血站HBV筛查ELISA阴性NAT阳性标本的确认结果分析
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摘要
目的对本中心核酸检测(NAT)HBV DNA阳性标本,对其结果进行确认和分析,探讨核酸检测在血站的可行性和无偿献血人群中隐匿性乙型肝炎的感染情况。方法采用上海浩源检测系统对2遍酶联免疫吸附试验(ELISA)阴性标本,和单、双试剂弱阳标本,采用8人份混检模式进行核酸检测,混检结果呈阳性POOL再进行拆分检测,拆分结果呈阳性的标本送卫生部临检中心进行确认。结果 101 566份2遍ELISA结果阴性和829份ELISA单、双试剂为弱阳性的无偿献血标本中,混检结果阳性POOL 143个,经拆分检测HBV DNA反应性53份,无HCV RNA,HIV RNA的检出,NAT阳性率0.05%(53/102 395),NAT拆分有效率为37%(53/143),其中50例HBV DNA阳性标本送卫生部临检中心确认,根据其反馈结果显示,50例标本中有25例为确认为NAT阳性,NAT阳性的确认阳性率50%(25/50),用化学发光法检测HBsAg显示, 25例确认NAT阳性标本中,抗-HBc阳性比例最高。结论无偿献血者中存在一定比例的隐匿性乙型肝炎, NAT能最大量的在ELISA阴性标本中筛查出核酸阳性的标本,减少隐匿性乙型肝炎的发生,进一步提高临床用血安全。将核酸检测呈阳性标本送检做鉴别确认,对核酸实验室的检测能力可以起到一定的监控评价作用。
Objective This paper aims to discuss the feasibility of the nucleic acid test(NAT) in the blood station workflows and the screening of occult HBV infection in voluntary blood donors. It confirmed and analyzed the reactive samples of HBV DNA in NAT in this blood station. Methods A Shanghai Haoyuan Detection System was adopted to examine the nonreactive samples in the two ELISA tests,the single and double reagent weak reactive samples in 8 participants.Reactive pools would be further divided and tested for reactive samples, which were the sent to National Center for Clinical Laboratories(NCCL)for conformational tests. Results In the 101 566 nonreactive samples, 829 single and double reagent weak reactive ELISA samples were detected. 143 reactive POOL were confirmed in the mixed tests. The entire process identified 53 reactive HBV DNA sampleswith no HCV-RNA, HIV-RNA samples. The positive rate of NAT was 0.05%; the separation effective rate of NAT was 37%. 50 HBV DNA reactive samples were sent to the NCCL for confirmation.The results showed 25 reactive samples, yielding a detection rate of positive NAT of 50%. In the 25 positive NAT samples, the serological markers were tested by the chemiluminescence tests, and the result indicated the positive anti-HBc samples tended to possess the highest portion in positive NAT. Conclusion HBV infection was detected in the donors. The NAT was able to screen the reactive nucleic acid samples in the nonreactive ELISA samples,reducing the possibility of occult infection of HBV for improved safety. It offers a way of monitoring and evaluation by sending the positive nucleic acid samples for testing.
Objective This paper aims to discuss the feasibility of the nucleic acid test(NAT) in the blood station workflows and the screening of occult HBV infection in voluntary blood donors. It confirmed and analyzed the reactive samples of HBV DNA in NAT in this blood station. Methods A Shanghai Haoyuan Detection System was adopted to examine the nonreactive samples in the two ELISA tests,the single and double reagent weak reactive samples in 8 participants.Reactive pools would be further divided and tested for reactive samples, which were the sent to National Center for Clinical Laboratories(NCCL)for conformational tests. Results In the 101 566 nonreactive samples, 829 single and double reagent weak reactive ELISA samples were detected. 143 reactive POOL were confirmed in the mixed tests. The entire process identified 53 reactive HBV DNA sampleswith no HCV-RNA, HIV-RNA samples. The positive rate of NAT was 0.05%; the separation effective rate of NAT was 37%. 50 HBV DNA reactive samples were sent to the NCCL for confirmation.The results showed 25 reactive samples, yielding a detection rate of positive NAT of 50%. In the 25 positive NAT samples, the serological markers were tested by the chemiluminescence tests, and the result indicated the positive anti-HBc samples tended to possess the highest portion in positive NAT. Conclusion HBV infection was detected in the donors. The NAT was able to screen the reactive nucleic acid samples in the nonreactive ELISA samples,reducing the possibility of occult infection of HBV for improved safety. It offers a way of monitoring and evaluation by sending the positive nucleic acid samples for testing.
