丙型肝炎病毒抗原检测试剂在临床诊断中的初步应用

The Test of Hepatitis C Virus Antigen by ELISA for Clinical Diagnosis

本文利用重组丙型肝炎病毒(HCV)多表位复合抗原免疫动物制备抗HCV多克隆抗体,建立HCAgELISA检测方法,对不同的临床样品进行检测,分析不同临床样品HCAg检出率,并与荧光定量PCR结果进行对比。95份HCAb阳性的样品中,51份样品HCAg阳性,阳性率为53.7%;88份重症肝病患者血清中检出HCAg阳性33份,阳性率为37.5%,均明显高于其它样品(P<0.05);73份肝功异常但HCAb阴性血清样品,检出HCAg阳性8份,阳性率为11.0%;HCAg与HCAb之间存在相关性(r=0.5076,P<0.01),HCAg与HCV-RNA符合率为85.7%。HCAg ELISA检测可作为临床HCV诊断的检测指标,为临床早期诊断及治疗预后提供依据。

To provide a testing technique for early clinical diagnosis of HCV infection by detecting HCV antigen（HCAg） through testing serum samples by ELISA, HCV polyclonal antibodies were prepared from animals immunized by mutli-epitope complex antigen of HCV expressed by E. coll. Using antibody sandwiched ELISA to detect the HCAg from serum samples, we analyzed the positive rate of HCAg and compared it with the findings of RT-PCR. The positive rate of HCAg was 53.7% from 95 serum samples of the HCAb positive cases; the positive rate of HCAg was 37.5% from 88 serum samples of serious hepatic damage cases, and 11.0% from 73 serum samples of high ALT but with negative HCAb. The results showed that HCAg was related with HCAb（r=0. 5076,P〈0.01）. In 87.5% of the cases, both HCAg and HCV-RNA were positive as compared with RT-PCR. The ELISA method of HCVAg that we developed is a possible technique for early clinical diagnosis of HCV infection,