核酸检测技术在青岛地区血液筛查中的应用研究

Application of nucleic acid amplification testing in blood screening in Qingdao area

目的为进一步提高血液安全性,了解本地区HBV、HCV和HIVELISA检测无反应性献血者中核酸阳性检出率,探讨开展血液核酸检测(NAT)的必要性。方法利用上海科华全自动核酸检测系统,采用8份混样的自动化检测模式,对2016年青岛地区ELISA检测无反应性和ALT检测合格的无偿献血者样本进行HBV、HCV和HIV-1核酸检测,对NAT检出标本用进口核酸试剂复核检测验证和定量检测,以及乙肝5项检测。并在有可能的情况下,对NAT检出献血者实施随访。结果从50582份ELISA检测无反应性的血标本中共检出15份HBV DNA反应性样本,总阳性检出率为0.03%(15/50582);未检出HCV和HIV-1RNA反应性样本。随访的9位献血者全部表现为OBI的检测特征。结论献血者血液虽经两遍酶免血液筛查后仍存在较高比例的HBVDNA感染,核酸检测可以有效降低ELISA漏检造成的输血风险,大大提高血液安全性。

Objective In order to improve the safety of the blood,it is necessary to understand the positive rate of nucleic acids detected by HBV,HCV and HIV ELISA in non reactive blood donors,and to explore the necessity of carrying out blood nucleic acid test(NAT).Methods Automatic nucleic acid detection system based on Shanghai KEHUA,we adopt the automatic detection mode of 8 mixed samples,we detected the HBV、HCV and HIV-1 nucleic acids in the anergy blood donors tested by ELISA and ALT qualified blood donors in Qingdao area in 2016,and we rechecked and quantified the NAT-positive samples by using imported nucleic reagents,we also tested the Hepatitis B.And we followed up the NAT-positive blood donors when possible.Results 15 HBV DNA-positive samples were detected in the 50,582 ELISA negative donor samples,the total positive rate was 0.03%( 15/50 582);No HCV and HIV-1 RNA positive samples were detected.The 9 followed up blood donors showed the detection characteristics of OBI.Conclusion Although the blood of donors has a higher proportion of HBV DNA infection after twice enzyme immunoassay blood screening,nucleic acid testing can effectively reduce the risk of blood transfusion caused by ELISA missed detection,and greatly improve the blood safety.