三种SARS-CoV-2核酸检测试剂盒的诊断效能评估

doi:10.12183/j.scjpm.2024.0800

摘要/Abstract

摘要： 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：Y_ORF1ab=1.049×X_ORF1ab_{（卡尤迪）}+13.20（R²= 0.937）,Y_N=1.101×X _N_{（卡尤迪）}+13.06（R²= 0.940）;硕世：Y_ORF1ab=1.066×X _ORF1ab_{（卡尤迪）}+15.49（R²=0.940）,Y_N=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。

关键词: 新型冠状病毒, 聚合酶链反应, 诊断效能, 线性回归方程, 诊断技术, 灵敏度, 特异度

Abstract: 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: Y_ORF1ab = 1.049×X_{ORF1ab(Coyote)} + 13.20 (R²=0.937), Y_N = 1.101×X_N(Coyote) + 13.06 (R²=0.940); Bioperfectus: Y_ORF1ab = 1.066×X_{ORF1ab(Coyote)} + 15.49 (R²=0.940), Y_N= 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.

Key words: SARS-CoV-2, Polymerase chain reaction, Diagnostic efficacy, The linear regression equation, Diagnostic techniques, Sensitivity, Specificity

中图分类号:

R115

张汉运, 丘晓婷, 彭芳, 王敏, 王伟佳, 谭志熹. 三种SARS-CoV-2核酸检测试剂盒的诊断效能评估[J]. 华南预防医学, 2024, 50(9): 800-803.

ZHANG Hanyun, QIU Xiaoting, PENG Fang, WANG Min, WANG Weijia, TAN Zhixi. Comparison of the diagnostic efficacy among three test kits for SARS-CoV-2 nucleic acid detection[J]. South China Journal of Preventive Medicine, 2024, 50(9): 800-803.

参考文献

[1] Chen PJ, Pusica Y, Sohaei D, et al.An overview of mental health during the COVID-19 pandemic[J]. Diagnosis (Berl), 2021, 8(4): 403-412.
[2] 张娟娟,吴谦惠,余宏杰. 新冠肺炎的流行病学、传播动力学、疫苗和非药物性干预措施评价的研究进展[J]. 中国科学基金,2022,36(4):660-671.
[3] Kim D, Lee JY, Yang JS, et al.The architecture of SARS-CoV-2 transcriptome[J]. Cell, 2020, 181(4): 914-921.
[4] Wang Y, Li X, Wang Y, et al.Comparison of the performance of two real-time fluorescent quantitative PCR kits for the detection of SARS-CoV-2 nucleic acid: A study based on large real clinical samples[J]. Virol J, 2022, 19(1): 191.
[5] Hirotsu Y, Mochizuki H, Omata M.Double-quencher probes improve detection sensitivity toward severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in a reverse-transcription polymerase chain reaction (RT-PCR) assay[J]. J Virol Methods, 2020, 284: 113926.
[6] Iglói Z, Leven M, Abdel-Karem AZ, et al.Comparison of commercial realtime reverse transcription PCR assays for the detection of SARS-CoV-2[J]. J Clin Virol, 2020, 129: 104510.
[7] 钟慧钰,赵珍珍,宋兴勃,等. 新型冠状病毒核酸临床检测要点及经验[J]. 国际检验医学杂志,2020,41(5) :523-526.
[8] 张益. 宏基因组二代测序技术在病毒病原检测中的应用研究[D]. 北京:中国疾病预防控制中心,2018.
[9] 李少波,王静,楼爽,等. 3种试剂检测新冠Delta变异毒株结果比较分析[J]. 标记免疫分析与临床,2022,29(8):1398-1401.
[10] Banko A, Petrovic G, Miljanovic D, et al.Comparison and sensitivity evaluation of three different commercial real-Time quantitative PCR kits for SARS-CoV-2 Detection[J]. Viruses, 2021, 13(7): 1321.
[11] Lu Y, Li L, Ren S, et al.Comparison of the diagnostic efficacy between two PCR test kits for SARS-CoV-2 nucleic acid detection[J]. J Clin Lab Anal, 2020, 34(10): e23554.
[12] 沈利华,黄菲,陈祥,等. 严重急性呼吸综合征冠状病毒2(SARS-CoV-2)核酸检测试剂盒临床诊断效能评估[J]. 浙江大学学报(医学版),2020,49(2):185-190.
[13] 颜新生,杨荟荟,蒿叶霞,等. 4种SARS-CoV-2核酸检测试剂一致性评价[J]. 检验医学,2020,35(7):706-709.
[14] 陈建波,杨勇,李慧源,等. 4种SARS-Cov-2核酸检测试剂盒测定结果分析[J]. 检验医学,2021,36(4):396-399.
[15] 黄忠平,杨慧萍,冯玉亮,等. 15种新型冠状病毒核酸检测试剂的检测性能比较[J]. 职业卫生与病伤,2023,38(1):60-64.
[16] 马雯,张伟宏,马瑛龙,等. 不同核酸提取试剂盒在新型冠状病毒核酸检测中的比较研究[J]. 分子诊断与治疗杂志,2020,12(5):552-556.