丙型肝炎国产诊断试剂与第三代进口试剂的临床比较研究

Evaluating Chinese anti HCV EIA kit and foreign third generation anti HCV EIA kit

目的考察丙型肝炎（丙肝）国产改进酶标诊断试剂与国外第三代主流试剂的灵敏度与特异性。方法用改进后的国产新伟凯公司丙肝试剂（ＸＷＫ）和两种国外第三代主流试剂（Ａ３，Ｏ３）检测了２８８２份供血员血样和５５６份各种肝炎病人血样。结果３种试剂（ＸＷＫ，Ａ３，Ｏ３）分别检出３８０，３７８和３７１份阳性样品，经免疫印迹条法（ＲＩＢＡ）和聚合酶链反应（ＰＣＲ）方法确证，３种试剂的假阳性数分别为７，６和１份，假阴性数分别为１，２和４份。结果说明，改进后的国产丙肝试剂，其检出灵敏度与目前国际上最新一代试剂接近，但其特异性略逊于国外两种第三代主流试剂。结论分析ＲＩＢＡ和ＰＣＲ所测得的３种试剂漏检样品的结果可以看出，目前国际上的第三代丙肝酶标试剂对丙肝核心抗体的检出灵敏度较低，这一点与我们以前的研究结果相同。而改进后的国产丙肝试剂既赶上了国外第三代试剂对丙肝ＮＳ３抗体的检出力度，同时又避免了国外试剂所暴露出的对丙肝核心抗体检出力弱的缺点。

Objective Toeevaluate the sensitivity and specificity of the improved Chinese anti HCV EIA kit and foreign third generation anti HCV EIA kit. Methods 2 882 Chinese blood donors and 556 Chinese hepatitis patient sera were tested with the improved Chinese anti HCV EIA kit (XWK) and two foreign third generation anti HCV EIA kits (A 3,O 3).Results The positive samples detected by XWK, A 3 and O 3 were 380, 378 and 371 respectively. According to the confirmed results by RIBA and PCR, the false positive samples given by XWK, A 3 and O 3 were 7, 6 and 1. And the false negative samples were 1, 2 and 4 respectively. The results showed that the sensitivity of the improved Chinese anti HCV EIA kit was similar to that of the third generation kit, but the specificity was poor than that of the late.Conclusion The conclusion also can be drawn that the capability of A 3 and O 3 in detecting anti HCV core antibody is poor.