商品化室内质控物用于新冠病毒核酸检测试剂检出限验证结果分析  

An Analysis of the Detection Limit Verification in SARS-CoV-2 Nucleic Acid Detection Reagents by Using Commercial Quality Control

作　　者：马丽 冯晓敏 柏国明 赵伟凯 姚瑶 MA Li;FENG Xiaomin;BAI Guoming;ZHAO Weikai;YAO Yao(Beijing Huairou Hospital,Beijing 101400, China)

机构地区：[1]北京怀柔医院,北京101400

出　　处：《标记免疫分析与临床》2021年第5期881-883,886,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的通过采用一种商品化弱阳性室内质控物进行相应稀释形成不同浓度规格的样本进行新型冠状病毒核酸检测,以验证不同核酸检测试剂检出限是否符合要求。方法将商品化室内质控品进行适当稀释制备成不同浓度梯度的待测样品,用两种不同品牌试剂进行检测,并分析阳性检出率,阳性结果Ct值的平均值、标准差、变异系数,以评价验证检测试剂盒的检出限是否与厂家声明相一致。结果当阳性质控物浓度均值为原倍、1∶2倍稀释和1∶4倍稀释时,伯杰试剂全部标本的两个靶基因(ORF1ab基因和N基因)检出率为100%,当阳性质控物1∶8倍稀释后,ORF1ab基因的检出率为70%,N基因的检出率为95%。当阳性质控物浓度均值为原倍和1∶5倍稀释时,卓诚惠生试剂全部标本的3个靶基因(ORF1ab基因、N基因和E基因)检出率为100%,当阳性质控物1∶10倍稀释后,ORF1ab基因的检出率为75%,N基因的检出率为90%,E基因的检出率为85%。阳性样本的Ct值变异系数均小于5%。结论采用商品化室内质控物对新型冠状病毒核酸检测试剂盒的检出限进行验证具备可行性。Objective To verify the detection limits of nucleic acid reagents for SARS-Cov-2 by comparing results of the commercial quality control diluted to different concentrations.Methods The samples with different concentration gradients were prepared by properly diluting the commercial quality control.Two different brands of reagents were used for the detection.The positive detection rate,the mean value,standard deviation and coefficient of variation of Ct value of the positive results were analyzed to evaluate whether the detection limit of the test kit was consistent with the manufacturer’s statement.Results When the average concentration of positive quality control material was original,1∶2 and 1∶4 times dilution,the detection rate of two target genes(ORF1ab gene and N gene)in all samples of Bojie reagent was 100%.When the positive quality control material was diluted 1∶8 times,the detection rate of ORF1ab gene was 70%,and the detection rate of N gene was 95%.When the average concentration of the positive quality control material was original and 1∶5 times diluted,the detection rate of three target genes(ORF1ab gene,N gene and E gene)in all samples of Zhuocheng Huisheng reagent was 100%.When the positive quality control material was 1∶10 times diluted,the detection rate of ORF1ab gene was 75%,the detection rate of N gene was 90%,and the detection rate of E gene was 85%.The coefficient of variation of Ct value of positive samples was less than 5%.Conclusion Our study suggests that it is feasible to verify the detection limit of nucleic acid detection reagent by commercial nucleic acid quality control.

关 键 词：2019新型冠状病毒 核酸检测 商品化室内质控物 检出限验证 

分 类 号：R737.9[医药卫生—肿瘤] R446[医药卫生—临床医学]