摘要
目的分析影响临床免疫检验质量的因素、控制对策。方法从我院检验科选取2020年6月至2020年9月酶联免疫吸附试验中适量质控品,运用即刻法、改良即刻法展开质量控制,分析质控效果。结果即刻法对目前3个质控值CV大的结果无控制意义;1~3个质控值CV值越小,则第4个质控值被允许的CV值也会发生对应减小;使用即刻法、改良即刻法统计20个质控数据,发现即刻法目前1~3个质控值CV<10%时,随后CV值会越来越大,结果显示质控状态均为在控,即刻改良方式以CV<25%为控制限,质控状态显示为失控较多;检验项目临界值恒定,可使用A值测定统计室内质量控制;若检验项目的结果判断值不恒定,则必须使用S/CO统计室内质控。结论实验步骤繁多、使用不同厂家试剂、使用同产家批号不同试剂等为临床免疫检验质量影响因素;使用即刻法统计一开始阶段质控数据,1~3个质控数值的CV值对随后质控数值CV值具有较大影响,尤其是第4个质控值受到影响最大,改良即刻法适合正态分布质控数据使用,选择质控方式需结合自身实际需求,选择合适方式提高免疫检验质量。
Objective To analyze the factors affecting the quality of clinical immunoassay and the control measures.Methods An appropriate amount of quality control products in enzyme-linked immunosorbent assay(ELISA)were selected from the laboratory department of our hospital from June 2020 to September 2020,and the quality control was carried out by using the instant method and improved instant method,and the quality control effect was analyzed.Results The instant method has no control significance for the results with large CV of the three quality control values at present.The smaller the CV value of 1~3 quality control values is,the allowable CV value of the fourth quality control value will also decrease correspondingly.According to the statistics of 20 quality control data by the instant method and the improved instant method,it was found that when the CV of 1~3 quality control values in the instant method was less than 10%,then the CV value would become larger and larger.The results showed that the quality control status was under control.The control limit of the immediate improvement method was CV<25%,and the quality control status was more out of control.The critical value of the test item is constant,and A value can be used to measure the quality control in the statistical room.If the result value of the test item is not constant,S/CO statistical indoor quality control must be used.Conclusion Various experimental procedures,different reagents from different manufacturers,different reagents from the same manufacturer and batch number of different reagents from the same manufacturer were the influencing factors for the quality of clinical immunoassay.Use immediately at the start of a quality control method of statistics,1~3 quality numerical CV value has great influence on later numerical CV value quality,especially the fourth quality value,the biggest impact modified immediate method suitable for normal distribution data quality control,quality control methods should be combined with their actual needs,choose the right way improve immune inspection quality.
作者
张琛
李晶晶
ZHANG Chen;LI Jing-jing(Ganzhou People’s Hospital,Zhangye,Gansu,734000)
出处
《智慧健康》
2021年第5期9-11,共3页
Smart Healthcare
关键词
免疫检验质量
质控方式
即刻法
质控值
检验试剂
Immunoassay quality
Quality control mode
Immediate method
Quality control values
Test reagent
