献血者HCV检测模式的初步探讨

Evaluation of HCV screening strategy in blood donors

目的探讨核酸扩增技术(NAT)检测后进行一次酶联免疫吸附试验(ELISA)检测的可能风险。方法收集双试剂(金伟凯及Ortho)HCVE LISA筛查判为不合格的献血者血液291份,进行核酸检测及血清学确证试验,分析单试剂检测漏检的情况。结果选用金伟凯anti-HCV ELISA作为单次ELISA检测,291份不合格血标本中97份被判为ELISA检测合格(S/CO<0.7)同时NAT检测合格,其中3份(1.0%)重组免疫印迹(RIBA)确证试验阳性的血液被NAT和ELISA漏检;选用Ortho anti-HCV ELISA作为单次ELISA检测,291份不合格血标本中88份被判为ELISA检测合格(S/CO<0.7)同时NAT检测合格,其中2份(0.7%)RIBA确证试验阳性的血液被漏检。结论 NAT检测后去掉两次ELISA检测中的一次检测模式暂时尚需慎重,需加大样本量进一步分析研究。

Objective To determine if nucleic acid tests （NAT） can effectively detect the unqualified blood which is positive by single HCV enzyme linked immunosorbent assay （ELISA） reagent and confirmed by recombinant immunoblot assay（RIBA） confirmation test, and study the possible risk of delete one of the two rounds of HCV ELISA screening. Meth-ods 291 unqualified blood samples, which were screened by two different anti-HCV ELISA kits GWK and Ortho, were collected. Samples were further tested by NAT and RIBA. The false negative risk by single ELISA kit was analyzed. Re-suits If specimens were only tested by GWK anti-HCV ELISA kits, 97 of 291 anti-HCV unqualified samples were nega-tive （S/CO〈0.7） by anti-HCV ELISA and NAT, and among which, 3 samples （3/291, 1.0%） which were positive confirmed by RIBA would be missed. If specimens were only tested by Ortho anti-HCV ELISA kits, 88 of 291 anti-HCV unqualified samples were negative （S/CO〈0.7） by anti-HCV ELISA and NAT, and among which, 2 samples （2/291, 0.7%） which were confirmed to be positive by RIBA would be missed. Conclusion It indicates that after the implementation of NAT, it should be cautious to delete one of the two anti-HCV ELISA kits examination and large samples are needed.