Relative sensitivity of third generation hepatitis C virus antibody detection assays: evaluation of 20 kits

ABSTRACT

The most important challenge in selecting suitable assays for the detection for the anti-HCV is sensitivity. In this study, 20 assays [EIA method] were compared with each other and with anti-HCV 3.0 Enhanced SAV [Ortho Company Production] as the reference assay recommended by WHO. 20 kits were compared by 3 to 4 serconversion and 2 to 3 performance panels. The relative sensitivity of kits was calculated based on WHO recommendations. In seroconversion relative sensitivity of 3 assays was the same as the reference assay and 5 assays showed lower relative sensitivity, but the differences between these five kits and the reference assay appeared just in two samples. In performance panels, two assays came out to be the same as the reference assay and the other 5 assays detected just 2 samples to have a level lower than anti-HCV 3. In all seroconversion and performance panels, the best results were obtained by ETI-AB-HCH-K4 [146] [Diasorin], Monalisa Anti-HCV plus Version 2 [BIO-RAD], Hepanostica Anti-HCV ULTRA [BIOMERIEUX], Anti-HCV-EIA 3rd [Avicenna Medial Center], and HCV AB [DIA PRO]. For improvement of blood safety, the assay with high sensitivity is recommended to be used, and the samples with weak positive reactions especially in seroconversion and low titer performance panels should be given more attention