Elecsys® Anti-HCV II

IVD For in vitro diagnostic use.
Elecsys<sup>®</sup> 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, causing more deaths than all other reportable infectious diseases combined since 2013. 1

An estimated 3.5 million people are living with chronic HCV infection in the US, with over 100,000 new cases and nearly 15,000 deaths reported in 2021. 2 Due to the high rate of asymptomatic infections, clinical diagnosis is difficult and screening assays are of major importance.3

Though now a curable disease, only 40% of those living with chronic HCV are diagnosed, and less than a third of those diagnosed have received treatment.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.4

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.5

Elecsys® Anti-HCV II specifications

  • Systems

    cobas e 411 module, cobas e 601 / cobas e 602 modules, cobas e 402 / e 801 modules

  • 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 = borderline zone

    COI ≥1 = reactive

    cobas e flow - automated duplicate repeat confirmation

  • Sample material

    Serum collected using standard sampling tubes or tubes containing separating gel.

    Li-heparin, Na-heparin, K2-EDTA, K3-EDTA, plasma gel separation, and sodium-citrate plasma

  • Sample volume

    50 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules

    30 μL cobas e 402 and e 801 modules

  • 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 402/e 801 module CV 1.4 – 2.4%

Would you like to know more about the Elecsys® Anti-HCV II assay?

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References

  1. US HHS. Viral Hepatitis in the United States: Data and Trends. Accessed January 2025.
  2. CDC.gov. Hepatitis C: by the numbers. Accessed January 2025.
  3. Easterbrook, P.J., Roberts, T., Sands, A., Peeling, R. (2017). Diagnosis of viral hepatitis. Current Opinion in HIV and AIDS. 12(3), 302-314.
  4. EASL Recommendations on Treatment of Hepatitis C (2020). Journal of Hepatology 66(1), 5.
  5. Elecsys Anti-HCV II. 08836981190 2024-09 V2.0; 08837058190 2024-09 V2.0.

Overview

Detailed Specifications

Ordering Information

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