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

Elecsys® Anti‑HCV II is an immunoassay for the in vitro qualitative detection of antibodies to HCV in human serum and plasma15.

 

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 hepatitis1. 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 proteins2,3. HCV is classified into eight genotypes with a total of currently 90 subtypes4.

 

Hepatitis C represents a major global health burden: approximately 100 – 150 million people worldwide have been infected with HCV, of which 71 million live with chronic hepatitis C1,5. A significant number of chronically infected will develop liver cirrhosis or hepatocellular carcinoma (HCC). About 400,000 people die each year from hepatitis C-related liver diseases1. Due to the generally asymptomatic nature of the disease, hepatitis C infection remains heavily undiagnosed6.

Most acute HCV infections (70 – 85 %) are 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)2,7-9.

 

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 cirrhosis2,7-9. Once cirrhosis is established, the risk of HCC is 1 – 4 % per year10.

 

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 infection11,12. 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 infection13,14.

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 assays15,19.

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 infection2,9,16-18

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

References

 

  1. WHO (2019). Hepatitis C factsheet. Available from: http://www.who.int/mediacentre/factsheets/fs164/en/.
  2. Hoofnagle, J.H. (2002). Course and Outcome of Hepatitis C. Hepatology 36, S21-S29.
  3. Lindenbach, B.D. and Rice, C.M. (2005). Unravelling hepatitis C virus replication from genome to function. Nature. 436, 933-938.
  4. International Committee on Taxonomy of Viruses (ICTV). Flaviviridae Study Group.  Confirmed HCV genotypes/subtypes (May 2019).
  5. Razzawi, H. (2017). Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol 2, 161-76.
  6. WHO (2017). Global Hepatitis Report. Available from: https://www.who.int/hepatitis/publications/global-hepatitis-report2017/en/.
  7. Boesecke, C. and Wasmuth, J.C. (2018). Hepatitis C. In: Mauss, S. et al. (eds.). Hepatology – A Clinical Textbook; 9th Edition. Available at: www.hepatologytextbook.com.
  8. Manns, M.P. et al. (2017). Hepatitis C virus infection. Nat Rev Dis Prim 3, 17006.
  9. Ahmad, J. (2017). Hepatitis C. BMJ 358, j2861.
  10. Lauer, G.M. and Walker, B.D. (2001). Hepatitis C virus infection. N Engl J Med. 345, 41-52.
  11. Hajarizadeh, B et al. (2015). InC3 Study Group. Patterns of hepatitis C virus RNA levels during acute infection: the InC3 study. PLoS One. 10(4), e0122232.
  12. Glynn, S.A. et al. (2005). Dynamics of viremia in early hepatitis C virus infection. Transfusion. 45(6), 994–1002.
  13. Centers for Disease Control and Prevention (CDC) (2013). Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. 62, 362-365.
  14. European Association for the Study of the Liver (EASL) (2020). Recommendations on Treatment of Hepatitis C. J Hepatol. https://doi.org/10.1016/j.jhep.2020.08.018.
  15. Elecsys® Anti-HCV II method sheet. V8.0 2020-09.
  16. Dufour, D.R. et al. (2001). Diagnosis and monitoring of hepatic injury. I. Performance characteristics of laboratory tests. Clin Chem. 46(12), 2027-49.
  17. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (2015). Viral Hepatitis Serology Training, Hepatitis C. Available from: https://www.cdc.gov/hepatitis/resources/professionals/training/serology/training.htm.
  18. WHO Guidelines on Hepatitis B and C Testing. Geneva: World Health Organization; 2017 Feb. Fig. 1, Approximate time course for HCV virological and serological markers in chronic HCV infection. Available from: https://www.ncbi.nlm.nih.gov/books/NBK442283/figure/annex6.fig1/.
  19. Esteban, J.I. et al (2013). Multicenter evaluation of the Elecsys® anti-HCV II assay for the diagnosis of hepatitis C virus infection. J Med Virol 85, 1362-1368.
  20. Yang, R. at al. (2013). Performance evaluation and comparison of the newly developed Elecsys® anti-HCV II assay with other widely used assays. Clin Chim Acta 15, 95-101.
  21. Yoo, S.J. et al. (2015). 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 64, 20-27.

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

  • 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.

  • cobas e flow

    cobas e 801 module: Duplicate repeat testing of initially reactive samples

     

  • 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 4.2 – 5.2 %
    cobas e 601 / cobas e 602 modules: CV 1.6 – 4.0 %
    cobas e 801 module: CV 1.2 – 1.5 %

  • 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 %)

* 95 % confidence interval (2-sided)