual measuement BILT2 Biliubin total DPD Gen. 2 acc. to Doumas BILT2 Biliubin total DPD Gen. 2 STAT acc. to Doumas BILT2 Biliubin total DPD Gen. 2 acc. to Doumas BILT2 Biliubin total DPD Gen. 2 STAT acc. to Doumas BILT3 Biliubin total Gen. 3 DPD acc. to Doumas BILT3 Biliubin total Gen. 3 DPD acc. to Doumas cobas c systems_c f a s _Ve 14 Page 3 of 12
4 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Calibato Value Uncetainty 1 Unit BILTS Biliubin total Diazo special acc. to Doumas BILTS Biliubin total Diazo special STAT acc. to Doumas BILTS Biliubin total Diazo special acc. to Doumas BILTS Biliubin total Diazo special STAT acc. to Doumas BUN Blood uea nitogen Uease/GLDH SRM 3 909b calculated BUN Blood uea nitogen Uease/GLDH STAT SRM 3 909b calculated Ca o-cesolphthaleine complexone SRM 3 956c L cobas c systems_c f a s _Ve 14 Page 4 of 12
5 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Calibato Value Uncetainty 1 Unit Ca o-cesolphthaleine complexone STAT SRM 3 956c L Ca o-cesolphthaleine complexone SRM 3 956c L Ca o-cesolphthaleine complexone STAT SRM 3 956c L Ca2 nm-bapta SRM 3 956c L Ca2 nm-bapta STAT SRM 3 956c L Ca2 nm-bapta SRM 3 956c L cobas c systems_c f a s _Ve 14 Page 5 of 12
6 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Calibato Value Uncetainty 1 Unit Ca2 nm-bapta STAT SRM 3 956c L CHE2 Cholinestease butyylthiocholine Gen. 2 Roche eagent, manual measuement CHE Cholinestease acethylthiocholine Roche eagent, manual measuement CHED2 Cholinestease butyylthiocholine Gen. 2 Roche eagent, manual measuement CHOL2 Cholesteol CHOD-PAP Gen. 2 stand. ID/MS ID-MS CHOL2 Cholesteol CHOD-PAP Gen. 2 stand. Abell- Kendall Abell-Kendall CKL Ceatine kinase IFCC liquid CK Ceatine kinase IFCC liquid Oiginal fomulation measuement Oiginal fomulation measuement cobas c systems_c f a s _Ve 14 Page 6 of 12
7 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Calibato Value Uncetainty 1 Unit CREP2 Ceatinine plus ve. 2 ID-MS CREJ2 Ceatinine Jaffé compensated Gen. 2 STAT seum, plasma ID-MS CREJ2 Ceatinine Jaffé ate-blanked and compensated Gen. 2 seum, plasma ID-MS GGT-2 Glutamyltansfease gamma liquid stand. Szasz Oiginal fomulation Pesijn/v.d. Slik (1976), manual measuement GGT-2 Glutamyltansfease gamma liquid stand. IFCC Oiginal fomulation measuement GLDH3 Glutamate dehydogenase opt. (DGKC) Gen. 3 Roche eagent, manual measuement GLUC2 Glucose HK ID -MS GLUC2 Glucose HK STAT ID -MS cobas c systems_c f a s _Ve 14 Page 7 of 12
8 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Calibato Value Uncetainty 1 Unit GLUC3 Glucose HK ID -MS GLUC3 Glucose HK STAT ID -MS GLUC2 Glucose ve. 2 HK hemolysate Gen. 2 ID -MS GLUC2 Glucose ve. 2 HK hemolysate Gen. 2 STAT ID -MS HBDH2 Hydoxybutyate dehydogenase alpha opt. (DGKC) Gen. 2 Roche eagent, manual measuement IRON2 Ion FeoZine Gen. 2 SRM μg/dl LACT2 Lactate enzymatic coloimetic test Gen. 2 Pimay efeence mateial (weighed in puified mateial) LACT2 Lactate enzymatic coloimetic test Gen. 2 STAT Pimay efeence mateial (weighed in puified mateial) cobas c systems_c f a s _Ve 14 Page 8 of 12
9 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Calibato Value Uncetainty 1 Unit LDHI2 Lactate dehydogenase IFCC liquid ve. 2 Oiginal fomulation measuement LDHI2 Lactate dehydogenase IFCC liquid ve. 2 sample pe-dilution Oiginal fomulation measuement LDHL Lactate dehydogenase opt. (DGKC) Roche eagent, manual measuement LIPC Lipase enzymatic coloimetic test Roche eagent, manual measuement LIPC Lipase enzymatic coloimetic test STAT Roche eagent, manual measuement LI Lithium coloimetic test Flame photomety MG Magnesium Chloophosphonazo III seum, plasma Atomic absoption cobas c 501, c 502, c 311 MG Magnesium Chloophosphonazo III seum, plasma STAT Atomic absoption cobas c 501, c 502, c 311 cobas c systems_c f a s _Ve 14 Page 9 of 12
