The accuracy of SM-HCV rapid test for the detection of antibody to hepatitis C virus

OBJECTIVE: Conventional tests for antibody to hepatitis C virus (HCV) requi re considerable time before results are available. The aim of this study is to examine the accuracy of a new quick test (SM-HCV Rapid Test) for the de tection of antibody to hepatitis C virus with reference to the well-establi shed third generation enzyme immunoblot assay (EIA-3; Abbott Laboratories, Chicago, IL). METHODS: A total of 290 subjects (100 patients with chronic hepatitis C inf ections, 95 patients with other chronic liver diseases, 95 healthy subjects ) were recruited. Thirty microliters of serum was tested for anti-HCV by SM -HCV Rapid Test according to the manufacturer's instruction. Liver function tests, and serum HCV RNA by polymerase chain reaction (PCR) were measured. RESULTS: In the 100 patients positive for anti-HCV by EIA-3, 98 of these pa tients were also positive for anti-HCV by SM-HCV Rapid Test. In the 95 pati ents with other chronic liver diseases, 94 samples were negative for anti-H CV by both EIA-3 and SM-HCV Rapid Test. The remaining one patient was posit ive for anti-HCV by the EIA-3 but negative by the SM-HCV Rapid Test. In the 95 controls, which were negative for anti-HCV by EIA-3. all were also nega tive for anti-HCV by SM-HCV Rapid Test and HCV RNA by PCR. Using EIA-3 as t he gold standard screening test fur anti-HCV, the sensitivity and the speci ficity of SM-HCV Rapid Test were 98% and 100%, respectively. The positive p redictive value and negative predictive value of SM-HCV Rapid Test were 100 % and 97.9%, respectively. CONCLUSIONS: SM-HCV Rapid Test is a reliable test with high sensitivity and specificity. The anti-HCV result can be available within a very short peri od of time. It is a useful screening test for anti-HCV. (C) 2001 by Am. Cel l. of Gastroenterology.