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Elecsys® Anti-HCV II

Immunoassay for the qualitative determination of antibodies against hepatitis C virus (HCV)

Elecsys Anti-HCV II
Immunoassay for the qualitative determination of antibodies against HCV

Elecsys® Anti‑HCV II is an immunoassay for the in vitro qualitative detection of antibodies to HCV in human serum and plasma1.

Hepatitis C

Hepatitis C is an inflammatory liver disease caused by infection with the hepatitis C virus (HCV), which can cause both acute and chronic hepatitis2. HCV is a member of the Flaviviridae family and has a single-stranded, positive-sense RNA genome, which encodes 3 structural and 7 non-structural proteins3,4. HCV is classified into eight genotypes with a total of currently 93 subtypes5.

Hepatitis C represents a major global health burden: approximately 170 - 200 million people worldwide have been infected with HCV, of which 58 million live with chronic hepatitis C2,6. In 2019, approximately 290,000 people died from hepatitis C, mostly from cirrhosis and hepatocellular carcinoma2. Due to the often asymptomatic nature of the disease, hepatitis C infection remains heavily underdiagnosed7.

Most acute HCV infections (70 – 85 %) are in the beginning asymptomatic  and approximately 15 – 45 % of patients will clear acute infection. When symptoms are present during acute hepatitis C, they usually appear within 7 – 8 weeks after exposure and consist of jaundice, malaise, and nausea (similar to hepatitis A and B)3,8-10.

Chronic HCV infection is characterized by persistence of HCV RNA for longer than 6 months. Most chronic infections will lead to hepatitis and to some degree of fibrosis, which may be accompanied by relatively nonspecific symptoms such as fatigue. 20 % of people with chronic hepatitis C will eventually develop cirrhosis3,8-10. Once cirrhosis is established, the risk of HCC is 1 – 4 % per year11.

Anti-HCV antibodies are detected on average 6 – 8 weeks after infection, but can be detected from the onset of symptoms or may develop late (up to 6 months) after infection. The antibody-negative but HCV RNA-positive window period in HCV infections can be as much as 40 – 60 days, but varies from patient to patient. Anti-HCV rises to higher levels during chronic infection12,13. Anti-HCV is used as a first-line test to screen for and diagnose HCV infection. A positive or indeterminate anti-HCV test result should be followed by a sensitive test for HCV RNA to confirm active HCV infection14,15.

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Seroconversion sensitivity

Seroconversion sensitivity

Seroconversion sensitivity of the Elecsys® Anti‑HCV II assay was shown by testing commercial anti-HCV seroconversion panels. The Elecsys® Anti‑HCV II assay detected more positive panel members than all other registered anti‑HCV assays tested and was more sensitive in the recognition of early HCV infection than the other registered anti‑HCV screening assays1,19.

Seroconversion sensitivity

Earlier detection of seroconversion by the Elecsys® Anti-HCV II assay in selected anti-HCV seroconversion panels compared to other registered anti‑HCV screening assays20,21

Marker profile

 

Hepatitis C infection marker profile after natural infection3,10,16-18

Marker profile

~ 15 – 45 % of infected people spontaneously clear the virus within 6 months of infection without any treatment.

Marker profile

Chronic HCV infection is characterized by persistence of HCV RNA for longer than 6 months.

Elecsys® Anti-HCV II

Elecsys® Anti-HCV II

  • Systems

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules, cobas e 402 / cobas e 801 analytical units

     

  • Testing Time

    18 minutes

  • Test principle

    One-step double antigen sandwich assay

  • Calibration

    2-point

  • Result interpretation

    COI < 0.9 = non-reactive
    0.9 ≤ COI < 1.0 = borderline
    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.

    Specimen collected from living patients, blood donors, or individual organ, tissue or cell donors may be used, including donor samples obtained while the donor’s heart is still beating, and cadaveric blood specimens (specimens collected post-mortem, non-heart-beating).