引文
[1] 李俊英,王艺芳,葛文超,等.2种核酸筛查系统应用于病毒核酸检测的比较.中国输血杂志,2015,28(6):720-723.
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[3] 赵红娜,王艺芳,李俊英,等.核酸检测与酶免检测在郑州地区血液筛查中的联合应用.中国输血杂志,2015,28(10):1269-1271.
[4] 张宏,杜鹏,程曦,等.HBsAg+/HBV DNA-献血者的追踪检测及预后分析.中国输血杂志,2016,29(10):1130-1133.
[5] 杨刚,马晓军,杨文勇,等.核酸检测技术在基层血站血液筛查中的应用.中国输血杂志,2016,29(11):1249-1251.
[6] 姚凤兰,汪德海,査祎,等.核酸检测单反应性无偿献血者HBV感染状态分析.国际检验医学杂志,2017,38(11):1513-1516+1519.
[7] 周怡,史恩溢,曹谊,等.HBsAg阴性献血者隐匿性HBV感染的血清学特征及其与病毒载量的关系.临床输血与检验,2017,19(6):570-573.
[8] 蒋昵真,朱绍汶,汤心怡,等.256例ELISA筛查无反应性/核酸检测反应性标本的确认分析.中国输血杂志,2016,29(10):1126-1129.
[9] 秦伟斐,田耘博,李小红,等.献血者乙型肝炎病毒筛查结果分析.中国输血杂志,2015,28(6):679-683.
[10] 景媛媛,蔡斌,郭燕,等.西安市无偿献血者隐匿性乙肝感染现状和感染因素分析.中国输血杂志,2015,28(2):168-171.
[11] 梁启忠,程玉根.核酸检测技术在献血者血液筛查中的应用.国际检验医学杂志,2015,36(22):3265-3267,3270.
[2] 来祝檩,韩惠云,张国平.核酸检测HBV DNA阳性献血者的追踪检测结果分析.中国输血杂志,2017,30(5):525-528.
[3] 赵红娜,王艺芳,李俊英,等.核酸检测与酶免检测在郑州地区血液筛查中的联合应用.中国输血杂志,2015,28(10):1269-1271.
[4] 张宏,杜鹏,程曦,等.HBsAg+/HBV DNA-献血者的追踪检测及预后分析.中国输血杂志,2016,29(10):1130-1133.
[5] 杨刚,马晓军,杨文勇,等.核酸检测技术在基层血站血液筛查中的应用.中国输血杂志,2016,29(11):1249-1251.
[6] 姚凤兰,汪德海,査祎,等.核酸检测单反应性无偿献血者HBV感染状态分析.国际检验医学杂志,2017,38(11):1513-1516+1519.
[7] 周怡,史恩溢,曹谊,等.HBsAg阴性献血者隐匿性HBV感染的血清学特征及其与病毒载量的关系.临床输血与检验,2017,19(6):570-573.
[8] 蒋昵真,朱绍汶,汤心怡,等.256例ELISA筛查无反应性/核酸检测反应性标本的确认分析.中国输血杂志,2016,29(10):1126-1129.
[9] 秦伟斐,田耘博,李小红,等.献血者乙型肝炎病毒筛查结果分析.中国输血杂志,2015,28(6):679-683.
[10] 景媛媛,蔡斌,郭燕,等.西安市无偿献血者隐匿性乙肝感染现状和感染因素分析.中国输血杂志,2015,28(2):168-171.
[11] 梁启忠,程玉根.核酸检测技术在献血者血液筛查中的应用.国际检验医学杂志,2015,36(22):3265-3267,3270.