Comparison of the GeneFinder™ COVID-19 Plus RealAmp Kit on the sample-to-result Platform ELITe InGenius to the national reference method: An added value of N gene target detection?
Comparison of the GeneFinder™ COVID-19 Plus RealAmp Kit on the sample-to-result Platform ELITe InGenius to the national reference method: An added value of N gene target detection?
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DOI：
10.1016/j.jcv.2020.104632
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发表时间：
2020-11-01
影响因子：
8.8
通讯作者：
Vaessen, Norbert
中科院分区：
文献类型：
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作者：
Ong, David S. Y.;Claas, Eric C. J.;Vaessen, Norbert
背景：由于2019冠状病毒病（COVID-19）大流行的出现，迫切需要对严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）进行快速准确的检测。目的：本研究的目的是评估GeneFinderTMCOVID-19 Plus RealAmp试剂盒在ELITe InGenius sample-to-result平台上的诊断性能，该平台是针对SARS-CoV-2基因的商业核酸扩增检测（NAT）。研究设计：患者在2020年3月18日至5月27日期间有疑似COVID-19的呼吸道症状，符合条件。将InGenius平台与常规的内部NAT进行比较，并根据国家参考进行验证。结果：在128名随机选择的患者中，58名（45%）在两个平台中检测为阳性，55名（43%）检测为阴性。InGenius平台的灵敏度为100%（95%置信区间为94-100）。其余15例（12%）在两种平台均未检测到E和RdRp基因，但在InGenius平台检测到核蛋白(N)基因阳性。所有孤立的N基因阳性病例均由内部验证的N基因特异性NAT确认，并且根据最近获得的其他COVID-19阳性呼吸道样本或高度可疑的放射学结果，这些患者中的大多数也可能被认为是阳性。结论：InGenius平台检测SARS-CoV-2灵敏度高，操作简便，结果快速。与国家参考方法相比，将N基因作为第三个基因靶点可能会进一步提高COVID-19诊断的敏感性。
Background: Due to the emergence of the coronavirus disease 2019 (COVID-19) pandemic there is an urgent need for rapid and accurate testing on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).Objectives: The aim of this study was to assess the diagnostic performance of the GeneFinderTMCOVID-19 Plus RealAmp Kit on the ELITe InGenius sample-to-result platform, which is a commercial nucleic acid amplification test (NAT) targeting genes of SARS-CoV-2.Study design: Patients were eligible between March 18 and May 27, 2020, when they had respiratory symptoms that were suspected for COVID-19. The InGenius platform was compared to routine in-house NAT that was validated according to the national reference.Results: Of 128 randomly selected patients, 58 (45 %) tested positive and 55 (43 %) tested negative in both platforms. Sensitivity of the InGenius platform was 100 % (95 % confidence interval 94-100). In the remaining 15 (12 %) cases E and RdRp genes were not detected in both platforms but the nucleoprotein (N) gene was tested positive by the InGenius platform. All solitary N gene positive cases were confirmed by a N-gene specific in-house validated NAT, and most of these patients could also be considered positive based on other recently available COVID-19 positive respiratory samples or highly suspected radiological findings.Conclusion: The InGenius platform for SARS-CoV-2 detection has excellent sensitivity, is easy to use and provides fast results. The inclusion of the N gene as a third gene target may further increase sensitivity for the diagnosis of COVID-19 in comparison to the national reference method.