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  • Traceability and Uncertainty: Cobas C 501 / C 502 / C 503 / C 303 / C 311/ C 701/ C 702 - C.F.A.S. Proteins

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    Laura Puentes Jiménez
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    This document provides information on protein and immunoglobulin measurements for various Roche cobas c systems, including the analytical method, reference method, reference material, assigned calibrator value, measurement uncertainty, and unit of measurement for each test. A total of 21 different analytes are listed, along with details about the reference standards and certified reference materials used to standardize the measurements on each cobas system. Uncertainties for the calibrator values range from 0.00621 to 11.6 g/L or mg/L depending on the particular analyte and system.

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    000cfas proteins

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    This document provides information on protein and immunoglobulin measurements for various Roche cobas c systems, including the analytical method, reference method, reference material, assigned calibrator value, measurement uncertainty, and unit of measurement for each test. A total of 21 different analytes are listed, along with details about the reference standards and certified reference materials used to standardize the measurements on each cobas system. Uncertainties for the calibrator values range from 0.00621 to 11.6 g/L or mg/L depending on the particular analyte and system.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    41 views3 pages

    Traceability and Uncertainty: Cobas C 501 / C 502 / C 503 / C 303 / C 311/ C 701/ C 702 - C.F.A.S. Proteins

    Uploaded by

    Laura Puentes Jiménez
    This document provides information on protein and immunoglobulin measurements for various Roche cobas c systems, including the analytical method, reference method, reference material, assigned calibrator value, measurement uncertainty, and unit of measurement for each test. A total of 21 different analytes are listed, along with details about the reference standards and certified reference materials used to standardize the measurements on each cobas system. Uncertainties for the calibrator values range from 0.00621 to 11.6 g/L or mg/L depending on the particular analyte and system.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 3

    TRACEABILITY and UNCERTAINTY 

    cobas c 501 / c 502 / c 503 / c 303 / c 311/ c 701/ c 702 - C.f.a.s. Proteins
    Cat. No. 11 355 279 216, 11 355 279 160

    Roche Diagnostics GmbH October 2020


    Routine Method Selected Measurement
    ACN Reference Method Reference Material Calibrator Value Uncertainty 1 Unit
    Roche/cobas c systems Procedure
    AAGP2 c 501/311: 229
    2
    Acid glycoprotein alpha 1 c 502/701/702: 8229 CRM 470 1.85 0.0290 g/L
    immunoturbidimetric Gen. 2 c 303/503: 20020
    AAT2 c 501/311: 048
    4 5
    Antitrypsin alpha 1 c 502/701/702: 8048 ERM -DA470k/IFCC 2.67 0.0240 g/L
    immunoturbidimetric ver. 2 c 303/503: 20030
    C3C-2 c 501/311: 036
    2
    Complement C3c c 502/701/702: 8036 CRM 470 2.80 0.0332 g/L
    immunoturbidimetric ver. 2 c 303/503: 20320
    C4-2 c 501/311: 032
    4 5
    Complement C4 c 502: 8032 ERM -DA470k/IFCC 0.460 0.00727 g/L
    immunoturbidimetric ver. 2 c 303/503: 20330
    C4-2
    4 5
    Complement C4 ERM -DA470k/IFCC 0.470 0.00621 g/L
    c 701/702: 8032
    immunoturbidimetric ver. 2
    CRPHS
    c 501/311: 217
    C-Reactive protein 2
    c 502: 8217 CRM 470 89.4 1.10 mg/L
    particle enhanced
    c 303/503: 20480
    immunoturbidimetric Latex high sens.
    CRPHS
    C-Reactive protein 2
    c 701/702: 8217 CRM 470 94.1 3.20 mg/L
    particle enhanced
    immunoturbidimetric Latex high sens.
    CRPLX ROW only
    C-Reactive protein 2
    c 501/311: 019 CRM 470 93.6 7.08 mg/L
    particle enhanced
    immunoturbidemetric Latex
    CRPL3
    c 501/311: 210
    C-Reactive Protein 2
    c 502/701/702: 8210 CRM 470 79.9 6.05 mg/L
    particle enhanced
    c 503: 20490
    immunoturbidimetric Gen. 3
    c 501: 256
    CRP4 4 5
    c 502/701/702: 8256 ERM -DA474/IFCC 95.7 2.05 mg/L
    Tina-quant C-Reactive Protein IV
    c 303/503: 20500
    TRACEABILITY and UNCERTAINTY 
    cobas c 501 / c 502 / c 503 / c 303 / c 311/ c 701/ c 702 - C.f.a.s. Proteins
    Cat. No. 11 355 279 216, 11 355 279 160

