Immunoassay for the qualitative determination of antibodies against hepatitis C virus (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 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 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.
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
Hepatitis C infection marker profile after natural infection2,9,16-18
~ 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.
* coefficient of variation
** 95 % confidence interval (2-sided)