贵阳地区无偿献血人群HCV筛查的结果分析

目的 比较献血人群抗-HCV反应性、HCV核酸检测结果及HCV重组免疫印迹试验(RIBA)确证实验结果.方法 对2013年10月至2015年3月采集的无偿献血者血液标本,采用2个不同厂家的国产酶联免疫吸附试验(ELISA)试剂检测和1个进口核酸检测试剂及配套检测系统对HCV进行筛查,对抗-HCV呈反应性或/和NAT检测阳性标本进行RIBA,将2种ELISA试剂检测反应性的结果与核酸检测结果、RIBA确证实验结果进行分析与比较.结果 共检测133 959例无偿献血者标本,其中覆盖核酸检测结果的标本113 380例,抗-HCV检测呈反应性标本比例0.19％(252/133 959),NAT检测阳性共27例,阳性检出的比例0.02％(27/113 380);HCV反应性标本经RIBA确证实验确证阳性的比例19.8％(50/252)、阴性的比例54.8％(138/252)、不确定的比例25.4％(64/252);27例核酸检测阳性的标本均为ELISA检测双试剂反应性和确证实验阳性;2家ELISA试剂检测结果、RIBA确证实验结果和核酸检测结果差异有统计学意义(P＜0.05).结论 选用2次ELISA+1次核酸检测的检测策略更为安全;针对较高比例的假阳性标本,应建立献血者跟踪随访制度,最大限度地保留献血人群.

Analysis on results of HCV screening among volunteer blood donors in Guiyang area

Objective To analyze and compare the anti-HCV reactivity,HCV nucleic acid detection results and HCV recom binantion immunoblot assay(RIBA) confirmatory test results in blood donors.Methods The blood samples collected from the volunteer blood donors from October 2013 to March 2015 were performed the HCV screening by using the domestic ELISA reagents from two different manufacturers and an imported nucleic acid detection reagent and matching detection system.The samples of anti-HCV reactivity or/and NAT detection positive were performed RIBA.Then the results of reactivity detected by two kinds of ELISA reagents,nucleic acid detection reagent and RIBA confirmatory test results were analyzed and compared.Results A total of 133959 samples of volunteer blood donors were detected,in which 113 380 samples covered the nucleic acid detection results,the reactivity samples proportion of anti-HCV detection was 0.19 ％ (252/133959),27 cases were positive in NAT detection with the positive detection ratio of 0.02 ％ (27/113 380);the proportion of HCV reactive samples confirmed by RIBA was 19.8 ％ (50/252),the negative proportion was 54.8％ (138/252),and the uncertain proportion was 25.4％ (64/252);27 samples of nucleic acid detection positive were double reagent reactivity in ELISA detection and positive in confirmatory test.The difference among the results of two ELISA reagents,RIBA confirmatory test results and nucleic acid detection results had statistical significance(P＜0.05).Conclusion The detection strategy selecting twice ELISA+1 kind of nucleic acid detection is more secure.Aiming at higher proportion of false positive samples,the follow up system of blood donors should be established for maximizing the retention of blood donors.