血清学阴性HBV感染献血者的确认与感染状态识别  

Hepatitis B virus infection confirmation and infection status identification in blood donors without serological markers

作　　者：邓雪莲[1] 于志军 孙鹏 王琳[1] 郭笑寒 臧亮[1] DENG Xuelian;YU Zhijun;SUN Peng;WANG Lin;GUO Xiaohan;ZANG Liang(Dalian Blood Center,Dalian 116001,China;Dalian Municipal Women and Children’s Medical Center)

机构地区：[1]大连市血液中心,辽宁大连116001 [2]大连市妇女儿童医疗中心

出　　处：《中国输血杂志》2021年第11期1181-1185,共5页Chinese Journal of Blood Transfusion

基　　金：辽宁省自然科学基金指导计划项目(2019-ZD-0882);中国输血协会威高科研基金(CSBT-WG-2017-01)。

摘　　要：目的识别无HBV血清学标志却核酸检测(NAT)呈反应性(Seroneg-NAT yield)献血者中的假阳性者,确认真感染者及其感染状态。方法以大连市血液中心2010年11月1日~2021年2月28日的Seroneg-NAT yield的献血者,采用TaqMan HBV定量检测和聚乙二醇(PEG)法病毒富集联合in-house的靶向HBV基因序列中S、BCP、Pre S/S、Pre core/core的巢式PCR对其做HBV DNA确认并展开随访检测。随访检测项目包括常规血液筛查和HBsAg、抗-HBc及抗-HBs。以HBV DNA检出和随访检测发现明显的抗-HBs和抗-HBc阳转确认HBV感染,必要时进行HBV DNA测序。结果在10年4个月的时间里,筛选出本组Seroneg-NAT yield献血者的比例为0.03%(126/466 911),其中46.8%(59/126)的人检出HBV DNA、53.2%(67/126)的人HBV DNA不确定;随访检测完成率40.5%(51/126)(28人检出HBV DNA、23人的HBV DNA不确定)。确认本组Seroneg-NAT yield者的HBV感染率为47.6%(60/126);在完成随访检测的对象中,识别血清学转换前的HBV早期感染者占54.9%(28/51),血清学阴性型隐匿性HBV感染(OBI)者占2.0%(1/51),另外排除NAT假阳性者占37.3%(19/51),不能确定者占5.9%(3/51)。结论 Seroneg-NAT yield献血者中近半数发生了HBV感染,且其中一半以上为血清学转换前的早期感染;绝大多数血清学检测阴性的HBV DNA不确定者为NAT假阳性。Objective To confirm Hepatitis B virus(HBV) infections and identify infection status by excluding false positive in blood donors reactive to nucleic acid testing(NAT) but without serological markers(Seroneg-NAT). Methods Seroneg-NAT yields were selected among blood donors in Dalian Blood Center from November 1, 2010 to February 28, 2021, and their HBV DNA was further confirmed with TaqMan HBV DNA quantification or virions concentration by polyethylene glycol(PEG) precipitation combined with in-house nested PCR targeting the S, BCP, PreS/S and Precore/core regions of the viral genome, and follow-up test was carried out, including blood routine screening and HBsAg, anti-HBs and anti-HBc testing. HBV infection was confirmed by HBV DNA yielding and anti-HBs/anti-HBc seroconversion in follow-up testing, and HBV DNA was further sequenced if necessary. Results During the period of 10 years and 4 months, 0.03%(126/466 911) Seroneg-NAT yields were selected, of which 46.8%(59/126) were HBV DNA+ and 53.2%(67/126) were unconfirmed. Among 126 Seroneg-NAT yields, 40.5%(51/126) were involved in follow-up test, of which 28 were HBV DNA+ and 23 were unconfirmed. HBV infections were confirmed in 48%(60/126) of Seroneg-NAT yields. Of follow-up donors, 54.9%(28/51) were identified as early infection before seroconversion, 2.0%(1/51) seronegative occult HBV infection(OBI), and 37.3%(19/51) NAT false positive. There were still 5.9%(3/51) classified as the indetermination. Conclusion Nearly half Seroneg-NAT yields in Dalian blood donors were infected with HBV and more than 50% were early infections before seroconversion. The majority of HBV DNA unconfirmed without serological markers were false positives.

关 键 词：乙型肝炎病毒 献血者 感染状态 核酸检测 血清学阴性 随访 确认试验 

分 类 号：R446[医药卫生—诊断学] R512.62[医药卫生—临床医学]