摘要
目的通过分析青岛地区献血者丙型肝炎病毒(hepatitis C virus,HCV)筛查及确认试验结果,了解献血者中HCV流行情况及感染状态,评估现有试剂检测水平,为血液筛查策略的选择提供参考。方法选取2019年1—12月青岛地区献血者标本119602人例进行抗-HCV检测,统计分析两遍抗-HCV血液筛查结果,并留取抗-HCV不合格标本,用双抗原夹心法试剂进行抗-HCV检测作为补充试验,可疑标本再进行确认试验:包括重组免疫印迹试验(recombinant strip immunoblot assay,RIBA)和核酸检测(nucleic acid amplification test,NAT)。结果61例抗-HCV筛查不合格标本中,双试剂反应性有15例,夹心法补充试验检测上述15例标本全部为反应性,RIBA确认试验阳性14例,阴性1例;核酸检测阳性9例,阴性6例(其中5例RIBA结果阳性)。而血液初筛单试剂反应性标本46例,夹心法试剂仅2例为反应性,经核酸检测全部阴性;RIBA确认试验不确定7例,阴性39例。结论现阶段血液核酸检测不能完全替代血清学检测,夹心法抗-HCV血筛试剂灵敏度可靠,并且假阳性率较低。
Objective To analyze the results of hepatitis C virus(HCV)screening and confirmation test of blood donors in Qingdao,so as to understand the prevalence and infection status of HCV among blood donors,and to evaluate the detection level of existing reagents,so as to provide reference for the selection of blood screening strategy.Methods A total of 119602 blood donors from January to December 2019 in Qingdao were included in the study.The results of two anti-HCV blood screenings were statistically analyzed,and the unqualified anti-HCV samples were taken.The anti-HCV detection was carried out with double antigen sandwich reagent as a supplementary test,and the confirmation test was carried out for suspicious samples,including recombinant strip immunoblot assay(RIBA)and nucleic acid test(NAT).Results Among the 61 unqualified samples of anti-HCV screening,15 were double reagent reactive.All the above 15 samples were reactive by sandwich supplementary test,14 were positive and 1 was negative by RIBA confirmation test.Nucleic acid test was positive in 9 cases and negative in 6 cases(5 of them were RIBA positive),while 46 blood primary screening single reagent reactive samples and only 2 sandwich reagent were reactive,which were all negative by nucleic acid test.RIBA confirmation test was uncertain in 7 cases and negative in 39 cases.Conclusion At present,blood nucleic acid detection can not completely replace serological detection.The sensitivity of sandwich anti-HCV blood screening reagent is reliable,and the false positive rate is low.
作者
许雷
马维娟
张志杰
张龙穆
XU Lei;MA Weijuan;ZHANG Zhijie;ZHANG Longmu(Department of Laboratory,Qingdao Blood Center,Qingdao Shandong 266071,China)
出处
《中国卫生标准管理》
2023年第5期161-164,共4页
China Health Standard Management
关键词
献血者
丙型肝炎病毒
血液筛查
核酸检测
血清学
确认试验
blood donor
hepatitis C virus
blood screening
nucleic acid amplification testing
serology
confirmation test
