摘要
目的对6家血站实验室单独使用1种和联合使用2种酶联免疫（ELISA）试剂检测乙型肝炎表面抗原（HBsAg）进行性能评价,为各实验室制定合理的HBsAg筛查策略提供参考依据。方法将来自16家实验室的898份HBsAg初筛反应性标本分别寄送至6家血站实验室,使用2种ELISA试剂检测HBsAg。采用化学发光法和中和试验作为确认方法。分别在各实验室选择1种性能相对优异的试剂作为比较试剂,利用统计学方法分析各实验室单独使用1种试剂和联合使用2种试剂的灵敏度、特异性和符合率。结果 898份HBsAg初筛反应性标本中,剔除16份数据不完整的标本,在余下的882份标本中,确认阳性571份,确认阴性311份。各实验室使用的2种试剂其灵敏度差异较大（P〈0.05）,其中在实验室B、D、E和F中,灵敏度相对优异的试剂其符合率亦更高（P〈0.05）。性能相对优异的试剂单独检测和2种试剂联合检测进行性能比较,各实验室2种检测模式的灵敏度差异无统计学意义（P〉0.05）;实验室C、D和F单一试剂检测的特异性优于2种试剂联合检测（P〈0.05）,其余实验室2种检测模式的特异性差异无统计学意义（P〉0.05）;实验室D和F单一试剂检测的符合率优于2种试剂联合检测（P〈0.05）,其余实验室2种检测模式的符合率差异无统计学意义（P〉0.05）。结论在血站实验室使用ELISA试剂盒进行HBsAg检测,存在单独使用1种试剂的检测性能等同于或优于联合使用2种试剂的情况,是否采用单一试剂代替2种试剂联合检测作为HBsAg的筛查策略,需进行科学的评估和确认。
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 lab
作者
尹丹
魏兰
张巧琳
谢晓艳
李维
王露楠
葛红卫
潘彤
王芳
朱海峰
释艳华
魏超
YIN Dan 1, WEI Lan1 , ZHANG Qiaolin1 ,XIE Xiaoyan1 , WANG Lunan2, GE Hongwei3 ,PAN Tong4, WANG Fang5, ZHU Haifeng6 ,SHI Yanhua7, WEI Chaos, LI Wei1(1. Chongqing Blood Center, Chongqing 400015, China ; 2. National Center for Clinical Labora- tories;3. Beijing Red Cross Blood Center; 4. Tianfin Blood Center; 5. Liaoning Blood Center; 6. Shandong Blood Center; 7.Xiangyang Blood Center; 8. Cangzhou Blood Center.)
出处
《中国输血杂志》
CAS
2018年第1期24-27,共4页
Chinese Journal of Blood Transfusion
