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

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..

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.

Errataetall:

CommentIn: J Clin Virol. 2020 Aug;129:104472. - PMID 32504944

Media Type:

Electronic Article

Year of Publication:

2020

Contained In:

Frontiers in medicine - Vol. 7 (2020), p. 225

Language:

English

Contributors:

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
LHUB-ULB SARS-CoV-2 Working Diagnostic Group
Gulbis, Béatrice
Brancart, Françoise
Bry, François
Cantinieaux, Brigitte
Corazza, Francis
Cotton, Fréderic
Dresselhuis, Maud
Mahadeb, Bhavna
Roels, Olivier
Vanderlinden, Jacques

Links:

Volltext

Keywords:

Antigen
COVID-19
Diagnostic
Immunochromatographic test
Journal Article
SARS-CoV-2

Notes:

Date Revised 28.09.2020

published: Electronic-eCollection

CommentIn: J Clin Virol. 2020 Aug;129:104472. - PMID 32504944

Citation Status PubMed-not-MEDLINE

Copyright: From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Physical Description:

Online-Ressource

doi:

10.3389/fmed.2020.00225

PMID:

32574326

PPN (Catalogue-ID):

NLM312432046