Aims: A commercial rapid test kit for anti-Hepatitis C Virus (anti-HCV) detection was
evaluated and compared for diagnosis of hepatitis C by detection of immunoglobulin
G(IgG) antibodies against a third generation Enzyme Immunoassay(EIA) as gold
standard.
Methodology: A total of 560 patient serum samples were subjected to rapid screening
with rapid test (immunochromatographic) strip supplied by Global Diagnostics and
commercially prepared IgG capture EIA by DIA.PRO, Italy.
Results: Of the 560 samples, anti HCV was detected in 31(5.54%) by ELISA, whereas
Research Article
British Journal of Medicine & Medical Research, 3(4): 2325-2330, 2013
2326
only 17(3.04%) by strip method. This gives 100% specificity as no false positive was
observed, but with 68.8% sensitivity. The number of false negative results was 14. The
positive and negative predictive values were 100% and 97.42% respectively.
Conclusion: The result pattern shows that sensitivity is compromised. It is therefore
recommended that third generation ELISA is used for blood donors screening, to reduce
transmission of hepatitis C virus through blood transfusion. When need arises to use
strip for anti-HCV testing, such strip should be validated locally before its adoption
because kits are directed against known range of strains of HCV and have minimum titer
of antibody below which detection becomes impossible.