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

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 des...

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Veröffentlicht in:	Frontiers in medicine Jg. 7; S. 551560
Hauptverfasser:	Mertens, Pascal, De Vos, Nathalie, Martiny, Delphine, Jassoy, Christian, Mirazimi, Ali, Cuypers, Lize, Van den Wijngaert, Sigi, Monteil, Vanessa, Melin, Pierrette, Stoffels, Karolien, Yin, Nicolas, Mileto, Davide, Delaunoy, Sabrina, Magein, Henri, Lagrou, Katrien, Bouzet, Justine, Serrano, Gabriela, Wautier, Magali, Leclipteux, Thierry, Van Ranst, Marc, Vandenberg, Olivier
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Lausanne Frontiers Media SA 08.05.2020 Frontiers Media S.A
Schlagworte:	antigen Antigens COVID-19 diagnostic Diagnostic tests immunochromatographic test Laboratories Medicine Monoclonal antibodies Nanoparticles Pandemics Proteins Reagents SARS-CoV-2 Serology Severe acute respiratory syndrome coronavirus 2 Belgium Sweden
ISSN:	2296-858X, 2296-858X
Online-Zugang:	Volltext
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Abstract	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.
AbstractList	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.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. 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.
Author	Magein, Henri Yin, Nicolas Van Ranst, Marc Stoffels, Karolien Mirazimi, Ali Vandenberg, Olivier Bouzet, Justine Wautier, Magali Mileto, Davide Lagrou, Katrien De Vos, Nathalie Jassoy, Christian Serrano, Gabriela Leclipteux, Thierry Mertens, Pascal Monteil, Vanessa Martiny, Delphine Cuypers, Lize Delaunoy, Sabrina Melin, Pierrette Van den Wijngaert, Sigi
AuthorAffiliation	2 Department of Clinical Chemistry, LHUB-ULB, Université Libre de Bruxelles , Brussels , Belgium 3 Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles , Brussels , Belgium 4 Medical Faculty and University Clinics, Institute for Virology, University of Leipzig , Leipzig , Germany 1 Coris BioConcept , Gembloux , Belgium 11 Division of Infection and Immunity, Faculty of Medical Sciences, University College London , London , United Kingdom 7 Clinical Department of Laboratory Medicine and National Reference Center for Respiratory Pathogens, UZ Leuven , Leuven , Belgium 10 Innovation and Business Development Unit, LHUB-ULB, Université Libre de Bruxelles , Brussels , Belgium 6 Department of Microbiology, Immunology and Transplantation, KU Leuven , Leuven , Belgium 8 Department of Clinical Microbiology, Centre Hospitalier Universitaire Sart-Tilman, Université de Liège , Liège , Belgium Author Affiliations: Department of Clinical Chemistry, LHUB-ULB, Université Libre de Bruxelles, Brusse
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ContentType	Journal Article
Copyright	2020. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 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. 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. 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
Copyright_xml	– notice: 2020. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. – notice: 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. – notice: 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. 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
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Notes	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 These authors share senior authorship Reviewed by: Nianyin Zeng, Xiamen University, China; Feng-Yih Yu, Chung Shan Medical University, Taiwan; Yohannes Berhane, Canadian Food Inspection Agency, Canada Edited by: Alexander Rodriguez-Palacios, Case Western Reserve University, United States These authors have contributed equally to this work This article was submitted to Infectious Diseases - Surveillance, Prevention and Treatment, a section of the journal Frontiers in Medicine
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References	Che (B5) 2004; 42 Ye (B3) 2020; 1 B10 Bussmann (B12) 2006; 122 Shi (B4) 2020; 27 B13 Sandberg (B11) 2008; 105 Di (B7) 2005; 12 Loeffelholz (B18) 2020; 9 Clancy (B14) 2008; 27 Diao (B19) 2020 Kogaki (B6) 2005; 19 Rubin (B2) 2020; 382 Busson (B15) 2019; 266 Vandenberg (B22) 2020; 33 Zhu (B1) 2020; 382 Chan (B8) 2020; 9 Cao (B21) 2020 Ishikawa (B17) 1976 Blaschke (B20) 2019; 8 Corman Victor (B16) 2020; 25 B9
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Snippet	Introduction: COVID-19 Ag Respi-Strip, an immunochromatographic (ICT) assay for the rapid detection of SARS-CoV-2 antigen on nasopharyngeal specimen, has been...
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SubjectTerms	antigen Antigens COVID-19 diagnostic Diagnostic tests immunochromatographic test Laboratories Medicine Monoclonal antibodies Nanoparticles Pandemics Proteins Reagents SARS-CoV-2 Serology Severe acute respiratory syndrome coronavirus 2
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Title	Development and Potential Usefulness of the COVID-19 Ag Respi-Strip Diagnostic Assay in a Pandemic Context
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