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SARS-CoV-2 rapid antigen test: High sensitivity to detect infectious virus

Authors
  • Nordgren, Johan1
  • Sharma, Sumit1
  • Olsson, Henrik2
  • Jämtberg, Mikael2
  • Falkeborn, Tina3
  • Svensson, Lennart1, 4
  • Hagbom, Marie1
  • 1 s, Linköping University, 581 85 Linköping, Sweden
  • 2 Noviral Sweden AB, Västmannagatan 3, 111 24 Stockholm, Sweden
  • 3 Division of Clinical Microbiology, Linköping University Hospital, 581 85 Linköping, Sweden
  • 4 Division of Infectious Diseases, Department of Medicine Solna, Karolinska Institute, 171 76 Stockholm, Sweden
Type
Published Article
Journal
Journal of Clinical Virology
Publisher
Published by Elsevier B.V.
Publication Date
Apr 24, 2021
Volume
140
Pages
104846–104846
Identifiers
DOI: 10.1016/j.jcv.2021.104846
PMID: 33971580
PMCID: PMC8105081
Source
PubMed Central
Keywords
Disciplines
  • Article
License
Unknown

Abstract

Background The COVID-19 pandemic has highlighted the need for rapid, cost effective and easy-to-use diagnostic tools for SARS-CoV-2 infections that can be used in point of care settings to limit disease transmission. Objective We evaluated two rapid antigen immunochromatographic tests, Abbott Panbio™ COVID-19 Ag Rapid Test (Panbio) and Zhejiang Orient Gene/Healgen Biotech Coronavirus Ag rapid test cassette (Orient gene) for detection of infectious SARS-CoV-2. Results The tests were evaluated on nasopharyngeal samples taken from individuals having respiratory and/or COVID-19 related symptoms, which had been analyzed for SARS-CoV-2 RNA using real-time PCR. In total 156 PCR-positive, and 130 (Panbio) and 176 (Orient Gene) PCR-negative samples were analyzed. Overall sensitivity and specificity were 71.8% and 100% for Panbio and 79.5% and 74.4% for the Orient Gene test respectively. The false positives by the Orient Gene test were verified as SARS-CoV-2 negative by in-house real-time PCR assay and were negative for the four seasonal coronaviruses. Subgroup analysis revealed that the antigen tests had high sensitivity for samples with Ct-values <25 (>88%) and for samples containing infectious viruses as determined by cultivation on Vero cells, 94.1% and 97.1% for the Panbio and Orient gene tests, respectively. Furthermore, both tests had a sensitivity of <50 picogram for nucleocapsid protein. No sample with a Ct-value >27 was shown to contain infectious virus. Conclusion The results indicate that the rapid antigen tests, especially the Panbio tests may be a valuable tool to detect contagious persons during the ongoing pandemic.

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