实施核酸检测后献血者丙型肝炎病毒检测模式的探讨  

Evaluation of hepatitis C virus screening strategy in blood donors after the implementation of NAT

作　　者：王卓妍[1] 陈立[1] 任芙蓉[1] 龚晓燕[1] 宋美兰[1] 冯博[1] 

机构地区：[1]北京市红十字血液中心安全输血室,100088

出　　处：《北京医学》2016年第8期854-858,共5页Beijing Medical Journal

基　　金：卫生公益性行业科研专项(200902008);北京市"新世纪百千万人才工程"(2007-01)

摘　　要：目的探讨献血者血液筛查中实施核酸检测(NAT)后去掉一次抗-HCV酶联免疫吸附试验(ELISA)检测后抗-HCV漏检的风险。方法从献血者血样中留取常规抗-HCV ELISA双试剂(国产金伟凯或万泰及进口Or-tho)2次筛查中任一试剂筛查不合格的献血者血样,进行NAT检测及重组免疫印迹(RIBA)抗体确证试验,并对ELI-SA单试剂不合格、NAT阴性但RIBA确证阳性或可疑标本进行追踪研究分析自然转归。分析去掉一次抗-HCV ELI-SA检测后抗-HCV漏检的风险性。结果 213 970人份献血者血样中常规血清学双试剂检测HCV不合格953份(0.445%)。该953份不合格标本中,有9份为国产试剂筛查合格NAT阴性但RIBA试验确证阳性,有10份为进口试剂筛查合格NAT阴性但RIBA确证阳性。如果去掉该进口ELISA,采用该国产ELISA试剂和NAT,那么将有4.20/10万(9/213 970)的抗-HCV确证阳性血液会被漏检;如果去掉该国产ELISA,采用该进口ELISA试剂和核酸检测,将有4.66例/10万(10/213 970)的抗-HCV确证阳性血液会被漏检;进口试剂和国产试剂漏检抗-HCV确证阳性血液的风险差异无统计学意义(P>0.05)。而另一方面,我中心自开展NAT研究及常规NAT检测以来(2007-2013年,约92万人次),尚未从"2次ELISA筛查"合格的血液中检出确证的HCV RNA单独阳性血液,因此"进口ELISA+NAT"或"国产ELISA+NAT"分别比"2次ELISA筛查"少检出4.66/10万及4.20/10万抗-HCV RIBA确证阳性的血液。结论就献血者血液HCV筛查策略而言,实施NAT检测后,去掉两次ELISA检测中的一次ELISA检测需慎重。Objectives To study the possible risk of deleting one of the two rounds of anti-HCV ELISA screening after the nucleic acid testing （NAT） was implemented in donor screening. Methods Unqualified blood samples, which were screened by two rounds of ELISA with two different anti-HCV ELISA kits （domestic GWK or Wantai and imported Ortho）, were collected. Samples were further tested by NAT and recombinant immunoblot assay （RIBA） confirmatory test. Donors with one kind of ELISA＋ and NAT-but confirmed RIBA positive were followed and followed samples were tested for the same tests. The false negative risk by deleting one ELISA kit was analyzed. Results Among 213 970 donation specimens, 953 （0.445%）were anti-HCV unqualified samples. Among 953 unqualified samples, 9 were the domestic ELISA-NAT-but RIBA Confirmatory test＋ and 10 were the imported ELISA-NAT-but RIBA Confirmatory test＋. There- fore, if specimens were screened by the domestic ELISA reagent and NAT, 4.20 confirmed anti-HCV＋ cases per 100 000 donation would be missed. On the other hand, if specimens were screened by the imported ELISA reagent and NAT, 4.66 confirmed anti-HCV＋ cases per 100 000 donors would be missed. The difference of false negative rate of the confirmed RIBA positive between the domestic ELISA and imported ELISA was not significant （P 〉 0.05）. On the other hand, since the NAT studies and the routine NAT screening in our Center （from 2007 to Dec 31, 2013, about 920 000 donor samples tested）, none additional confirmed HCV RNA positive cases had been detected among the two- round anti-HCV ELISA qualified samples, ＂the imported ELISA＋NAT＂ or ＂the domestic ELISA＋NAT＂ screening strategy would detected less 4.66 per 100 000 or 4.20 per 100 000, respectively, anti-HCV RIBA confirmed cases than the ＂two-round ELISA＂ screen-ing strategy. Conclusion As for HCV screening strategy, after the implementation of NAT, it should be cautious to delete one of the two rounds of anti-HCV ELISA screening.

关 键 词：丙型肝炎病毒(HCV) 抗-HCV ELISA HCV RNA NAT 献血者 筛查策略 

分 类 号：R446.6[医药卫生—诊断学] R512.63[医药卫生—临床医学]