两种HBsAg ELISA试剂检测关键性能指标回顾性比较分析  

Key performance indexes of two HBsAg ELISA reagents: A retrospectively comparative analysis

作　　者：程卫芳[1] 周学勇[1] 胡晓玉[1] 张云[1] 王盼盼 崔伟娅 CHENG Weifang;ZHOU Xueyong;HU Xiaoyu;ZHANG Yun;WANG Panpan;CUI Weiya(Blood Center of Anhui Province,Hefei 230031,China)

机构地区：[1]安徽省血液中心,安徽合肥230031

出　　处：《中国输血杂志》2021年第4期414-417,共4页Chinese Journal of Blood Transfusion

摘　　要：目的对血站常规使用的2种乙肝表面抗原(HBsAg)酶联免疫吸附试验(ELISA)试剂关键性能指标进行回顾性分析,从试剂的实验室使用性能角度为试剂选择提供依据。方法对本中心2016~2019年使用的2种HBsAgELISA试剂的检测结果、初试反应率、复试反应率、复检符合率以及单试剂反应性与核酸检测(NAT)结果的符合性进行统计,比较试剂的检测性能。结果 HBsAg检测总不合格率为0.39%(1 863/480 741);2种试剂的检测不合格率(同复试反应率)分别为0.31%、0.29%,初试反应率分别为0.44%、0.39%,复检符合率分别为70.21%、74.55%;HBsAg单试剂和NAT共同反应性标本有43份。结论 2种试剂检测性能存在一定差异,实验室在选择试剂时要结合各关键性能指标及检测结果等综合考虑,既要避免血液浪费,更要保证血液安全。Objective To retrospectively analyze the key performance indicators of two hepatitis B surface antigen(HBsAg) ELISA reagents used in blood stations, so as to provide basis for reagent selection from the perspective of laboratory performance. Methods The test results, reactive rate of initial/repeat test, concordance rate of initial and repeat test, and the NAT-yield implicated in ELISA-reactive samples with one assay from 2016 to 2019 were analyzed to compare the detection performance of two ELISA reagents. Results The total ELISA reactive rate of HBsAg was 0.39%(1 863/480 741), with 0.31% and 0.29% in two reagents, respectively. The initial reactive rate were 0.44% and 0.39%, concordance rate of initial and repeat test was 70.21% and 74.55%, respectively. 43 NAT-yield samples were implicated in ELISA-reactive samples with one assay. Conclusion There are differences underlying in the detection performance of the two reagents. In order to avoid blood waste and ensure blood safety, the key performance indexes and test results should be taken into consideration when selecting reagents.

关 键 词：乙型肝炎表面抗原(HBsAg) 酶联免疫吸附法(ELISA) 关键性能指标 

分 类 号：R446.6[医药卫生—诊断学]