SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluation From the Near Patient Testing to the Automated Diagnostic Platform.

Autor:	Yin N; Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Debuysschere C; Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Decroly M; General Practitioner, Brussels, Belgium., Bouazza FZ; Emergency Department, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium., Collot V; Emergency Department, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium., Martin C; Department of Infectious Diseases, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium., Ponthieux F; Department of Clinical Chemistry, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Dahma H; Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Gilbert M; Spatial Epidemiology Laboratory, Université Libre de Bruxelles, Brussels, Belgium., Wautier M; Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Duterme C; Department of Clinical Chemistry, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., De Vos N; Department of Clinical Chemistry, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Delforge ML; Institut de Biologie Clinique, Université Libre de Bruxelles, Brussels, Belgium., Malinverni S; Emergency Department, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium., Cotton F; Department of Clinical Chemistry, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Bartiaux M; Emergency Department, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium., Hallin M; Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium.; Center for Environmental Health and Occupational Health, Public Health School, Université Libre de Bruxelles, Brussels, Belgium.
Jazyk:	angličtina
Zdroj:	Frontiers in medicine [Front Med (Lausanne)] 2021 Apr 06; Vol. 8, pp. 650581. Date of Electronic Publication: 2021 Apr 06 (Print Publication: 2021).
DOI:	10.3389/fmed.2021.650581
Abstrakt:	Introduction: Since the first wave of COVID-19 in Europe, new diagnostic tools using antigen detection and rapid molecular techniques have been developed. Our objective was to elaborate a diagnostic algorithm combining antigen rapid diagnostic tests, automated antigen dosing and rapid molecular tests and to assess its performance under routine conditions. Methods: An analytical performance evaluation of four antigen rapid tests, one automated antigen dosing and one molecular point-of-care test was performed on samples sent to our laboratory for a SARS-CoV-2 reverse transcription PCR. We then established a diagnostic algorithm by approaching median viral loads in target populations and evaluated the limit of detection of each test using the PCR cycle threshold values. A field performance evaluation including a clinical validation and a user-friendliness assessment was then conducted on the antigen rapid tests in point-of-care settings (general practitioners and emergency rooms) for outpatients who were symptomatic for <7 days. Automated antigen dosing was trialed for the screening of asymptomatic inpatients. Results: Our diagnostic algorithm proposed to test recently symptomatic patients using rapid antigen tests, asymptomatic patients using automated tests, and patients requiring immediate admission using molecular point-of-care tests. Accordingly, the conventional reverse transcription PCR was kept as a second line tool. In this setting, antigen rapid tests yielded an overall sensitivity of 83.3% (not significantly different between the four assays) while the use of automated antigen dosing would have spared 93.5% of asymptomatic inpatient screening PCRs. Conclusion: Using tests not considered the "gold standard" for COVID-19 diagnosis on well-defined target populations allowed for the optimization of their intrinsic performances, widening the scale of our testing arsenal while sparing molecular resources for more seriously ill patients. Competing Interests: Becton Dickinson, Coris BioConcept, and Fujirebio have offered reagents for this study. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2021 Yin, Debuysschere, Decroly, Bouazza, Collot, Martin, Ponthieux, Dahma, Gilbert, Wautier, Duterme, De Vos, Delforge, Malinverni, Cotton, Bartiaux and Hallin.)
Databáze:	MEDLINE
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