Service de Microbiologie Clinique, Groupe Hospitalier Paris Saint-Joseph, Paris, France.
Service des Urgences, Groupe Hospitalier Paris Saint-Joseph, Paris, France.
J Clin Virol. 2021 Dec;145:105021. doi: 10.1016/j.jcv.2021.105021. Epub 2021 Oct 30.
Rapid testing for COVID-19 has been clearly identified as an essential component of the strategy to control the SARS-CoV-2 epidemic, worldwide. The ID NOW COVID-19 assay is a simple, user-friendly, rapid molecular biology test based on nicking and extension amplification reaction (NEAR).
The aim of this study was to evaluate the ID NOW COVID-19 assay when used as a point-of-care test (POCT) in our Emergency Department (ED).
This prospective study enrolled 395 consecutive patients; paired nasopharyngeal swabs were collected from each study participant. The first swab was tested with the ID NOW COVID-19 assay at the point-of-care by ED nurses. The second swab was diluted in viral transport medium (VTM) and sent to the clinical microbiology department for analysis by both the RT-PCR Simplexa test COVID-19 Direct assay as the study reference method, and the ID NOW COVID-19 assay performed in the laboratory.
Nasopharyngeal swabs directly tested with the ID NOW COVID-19 assay yielded a sensitivity, specificity, PPV and NPV of 98.0%, 97.5%, 96.2% and 98.7%, respectively, in comparison with the RT-PCR study reference assay. When the ID NOW COVID-19 assay was performed in the laboratory using the VTM samples, the sensitivity decreased to 62.5% and the NPV to 79.7%. Three false negative test results were reported with the ID NOW COVID-19 assay when performed using undiluted swabs directly in the ED; these results were obtained from patients with elevated CT values (> 30).
We demonstrated that the ID NOW COVID-19 assay, performed as a point of care test in the ED using dry swabs, provides a rapid and reliable alternative to laboratory-based RT-PCR methods.
快速检测 COVID-19 已被明确确定为控制 SARS-CoV-2 疫情的全球策略的重要组成部分。ID NOW COVID-19 检测是一种简单、易用、基于切口和延伸扩增反应（NEAR）的快速分子生物学检测。
本研究旨在评估 ID NOW COVID-19 检测在我们的急诊科（ED）中作为即时护理检测（POCT）的应用。
这项前瞻性研究纳入了 395 例连续患者；每位研究参与者都采集了配对的鼻咽拭子。第一个拭子由 ED 护士在即时护理点使用 ID NOW COVID-19 检测进行检测。第二个拭子在病毒运输培养基（VTM）中稀释，并送到临床微生物学部门，由 RT-PCR Simplexa 测试 COVID-19 Direct 检测作为研究参考方法和 ID NOW COVID-19 检测在实验室中进行分析。
直接使用 ID NOW COVID-19 检测鼻咽拭子与 RT-PCR 研究参考检测相比，敏感性、特异性、PPV 和 NPV 分别为 98.0%、97.5%、96.2%和 98.7%。当使用 VTM 样本在实验室中进行 ID NOW COVID-19 检测时，敏感性降至 62.5%，NPV 降至 79.7%。在 ED 直接使用未稀释拭子进行 ID NOW COVID-19 检测时，报告了 3 例假阴性检测结果；这些结果来自 CT 值升高（>30）的患者。
我们证明了 ID NOW COVID-19 检测在 ED 中作为即时护理检测使用干拭子进行检测，可以快速可靠地替代基于实验室的 RT-PCR 方法。
