Development and Clinical Performance of InteliSwab® COVID-19 Rapid Test: Evaluation of Antigen Test for the Diagnosis of SARS-CoV-2 and Analytical Sensitivity to Detect Variants of Concern Including Omicron and Subvariants

• Published in: Viruses Vol. 16; no. 1; p. 61
• Main Authors: Fischl, Mark J., Young, Janean, Kardos, Keith, Roehler, Michele, Miller, Tiffany, Wooten, Melinda, Holmes, Natalie, Gula, Nicole, Baglivo, Mia, Steen, Justin, Zelenz, Nori, Joyee, Antony George, Munster, Vincent, Weishampel, Zack, Yinda, Claude Kwe, Rouse, Kevin G., Gvozden, Cathy, Wever, David, Yanez, Giralt, Anderson, Marc, Yu, Song, Bearie, Brian, Young, Stephen, Berry, Jody D.
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 29.12.2023; MDPI
• Subjects: Antibodies; Antigens; Biological Assay; Blotting, Western; Contact tracing; COVID-19; COVID-19 - diagnosis; COVID-19 infection; COVID-19 Testing; detection limit; Diagnosis; Diagnostic tests; Disease transmission; Guardians; Humans; Infections; Medical laboratories; Monoclonal antibodies; nucleocapsid; Nucleocapsids; Omicron; pandemic; Pandemics; Performance evaluation; point-of-care systems; Polymerase chain reaction; Proteins; rapid antigen test; rapid methods; reference standards; SARS-CoV-2; SARS-CoV-2 - genetics; Sensitivity analysis; Severe acute respiratory syndrome coronavirus 2; variants of concern; viruses; United States; United States > US; COVID-19; diagnosis; rapid antigen test; SARS-CoV-2; Omicron; variants of concern

Background and objectives: Timely detection of SARS-CoV-2 infection with subsequent contact tracing and rapid isolation are considered critical to containing the pandemic, which continues with the emergence of new variants. Hence, there is an ongoing need for reliable point-of-care antigen rapid dia...