Development and Potential Usefulness of the COVID-19 Ag Respi-Strip Diagnostic Assay in a Pandemic Context
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Open Access
- 8 May 2020
- journal article
- research article
- Published by Frontiers Media SA in Frontiers in Medicine
- Vol. 7, 225
- https://doi.org/10.3389/fmed.2020.00225
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 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.This publication has 18 references indexed in Scilit:
- A Novel Coronavirus from Patients with Pneumonia in China, 2019The New England Journal of Medicine, 2020
- Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCREurosurveillance, 2020
- Prospective evaluation of diagnostic tools for respiratory viruses in children and adultsJournal of Virological Methods, 2019
- Midturbinate Swabs Are Comparable to Nasopharyngeal Swabs for Quantitative Detection of Respiratory Syncytial Virus in InfantsJournal of the Pediatric Infectious Diseases Society, 2018
- [Laboratory equipment for primary health care should be tested by independent authorities. Scandinavian SKUP is a good alternative].2008
- The development of a qualitative real-time RT-PCR assay for the detection of hepatitis C virusEuropean Journal of Clinical Microbiology & Infectious Diseases, 2008
- Antigenic and cellular localisation analysis of the severe acute respiratory syndrome coronavirus nucleocapsid protein using monoclonal antibodiesVirus Research, 2006
- Novel rapid immunochromatographic test based on an enzyme immunoassay for detecting nucleocapsid antigen in SARS-associated coronavirusJournal of Clinical Laboratory Analysis, 2005
- Monoclonal Antibody-Based Antigen Capture Enzyme-Linked Immunosorbent Assay Reveals High Sensitivity of the Nucleocapsid Protein in Acute-Phase Sera of Severe Acute Respiratory Syndrome PatientsClinical and Vaccine Immunology, 2005
- Sensitive and Specific Monoclonal Antibody-Based Capture Enzyme Immunoassay for Detection of Nucleocapsid Antigen in Sera from Patients with Severe Acute Respiratory SyndromeJournal of Clinical Microbiology, 2004