摘要
目的比较检测原理相同的2套核酸筛查系统的检测结果,分析2套系统的无效情况,为提高实验室检测能力,完善实验室质量体系提供相关依据。方法统计本实验室2016年10月—2017年9月2套核酸筛查系统的联检阳性率,可鉴别率,同时比较分析2套系统的无效检测率和无效列表率,并对引起无效结果的错误类型进行分析。结果 TIGRIS和PANTHER 2套核酸筛查系统联检阳性率分别为0.56%,0.47%,差异具有统计学意义;可鉴别率分别为66.44%,70.29%,差异不具统计学意义;无效检测率分别为0.327%,0.649%,PANTHER的无效检测率显著高于TIGRIS,差异具有统计学意义;无效列表率分别为2.46%,2.67%,差异不具统计学意义;两套系统引起无效检测的首要错误信息均为磁清洗台故障。结论 TIGRIS和PANTHER两套系统的可鉴别率无差异,联检试验实验阳性率差异很可能是所检测标本不同造成的; PANTHER的无效检测率更高,设备故障相对频繁;标本质量问题是引起2套筛查设备无效检测的常见原因,日常维护保养对于2套筛查系统意义重大。
Objective Compare the results of two nucleic acid screening systems with the same detection principle. False negative results from the 2 systems were analyzed to improve the laboratory testing ability and quality control criteria. Methods The positive rate of the ultrio assay and discriminatory assay on the 2 sets of nucleic acid screening systems from October 2016 to September 2017 were statistically compared;At the same time, the total rate of invalid tests and the rate of invalid worklists on 2 systems were compared and analyzed, and the types of error messages that caused invalid results were analyzed. Results The positive rate of ultrio assays on TIGRIS and PANTHER were respectively 0.56% and 0.47% and the difference was statistically significant;the positive rates of discriminatory assay were respectively 66.44% and 70.29%. The difference was not statistically significant;the rates of invalid tests were respectively 0.327% and 0.429% and the difference was statistically significant. the rate of invalid tests from PANTHER was significantly higher than that of TIGRIS;the rates of invalid worklists were 2.46% and 2.67% respectively with no statistical difference. The primary error message which resulted in invalid tests for 2 sets of system were both ML. Conclusion Tigris and Panther had the same ability of discriminatory assay and the difference between two positive rates of the ultrio assay was probably caused by the different samples tested;PANTHER ′s total rate of invalid tests was higher and the equipment failure occurred more frequently;specimen quality was a common cause of invalid detection for 2 sets of systems and routine maintenance is of great significance for 2 sets of systems.
作者
谢月娜
潘彤
刘淼
李凤园
赵倩
姚娜
李娜
XIE Yuena;PAN Tong;LIU Miao;LI Fengyuan;ZHAO Qian;YAO Na;LI Na(Tianjin Blood Center,Tianjin 300110,China)
出处
《中国输血杂志》
CAS
2019年第2期162-165,共4页
Chinese Journal of Blood Transfusion
关键词
核酸检测
无效测试
错误信息
nucleic acid amplification test(NAT)
invalid test
error message
