https://socictopen.socict.org/files/original/3c04a4e82660d0f0c825eb6ab387dd7e.pdf cd1d8aa5625e012b64bdfe3b1a09b8e6 Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Coronavirus Description An account of the resource Dominio científico: Coronavirus Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Development and Potential Usefulness of the COVID-19 Ag Respi-Strip Diagnostic Assay in a Pandemic Context Creator An entity primarily responsible for making the resource Francis Corazza, Ali Mirazimi, Katrien Lagrou, Marc Van Ranst, Pierrette Melin, Francois Bry, Vanessa Monteil, Béatrice Gulbis, Olivier Vandenberg, Lize Cuypers, Pascal Mertens, Delphine Martiny, Nathalie Devos, Sigi Van den Wijngaert, Gabriela Serrano, Magali Wautier, Christian Jassoy, Frédéric Cotton, Karolien Stoffels, Thierry Leclipteux, Bhavna Mahadeb, Nicolas Yin, Davide Mileto, Sabrina Delaunoy, Henri Magein, Justine Bouzet, LHUB-ULB SARS-CoV-2 Working Diagnostic Group, Françoise Brancart, Brigitte Cantinieaux, Maud Dresselhuis, Olivier Roels, Jacques Vanderlinden Description An account of the resource Introduction: COVID-19 Ag Respi-Strip, an immunochromatographic (ICT) assay for the rapid detection of SARS-CoV-2 antigen on nasopharyngeal specimen, has been developed to identify positive COVID-19 patients allowing prompt clinical and quarantine decisions. In this original research article, we describe the conception, the analytical and clinical performances as well as the risk management of implementing the COVID-19 Ag Respi-Strip in a diagnostic decision algorithm.Materials and Methods: Development of the COVID-19 Ag Respi-Strip resulted in a ready-to-use ICT assay based on a membrane technology with colloidal gold nanoparticles using monoclonal antibodies directed against the SARS-CoV and SARS-CoV-2 highly conserved nucleoprotein antigen. Four hundred observations were recorded for the analytical performance study and thirty tests were analyzed for the cross-reactivity study. The clinical performance study was performed in a retrospective multi-centric evaluation on aliquots of 328 nasopharyngeal samples. COVID-19 Ag Respi-Strip results were compared with qRT-PCR as golden standard for COVID-19 diagnostics.Results: In the analytical performance study, the reproducibility showed a between-observer disagreement of 1.7%, a robustness of 98%, an overall satisfying user friendliness and no cross-reactivity with other virus-infected nasopharyngeal samples. In the clinical performance study performed in three different clinical laboratories during the ascendant phase of the epidemiological curve, we found an overall sensitivity and specificity of 57.6 and 99.5%, respectively with an accuracy of 82.6%. The cut-off of the ICT was found at CT <22. User-friendliness analysis and risk management assessment through Ishikawa diagram demonstrate that COVID-19 Ag Respi-Strip may be implemented in clinical laboratories according to biosafety recommendations.Conclusion: The COVID-19 Ag Respi-Strip represents a promising rapid SARS-CoV-2 antigen assay for the first-line diagnosis of COVID-19 in 15 min at the peak of the pandemic. Its role in the proposed diagnostic algorithm is complementary to the currently-used molecular techniques. Date A point or period of time associated with an event in the lifecycle of the resource 2020 Subject The topic of the resource Diagnostic, antigen, Immunochromatographic test, SARS-CoV-2, COVID-19 Identifier An unambiguous reference to the resource within a given context DOI: 10.3389/fmed.2020.00225 Source A related resource from which the described resource is derived Frontiers in Medicine Publisher An entity responsible for making the resource available Frontiers Media S.A. Coverage The spatial or temporal topic of the resource, the spatial applicability of the resource, or the jurisdiction under which the resource is relevant Medicine (General)