Hepatitis C virus (HCV) is a major cause of chronic liver disease worldwide. The severity of disease varies widely from mild illness to cirrhosis and hepatocellular carcinoma. The routine diagnostic test for HCV infection is performed using anti-HCV antibodies and an enzyme immunoassay (EIA) for serologic identification and HCV-RNA assay employing the polymerase chain reaction(PCR) for genetic identification. This study assessed the sensitivity and specificity of HCV-RNA diagnostic tests on analysis of the literature. A literature search was performed using the criteria from The standards for Reporting of Diagnostic Accuracy (STARD) steering committee for the assessment of diagnostic tests. The selected studies were searched for identifying publications on the appropriate conducting and reporting of diagnostic studies, and we extracted potential items to generate an extensive list. Out of 409 studies, 38 were selected. Further studies are necessary to accurately access HCV-RNA in various populations compared with reference tests.
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