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Elecsys® Anti-HCV II

Immunoassay for the qualitative determination of antibodies against HCV

Elecsys Anti-HCV II

Elecsys® Anti-HCV II

  • Systems

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules, cobas e 801 module

  • Testing Time

    18 minutes

  • Test principle

    One-step double antigen sandwich assay

  • Calibration

    2-point

  • Interpretation

    COI <0.9 = non-reactive
    0.9 ≤COI <1.0 = gray zone
    COI ≥1 = reactive

  • Sample material

    Serum collected using standard sampling tubes or tubes containing separating gel. Li-heparin, Na-heparin, K2-EDTA, K3-EDTA, ACD, CPDA and Na-citrate plasma. Plasma tubes containing separating gel can be used.

  • Sample volume

    50 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    30 μL cobas e 801 module

  • Onboard stability

    31 days if continuously stored onboard (20 – 25 °C) or 7 weeks and up to 80 hours in total onboard (20 – 25 °C) if stored alternately in the refrigerator and on the analyzer. cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    31 days cobas e 801 module

  • Intermediate precision in positive samples

    cobas e 411 analyzer: CV 3.8 – 5.2 %
    cobas e 601 / cobas e 602 modules CV 1.6 – 4.0 %
    cobas e 801 module CV 1.2 – 2.1 %

  • Relative sensitivity

    100 % (n = 765)

  • Relative specificity

    99.84 % (n = 6,850, blood donors)
    99.66 % (n = 3,922, hospitalized patients)

References

 

  1. Global Hepatitis Report 2017. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO. http://apps.who.int/iris/bitstream/10665/255016/1/9789241565455-eng.pdf
  2. Easterbrook, P.J., Roberts, T., Sands, A., Peeling, R. (2017). Diagnosis of viral hepatitis. Current Opinion in HIV and AIDS. 12(3), 302-314.
  3. EASL Recommendations on Treatment of Hepatitis C 2016 (2017). Journal of Hepatology 66(1), 153-194.