Department of Medical Microbiology and Infection Control, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands; Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
Department of Medical Microbiology and Infection Control, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands; Department of Medical Microbiology, Leiden University Medical Center, Leiden, the Netherlands.
J Clin Virol. 2020 Nov;132:104632. doi: 10.1016/j.jcv.2020.104632. Epub 2020 Sep 7.
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).
The aim of this study was to assess the diagnostic performance of the GeneFinderCOVID-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.
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.
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.
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.
由于 2019 年冠状病毒病（COVID-19）大流行的出现，迫切需要对严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2）进行快速准确的检测。
本研究旨在评估 GeneFinderCOVID-19 Plus RealAmp 试剂盒在 ELITe InGenius 样本到结果平台上的诊断性能，该平台是一种针对 SARS-CoV-2 基因的商业核酸扩增检测（NAT）。
符合条件的患者为 2020 年 3 月 18 日至 5 月 27 日期间出现疑似 COVID-19 呼吸道症状的患者。InGenius 平台与根据国家参考标准验证的常规内部 NAT 进行了比较。
在随机选择的 128 名患者中，58 名（45%）在两个平台上均为阳性，55 名（43%）均为阴性。InGenius 平台的敏感性为 100%（95%置信区间 94-100）。在其余 15 例（12%）中，两个平台均未检测到 E 和 RdRp 基因，但 InGenius 平台检测到核蛋白（N）基因呈阳性。所有单独的 N 基因阳性病例均通过内部验证的 N 基因特异性 NAT 得到确认，这些患者中的大多数还可以根据其他最近可用的 COVID-19 阳性呼吸道样本或高度疑似的放射学发现被认为是阳性。
用于 SARS-CoV-2 检测的 InGenius 平台具有出色的敏感性，易于使用，并能快速提供结果。与国家参考方法相比，将 N 基因作为第三个基因靶标可能会进一步提高 COVID-19 诊断的敏感性。
