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Article Dans Une Revue Journal of Clinical Virology Année : 2021

Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department

Résumé

Background: 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). Objectives: 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). Type of study: 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. Results: 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). Conclusion: 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.

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hal-04096891 , version 1 (13-05-2023)

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Jean-Claude Nguyenvan, Camille Gerlier, Benoît Pilmis, Assaf Mizrahi, Gauthier Péan de Ponfilly, et al.. Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department. Journal of Clinical Virology, 2021, 145, pp.105021. ⟨10.1016/j.jcv.2021.105021⟩. ⟨hal-04096891⟩
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