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 proteins^2,3. 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 C^1,5. 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 cirrhosis^2,7-9. 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 infection^11,12. 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 infection^13,14.

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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 assays^15,19.

Earlier detection of seroconversion by the Elecsys^® Anti-HCV II assay in selected anti-HCV seroconversion panels compared to other registered anti‑HCV screening assays^20,21

Marker profile

Hepatitis C infection marker profile after natural infection^2,9,16-18

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

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

References

WHO (2019). Hepatitis C factsheet. Available from: http://www.who.int/mediacentre/factsheets/fs164/en/.
Hoofnagle, J.H. (2002). Course and Outcome of Hepatitis C. Hepatology 36, S21-S29.
Lindenbach, B.D. and Rice, C.M. (2005). Unravelling hepatitis C virus replication from genome to function. Nature. 436, 933-938.
International Committee on Taxonomy of Viruses (ICTV). Flaviviridae Study Group. Confirmed HCV genotypes/subtypes (May 2019).
Razzawi, H. (2017). Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol 2, 161-76.
WHO (2017). Global Hepatitis Report. Available from: https://www.who.int/hepatitis/publications/global-hepatitis-report2017/en/.
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.
Manns, M.P. et al. (2017). Hepatitis C virus infection. Nat Rev Dis Prim 3, 17006.
Ahmad, J. (2017). Hepatitis C. BMJ 358, j2861.
Lauer, G.M. and Walker, B.D. (2001). Hepatitis C virus infection. N Engl J Med. 345, 41-52.
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.
Glynn, S.A. et al. (2005). Dynamics of viremia in early hepatitis C virus infection. Transfusion. 45(6), 994–1002.
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.
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.
Elecsys® Anti-HCV II method sheet. V8.0 2020-09.
Dufour, D.R. et al. (2001). Diagnosis and monitoring of hepatic injury. I. Performance characteristics of laboratory tests. Clin Chem. 46(12), 2027-49.
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.
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/.
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.
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.
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.