Human Anti-Hepatitis C Virus Antibody, Anti-HCV ELISA Kit (DEIA015s)

Regulatory status: For research use only, not for use in diagnostic procedures.

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Size
96T
Sample
serum, plasma
Species Reactivity
Human
Intended Use
Anti-HCV ELISA is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of antibodies to hepatitis C virus in human serum or plasma. It is intended for screening blood donors and diagnosing patients related to infection with hepatitis C virus.
Storage
The components of the kit will remain stable through the expiration date indicated on the label and package when stored between 2-8°C, do not freeze. To assure maximum performance of this Anti-HCV ELISA, during storage, protect the reagents from contamination with microorganism or chemicals.
Performance Characteristics
1. Clinical Specificity: A blood donor population of 2948 individuals was tested with 3 different kits from different manufacturers. The specificity of this Anti-HCV ELISA was 99.55%.

2. Clinical Sensitivity: Among 480 clinical hepatitis C patients confirmed positive by RIBA 3.0, 480 were positive when tested with this Anti-HCV ELISA. The sensitivity was 100%.
3. Analytical Specificity:
- No cross reactivity observed with samples from patients infected with HAV, HBV, HIV, CMV and TP. No interference was observed from rheumatoid factors up to 2000U/ml.
- The performance characteristics of this assay are unaffected from elevated concentrations of bilirubin, hemoglobin, and triolein.
- Same day and frozen specimens have been tested to check for interferences due to collection and storage.
4. Performance on BBI low and mixed titers anti-HCV panels.


5. HCV genotype antibody testing

6. Reproducibility
General Description
Hepatitis C virus (HCV) is an envelope, single stranded positive sense RNA (9.5 kb) virus belonging to the family of Flaviviridae. Six major genotypes and series of subtypes of HCV have been identified. Isolated in 1989, HCV is now recognized as the major cause for transfusion associated non-A, non-B hepatitis. The disease is characterized with acute and chronic form although more than 50% of the infected individuals develop severe, life threatening chronic hepatitis with liver cirrhosis and hepatocellular carcinomas. Since the introduction in 1990 of anti-HCV screening of blood donations, the incidence of this infection in transfusion recipients has been significantly reduced. The first generation of HCV ELISAs showed limited sensitivity and specificity and was produced using recombinant proteins complementary to the NS4 (c100-3) region of the HCV genome as antigens. Second generation tests, which included recombinant / synthetic antigens from the Core (c22) and nonstructural regions NS3 (c33c, c100-3) and NS4 (c100-3, c200) resulted in a remarked improvement in sensitivity and specificity. Clinical studies show that significant amount of HCV infected individuals develop antibodies to NS5 non-structural protein of the virus. For this, the third generation tests include antigens from the NS5 region of the viral genome in addition to NS3 (c200), NS4 (c200) and the Core (c22). Third generation tests have improved sensitivity and shorten the time between infection with HCV and the appearance of detectable antibodies (window period) to 60 days.

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