摘要
目的探讨血站实验室酶联免疫吸附检测(enzyme linked immunosorbent assay, ELISA)室内质控预设框架适应性。方法分析2016年7月至2018年6月北京市红十字血液中心ELISA检测实验室室内质控(internal quality control,IQC)检测值,分别绘制8项检测项目(HBsAg、抗HCV、HIV、抗TP 4项病原体血站检测项目分别应用两种不同试剂盒检测)质控品的所有检测值数据分布图,以验证实施质控方法的可行性;比较累积5 d且至少50个检测值(A)、20 d 20个检测值(B)以及与该检测项的质控品所有检测值(C)的差异性,以分析5 d 50个点建立预设框架的可行性;进一步比较同一项目2个不同试剂或质控品批号之间质控品检测值(C1,C2)之间的差异性,以评估该预设框架的适用条件。结果 8项检测项目IQC检测值数据分布均为近正态分布(P> 0.05),同一项目A与B差异无统计学意义(P> 0.05),与C的差异有统计学意义(P <0.05);同一项目2个不同试剂或质控品批号的C1、C2数据差异有统计学意义(P <0.05)。结论本实验室可采用L-J质控图实施ELISA检测室内质控。采用5 d至少50个点较20 d 20个点的质控预设框架更具可操作性,且需要关注该框架的适应性。当试剂或质控品批号更换时,需变更该项质控预设框架。
Objective To explore the applicability of internal quality control(IQC) framework in the enzyme-linked immunosorbent assay(ELISA) laboratory. Methods The data of IQC from July 2016 to June 2018 of the ELISA test lab were statistical analyzed. To verify the feasibility of implementing Levey-Jennings(L-J) quality control chart method, data distribution maps of all test values of quality control products of eight test items(HBsAg, anti-HCV, HIV and anti-TP were detected by two methods respectively) were drawn respectively. The difference of accumulated 5 d at least 50 test values(A), 20 d 20 test values(B) and all IQC(C) of quality control products with the test items were compared to analyze the feasibility of establishing presupposed framework at 5 d 50 points. The application conditions of the presupposed framework were further evaluated by comparing the differences of quality control test values(C1, C2) between two different reagents or batches of quality control products in the same project. Results The data of quality control points was nearly normal distribution(P >0.05). There were no significant difference between A and B(P > 0.05). There were significant differences between A and C(P < 0.05). There were significant differences in data of C between the two batches(C1\C2, P < 0.05). Conclusions L-J quality control chart is fit for our lab. When the batch number of reagents or quality control products is changed, the quality control framework should be changed. The quality control framework with at least 50 points for 5 days in our laboratory is more operable than that with 20 points for 20 days, and the adaptability of the framework should be focus.
作者
冷婵
王瑞
葛红卫
Leng Chan;Wang Rui;Ge Hongwei(Blood Screening Laboratory, Beijing Red Cross Blood Center, Beijing 100088, China)
出处
《北京医学》
CAS
2019年第8期732-735,共4页
Beijing Medical Journal
关键词
室内质控
ELISA检测系统
质控框架
L-J质控图
internal quality control(IQC)
enzyme-linked immunosorbent assay(ELISA) detection system
quality control framework
Levey-Jennings quality control chart
