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目的:分析ELISA法检测HIV抗体的室内质控,总结失控原因,加强实验室管理,保证检验结果准确可靠。方法:运用L-J质控图,结合Westgard多规则质控法,进行室内质控及分析。结果:2013-01-2014-10共检测2 033批次,其中警告57次,失控29次,分别占质控总数的2.80%和1.42%。其中随机误差10次,系统误差19次,分别占质控总数的0.49%和0.93%。22个RCV处于9.72%~22.85%,其中21个均处于20.00%以内,1次是22.85%。结论:ELISA法影响因素较多,要严格按照操作规程,加强室内质控,以保证检验结果的准确性。
OBJECTIVE: To analyze the ELISA method for detecting HIV antibody indoor quality, summarize the causes of out of control, and strengthen laboratory management to ensure the test results are accurate and reliable. Methods: The L-J quality control chart and the Westgard multi-rule quality control method were used to analyze and analyze the quality of the products. Results: A total of 2 033 batches were detected during 2013-01-2014-10, including 57 warnings and 29 out of control measures, accounting for 2.80% and 1.42% of the total quality control respectively. Among them, there were 10 random errors and 19 systematic errors, accounting for 0.49% and 0.93% of the total quality control respectively. 22 RCVs ranged from 9.72% to 22.85%, of which 21 were within 20.00% and 1 was 22.85%. Conclusion: There are many influencing factors in ELISA method. The rules of laboratory should be strictly followed to improve the quality control of laboratory to ensure the accuracy of test results.