摘要
目的通过使用相同试剂在不同酶联免疫设备间的结果比对,探索各酶联免疫分析系统是否有差异,或有需改进、关注、更换等情况。方法用HBsAg、抗-HCV、抗-HIV、抗-TP试剂检测己知结果的阴性标本30份,权威机抅己知结果的定性盲样5份,各项目定值质控品平行随板测9次,应用χ2检验和Kappa检验,比较不同设备间的结果是否一致。结果酶联免疫处理系统两台前处理设备经Kappa检验一致为100%,各后处理设备间的板内CV均<15%,符合标准要求,并经χ2检验差异无统计学意义(p>0.05)。有2台后处理设备,因使用年份长和频率高等因素,检测的CV值略高于另一台,但都在接受标准内。结论定期的设备比对,将对保证实验的可靠运行和提升设备的管理能力起到推动作用,也是实验室设备的重要质控工作。
Objective By comparing the results of using the same reagent in different enzyme-linked immunosorbent assay(ELISA)equipment,to explore whether there are differences among ELISA systems,or whether there is a need for improvement,attention and replacement.Methods HBsAg,anti-HCV,anti-HIV,anti-TP reagents were used to detect 30 negative samples with known results,5 qualitative blind samples with known results by authoritative machines,and the fixed quality control products of each item were tested 9 times in parallel with the board.Two tests and Kappa tests were used to compare the consistency of the results among different devices.Results The coincidence of two pretreatment equipments of enzymelinked immunosorbent assay system was 100%by Kappa test,and the intra-plate CV of each post-treatment equipment was less than 15%,which met the standard requirements.There was no statistical difference between the two tests(p>0.05).There were two post-processing equipments,and the CV value detected by them was slightly higher than that of the other one due to the long service years and high frequency,but both were within the acceptable standard.Conclusion Regular equipment comparison will promote the reliable operation of experiments and improve the management ability of equipment,and it is also an important quality control work of laboratory equipment.
作者
刘祎
桑列勇
傅立强
LIU Yi;SANG Lie-yong;FU Li-qiang(Shaoxing Central Blood Station)
出处
《医院管理论坛》
2023年第7期66-69,共4页
Hospital Management Forum
关键词
设备管理
全自动酶联免疫处理系统
乙肝表面抗原
Device management
Automatic enzyme-linked immunosorbent assay
Hepatitis B surface antigen HbsAg
