丙型肝炎诊断试剂的研究

本文用分子生物学方法根据中国人HCV基因特点进行多肽合成,研究丙型肝炎C区、E区酶标试剂的临床应用以及与抗C 100-3试剂的比较,并以 RT双 PCR的方法建立了HCV RNA的检测试剂及临床应用。结果发现抗-CP试剂敏感性、特异性均优于抗C100-3,从临床检测结果看,在自然人群中感染率抗-CP为2.8％,抗C100-3为2.1％,特别在输血后肝炎中,抗 CP阳性率高达 71.7％～75.9％。因此提出对HCV的诊断确立与愈后判断各类试剂有各自的作用,不能只根据某一试剂的某一次结果而简单地否定 HCV感染。HCV RNA测定,建立了5’末端非编码区及非结构区(NS 1),采用双PCR观察结果抗-CP阳性者绝大多数为RNA阳性,并提示将有助于抗病毒药物疗效的观察指标。

RESEARCH IN DIAGNOSTIC REAGENTS FOR HEPATITIS C

We have synthesed several peptides with moleculo-biological mettiod in the light of characteristicsof HCV genome in C and E regions of the Chinese and compared the reagents from these peptideswith that from C100-3. we have also established "nested" cPCR assay for detecting the HCV RNA inthe serum of patients. The sensitivity and specificity of anti-cp reagents were found significantly superiorto those of the reagent prepared only from C100-3. The positive percent age of anti-cp is 2.8 in thenatural population, while that of anti-C100-3 is 2.1. The positive rate of anti-cp in posttransfusionhepatitis is as high as 71.7-75.9K. The observations suggest the different diagnostic reagents ofHCV have a different role to play in the diagnosis of HCV and prognosis of hepatitis C. The resultof one reagent cannot simply exclude the HCV infection. We have also established the "nested"cPCR tests based on the seqences of noncoding and NS, regions of HCV cases positive of anti-CPwere almost positive of HCV RNA by the 'nested" cPCRs. The detection of HCV RNA can be used toshow the efficiency of anti-viral drugs in hepatitis C patients.