Development and Clinical Performance of InteliSwab<sup>®</sup> 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
Mark J. Fischl,
Janean Young,
Keith Kardos,
Michele Roehler,
Tiffany Miller,
Melinda Wooten,
Natalie Holmes,
Nicole Gula,
Mia Baglivo,
Justin Steen,
Nori Zelenz,
Antony George Joyee,
Vincent Munster,
Zack Weishampel,
Claude Kwe Yinda,
Kevin G. Rouse,
Cathy Gvozden,
David Wever,
Giralt Yanez,
Marc Anderson,
Song Yu,
Brian Bearie,
Stephen Young,
Jody D. Berry
Affiliations
Mark J. Fischl
OraSure Technologies, Inc., 220 East First St., Bethlehem, PA 18015, USA
Janean Young
OraSure Technologies, Inc., 220 East First St., Bethlehem, PA 18015, USA
Keith Kardos
OraSure Technologies, Inc., 220 East First St., Bethlehem, PA 18015, USA
Michele Roehler
OraSure Technologies, Inc., 220 East First St., Bethlehem, PA 18015, USA
Tiffany Miller
OraSure Technologies, Inc., 220 East First St., Bethlehem, PA 18015, USA
Melinda Wooten
OraSure Technologies, Inc., 220 East First St., Bethlehem, PA 18015, USA
Natalie Holmes
OraSure Technologies, Inc., 220 East First St., Bethlehem, PA 18015, USA
Nicole Gula
OraSure Technologies, Inc., 220 East First St., Bethlehem, PA 18015, USA
Mia Baglivo
OraSure Technologies, Inc., 220 East First St., Bethlehem, PA 18015, USA
Justin Steen
OraSure Technologies, Inc., 220 East First St., Bethlehem, PA 18015, USA
Nori Zelenz
OraSure Technologies, Inc., 220 East First St., Bethlehem, PA 18015, USA
Antony George Joyee
OraSure Technologies, Inc., 220 East First St., Bethlehem, PA 18015, USA
Vincent Munster
Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Hamilton, MT 59840, USA
Zack Weishampel
Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Hamilton, MT 59840, USA
Claude Kwe Yinda
Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Hamilton, MT 59840, USA
Kevin G. Rouse
The Children’s Clinic, Jonesboro, AR 72401, USA
Cathy Gvozden
Gvozden Pediatrics, Millersville, MD 21108, USA
David Wever
Cahaba Research Inc., Pelham, AL 35124, USA
Giralt Yanez
South Florida Research Organization, Medley, FL 33166, USA
Marc Anderson
Tanner Clinic, Layton, UT 84041, USA
Song Yu
Cahaba Research Inc., MedHelp Urgent Care, Birmingham, AL 32535, USA
Brian Bearie
Urgent Care of Colton, Benchmark Research Group, Colton, CA 92324, USA
Stephen Young
TriCore Reference Laboratories, Albuquerque, NM 87102, USA
Jody D. Berry
OraSure Technologies, Inc., 220 East First St., Bethlehem, PA 18015, USA
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 diagnostic tests (Ag-RDT). This report describes the development, evaluation, and analytical sensitivity of the diagnostic performance of the InteliSwab® COVID-19 Rapid Test. Methods: Samples from 165 symptomatic subjects were tested with InteliSwab® and the results were compared to RT-PCR to determine the antigen test performance. The analytical sensitivity of InteliSwab® for the detection of different variants was assessed by limit of detection (LOD) determination using recombinant nucleocapsid proteins (NPs) and testing with virus isolates. Western immunoblot independently confirmed that each monoclonal Ab is capable of binding to all variants tested thus far. Results: The overall positivity rate by RT-PCR was 37% for the 165 symptomatic subjects. Based on RT-PCR results as the reference standard, InteliSwab® showed clinical sensitivity and specificity of 85.2% (95% CI, 74.3–92.0%) and 98.1% (95% CI, 93.3–99.7%), respectively. The overall agreement was 93.3% (Kappa index value 0.85; 95% CI, 0.77–0.74) between RT-PCR and InteliSwab® test results. Furthermore, the evaluation of analytical sensitivity for different SARS-CoV-2 variants by InteliSwab® was comparable in the detection of all the variants tested, including Omicron subvariants, BA.4, BA.5, and BQ.1. Conclusions: Due to the surge of infections caused by different variants from time to time, there is a critical need to evaluate the sensitivity of rapid antigen-detecting tests for new variants. The study findings showed the robust diagnostic performance of InteliSwab® and analytical sensitivity in detecting different SARS-CoV-2 variants, including the Omicron subvariants. With the integrated swab and excellent sensitivity and variant detection, this test has high potential as a point-of-care Ag-RDT in various settings when molecular assays are in limited supply and rapid diagnosis of SARS-CoV-2 is necessary.