Hepatitis C Virus Antibody (HCV Ab) EIA

The Alinity s Anti-HCV assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma specimens on the Alinity s System.

The Alinity s Anti-HCV assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HCV. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing serum specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens.

About Hepatitis C virus (HCV)

Hepatitis C virus (HCV) is the causative agent of acute and chronic hepatitis infection. Globally, an estimated 71 million individuals are chronically infected, of whom approximately 399, 000 die annually of HCV-related liver disease. A significant number of those who are chronically infected will develop liver cirrhosis or liver cancer.¹

HCV belongs to the genus Hepacivirus in the family Flaviviridae and is a linear, single-stranded, positive-sense RNA virus. It is divided into at least 6 different genotypes (1-6) and several subtypes based on nucleotide sequence homology.² Each HCV genotype can be present in any given country, but there are geographical differences in prevalence. Differences between genotypes are associated with responses to treatment.³ HCV is transmitted by exposure to blood or blood products, contaminated needle sticks, or unsterilized needles. It can also be transmitted through sexual or perinatal routes, or through contact with contaminated personal items, however these modes are less common. Because of effective blood screening using serological and nucleic acid testing (NAT) methods, the risk of transfusion transmitted HCV infections has been reduced.⁴

HCV RNA can be detected within a few days of exposure to HCV, prior to the development of antibodies.² This time period, referred to as the pre-seroconversion window period, often extends for several weeks after initial infection with HCV. In general, antibodies to HCV are absent in the early weeks of infection and are not detected until approximately 4-10 weeks after infection.⁵ In general 75%-85% of HCV infected individuals develop chronic infection, which is characterized by the continued detection of both HCV RNA and antibodies to HCV, persisting for decades after initial infection.^{2, 5} About 30% of infected individuals resolve their infection, which is characterized by continued detection of antibodies to HCV, but with HCV RNA no longer being detectable.^{1, 2} Anti-HCV assays are used to identify individuals infected with HCV and to prevent transmission of the virus to recipients of blood or blood products. The Alinity s Anti-HCV assay is designed to detect antibodies to recombinant antigens representing Core, NS3, and NS4 regions of the HCV genome.

This assay is a two-step immunoassay for the qualitative detection of anti-HCV in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.

Sample, recombinant HCV antigen coated paramagnetic microparticles, and assay diluent are combined and incubated. The anti-HCV present in the sample binds to the recombinant HCV antigen coated microparticles. The mixture is washed. Anti-human IgG and IgM acridinium-labeled conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added.

The resulting chemiluminescent reaction is measured as relative light units (RLU). There is a direct relationship between the amount of anti-HCV in the sample and the RLU detected by the system optics. The presence or absence of anti-HCV in the sample is determined by comparing the chemiluminescent RLU in the reaction to the cutoff RLU determined from an active calibration.

Test performed by Eurofins DPT, 6933 S. Revere Parkway, Centennial, CO 80112.

This test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. See package insert for more information.