新冠病毒核酸检测实验室质量控制措施建立初探

Preliminary study on the quality control measures of COVID-19 testing in laboratory

目的分析、评价新冠病毒核酸检测实验室质量控制措施,为优化完善质控方案提供依据。方法采用Excel 2010计算新冠病毒核酸检测室内质控、环境监测质控、检测人员比对质控、试剂验证质控4个层次质量控制的Ct值,并对数据进行分析。结果实验室中质控品检测靶标N基因有2次超出■±s范围,其变异系数(CV)为7.68%;靶标ORF1ab基因检测中有4次超出了■±s范围,CV为5.29%。环境监测共8份拭子样本,检测均为阴性。在不同检测人员的检测结果中,N基因CV较大,为7.9%,工作年限>5年组和工作年限≤5年组检测人员检测结果比较差异无统计学意义(χ^(2)=0.431,P=0.621)。试剂验证中,低值对照品、中值对照品和高值对照品的两个通道的CV均≤5.0%,判为合格。结论内部质控、环境监测、人员比对和试剂验证可以作为新冠病毒核酸检测实验室常用的质控措施,应推广实施。

Objective To evaluate and analyze laboratory quality control measures for COVID-19 viral nucleic acid test,in order provide the quality control scheme.Methods Ct values of the quality control,environmental monitoring quality and control,inspection personnel comparison quality control and reagent verification quality control of COVID-19 viral nucleic acid were adopted through Excel 2010,and data was analyzed.Results The N gene had 2 times exceeding the ■±s range,and the CV was 7.68%.The ORF1 ab gene had 4 times beyond the ■±s range,and the CV was 5.29%.A total of 8 swab samples were collected for environmental monitoring,and the results were all negative.In the detection result of different inspectors,CV of N gene was 7.9%.There was no significant difference between the >5 working years and ≤5 working years groups (χ^(2)=0.431,P=0.621).The CV values in the two channels of the low-value,medium-value and the high-value reference substance verified by the reagent were ≤5.0%,and they were judged as qualified.Conclusion Internal quality control,environmental supervision,staff comparison and reagent verification can be used as common quality control measures in laboratory,which should be popularized and implemented.