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

Medientyp: E-Artikel

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

Beteiligte: Mertens, Pascal [Verfasser:in]; De Vos, Nathalie [Verfasser:in]; Martiny, Delphine [Verfasser:in]; Jassoy, Christian [Verfasser:in]; Mirazimi, Ali [Verfasser:in]; Cuypers, Lize [Verfasser:in]; Van den Wijngaert, Sigi [Verfasser:in]; Monteil, Vanessa [Verfasser:in]; Melin, Pierrette [Verfasser:in]; Stoffels, Karolien [Verfasser:in]; Yin, Nicolas [Verfasser:in]; Mileto, Davide [Verfasser:in]; Delaunoy, Sabrina [Verfasser:in]; Magein, Henri [Verfasser:in]; Lagrou, Katrien [Verfasser:in]; Bouzet, Justine [Verfasser:in]; Serrano, Gabriela [Verfasser:in]; Wautier, Magali [Verfasser:in]; Leclipteux, Thierry [Verfasser:in]; Van Ranst, Marc [Verfasser:in]; Vandenberg, Olivier [Verfasser:in]; working diagnostic group, LHUB-ULB SARS-CoV-2 [Verfasser:in]

Erschienen: Lausanne: Frontiers Research Foundation, [2023]

Sprache: Englisch

Schlagwörter: COVID-19 ; SARS-CoV-2 ; immunochromatographic test ; diagnostic ; antigen

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Beschreibung: Introduction: COVID-19 Ag Respi-Strip, an immunochromatographic (ICT) assay forthe rapid detection of SARS-CoV-2 antigen on nasopharyngeal specimen, has beendeveloped to identify positive COVID-19 patients allowing prompt clinical and quarantinedecisions. In this original research article, we describe the conception, the analytical andclinical performances as well as the risk management of implementing the COVID-19 AgRespi-Strip in a diagnostic decision algorithm.Materials and Methods: Development of the COVID-19 Ag Respi-Strip resultedin a ready-to-use ICT assay based on a membrane technology with colloidal goldnanoparticles using monoclonal antibodies directed against the SARS-CoV andSARS-CoV-2 highly conserved nucleoprotein antigen. Four hundred observations wererecorded for the analytical performance study and thirty tests were analyzed for the crossreactivitystudy. The clinical performance study was performed in a retrospective multicentricevaluation on aliquots of 328 nasopharyngeal samples. COVID-19 Ag Respi-Stripresults were compared with qRT-PCR as golden standard for COVID-19 diagnostics.Results: In the analytical performance study, the reproducibility showed abetween-observer disagreement of 1.7%, a robustness of 98%, an overall satisfying userfriendliness and no cross-reactivity with other virus-infected nasopharyngeal samples. Inthe clinical performance study performed in three different clinical laboratories duringthe ascendant phase of the epidemiological curve, we found an overall sensitivity andspecificity of 57.6 and 99.5%, respectively with an accuracy of 82.6%. The cut-offof the ICT was found at CT < 22. User-friendliness analysis and risk managementassessment through Ishikawa diagram demonstrate that COVID-19 Ag Respi-Strip maybe implemented in clinical laboratories according to biosafety recommendations.Conclusion: The COVID-19 Ag Respi-Strip represents a promising rapid SARS-CoV-2antigen assay for the first-line diagnosis of COVID-19 in 15min at the peak of thepandemic. Its role in the proposed diagnostic algorithm is complementary to thecurrently-used molecular techniques.

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