  • cobas e flow

    cobas e 402 / cobas e 801 analytical units: Duplicate repeat testing of initially reactive samples

     

  • Sample volume

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules: 50 µL
    cobas e 402 / cobas e 801 analytical units: 30 µL

     

     

     

  • Onboard stability

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules: 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 402 / cobas e 801 analytical units: 31 days

  • Intermediate precision in positive samples

    cobas e 411 analyzer: CV* 5.1 - 5.4 %
    cobas e 601 / cobas e 602 modules: CV 2.0 - 7.7 %
    cobas e 402 / cobas e 801 analytical units: CV 1.3 - 6.8 %

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

  • Relative sensitivity

    HCV infected patients with different stages of disease (N=765): 100 %

  • Relative specificity

    Blood donors (N=6,850): 99.85 % (99.73 – 99.93 %**)

    Hospitalized patients (N=3,922): 99.66 % (99.41 – 99.82 %)

     

* coefficient of variation
** 95 % confidence interval (2-sided)

References

 

  1. Elecsys® Anti-HCV II Material Numbers 08836981190 & 08837031190, Method Sheet 2022-08, V1.0. Material Number 08837058190, Method Sheet 2022-07. V1.0.
  2. World Health Organization. Hepatitis C: Fact sheet [Internet; updated 2022 Jun 24; cited 2022 Sep 19]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-c.
  3. Hoofnagle JH. Course and Outcome of Hepatitis C. Hepatology 2002;36:21-29.
  4. Lindenbach BD and Rice CM. Unravelling hepatitis C virus replication from genome to function. Nature 2005;436:933-938.
  5. International Committee on Taxonomy of Viruses (ICTV). Flaviviridae Study Group. Confirmed HCV genotypes/subtypes [Internet; updated 2022 Mar]. Available from: https://ictv.global/sg_wiki/flaviviridae/hepacivirus.
  6. Salari N. et al. Global prevalence of hepatitis C in general population: A systematic review and meta-analysis. Travel Medicine and Infectious Disease 2022;46:102255.
  7. World Health Organization. Global Hepatitis Report, 2017 [Internet; updated 2017 Apr 19; cited 2022 Sep 19]. Available from: https://www.who.int/publications/i/item/9789241565455.
  8. Boesecke C and Wasmuth JC. Hepatitis C. In: Mauss S, et al. (eds.). Hepatology - A Clinical Textbook; 10th Edition [Internet; updated 2020; cited 2022 Sep 19]. Available at: www.hepatologytextbook.com.
  9. Manns MP, et al. Hepatitis C virus infection. Nat Rev Dis Prim 2017;3:17006.
  10. Ahmad J. Hepatitis C. BMJ 2017;358:j2861.
  11. Lauer GM and Walker BD. Hepatitis C virus infection. N Engl J Med 2011;345:41-52.
  12. Hajarizadeh B, et al. lnC3 Study Group. Patterns of hepatitis C virus RNA levels during acute infection: the lnC3 study. PLoS One 2015;10:e0122232.
  13. Glynn SA, et al.. Dynamics of viremia in eariy hepatitis C virus infection. Transfusion 2005;45:994-1002.
  14. Centers for Disease Control and Prevention (CDC). Testing for HCV infection: an update of guidance for clinicians and laboratorians. Morb Mortal Wkly Rep 2013;62:362-365.
  15. European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C. Final update of the series. J Hepatol 2020;73:1170-1218.
  16. Dufour DR, et al. Diagnosis and monitoring of hepatic injury. I. Performance characteristics of laboratory tests. Clin Chem 2001;46:2027-49.
  17. Centers for Disease Control and Prevention. Viral Hepatitis Serology Training, Hepatitis C [Internet; updated 2015 Nov 25; cited 2022 Sep 19]. Available from: https://www.cdc.gov/hepatitis/resources/professionals/training/serology/training.htm.
  18. World Health Organization. Guidelines on Hepatitis B and C Testing. Annex 6.1 Testing strategies for hepatitis B and C infection [Internet; updated 2017 Feb 16; cited 2022 Sep 19]. Available from: https://www.who.int/publications/i/item/9789241549981.
  19. Esteban Jl, et al. Multicenter evaluation of the Elecsys anti-HCV II assay for the diagnosis of hepatitis C virus infection. J Med Virol 2013;85:1362-1368.
  20. Yang R, at al. Performance evaluation and comparison of the newly developed Elecsys anti-HCV II assay with other widely used assays. Clin Chim Acta 2013;15:95-101.
  21. Yoo SJ, et al. Evaluation of the Elecsys Anti-HCV II assay for routine hepatitis C virus screening of different Asian Pacific populations and detection of early infection. J Clin Virol 2015;64:20-27.