An Evaluation of Commercial Reagent Kits for Detecting HCV Antibodies: GenediaTM HCV ELISA 3.0, GenediaTM HCV Rapid and GenediaTM HCV Confirm 4.0

Lim, Young Ae; Jeon, Hee Sun; Kwak, Yun Sik; Cho, Young Shik; Lee, Dong Soon

Abstract

BACKGROUND: This study was conducted to evaluate accuracy of newly developed HCV Ab test kits by Korea Green Cross Co.(Yongin, Kyunggi), namely GenediaTM HCV ELISA 3.0 (ELISA) for routine test, GenediaTM HCV Rapid (RAPID) for quick screening. and GenediaTM HCV Confirm 4.0 (CONFIRM) for confirmation.
METHODS
Performance of ELISA was compared with that of Ortho HCV 3.0 ELISA (Neckargemund, Germany; ORTHO ELISA) using 990 patients' sera. Accuracy of RAPID was evaluated by testing on 114 HCV Ab negative and 86 positive specimens by ELISA. Discrepant results obtained by RAPID were confirmed by Chiron RIBA HCV 3.0 Strip Immunoblot Assay (Ca, USA; RIBA) and HCV Blot 3.0 (Genelabs Diagnostics, Singapore; BLOT). Accuracy of CONFIRM test was compared between RIBA and BLOT using 78 ELISA positive sera. To elucidate prevalence of viremia, RT-PCR was performed on 165 serum samples and results were compared with that of ELISA and RAPID.
RESULTS
Agreement of test results between ELISA and ORTHO ELISA was 99.6% (986/990). On HCV Ab negative specimens 99.1% (113/114) agreed among RAPID, ELISA and ORTHO ELISA. However, on seropositive specimens 91.7% (79/86) agreed between RAPID and ELISA. Agreement between CONFIRM and RIBA was 83.3% (65/78). Core antigen showed the highest reactivity and NS5 antigen showed the lowest reactivity with CONFIRM. HCV RNA was detected in 58.3% (28/48) of ELISA positive specimens, however, it was not detected in ELISA negative specimens. There was no correlation between prevalence of HCV RNA and 5 antigens used in ELISA test.
CONCLUSIONS
Newly developed Korea Green Cross GenediaTM HCV ELISA 3.0, Rapid and HCV Confirm were considered to be clinically accurate routine, quick screening and confirmatory test for detecting HCV Ab in serum samples.