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

التفاصيل البيبلوغرافية
العنوان: Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department
المؤلفون: Assaf Mizrahi, Olivier Ganansia, Benoit Pilmis, Alban Le Monnier, Jean-Claude Nguyen Van, Vincent Enouf, Amir khaterchi, Camille Gerlier, Gauthier Péan de Ponfilly
المساهمون: Groupe Hospitalier Paris Saint-Joseph (hpsj), Centre National de Référence des virus des infections respiratoires (dont la grippe) - National Reference Center Virus Influenzae [Paris] (CNR - laboratoire coordonnateur), Institut Pasteur [Paris] (IP)-Université Paris Cité (UPCité)
المصدر: Journal of Clinical Virology
Journal of Clinical Virology, 2021, 145, pp.105021. ⟨10.1016/j.jcv.2021.105021⟩
بيانات النشر: Elsevier BV, 2021.
سنة النشر: 2021
مصطلحات موضوعية: medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Point-of-care testing, Sensitivity and Specificity, Article, Prospective evaluation, Isothermal amplification, COVID-19 Testing, Nasopharynx, Virology, Internal medicine, medicine, Humans, Prospective Studies, Prospective cohort study, Point-of-care test, SARS-CoV-2, Emergency department, business.industry, COVID-19, Clinical microbiology, [SDV.MP]Life Sciences [q-bio]/Microbiology and Parasitology, Infectious Diseases, Direct assay, Point-of-Care Testing, ID NOW COVID-19, Viral Transport medium, Emergency Service, Hospital, business
الوصف: BackgroundRapid 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).ObjectivesThe 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 studyThis 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.ResultsNasopharyngeal 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).ConclusionWe 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
تدمد: 1386-6532
1873-5967
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f4be9341cfa3775b589e4b64b85e5dd1Test
https://doi.org/10.1016/j.jcv.2021.105021Test
حقوق: OPEN
رقم الانضمام: edsair.doi.dedup.....f4be9341cfa3775b589e4b64b85e5dd1
قاعدة البيانات: OpenAIRE