Elecsys® Anti-HCV II

Immunoassay for the qualitative determination of antibodies against HCV

Elecsys Anti-HCV II

Immunoassay for the qualitative determination of antibodies against HCV

The hepatitis C virus is a leading cause of liver disease and a major healthcare concern with over 71 million people chronically infected worldwide resulting in 399,000 deaths per year.1 Due to the high rate of asymptomatic infections, clinical diagnosis is difficult and screening assays are of major importance.2

Chronic HCV infection may lead to cirrhosis and hepatocellular carcinoma, therefore, early detection of antibodies to HCV is the first step in the management of chronic hepatitis and in the selection of patients needing treatment.3

Elecsys® Anti-HCV II is used to demonstrate the presence of antibodies against HCV during acute and chronic infection, and after a resolved infection.

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.