Evaluation of Third Generation Anti-HCV Test Kit (SYNPEP^TM HCV-EIA II) Using Sera of Inhabitants from HCV Hyperendemic Area

Abstract

We examined the characteristics and usefulness of a third generation anti-HCV test kit, SYNPEP^TM HCV-EIA II (Kyokuto Pharmaceutical Inc., Tokyo, Japan). The sera of inhabitants from a hepatitis C virus (HCV) hyperendemic area were used. The kit had even or more anti-HCV detection sensitivity and reproducibility than ORTHO HCVIII ELISA Test System^TM (Ortho-Clinical Diagnostic K.K., Tokyo, Japan) or HCV PHA 2nd Generation^TM (Dinabot Co., Ltd., Tokyo, Japan). SYNPEP^TM HCV-EIA II needed less total reaction time than other EIA kits, resulting in a simple procedure. Also, HCV RNA was detected in 90% of subjects who had a 7.5 or greater cut-off index (COI) of SYNPEP^TM HCV-EIA II kit. In conclusion, SYNPEP^TM HCV-EIA II require cheap cost and simple procedure and it could be applied to mass screening to find out HCV RNA positive persons who may need clinical care.