Abstract：
Amongst the multiple ways to diagnose coronavirus disease-2019 (COVID-19), reverse transcription polymerase chain reaction (RT-PCR) remains the reference gold standard, providing fast and accurate results. This study evaluated and compared the performance of three commercially available COVID-19 RT-PCR kits-Aridia® COVID-19 Real-Time PCR Test (CTK Biotech, Inc., Poway, CA, USA), Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Sansure Biotech Inc., Changsha, China) and AllplexTM 2019-nCoV assay (Seegene Inc., Seoul, Republic of Korea) for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A total of 326 clinically suspected patients were enrolled for the study, and among them, 209 were diagnosed as positive and 117 as negative when tested with the reference method, US CDC 2019-Novel Coronavirus (2019-nCoV) Real Time RT-PCR Diagnostic Panel. The Aridia® kit showed total agreement with the reference test, with a sensitivity of 100% (95% CI: 98.25% to 100.0%) and a specificity of 100% (96.90% to 100.00%). The AllplexTM kit also showed 100% specificity (95% CI: 96.90% to 100.00%), but a lower sensitivity (98.09%, 95% CI: 95.17% to 99.48%). Among the three kits, the Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit showed the worst performance, with a sensitivity of 98.6% (95% CI: 95.9% to 99.7%) and a specificity of 95.73, 95% (CI: 90.31% to 98.60%). While all these kits conform to the requirement for routine molecular diagnosis with high performances, the Aridia® COVID-19 Real-Time PCR Test showed the best performance among the three kits.
摘要：
在诊断冠状病毒病-2019(COVID-19)的多种方法中，逆转录聚合酶链反应（RT-PCR）仍然是参考金标准，提供快速准确的结果。本研究评估并比较了三种市售COVID-19RT-PCR试剂盒-Aridia®COVID-19实时PCR测试(CTKBiotech，Inc.,波威,CA,美国),新型冠状病毒（2019-nCoV）核酸检测试剂盒（SansureBiotechInc.，长沙,中国)和AllplexTM2019-nCoV测定(SeegeneInc.，首尔,大韩民国）用于检测严重急性呼吸道综合症冠状病毒2（SARS-CoV-2）。共有326名临床可疑患者被纳入研究，其中,209个被诊断为阳性，117个被诊断为阴性，当用参考方法测试时，美国CDC2019-新型冠状病毒（2019-nCoV）实时RT-PCR诊断小组。Aridia®套件显示与参考测试完全一致，灵敏度为100%（95%CI：98.25%至100.0%），特异性为100%（96.90%至100.00%）。AllplexTM试剂盒还显示出100％的特异性（95％CI：96.90％至100.00％），但灵敏度较低(98.09%，95%CI：95.17%至99.48%）。在三个工具包中，新型冠状病毒（2019-nCoV）核酸检测试剂盒表现最差，敏感性为98.6%（95%CI：95.9%至99.7%），特异性为95.73、95%（CI：90.31%至98.60%）。虽然所有这些试剂盒符合常规分子诊断的要求，但具有高性能，Aridia®COVID-19实时PCR测试表明，这三种试剂盒的性能最好。
