Development of hepatitis C virus(HCV) fluorescence PCR (F-PCR) diagnostic kit and its clinical trial comparing with immunological method / 中国免疫学杂志

ABSTRACT

Objective:Use a new F-PCR method to develop a hepatitis C virus(HCV) diagnostic kit, test the kit through clinical trial and compare it with immunological method. Methods: Fluorescence PCR(F-PCR) is a method which combines PCR and fluorescence probe hybridization together to measure DNA/RNA. Because in-tube monitoring of fluorescence signal can be done to stand for the quantitity of PCR product. Electrophoresis and UV detection are eliminated, so after-PCR cross-contamination which causes false positive can be avoided. Results:A clinical diagnostic kit for HCV with this method is developed. 512 clinical serum samples were tested with this kit, using HCV FLISA kit from Abbott Co.and HCV Fluorescence RT-PCR kit from Biotronics Co. (B-PCR) as control. The results showspositive rate is 30.5%,sensitivity 97.3 % and specificity 98.1% . Conclusion: F-PCR is obviously superior to ELBA, and higher than B-PCR in sensitivity. The specificity of those three kits have no statistic difference. F-PCR can be used to monitor RNA of HCV in serum, and could be useful for clinical diagnose and therapy effects monitoring.