广西新冠病毒核酸检测室间质评情况总结分析

Summary and analysis of external quality assessment for nucleic acid detection of SARSCoV-2 in Guangxi

目的:通过连续8次室间质量评价(EQA)结果分析我区新型冠状病毒(SARS-CoV-2)核酸检测实验室检测能力,以保证检测质量。方法:以假病毒作为考核样本,通过冷链物流按计划向所有参加实验室发放,根据实验室所回报数据进行综合分析评价。结果:考核样本验证符合要求。总共377家实验室参加,绝大部分获得合格结果,实验室的检测能力不受Delta变异株的影响。各实验室在使用的提取试剂共有27种,扩增试剂有13种,扩增仪有20种。第六次质评阳性样本的Ct值变异系数在4.8%~6.1%之间,超过Ct值均值±3的比例在4.7%-16.7%之间。结论:广西地区SARS-CoV-2核酸检测实验室总体质量较好,个别实验室检测能力有待提高。各实验室应不断通过EQA和室内质控来保证检测质量,以保证结果的准确性和可靠性。

Objective:Analyzing the laboratory's detection ability of nucleic acid detection of SARS-CoV-2 in Guangxi through 8 consecutive external quality assessment(EQA)results to ensure the quality of detection.Methods:The fake virus was used as the assessment sample,distributed to all participating laboratories through cold chain logistics as planned,and comprehensive analysis and evaluation were carried out according to the data returned by the laboratory.Results:The test sample is verified to meet the requirements.A total of 377 laboratories participated,and most of them obtained qualified results.The detection ability of laboratories was not affected by the Delta variant.There are 27 kinds of extraction reagents,13 kinds of amplification reagents and 20 kinds of amplification instruments in use in all laboratories.The coefficient of variation of the Ct value of the positive samples in the sixth quality assessment was between 4.8%and 6.1%,and the proportions exceeding the mean±3 of the Ct value were between 4.7%and 16.7%.Conclusion:The overall quality of SARSCoV-2 nucleic acid detection laboratories in Guangxi is good,but the detection capacity of individual laboratories needs to be improved.Each laboratory should continuously ensure the quality of testing through EQA and internal quality control to ensure the accuracy and reliabilityoftheresults.