Abstract
To determine if chemiluminescence can be used in an enzyme immunoassay (EIA) format to test for hepatitis C virus (HCV) antibody and to compare sensitivity and specificity of chemiluminescence to a licensed anti-HCV EIA method, random volunteer donor samples were evaluated. One thousand and seventy-four random volunteer donor samples were collected during a 2-week period. Two aliquots of each sample were tested for anti-HCV. One aliquot was tested using a licensed anti-HCV 2.0 EIA test. The second aliquot was tested using the research anti-HCV chemiluminescence assay. Confirmatory testing was done using Recombinant Immuno Blot Assay (RIBA) 2.0 HCV and HCV RNA. Of the 1074 samples, eight were found to be reactive for anti-HCV. Seven were positive by the anti-HCV 2.0 EIA and the chemiluminescence system. The eighth sample was chemiluminescence reactive, but EIA negative; when tested by an unlicensed EIA 3.0 HCV test, RIBA 3.0 HCV test and an HCV-RNA assay, the sample was still negative. The same sample was also tested by RIBA 2.0 HCV and showed a reactive band to SOD. The chemiluminescence assay has a 100% sensitivity and 99.9% specificity compared to EIA and can be used as an alternative to EIA for detecting antibodies to HCV.
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