2020年血清中总胆红素测定比对试验结果分析  

Comparative test of determination for total bilirubin in serum in 2020

作　　者：于婷[1] 张娟丽 孙晶 曲守方[1] 黄杰[1] YU Ting;ZHANG Juanli;SUN Jing;QU Shoufang;HUANG Jie(National Institutes for Food and Drug Control,Beijing 100050,China;Henan Province Medical Instrument Testing Institute,Zhengzhou,Henan 450003,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]河南省医疗器械检验所,河南郑州450003

出　　处：《国际检验医学杂志》2021年第20期2523-2526,共4页International Journal of Laboratory Medicine

摘　　要：目的评价参与比对试验的实验室血清中总胆红素的测定能力。方法以总胆红素参考方法测定值为指定值,对各实验室提交的比对试验结果进行分析及检测能力评价。要求比对样本测定值应在(27.10±2.71)μmol/L范围内,全部样本测定值的变异系数均应不大于5.00%。结果39家实验室(共40家)按要求提交了有效数据,其中有8家结果不满足要求,结果满意率为77.25%。结论该次比对试验为进一步加强对检测机构、相关企业的监督管理、规范检测市场提供了依据,少数参加实验室总胆红素检测能力存在一定问题,应积极寻找产生不满意的原因,以提高自身检测工作质量和水平。Objective To evaluate the capacity of laboratories participated in the comparative test of determination for total bilirubin in human serum.Methods Setting the value assigned by reference method to the specified value,we can analyze and evaluate the detection ability of participating laboratories submitted the comparative test results.By taking the measured value of total bilirubin reference method as the specified value,the comparison test results submitted by each laboratory was analyzed and the detection ability was evaluated.It was required that the measured value of the comparative test sample should be within assigned value range(27.10±2.71)μmol/L,and coefficient of variation of all samples should not be greater than 5.00%.Results A total of 39 laboratories(40 in total)participated in the comparative test submitted valid data according to the requirements.The results of 8 laboratories did not meet the requirements,and the satisfaction rate was 77.25%.Conclusion This comparative test provides a basis for further strengthening the supervision and management of testing institutions and related enterprises,and standardizing the testing market.There are some problems in the total bilirubin testing ability of a few participating laboratories.They should actively find the reasons for dissatisfaction,so as to improve the quality and level of own testing work.

关 键 词：比对试验 总胆红素 指定值 

分 类 号：R446.1[医药卫生—诊断学]