中国输血杂志2018，Vol.31Issue(1)：24-27,4.DOI:10.13303/j.cjbt.issn.1004-549x.2018.01.007
血站实验室采用不同模式检测HBsAg的性能评价
The performance evaluation of HBsAg determination using different models in blood bank laboratories
尹丹 1朱海峰 2释艳华 3魏超 4魏兰 1张巧琳 1谢晓艳 1李维 1王露楠 5葛红卫 6潘彤 7王芳8
作者信息
- 1. 重庆市血液中心,重庆400015
- 2. 山东省血液中心
- 3. 襄阳市中心血站
- 4. 沧州市中心血站
- 5. 国家卫生和计划生育委员会临床检验中心
- 6. 北京市红十字血液中心
- 7. 天津市血液中心
- 8. 辽宁省血液中心
- 折叠
摘要
Abstract
Objective To make a performance evaluation of hepatitis B surface antigen (HBsAg) determination using one and two kinds of enzyme-linked immunosorbent assay (ELISA) reagents in six blood bank laboratories,and to provide a reference for establishment of reasonable HBsAg screening strategy in each laboratory.Methods 898 HBsAg preliminary screening reactive specimens collected from sixteen laboratories were sent to six blood bank laboratories,respectively.These specimens were used for HBsAg determination by two kinds of ELISA reagents in each laboratory.Chemiluminescence assay and neutralization test were set as confirmatory methods.We chose one reagent which the performance was relatively superior as a comparative reagent in each laboratory,respectively.The sensitivity,specificity and coincidence rate of single reagent and combination of two ELISA reagents were analyzed by statistical methods.Results Sixteen samples were removed from the 898 HBsAg preliminary screening reactive specimens because of incomplete data.There were 571 positive and 311 negative in the 882 remaining specimens.The sensitivity difference of the two reagents used in each laboratory was significant (P ＜0.05).In laboratory B,D,E and F,the reagent which sensitivity was relatively superior and its coincidence rate was also higher (P＜0.05).There was no significant difference (P＞0.05) of the sensitivity between the reagent which the performance was relatively superior and combination of dual reagents in each laboratory.In laboratory C,D and F,the specificity of single reagent was better than that of dual reagents (P＜0.05),and there was no significant difference (P＞0.05) between these two models in other laboratories.In laboratory D and F,the coincidence rate of single reagent was better than that of dual reagents (P＜0.05),and there was no significant difference (P＞0.05) between these two models in other laboratories.Conclusion When using ELISA kits for HBsAg determination in blood bank laboratories,there was a phenomenon that the performance of single reagent was similar to or better than that of dual reagents.It is need scientific assessment and confirmation,whether to use single reagent instead of dual reagents as the screening strategy of HBsAg.关键词
乙型肝炎表面抗原(HBsAg)/酶联免疫吸附法(ELISA)/性能评价/筛查策略Key words
hepatitis B surface antigen (HBsAg)/enzyme-linked immunosorbent assay (ELISA)/performance evaluation/screening strategy分类
医药卫生引用本文复制引用
尹丹,朱海峰,释艳华,魏超,魏兰,张巧琳,谢晓艳,李维,王露楠,葛红卫,潘彤,王芳..血站实验室采用不同模式检测HBsAg的性能评价[J].中国输血杂志,2018,31(1):24-27,4.
