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PERFORMANCE EVALUATION OF THE AFIAS-6 ANTI-HCV ASSAY FOR THE DETECTION OF HEPATITIS C VIRUS ANTIBODIES

Author : Diana Shintawati Purwanto*, Yusra

Abstract

Background: The accurate examination for diagnosis of HCV infection is very important in order to receive an adequate treatment. The serology test which detects specific antibodies to HCV is recommended. The AFIAS-6 anti-HCV assay was recently introduced in Indonesia. This study aimed to evaluate performance of the AFIAS-6 anti-HCV in comparison to Cobas e601, which is routinely used in Dr. Cipto Mangunkusumo General Hospital, for the detection of anti-HCV antibodies in the population of Indonesia. Methods: 200 samples, which comprised of 100 positive samples and 100 negative samples according to the Cobas e601, were tested by AFIAS-6. The Cohen’s Kappa coefficient was used to assess the agreement. Results: The Kappa coefficient result was 0.890 (p=0.032, 95%CI 0.827-0.953) and total agreement rate between AFIAS-6 and Cobas e601 anti-HCV assays was 94%. The sensitivity and the specificity of the AFIAS-6 assay were calculated to be 93% and 95%, respectively. Conclusions : The AFIAS-6 anti-HCV assay showed good agreement with the Cobas e601 anti-HCV assay. The result indicates that AFIAS-6 is a reliable tool for detection of hepatitis C virus antibody, and may be useful in small or medium sized laboratories or as a back-up analyzer in bigger ones. Key words: Hepatitis C, Hepatitis C antibodies, sandwich immunoassay.

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