摘要
目的分析抗-HCV反应性献血者检测结果,甄别献血者HCV感染情况,讨论对反应性献血者分类管理的可行性。方法按照献血者HCV检测结果(2遍ELISA、1遍NAT),将HCV检测反应性献血者标本分为3组(抗-HCV和HCV RNA均为反应性的标本组、单独HCV RNA反应性标本组、单独抗-HCV反应性标本组)。分析2017年5月-12月期间HCV检测反应性献血者标本检测结果,以重组免疫印记试验(RIBA)结果作为确证结果,比较不同组别阳性预期值(PPV)差异;分析不同屏蔽界值(常规检测屏蔽界值、最佳屏蔽界值、最高PPV对应屏蔽界值)下每种试剂灵敏度、特异性、阳性预测值。对于PPV低的分组标本进行ELISA S/CO值分层分析并比较不同屏蔽界值下PPV。结果检测期间不合格标本939例(0.49%,937/191627),经RIBA确证,抗-HCV阳性率为10.67%(100/937);单独HCV RNA反应性组标本2例(0.001%,2/939);抗-HCV和HCV RNA均为反应性组标本63例(6.71%,63/939),PPV为96.83%(61/63);单独抗-HCV反应性组标本874例(93.08%,874/939),PPV为4.46%(39/874),其ELISA双试剂均为反应性标本和单试剂反应性标本的PPV分别为18.72%、0.15%,两者PPV差异有统计学意义(P<0.05),比较不同S/CO值分层的PPV差异有统计学意义(P<0.05)。ROC曲线获得试剂抗HCV最佳屏蔽界值分别为9.29、3.97,不同屏蔽界值下PPV差异有统计学意义(P<0.05)。单独抗-HCV反应性标本组PPV由常规检测屏蔽界值下的4.46%提高到最佳屏蔽界值下49.35%,差异有统计学意义(χ^(2)=191.62,P<0.05)。结论抗-HCV和HCV RNA均为反应性献血者可判断为HCV感染者,可永久性屏蔽;单独抗-HCV反应性标本的S/CO值与RIBA确证结果呈正相关,S/CO值越高,确证阳性率越高。实验室可在现行血液检测策略下,通过建立具有高阳性预期值的屏蔽界限值或者增加确证试验,判断单独抗-HCV反应性献血者的HCV感染状态。
Objective To assess the status of HCV infection by analyzing the results of anti-HCV reactive blood samples detected by the current blood testing strategy,and discuss the viability of classified management of reactive blood donors.Methods The anti-HCV reactive samples(dual ELISA and once NAT),from May 2017 to October 2018,were divided into three groups:samples both anti-HCV and HCV RNA reactive,sole HCV RNA reactive,and sole anti-HCV reactive,and all of them were confirmed by recombinant immunoblot assay(RIBA).The positive predictive value(PPV)between groups were compared.The sensitivity,specificity and PPV for each reagent under different screening threshold(screening threshold for routine detection,optimal screening threshold,and corresponding screening threshold of the highest PPV)were analyzed.The group with low PPV were stratified by ELISA S/CO values,and PPV by different screening threshold was compared.Results There were 939 reactive samples(0.49%,937/191627).Confirmed by RIBA,the positive rate of anti-HCV reactive samples was 10.67%(100/937).Two samples were sole HCV RNA reactive(0.001%).Both anti-HCV+HCV RNA reactive samples were 6.71%(63/939),with the PPV of 96.83%(61/63).Sole anti-HCV reactive samples were 93.08(874/939),with the PPV of 4.46%(39/874),among which PPV by dual and one ELISA reagent were 18.72%and 0.15%,respectively,showing statistically significant difference(P<0.05).The PPV between different S/CO values was statistically significant(P<0.05).The optimal screening thresholds of anti-HCV reagent were 9.29 and 3.97,according to the ROC curve,with significant difference noticed in PPV by different screening threshold(P<0.05).PPV in the sole anti-HCV reactive group increased from 4.46%(the routine screening threshold)to 49.35%(the optimal screening threshold),and the difference was statistically significant(P<0.05).Conclusion The blood donors with both anti-HCV and HCV RNA reactive can be determined as HCV infection and need to be permanently deferred.The S/CO value of sole anti-HCV reactive s
作者
刘正敏
王瑞
郭瑾
张婧
查祎
葛红卫
李玲
LIU ZhengMin;WANG Rui;GUO Jin;ZHANG Jing;ZHA Yi;GE Hongwei;LI Ling(Beijing Red Cross Blood Center,Beijing 100088,China;Institute of Blood Transfusion,Peking Union Medical College&Chinese Academy of Medical Sciences)
出处
《中国输血杂志》
CAS
2022年第1期53-57,共5页
Chinese Journal of Blood Transfusion
