丙型肝炎病毒核心抗原检测试剂的临床评价

[目的]对研制的丙型肝炎病毒核心抗原（HCV—cAg）ELISA检测试剂进行临床特异性及敏感性评价。[方法]制备抗HCV-核心区（Core）抗原四株单克隆抗体，研制出双抗体夹心检测HCV～core抗原酶联免疫检测（ELISA）试剂。三家临床单位收集抗HCV阴性样品3040份，HBsAg阳性100份，抗HIV阳性40份，从10万份抗-HCV筛查出临界样品28人份。[结果]3040份阴性样品检测有3份HCV—cAg阳性，3份经HCVPCR检测有1份阳性，100份HBsAg阳性，40份抗HIV阳性样本检测均为阴性，在10万份抗HCV抗体筛查样品中，选择28份抗-HCV检测临界样品进行HCV—cAg检测，有4份阳性，4份HCV—cAg阳性样品中有3份HCV—RNA检测阳性。[结论]研制的双抗体夹心HCV-核心抗原ELISA试剂具有很好的特异性和灵敏度。

CLINICAL EVALUATION OF HCV CORE ANTIGEN ELISA KIT

[ Objective] To evaluate specificity and sensitivity of the HCV core antigen ELISA Kit. [ Methods] A double antibody sandwich ELISA kits for detecting HCV - eAg were developed using four MeAbs against HCV core Ag, The collected serum samples were composed of 3040 serum samples negative for anti - HCV, 40 serum samples positive for anti - HIV, 100 serum samples positive for HB- sag, as well as 28 serum samples negative for anti - HCV, but OD value was of close to cutoff. [ Results ] Amomg 3040 serum samples negative for anti - HCV, 5 were primarily detected positive, The 3 serum samples were tested repeatly HCV - eAg positive, By HCV PCR detection, only 1 of the above - mentioned 3 serum samples was positive. The 100 HBsAg positive samples and 40 anti - HIV positive ones were detected negative by double antigen sandwich ELISA kit. The 4 of 28 serum samples in which anti - HCV close to cutoff value were detected positve by HCV - cAg Kit, where as 3 serum samples were detected positive by HCV - RNA. [ Conclusion ] The developed detecting HCV - cAg - ELISA Kit is better in specificity and sensitivity.