abia HCV Ab
abia HCV Ab is an enzyme immunoassay for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum or plasma.
The assay is intended for screening for potentially infectious samples to prevent their use as donor materials. For professional use only.
Clinical value
Hepatitis C is an infectious disease affecting the liver, caused by the hepatitis C virus (HCV). The infection is often asymptomatic, but once established, chronic infection can progress to scarring of the liver (fibrosis), and advanced scarring (cirrhosis) which is generally apparent after many years. In some cases those with cirrhosis will go on to develop liver failure or other complications of cirrhosis, including liver cancer1.
The hepatitis C virus is an enveloped RNA positive sense virus belonging to the Flaviviridae family. First line hepatitis C screening is third-generation ELISA immunoassay for detecting anti-HCV antibodies. These tests are successfully used for long time for blood donors screening.
Principle of the test
abia HCV Ab is an indirect solid-phase enzyme assay based on microwells coated with recombinant antigens representing immunodominant regions of HCV structural (core) and nonstructural (NS3, NS4, NS5) proteins.
In the first stage antibodies specific for HCV core, NS3, NS4 or/and NS5 present in the sample binds with HCV recombinant antigens coated on the wells and at the same time with biotinylated recombinant HCV core Ag (conjugate 1). The unbound components are removed by washing.
In the second stage HRP-labeled anti-human IgG and streptavidin binds to any human IgG and biotin labeled core Ag captured on the well in the first stage. The unbound components are removed by washing.
After addition of the solution containing TMB and hydrogen peroxide, the wells with bound conjugate develop a blue color which is converted to yellow after the reaction has been stopped with sulphuric acid.
The color intensity is directly proportional to the concentration of HCV antibodies in the specimen and can be read at 450 nm or 450/620 nm.