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Year : 1999  |  Volume : 17  |  Issue : 3  |  Page : 140-141

Evaluation of a rapid assay for HCV antibody detection


Department of Clinical virology, Christian Medical College and Hospital, Vellore 632 004, India

Correspondence Address:
S Raghuraman
Department of Clinical virology, Christian Medical College and Hospital, Vellore 632 004
India
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Source of Support: None, Conflict of Interest: None


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ABSTRACT: The laboratory performance of a commercially available `rapid' HCV antibody (anti-HCV) assay (MT-HCV/Ulti-Med Anti-HCV, Pharma Health BVBV, Belgium, marketed in India by Rapid Diagnostics Pvt. Ltd, New Delhi) was evaluated. The assay was initially evaluated with a panel of 100 sera comprising 70 negatives and 30 positives. The assay yielded a sensitivity of 100 percent and specificity of 100 percent. However when the assay was subsequently evaluated against another 186 sera, received at the laboratory for routine determination of anti-HCV antibody , the specificity remained at 100 percent while the sensitivity dropped to 95 percent on the cumulative panel. The `gold standard' used for evaluation was a third generation microparticle enzyme immunoassay (IMX)/Axsym, Abbott Laboratories, USA). The fall in sensitivity while using a larger evaluation panel can be explained by (i) chance variation (ii) inadequate representation of antigens on the rapid devices. The study emphasizes the need for testing larger and different kinds of population groups before any rapid assay can be approved for use as a screening test.






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2004 - Indian Journal of Medical Microbiology
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