Development and Potential Usefulness of the COVID-19 Ag Respi-Strip Diagnostic Assay in a Pandemic Context.

Autor:	Mertens P; Coris BioConcept, Gembloux, Belgium., De Vos N; Department of Clinical Chemistry, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Martiny D; Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Jassoy C; Medical Faculty and University Clinics, Institute for Virology, University of Leipzig, Leipzig, Germany., Mirazimi A; Division of Clinical Microbiology, Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden., Cuypers L; Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.; Clinical Department of Laboratory Medicine and National Reference Center for Respiratory Pathogens, UZ Leuven, Leuven, Belgium., Van den Wijngaert S; Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Monteil V; Division of Clinical Microbiology, Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden., Melin P; Department of Clinical Microbiology, Centre Hospitalier Universitaire Sart-Tilman, Université de Liège, Liège, Belgium., Stoffels K; Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Yin N; Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Mileto D; Laboratory of Clinical Microbiology, Virology and Bioemergency, ASST Fatebene fratelli Sacco, Luigi Sacco Hospital, Milan, Italy., Delaunoy S; Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Magein H; Coris BioConcept, Gembloux, Belgium., Lagrou K; Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.; Clinical Department of Laboratory Medicine and National Reference Center for Respiratory Pathogens, UZ Leuven, Leuven, Belgium., Bouzet J; Coris BioConcept, Gembloux, Belgium., Serrano G; Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium.; Innovation and Business Development Unit, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Wautier M; Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium., Leclipteux T; Coris BioConcept, Gembloux, Belgium., Van Ranst M; Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.; Clinical Department of Laboratory Medicine and National Reference Center for Respiratory Pathogens, UZ Leuven, Leuven, Belgium., Vandenberg O; Innovation and Business Development Unit, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium.; Division of Infection and Immunity, Faculty of Medical Sciences, University College London, London, United Kingdom.
Jazyk:	angličtina
Zdroj:	Frontiers in medicine [Front Med (Lausanne)] 2020 May 08; Vol. 7, pp. 225. Date of Electronic Publication: 2020 May 08 (Print Publication: 2020).
DOI:	10.3389/fmed.2020.00225
Abstrakt:	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. (Copyright © 2020 Mertens, De Vos, Martiny, Jassoy, Mirazimi, Cuypers, Van den Wijngaert, Monteil, Melin, Stoffels, Yin, Mileto, Delaunoy, Magein, Lagrou, Bouzet, Serrano, Wautier, Leclipteux, Van Ranst, Vandenberg and LHUB-ULB SARS-CoV-2 working diagnostic group.)
Databáze:	MEDLINE
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