核酸检测系统联检与鉴别检测结果不一致原因分析  

Analysis of the discrepancy between reactivity in NAT and non-reactivity in NAT identification test

作　　者：黄力勤[1] 姚凤兰[1] 葛红卫[1] HUANG Liqin YAO Fenglan GE Hongwei.(Department of Blood Screening Laboratory, Beijing Red Cross Blood Center, Beijing 100088, China.)

机构地区：[1]北京市红十字血液中心,北京100088

出　　处：《中国输血杂志》2016年第8期802-806,共5页Chinese Journal of Blood Transfusion

摘　　要：目的探究献血者常规血液筛查过程中核酸检测系统HBV、HCV、HIV联测(NAT联检)反应性而鉴别检测非反应性结果的原因。方法收集2010年11月-2012年3月本中心献血者常规血液筛查过程中NAT联检单反应性且和鉴别检测结果不一致的献血者标本504(人)份。采用化学发光法检测其HBsAg、抗-HBs、抗-HBc、HBe Ag及抗-HBe(乙肝5项),采用荧光定量PCR技术(Taq Man核酸检测系统)对这些标本再次做NAT检测,以确定其感染的血清学和分子生物学状态;同时回溯其中的40名检测结果不一致献血者,做血清学乙肝标志物及HBV DNA、HCV RNA和HIV RNA追踪检测。结果常规血液筛查过程中核酸联检单反应性且联检和鉴别检测结果不一致标本中,72.82%(367/504)呈乙肝相关抗体或抗原反应性,13.35%(49/367)的标本在荧光定量PCR检测中呈现HBV反应性。追踪检测结果显示,22.50%(9/40)可能为初次联检假阳性标本,其余77.50%(31/40)均为乙肝隐匿型感染(OBI)均未出现HCV RNA、HIV RNA反应性结果。结论 OBI是导致献血者血液NAT联检反应性而鉴别非反应性结果不一致的1个主要原因;基于血液安全性和检测效率的考虑,该部分血液应废弃,但对于血清学乙肝5项检测和NAT联检重复检测非反应性的献血者,应作检测追踪并考虑其再次献血的可能性。Objective To analyze the discrepancy between reactivity in NAT （HBV, HCV and HIV combined test） and non-reactivity in nucleic acid identification test among routine blood donor screening. Methods 504 NAT reactive but nonreactive samples in identification test from November 2010 to March 2012 were collected. All the samples underwent screen- ing for HBsAg, HBsAb, HBeAb and HBcAb using CLIA test and fluorescence quantitative PCR for HIV, HCV and HBV （Taqman NAT system）. The HBV infection marker, HBV DNA, HCV RNA and HIV RNA from 40 follow-up samples were then analyzed. Results Out of 504 cases that were reactive in NAT but non-reactive in identification test, 72. 85% （364/ 504） samples showed HBV-associated antigen or antibody response, and 13.35 % （49/367） samples showed HBV DNA response. Then, in the 40 cases that were non-reactive in identification test, 22. 50% （9/40） were first-time NAT test false positive samples, and the remaining 77.50% （31/40） cases were occult infection of HBV （OBI）. None of the samples showed HCV RNA or HIV RNA reactivity. Conclusion Occult infection of HBV is the main cause for ＂ the discrepancy between NAT reactivity and non-reactivity in identification test. ＂ Based on the safety of blood supply, such blood should be disposed. However, such blood donor should be followed up and be determined whether or not they can continue to donate blood.

关 键 词：核酸联检 核酸鉴别检测 献血者 核酸检测策略 血液安全 乙肝5项 

分 类 号：R446[医药卫生—诊断学] Q503[医药卫生—临床医学]