改良即刻法用于酶联免疫吸附试验室内质量控制的探索

目的建立一种适用于酶联免疫吸附实验(ELISA)室内质量控制(IQC)的方法。方法采用即刻法和用控制变异系数(CV)的方法(改良即刻法)同时统计初始阶段的质控数据,制作质控图。结果检验方法学的CV在15%左右,前3个质控数据的CV<5%时,采用即刻法统计随后的结果会出现假失控,前3个质控数据的CV>10%时,随后的结果会出现假在控。采用改良即刻法统计,只要设定好一个实验室或一个地区的允许CV值就没有假失控和假在控的结果。结论改良即刻法适用于CV较大、检测频次较低的免疫学检验项目IQC初始阶段的统计,操作简便易行。

The discussion about the improved instant method used for the internal quality control of immunology laboratory

Objective To establish a method used for the internal quality control of enzyme linked immunosorbent assay(ELISA) in immunology laboratory. Methods The primary quality control(QC)data were calculated statistically by instant method and controlling coefficient of variation(CV) method(improved instant method),and both quality control charts were drawn. Results When the CV of laboratory methodology was about 15% and the CV of the first three QC data was <5%,the subsequent results by using instant method may be false reject.When the CV of the first three QC data was >10%,the subsequent results may be false accept.However,if a suitable allowed CV values was established in a laboratory or an area by the improved instant method,no false reject and no false accept would be found. Conclusions The improved instant method is suitable and convenient to be used for the statistic in primary internal QC of immunology tests,characterized by higher CV and lower testing frequency.