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目的研究献血者HBsAg ELISA筛查阴性血液中HBV漏检情况,分析漏检血液中HBV基因型、血清型及S区基因变异与漏检的关系。方法收集从2013年11月-2015年10月HBsAg ELISA筛查阴性血液31 184份,以高敏HBV DNA及HBV核酸相关抗原(HBVNRAg)方法检测;测定分析HBV DNA阳性者HBV基因序列。结果 31 184份标本中,HBVNRAg全部阴性,HBV DNA阳性82例,检出率0.26%(82/31 184),其中,HBV B型79例(79/82,96.3%),C型3例(3/82,3.7%)。血清型全部为adw(82/82,100%);检测到27个样本分别存在S区突变(27/82,32.9%),其中的21个氨基酸位点突变都集中在主要亲水区(major hydrophilic region,MHR)HBsAg第99~169位氨基酸之间。主要突变位点有S区133号氨基酸位点(7/82,8.5%);126号位(6/82,7.3%);161号位(5/82,6.1%);134号位(4/82,4.8%);145号位(2/82,2.4%),其他还检测到121、122、125、128、129、131、132、140、143、150、156、157、158、159、164、166共计21个氨基酸位点47种突变。结论 HBVNRAg对血筛意义不大,HBsAg第99~169位氨基酸之间MHR免疫逃逸变异是导致酶免法筛查漏检的主要原因之一,其它漏检可由血液中HBsAg浓度较低而检测试剂灵敏度不够等原因引起。血液筛查加入核酸检测方法,能够有效减少单独酶免法检测漏检现象,显著提高血液安全性。
Objective To study the HBV undetectable blood samples of negative blood of HBsAg ELISA screening blood donors and to analyze the relationship between HBV genotypes, serotypes and S-region gene mutations in missed blood tests. Methods 31 184 HBsAg ELISA negative blood samples collected from November 2013 to October 2015 were collected and detected by high sensitivity HBV DNA and HBV nucleic acid antigen (HBVNRAg). The HBV DNA sequence was analyzed by HBV DNA positive. Results Of the 31 184 specimens, all of HBVNRAg were negative and HBV DNA was positive in 82 of them (detection rate was 0.26% (82/31 184)), among which, 79 cases (79/82, 96.3%) of HBV B type and 3 cases of C type 3/82, 3.7%). The serotypes were all adw (82/82, 100%). 27 mutations (27/82, 32.9%) were detected in 27 samples, of which 21 amino acid mutations were found in the major hydrophilic region , MHR) between amino acids 99 to 169 of HBsAg. The main mutation sites were amino acid position 133 of S region (7/82, 8.5%); position 126 (6/82, 7.3%); position 161 (5/82, 6.1%); position 134 /82, 4.8%); position145 (2/82, 2.4%), others also detected 121,122,125,128,129,131,132,140,143,150,156,157,158,159 , 164,166 a total of 21 amino acid sites 47 kinds of mutations. Conclusion HBVNRAg is of little significance for blood screening. The variation of MHR immune escape between amino acids 99-169 of HBsAg is one of the major causes of missed screening of enzyme-free screening. Other missed tests may be based on the lower concentration of HBsAg in blood and the detection reagent Sensitivity is not enough and other causes. Blood screening by adding nucleic acid detection methods, can effectively reduce the single enzyme-free detection of missed detection, significantly improve blood safety.