Evaluation of a rapid on-site anti-HCV test as screening tool for hepatitis C infection

BackgroundThe clinical course of hepatitis C virus (HCV) infection is frequently asymptomatic and proper diagnosis therefore often missed. While certified laboratories usually take care to screen patients for possible HCV infection we now evaluated a rapid–on site anti-HCV test and compared the results with a certified assay.

Methods10µl serum or EDTA whole blood were analyzed with a chromatographic immunoassay (Toyo® anti-HCV Test, Turklab, Turkey). Results were available on-site 5–15 min after sample centrifugation.The Architect® anti-HCV-Test (Abbott, Germany) served as reference method.

ResultsSera of 192 patients were analyzed (without HCV-infection: n=109; HCV-infection: n=83 (chronic HCV-infection: n=81, acute HCV-infection n=2), HCV-genotype 1/2/3/4/unknown: n=62/4/9/1/7).The chromatographic immunoassay was evaluable in 188 cases (98%). Presence of HCV infection was correctly diagnosed in 82/83 individuals (sensitivity 99%). False positive results were obtained in 15/105 cases (specificity 86%). The positive and negative predictive value was 85% and 99%, respectively.A serum re-test was performed in 61 of the 148 individuals (re-test reliability 85%, n=52/61). The initially false-negative patient and 71% (n=5/7) of the initially false-positive cases were correctly classified in the re-test. Non-classifiable tests (n=2) were evaluable with correct anti-HCV negative result after assay repetition.The test was also repeated with EDTA whole blood. It was evaluable in 46/52 EDTA samples (88%). 51/52 evaluable tests were concordant with serum results. One HCV-patient with un-evaluable serum test was correctly diagnosed with the EDTA sample.

ConclusionsThe rapid chromatographic anti-HCV immunoassay can be used as on-site screening tool. However, due to its limited specificity a positive result warrants re-evaluation with a certified serologic assay.

diagnosis - hepatitis C - screening