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

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

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). Thi...

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Bibliographic Details
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 Testing
Diagnosis
Diagnostic tests
Disease transmission
Guardians
Humans
Infections
Medical laboratories
Monoclonal antibodies
Nucleocapsids
Omicron
Pandemics
Performance evaluation
Polymerase chain reaction
Proteins
rapid antigen test
SARS-CoV-2
SARS-CoV-2 - genetics
Sensitivity analysis
Severe acute respiratory syndrome coronavirus 2
variants of concern
United States
United States > US
COVID-19
diagnosis
rapid antigen test
SARS-CoV-2
Omicron
variants of concern
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Summary: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. 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. 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.
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ISSN:1999-4915
1999-4915
DOI:10.3390/v16010061