摘要
目的对核酸筛查后HBsAg-/NAT＋/HBV DNA-献血者标本做确认试验及调查HBsAg-/HBV DNA＋标本检出率。方法采用核酸检测方法（NAT）筛查本中心2011年11月-2012年7月的52 672（人）份无偿献血者标本,对其中HBsAg阴性NAT初筛阳性、HBV DNA鉴别试验阴性的81（人）份标本,使用巢式PCR（NestedPCR）和实时荧光定量检测方法（QPCR）确认其HBV DNA是否存在。结果从52 672份NAT无偿献血者标本中,筛得HBsAg-/NAT＋/HBV DNA-81份、HBsAg-/NAT＋/HBV DNA＋15份;经Nested-PCR和QPCR方法扩增,81份HBsAg-/NAT＋/HBV DNA-标本共检出10份HBV DNA＋,HBsAg-/HBV DNA＋检出率为0.05%[（10＋15/52 672）;25例HBsAg-/HBV DNA＋标本病毒载量介于不可检出到至108.9 IU/mL,抗-HBc＋/HBsAg-/HBV DNA＋标本病毒载量（不可检出到至108.9 IU/mL）明显高于与抗-HBc-/HBsAg-/HBV DNA＋标本（不可检出到至54.0 IU/mL）（P〈0.05）。结论目前采用的核酸检测存在假阳性或假阴性情况,应提高核酸检测试剂灵敏度与特异性,确保检测HBsAg-/HBV DNA＋准确性。
Objective To investigate the confirmation of HBV DNA positive from HBsAg/NAT ＋ samples and study on the detection of HBsAg/ HBV DNA ＋ samples. Methods From November 2011 to July 2012,the 81 out of 52 672 samples with HBsAgNAT ＋,but identification test-,were re-examined for the HBV DNA presence by both Nested-PCR and Real-time fluorescence quantitative detection. Results We obtained 15 HBsAg/ NAT ＋ / HBV DNA ＋ samples in 52 672 donors,of which 81 samples were HBsAg/ NAT ＋ / HBV DNA-. After examined by Nested-PCR and QPCR,we finally confirmed 10 HBV DNA ＋ samples in those previous 81 HBsAg/ NAT ＋ / HBV DNAsamples; The detection rate of HBsAg/ HBV DNA ＋ samples was 0. 05% [（ 10 ＋ 15 /52 672） ] and the viral load varied between undetection to 108. 9IU / mL. The viral load was more higher in anti-HBc ＋ samples than anti-HBcsamples（ P 0. 05）. Conclusion The potential presence of false positive or false negative results in nucleic acid screening cannot be ignored,in order to guarantee the veracity of HBsAg/ HBV DNA ＋ detection,it＇s important to improve both sensitivity and specificity in nucleic acid screening.
出处
《中国输血杂志》
CAS
CSCD
北大核心
2013年第12期1215-1218,共4页
Chinese Journal of Blood Transfusion
基金
国家自然科学基金面上项目(81071348)