    Roche Diagnostics GmbH October 2020


    Routine Method Selected Measurement
    ACN Reference Method Reference Material Calibrator Value Uncertainty 1 Unit
    Roche/cobas c systems Procedure
    CRP4 4 5
    c 311: 256 ERM -DA474/IFCC 93.8 2.01 mg/L
    Tina-quant C-Reactive Protein IV
    FERR4
    c 501/311: 692 3
    Ferritin NIBSC Reagent Ferritin
    c 502/701/702: 8692 999 11.6 µg/L
    particle enhanced (human liver) 80/602
    c 303/503: 20570
    immunoturbidimetric Gen. 4
    HAPT2 c 501/311: 228
    4 5
    Haptoglobin c 502/701/702: 8228 ERM -DA470k/IFCC 2.04 0.0206 g/L
    immunoturbidimetric ver. 2 c 303/503: 20640
    IGA-2 c 501/311: 458
    2
    Immunoglobulin A c 502/701/702: 8458 CRM 470 4.20 0.0589 g/L
    immunoturbidimetric Gen. 2 standard c 303/503: 20720
    IGA-2 c 501/311: 295
    2
    Immunoglobulin A c 502/701/702: 8295 CRM 470 4.20 0.0589 g/L
    immunoturbidimetric Gen. 2 sensitive c 303/503: 20721
    IGG-2 c 501: 674
    4 5
    Immunoglobulin G c 502: 8674 ERM -DA470k/IFCC 19.6 0.209 g/L
    immunoturbidimetric Gen. 2 standard c 303/503: 20740
    IGG-2
    c 701/702: 8674 4 5
    Immunoglobulin G ERM -DA470k/IFCC 18.8 0.201 g/L
    c 311: 674
    immunoturbidimetric Gen. 2 standard
    IGM-2 c 501/311: 465
    2
    Immunoglobulin M c 502/701/702: 8465 CRM 470 1.47 0.0182 g/L
    immunoturbidimetric Gen. 2 standard c 303/503: 20750
    IGM-2 c 501/311: 274
    2
    Immunoglobulin M c 502/701/702: 8274 CRM 470 1.47 0.0182 g/L
    immunoturbidimetric Gen. 2 sensitive c 303/503: 20751
    2
    KAPP2 ROW only c 501/311: 283 CRM 470
    Kappa c 502/701/702: 8283 (calculated over Lievens 5.08 0.0548 g/L
    immunoturbidimetric Gen. 2 c 303/503: 20780 equation)
    2
    LAMB2 ROW only c 501/311: 284 CRM 470
    Lambda c 502/701/702: 8284 (calculated over Lievens 2.80 0.0249 g/L
    immunoturbidimetric Gen. 2 c 303/503: 20800 equation)
    TRACEABILITY and UNCERTAINTY 
    cobas c 501 / c 502 / c 503 / c 303 / c 311/ c 701/ c 702 - C.f.a.s. Proteins
    Cat. No. 11 355 279 216, 11 355 279 160

    Roche Diagnostics GmbH October 2020


    Routine Method Selected Measurement
    ACN Reference Method Reference Material Calibrator Value Uncertainty 1 Unit
    Roche/cobas c systems Procedure
    TRSF2 c 501/311: 187
    2
    Transferrin c 502/701/702: 8187 CRM 470 2.69 0.0385 g/L
    immunoturbidimetric ver. 2 c 303/503: 21150
    TRSFU c 501/311: 401
    4 5
    Transferrin c 502/701/702: 8401 ERM -DA470k/IFCC 2700 25.4 mg/L
    immunoturbidimetric ver. 2 (urine) c 303/503: 21151

    1
    This uncertainty (expanded uncertainty; k = 2) was calculated in accordance with the “Guide to the expression of uncertainty in measurement” (GUM: 1993). For the estimation of
    the single standard uncertainties normal distribution of the measurement results is assumed; the level of confidence of the expanded uncertainty is about 95% with the coverage
    factor k=2 (analogue to the 2sd of the standard uncertainty).
    2
    CRM = Certified Reference Material, European
    3
    NIBSC = National Institute for Biological Standards and Control
    4
    ERM = European Reference Materials
    5
    IFCC = International Federation of clinical chemistry and laboratory medicine

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