【摘要】 目的：分析本实验室血液标本的抗-HCV筛查结果和确证试验结果，为血液筛查策略的选择提供依据。方法：随机选取本中心2015年-2023年无偿献血人群抗-HCV酶联免疫印迹试验（ELISA）筛查不合格标本946例，对ELISA试验结果和免疫印迹（WB）确证试验结果进行统计，分析4种试剂（A、B、C、D）的ELISA复检符合率、确证阳性标本占比、真阳性标本检出率和最佳屏蔽界值。结果：4种试剂初筛不合格标本的总体复检符合率分别为69.88%、27.54%、84.00%和69.08%。WB确证结果显示，4种试剂的真阳性检出率分别为99.49%(391/393)、98.00%(49/50)、93.88%(92/98)、97.20%(382/393)。4种试剂不合格标本的S/CO值与WB结果呈正相关，S/CO值越高，确证阳性标本占比越高（r=0.99、0.95、0.87和0.99）。根据WB结果绘制4种试剂检测性能的受试者工作特征（ROC）曲线，曲线下面积（AUC）分别为0.946、0.909、0.934和0.967,S/CO最佳屏蔽界值分别为5.64、1.61、1.58和2.42，对应的阳性预测值（PPV）分别为93.50%、100%、100%、92.66%。结论：不同的抗-HCVELISA筛查试剂的检出能力存在一定的差异，各实验室可以根据自身的需求选择不同的试剂组合进行优势互补或设定S/CO最佳屏蔽界值，在提高检测的准确率、保证血液安全的同时，避免血液和试剂资源的浪费。更多还原

【Abstract】 Objective:To analyze the anti-HCV(hepatitis C virus) screening results and confirmatory test results of blood samples in our laboratory,so as to provide a basis for the selection of blood screening strategies.Methods:946anti-HCV ELISA screening non-conforming samples from volunteer blood donors at our center between 2015 and 2023were randomly selected.Statistical analysis was performed on ELISA results and Western blot(WB) confirmatory test results.The ELISA retest concordance rate,proportion of confirmed positive samples,true positive detection rate and optimal shielding threshold value of four reagents(A,B,C and D) were analyzed.Results:The overall retesting concordance rates of the initial screening non-conforming specimens for the four reagents were 69.88%,27.54%,84.00% and 69.08%,respectively.Results of WB confirmatory tests showed that the true positive detection rates of the four reagents were 99.49%(391/393),98.00%(49/50),93.88%(92/98),and 97.20%(382/393),respectively.The S/CO(sample/cut-off ratio) values of non-conforming samples detected by the four reagents were positively correlated with WB results:the higher the S/CO value,the higher the proportion of confirmed positive samples(r=0.99,0.95,0.87,and 0.99,respectively).The receiver operating characteristic(ROC) curves for the detection performance of the four reagents were drawn according to the WB results,and the areas under the curves(AUC) were 0.946,0.909,0.934,and 0.967,respectively.The optimal shielding threshold value of S/CO were5.64,1.61,1.58,and 2.42,with corresponding positive predictive values(PPV) of 93.50%,100%,100%,and92.66%,respectively.Conclusion:There are certain differences in the detection capabilities of different anti-HCV ELISA screening reagents.Each laboratory can choose different reagent combinations for complementary advantages or set the optimal shielding threshold value of S/CO according to its own needs,so as to improve the accuracy of detection,ensure blood safety,and avoid waste of blood and reagents.更多还原