三种SARS-CoV-2核酸检测试剂盒的诊断效能评估

Comparison of the diagnostic efficacy among three test kits for SARS-CoV-2 nucleic acid detection

目的比较和分析3种不同的商用新型冠状病毒(SARS-CoV-2)核酸检测试剂盒对SARS-CoV-2核酸检测的诊断效果。方法收集49例新冠患者和11名健康者的咽拭子样本。采用武汉明德生物科技有限公司、江苏硕世生物科技股份有限公司、卡尤迪生物科技宜兴有限公司SARS-CoV-2核酸RT-PCR检测试剂盒检测SARS-CoV-2核酸,对敏感度(sensitivity,Sn)、特异度(specificity,Sp)、整体准确度(overall accuracy)、阳性预测值(positive predictive value,PPV)、阴性预测值(negative predictive value,NPV)和kappa值进行分析,对3个不同水平样本进行了3次平行试验,建立及验证卡尤迪快检值预测明德和硕世常规值的线性回归方程。结果明德公司试剂盒检测SARS-CoV-2核酸的Sn、Sp、overall accuracy、PPV、NPV和Kappa值分别为0.98、1.00、0.98、1.00、0.92和0.95,硕世公司试剂盒分别为0.96、1.00、0.97、1.00、0.85和0.90,卡尤迪试剂盒分别为0.94、1.00、0.95、1.00、0.79和0.85。在3个平行检测中,明德和硕世试剂盒在3个不同水平样本中ORF1ab和N基因的变异系数小于卡尤迪试剂盒。成功建立并验证了卡尤迪快检值预测明德和硕世常规值的线性回归方程[明德:YORF1ab=1.049×XORF1ab(卡尤迪)+13.20(R2=0.937),YN=1.101×X N(卡尤迪)+13.06(R2=0.940);硕世:YORF1ab=1.066×X ORF1ab(卡尤迪)+15.49(R2=0.940),YN=1.107×X N(卡尤迪)+14.61(R2=0.944)],明德、硕世的预测值与实测值差异均无统计学意义(均P>0.05)。结论3种试剂盒对SARS-CoV-2核酸的检测效果具有较好的符合率和一致性,卡尤迪试剂盒快检值建立的线性回归方程可以较好地预测明德和硕世常规值。

Objective To compare and analyze the diagnostic efficacy of three different commercial test kits for SARS-CoV-2 nucleic acid detection.Methods Throat swab samples were collected from 49 COVID-19 patients and 11 healthy individuals.The SARS-CoV-2 nucleic acid was detected with RT-PCR test kits from Mde Biotech,Jiangsu Bioperfectus Technologies,and Coyote Biotech.The sensitivity,specificity,overall accuracy,positive predictive value(PPV),negative predictive value(NPV),and kappa value were analyzed,and three parallel tests were performed with three samples at different levels.The linear regression equation of Coyote quick detection value was established and verified,which to predict the conventional values of Mde and Bioperfectus.Results The sensitivity,specificity,overall accuracy,PPV,NPV,and kappa value of the Mde PCR kit were 0.98,1.00,0.98,1.00,0.92,and 0.95,respectively,and that of the Bioperfectus PCR kit were 0.96,1.00,0.97,1.00,0.85,and 0.90,respectively,and that of the Coyote PCR kit were 0.94,1.00,0.95,1.00,0.79,and 0.85.For the three parallel tests,the coefficient of variation value of the Mde and Bioperfectus PCR kit in all three samples were smaller than that of Coyote PCR kit for both the ORF1ab and N gene.The linear regression equation of Coyote quick detection value was established and verified successfully[Mde:YORF1ab=1.049×XORF1ab(Coyote)+13.20(R2=0.937),YN=1.101×X N(Coyote)+13.06(R2=0.940);Bioperfectus:YORF1ab=1.066×X ORF1ab(Coyote)+15.49(R2=0.940),YN=1.107×X N(Coyote)+14.61(R2=0.944)].Conclusions The three test kits have good coincidence rate and consistency for the detection of SARS-CoV-2 nucleic acid.The linear regression equation established by the quick detection value of Coyote kit can better predict the routine value of Mde and Biopefectus.