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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 explore the reasons for the non-responsiveness of non-reactivity test by detecting the reactivity of HBV, HCV and HIV in routine blood screening of blood donors during blood screening. Methods A total of 504 blood samples were collected from blood donors whose NAT co-reactivity and blood test results were inconsistent with those from routine blood tests of blood donors from November 2010 to March 2012. The HBsAg, anti-HBs, anti-HBc, HBeAg and anti-HBe (5 hepatitis B) were detected by chemiluminescence method. NAT detection was performed on these samples again by using fluorescent quantitative PCR (TaqMan nucleic acid detection system) to determine The serology and molecular biology status of the infection were analyzed. At the same time, 40 blood test results were retrospectively analyzed. Serum HBV markers, HBV DNA, HCV RNA and HIV RNA were traced. Results In routine blood screening, single nucleotide polymorphisms (SNPs) of single nucleotide polymorphism (SNP) were detected in the blood samples, and 72.82% (367/504) of them showed hepatitis B related antigen or antigenic reactivity. 13.35% (49/367) HBV test showed HBV reactivity. The results of follow-up test showed that 22.50% (9/40) of the samples could be positive for the first time, and 77.50% (31/40) of the remaining samples showed no HBV RNA or HIV RNA reactivity results in OBI. Conclusions OBI is one of the major causes for inconsistencies in non-reactivity of blood due to NAT co-reactivity in blood donors. Based on blood safety and detection efficiency, this portion of blood should be discarded, but for serological hepatitis B testing and NAT Joint retest non-reactive blood donors, should be tested to track and consider the possibility of another blood donation.