10 Roche Diagnostics GmbH Novembe 2012 MG2 Magnesium xylidyl blue method seum, plasma cobas c 501, c 502, c 311 MG2 Magnesium xylidyl blue method seum, plasma STAT cobas c 501, c 502, c 311 MG2 Magnesium xylidyl blue method seum, plasma cobas c 701, c 702 MG2 Magnesium xylidyl blue method seum, plasma STAT cobas c 701, c 702 PHOS2 Phosphate (inoganic) molybdate UV ve. 2 Refeence Method Refeence Mateial Selected Measuement Pocedue Atomic absoption Atomic absoption Atomic absoption Atomic absoption Pimay efeence mateial (NERL2338-C) (weighed in puified mateial) Calibato Value Uncetainty 1 Unit PHOS2 Phosphate (inoganic) molybdate UV ve. 2 STAT Pimay efeence mateial (NERL2338-C) (weighed in puified mateial) TRIGL Tiglyceides GPO-PAP ID -MS cobas c systems_c f a s _Ve 14 Page 10 of 12
11 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Calibato Value Uncetainty 1 Unit TRIGB Tiglyceides/Glyceol Blanked glyceol blanked SRM 909b TP2 Total potein Biuet Gen. 2 SRM 3 927d g/dl g/l TP2 Total potein Biuet Gen. 2 STAT SRM 3 927d g/dl g/l UA2 Uic acid enzymatic coloimetic test ve. 2 ID-MS UIBC Unsatuated ion-binding capacity FeoZine Pimay efeence mateial (weighed in puified mateial) though ion μg/dl UREAL Uea Uease/GLDH SRM 3 909b UREAL Uea Uease/GLDH STAT SRM 3 909b This uncetainty (expanded uncetainty; k = 2) was calculated in accodance with the Guide to the expession of uncetainty in measuement (GUM:1993). Fo the estimation of the single standad uncetainties nomal distibution of the measuement 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 cobas c systems_c f a s _Ve 14 Page 11 of 12
12 Roche Diagnostics GmbH Novembe IFCC = Intenational Fedeation of 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_c f a s _Ve 14 Page 12 of 12
TRACEABILITY and UNCERTAINTY 7 cobas c 501 / c 502 / c 311 / c 701 / c Precinorm U
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
More informationTRACEABILITY and UNCERTAINTY 7 COBAS INTEGRA / cobas c Precipath U
Refeence Method Refeence Mateial Selected Measuement Acid phosphatase total 1-naphthyl phosphate Gen. 2 Intega 400 47.2 0.788 0.605 0.0101 Acid phosphatase total 1-naphthyl phosphate Gen. 2 Intega 800
More informationTRACEABILITY and UNCERTAINTY 7 COBAS INTEGRA / c Precinorm U
Roche Diagnostics GmbH Decembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit Acid phosphatase total 1-naphthyl phosphate Gen. 2 Intega 400 20.4 0.341
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COBAS INTEGRA / cobas c - C.f.a.s. Cat. No. 0 79 30 90 Roche Diagnostics GmbH May 20 Acid phosphatase total -naphthyl phosphate Gen. 2 Integra 00 plus Acid phosphatase total -naphthyl phosphate Gen. 2
More informationTRACEABILITY and UNCERTAINTY 7
Routine Method COBAS INTEGRA systems Acid phosphatase total 1-naphthyl phosphate Integra 00 plus Acid phosphatase total 1-naphthyl phosphate Acid phosphatase, non-prostatic Integra 00 plus Acid phosphatase,
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Cat. No. 0 79 0 90 ACP Acid phosphatase total -naphthyl phosphate NPP Acid phosphatase, non-prostatic -naphthyl phosphate (Inhib.:tartrate) ALB Albumin BCG plus ALB Albumin BCP ALP Alkaline phosphatase
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ACP Acid phosphatase total 1-naphthyl phosphate NPP Acid phosphatase, non-prostatic 1-naphthyl phosphate (Inhib.:tartrate) ACP-P Acid phosphatase, prostatic 1-naphthyl phosphate (Inhib.:tartrate) ALB Albumin
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AAT Antitrypsin alpha 1 AAGP Acid glycoprotein alpha 1 immunoturbidimetric Gen. Acid phosphatase total 1-naphthyl phosphate Gen. Acid phosphatase total 1-naphthyl phosphate Gen. Integra 00 plus Acid phosphatase,
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ATRYP Antitrypsin alpha 1 ERM-DA470k/IFCC 9 136 1.36 1.84 0.0184 GPROT Acid glycoprotein alpha 1 CRM 470 2 90.1 0.901 0.890 0.00890 ACP Acid phosphatase total 1-naphthyl phosphate 0.720 43.1 0.00703 0.421
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