血站实验室献血者HCV抗体检验报告新模式探讨

A study on optimizing reporting process for hepatitis C virus antibody test for blood donors in blood center' laboratory

目的评估血站日常抗-HCV间接法酶联免疫吸附实验检测结果的准确性,探讨如何转换抗-HCV报告流程,保护献血者的积极性及珍贵的血液资源。方法使用上海科华间接法丙型肝炎试剂盒(试剂A)、北京万泰间接法丙型肝炎试剂盒(试剂B)对116份标本进行间接法酶联免疫检测,测定结果为阳性或灰区的标本,使用确认试剂进一步检测,确定其真实结果,统计本地区丙型肝炎确认结果与双试剂检测结果的对应分布情况。两种抗-HCV试剂对116份标本的检测采用配对χ2检验,对两种试剂的检验结果采用一致性检验。结果两种间接法试剂对116例标本的检测结果,差异具有统计学意义(P=0.04),而两种试剂一致性较差,双试剂强阳性标本、弱阳性标本的假阳性率分别为0、35.7%;两种试剂的单试剂阳性标本、灰区标本的假阳性率分别为A试剂:94.3%、100%;B试剂:84.2%和88.9%。结论间接法试剂假阳性率较高,特异性较差,国产间接法试剂之间存在较大差异,应对原丙型肝炎报告方式进行修改,对弱阳性标本应进行进一步的确证实验以保护献血者积极性。

Objective To assess the accuracy of indirect enzyme- linked immunosorbent assay（ ELISA） for hepatitis C virus（ HCV） antibody as a routine test in the blood center,discuss how to optimize the reporting process for HCV antibody,and protect donors＇ enthusiasm and precious blood resources. Methods A total of 116 samples were screened by two indirect anti- HCV ELISA kits available from Shanghai Kehua（ reagent A） and Beijing Wantai（ reagent B）,respectively. Samples that yielded positive results or gray- zone results were further validated using a confirmation reagent to establish definitive results and compare confirmed positive results and the results with the two reagents for indirect ELISA. Differences in the ELISA results of the 116 samples between the two anti- HCV reagents were compared using the paired chi- square test and the agreement between the results with the two reagents were compared using the Kappa test. Results There were significant differences in the test results between the two reagents used for indirect ELISA（ P = 0. 04）,but the two reagents varied greatly from each other. The false positive rates of samples strongly or weakly positive with both reagents were 0 and 35. 7%,respectively;the false positive rates of samples positive with either reagent or samples with gray- zone results were 94. 3% and 100% for reagent A and84. 2% and 88. 9% for reagent B. Conclusion Reagents used for indirect ELISA have high false positive rates and poor specificity and considerable differences exist between homemade indirect reagents. The existing HCV reporting process should be modified. Weakly positive specimens should be further validated by a confirmatory test to protect blood donors＇ enthusiasm.