Elecsys® Anti-HCV II

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 an immunoassay for the in vitro qualitative detection of antibodies to hepatitis C virus in human adult and pediatric samples.

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.

Elecsys® Anti-HCV II

  • Systems

    cobas e 411 module, 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 <0.90 = non-reactive
    0.90 ≤COI <1.0 = gray zone
    COI ≥1 = reactive

  • Sample material

    Serum and plasma (K2-EDTA, K3-EDTA, Li-heparin, Na-heparin, Na-citrate).

  • Sample volume

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

  • Intermediate precision in positive samples

    cobas e 411 module: CV 3.1 – 6.5%
    cobas e 601 module: CV 2.33 - 4.34%
    cobas e 602 module CV 1.9 – 3.0%
    cobas e 801 module CV 1.4 – 2.4%