2022年结核分枝杆菌分子检测能力验证结果分析

Proficiency testing for molecular detection of mycobacterium tuberculosis in 2022

目的通过组织实施能力验证了解我国实验室在结核分子检测能力方面的现状。方法在2022年组织相关实验室报名参加本次能力验证,并制备能力验证样本并发放给参加实验室。通过对参加实验室的所在地区、实验室类型、上报结果和错误类型等方面进行统计和分析,评估其结核分子检测能力和管理水平。结果共有来自于11个省份的20家实验室参加本次能力验证活动,总体满意率为89.5%。不满意的原因主要为将阴性样本错误地检测为阳性。部分实验室出现填报结果错误等实验室管理问题。结论大多数参加本次能力验证的实验室具有较好的结核分子检测能力,但部分实验室应当关注实验室核酸交叉污染和实验室质量管理问题。本能力验证有助于进一步提升我国实验室的结核分子检测能力。

Objective To understand the current status of tuberculosis molecular testing capabilities of laboratories in China through proficiency testing.Methods In 2022,relevant laboratories were invited to participate in proficiency testing.Samples were prepared and distributed to these laboratories.Statistical analysis was then conducted on various aspects,including the geographical distribution of participating laboratories,types of laboratories,reported results,and types of errors.This analysis aimed to assess their capabilities in tuberculosis molecular testing and their overall management level.Results A total of 20 laboratories from 11 provinces participated in this proficiency testing,resulting in an overall satisfaction rate of 89.5%.The primary reason for dissatisfaction was the misidentification of negative samples as positive.Some laboratories also faced challenges with reporting inaccurate results and managing their laboratories.Conclusion Most labo⁃ratories participating in this proficiency testing demonstrated good capabilities in tuberculosis molecular testing.However,some laboratories need to pay attention to nucleic acid cross⁃contamination and laboratory quality management.This proficiency testing contributes to enhancing the tuberculosis molecular testing capabilities of laboratories in China even further.