上海地区氯吡格雷药物代谢基因检测室间质量评价

External quality assessment for clopidogrel therapy-related genotyping in Shanghai

目的通过开展氯吡格雷药物代谢基因——细胞色素P450 2C19(CYP2C19)*2、*3、*17位点检测室间质量评价(简称室间质评)项目,评估参评临床实验室的检测能力及存在的问题。方法 2015年2次室间质评样本盘均分为2组,每组各包含5支样本。要求参评实验室收到样本后在规定时间内检测样本并网上上报检测结果。依据回报结果计算各实验室成绩,汇总不同位点的总体符合率,并分析检测方法和试剂的符合率。结果 2015年2次室间质评分别收到16份和17份有效回报结果,成绩满分的实验室分别占93.75%和88.24%,CYP2C19*2、*3和*17检测总符合率分别为95.00%、95.00%、100.00%和98.82%、98.82%、95.00%。2次室间质评中,使用自配试剂进行检测的实验室分别占37.5%和35.3%,满分实验室占83.33%和83.33%。使用注册试剂检测实验室成绩为满分的分别占100%和90.91%。结论各实验室在CYP2C19基因各位点检测总体准确率很高,但个别实验室检测能力有待提高。临床实验室的质量控制对于保证检测结果准确性具有十分重要的作用。

Objective Through external quality assessment for clopidogrel therapy-related genotyping for cytochrome P450 2C19(CYP2C19)*2,*3 and *17,to evaluate and discuss the problems in clinical laboratories participated in the programs. Methods The sample panel of external quality assessment 2015 contained 2 different groups,and each group consisted of 5 different samples. Participating laboratories were asked to report the results before deadlines. The scores of these laboratories were calculated based on their results,and the overall coincidence rates of different loci,methods and reagents were calculated. Results External quality assessment 2015 for clopidogrel therapy-related genotyping was set twice a year. A total of 16 and 17 valid laboratory results were received respectively. About 93.75% and 88.24% of the laboratories submitted correct results for all samples. The overall coincidence rates of CYP2C19 *2,*3 and *17 were 95.00%,95.00%,100.00% and 98.82%,98.82%,95.00%,respectively. The laboratories using laboratory-developed tests accounted for 37.5% and 35.3% of all participating laboratories,of which 83.33% and 83.33% of them got full marks in 2 programs of external quality assessment 2015.Meanwhile,100% and 90.91% of laboratories using registered reagents got full marks. Conclusions The overall accuracy rate of participating laboratories is high,while some laboratories' performance still needs to be improved.Quality controls in clinical laboratories are essential to assure the accuracy of results.