• Paola Chionne, Elisabetta Madonna, Umbertina Villano, Elena Tritarelli, Giulio Pisani, Angela Costantino, Michele Equestre, Cinzia Marcantonio, Roberto Bruni, and Anna R Ciccaglione.
• Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy.
• Panminerva Med. 2020 Sep 1; 62 (3): 125-130.

BackgroundEvaluation of clinical performance of the anti-hepatitis C virus (HCV) rapid tests were carried out mostly in chronic hepatitis C patients and in individuals at high risk of HCV infection.MethodsThe aim of this study was to evaluate the performance of OraQuick and Wantai rapid tests on archived serum samples from 1408 individuals (mean age 46, range 18-90; 65% female) recruited with a systematic sampling procedure during a general population survey.ResultsThe analysis of samples by Ortho HCV 3.0 ELISA and Cobas Taqman HCV RNA assays resulted in 69 anti-HCV antibody positive sera, including 42 HCV RNA positive (group 1) and 27 HCV RNA negative (group 2) samples. The performance of rapid tests was evaluated on the 69 anti-HCV positive (group 1+2) and 206 (OraQuick) and 198 (Wantai) anti-HCV negative sera, randomly selected from the 1339 anti-HCV negative samples. The OraQuick and Wantai rapid assays showed a sensitivity in group 1 of 92.9% and 90.5%, respectively. The sensitivity in group 2 was 40.7% and 51.9%, respectively. The anti-HCV antibodies signal/cutoff mean value was the only parameter that statistically differed between group 1 and group 2 individuals (P<0.0001). Further, 3 (OraQuick) and 4 samples (Wantai) from group 1, with very low HCV RNA level (<25 UI/mL), were misdiagnosed by rapid assays as false negative.ConclusionsThe proportion of infections with low level of viremia and the risk associated with rapid assay failure remained to be carefully estimated in general population.

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