• 中国科学论文统计源期刊
  • 中国科技核心期刊
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  • 日本科学技术振兴机构数据库(JST)
临床输血与检验

临床输血与检验 ›› 2019, Vol. 21 ›› Issue (4): 383-386.DOI: 10.3969/j.issn.1671-2587.2019.04.013

• 血液检测 • 上一篇    下一篇

ECLIA常规应用于献血者血液HBsAg检测的结果分析*

陈少彬, 何子毅, 陈庆恺, 刘泽民, 王庆, 黄素媛, 陈静文, 余霖, 车嘉琳   

  1. 523930 广东东莞市中心血站
  • 收稿日期:2018-10-08 出版日期:2019-08-20 发布日期:2019-08-28
  • 作者简介:陈少彬（1982-）,男,广东揭东人,副主任技师,学士,主要从事血液检测工作,(E-mail)chenshao163@163.com。
  • 基金资助:
    *本课题受东莞市社会科技发展一般项目（No.201750715-026368）资助

HBsAg Detection for Blood Donors by Electrical Chemiluminescence Immunoassay Routinely

CHEN Shao-bin, HE Zi-yi, CHEN Qing-kai, et al   

  1. Dongguan blood center, Dongguan, Guangdong 523930
  • Received:2018-10-08 Online:2019-08-20 Published:2019-08-28

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摘要： 目的 分析电化学发光免疫分析法（ECLIA）与酶联免疫吸附法（ELISA）在献血者HBsAg检测结果的一致性,探讨ECLIA常规应用于献血者血液检测的效果。方法 对2016年12月~2017年11月本站献血者血液标本,使用2种不同厂家ELISA HBsAg（试剂A和试剂B）和ECLIA（试剂C）进行检测,对部分ELISA HBsAg无反应性而核酸检测（NAT）HBV DNA有反应性的标本再进行ECLIA检测。以ELISA检测0≤S/CO<0.3、0.3≤S/CO<0.9和S/CO≥0.9进行分类统计ECLIA阳性数,并分析ECLIA与ELISA结果的一致性;以ECLIA为参考方法分析2种ELISA试剂的灵敏度和特异性。结果 HBsAg共检测11 127人份,试剂A、B、C检测的阳性率分别为2.642%、3.020%和2.894%,差异无统计学意义（P>0.05）;ECLIA与2种ELISA试剂结果一致性均极高（К试剂A=0.927、К试剂B=0.900）;ELISA检测无反应性的标本中,“0.3≤S/CO<0.9”段ECLIA阳性率0.35%高于“0≤S/CO<0.3”段的0.11%（P<0.05）;以试剂C为参考方法,试剂A的灵敏度88.82%低于试剂B的灵敏度92.24%,试剂A的特异性99.93%略高于试剂B的99.64%;78例ELISA HBsAg无反应性而NAT反应性的标本ECLIA检测阳性有16例,阳性率15.5%。结论 2遍ELISA血清学方法检测HBsAg阴性的标本仍有漏检几率,ECLIA能缩短ELISA检测的“窗口期”,且与ELISA结果一致性高;现有血液检测方法增加一遍ECLIA可进一步提高血液安全。

关键词: 电化学发光免疫分析法, 献血者, HBsAg, ELISA, 血液检测

Abstract: Objective To analyze the consistency of results for detection of hepatitis B virus surface antigen (HBsAg) in blood donors between electrical chemiluminescence immunoassay (ECLIA) and enzymelinked immunosorbent aasay (ELISA) and to explore the effect of ECLIA application routinely in the detection of blood donors. Methods Blood samples from blood donors were collected from December 2016 to November 2017. HBsAg was detected by ECLIA and two ELISA reagents (Reagent A and Reagent B) from different manufacturers. ECLIA were also performed for some samples which were non-reactivity in HBsAg but were reactivity in nucleic acid detection (NAT) HBV DNA. According to the 0≤S/CO<0.3, 0.3≤S/CO<0.9and S/CO≥0.9 in the ELISA, the ECLIA positive samples were grouped and counted to analyze the consistency of results between ECLIA and ELISA. ECLIA was used as a reference method to analyze the sensitivity and specificity of the two ELISA reagents. Results A total of 11 127 HBsAg were detected. The positive rates of reagent A,reagent B and ECLIA were 2.642%, 3.020, and 2.894%, respectively, the differences among them were not statistically significant (P>0.05).ECLIA showed excellent consistency with the two ELISA reagents (Кreagent A=0.927, Кreagent B=0.900). With ECLIA as the reference method, in the non-reactive samples in the ELISA detection, the ECLIA positive rate of group in “0.3≤S/CO<0.9” was0.35% higher than that of group in “0≤S/CO<0.3”0.11% (P<0.05). The sensitivity of reagent A was 88.82% lower than that of reagent B 92.24%, the specificity of reagent A was 99.93% slightly higher than 99.64% of reagent B. 16 cases were positive in ECLIA from 78 cases of HBsAg which were non-reactive in ELISA but reactive in NAT, with a positive rate of 15.5%. Conclusion The detection of HBsAg samples by twice of ELISA still has the possibility of missed detection. ECLIA can shorten the "window period" of ELISA detection, and has a high consistency with the ELISA results. The existing blood detection method can add once of ECLIA to improve blood safety.

Key words: Electrical chemiluminescence immunoassay, Blood donors, HBsAg, ELISA, Blood detection

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