Editorial
Volume 17 Issue 9 - 2021
Rapid Antigen Testing for Detection of SARS-CoV-2 (COVID-19) Infection
Attapon Cheepsattayakorn1,2*, Ruangrong Cheepsattayakorn3 and Porntep Siriwanarangsun1
1Faculty of Medicine, Western University, Pathumtani Province, Thailand
210th Zonal Tuberculosis and Chest Disease Center, Chiang Mai, Thailand
3Department of Pathology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
*Corresponding Author: Attapon Cheepsattayakorn, 10th Zonal Tuberculosis and Chest Disease Center, Chiang Mai, Thailand.
Received: August 07, 2021; Published: August 30, 2021




N and S proteins of SARS-CoV-2 (COVID-19) are the main immunogens among the four structural proteins (E, M, N, and S) [1]. The N protein-IgG ELISA provides a sensitivity of 94.7% that is significant higher than that of the S protein-IgG ELISA [2]. Antibodies against N proteins are longer-lived and have greater volume, in comparison to E, M, and S proteins [2]. Approximately, 100 companies are manufacturing or developing rapid antigen tests (RATs), one of the four types (virus isolation with cell cultures, serological testing, RATs, and molecular techniques) [2] for SARS-CoV-2 (COVID-19) detection [3]. Most RATs for SARS-CoV-2 (COVID-19) detection use a simple-to-use lateral flow test format that commonly use for influenza, malaria, and HIV testing as a sandwich immunodetection [4]. The testing results are interpreted by the operator within 10 to 30 minutes after collecting the respiratory specimen and applying it to the test strip [5]. In comparison to the nucleic acid amplification tests (NAATs), a decreasing sensitivity is found in the trade-off for simplicity of RATs for SARS-CoV-2 (COVID-19) operation [4]. As of September 11, 2020, only three companies submitted documents towards WHO’s Emergency Use Listing (EUL) procedure, two tests have been approved by Japan’s Pharmaceutical and Medical Devices Agency, and only four tests have received United States Food and Drug Administration (FDA) Emergency Use Authorization (EUA) [6,7]. In comparison to NAATs in respiratory specimens (nasal or nasopharyngeal swabs), the specificity is consistently high (> 97%), whereas the sensitivity ranges from 0 to 94% [8-17

References

  1. Meyer B., et al. “Serological assays for emerging coronaviruses: challenges and pitfalls”. Virus Research 194 (2014): 175-183.
  2. Li D and Li J. “Immunologic testing for SARS-CoV-2 infection from the antigen perspective”. Journal of Clinical Microbiology5 (2021): e02160-021620.
  3. Foundation for Innovative New Diagnostics. SARS-CoV-2 diagnostics pipeline (2020).
  4. World Health Organization. Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays: interim guidance (2020).
  5. Peto T. “UK COVID-19 Lateral Flow Oversight Team. COVID-19: rapid antigen detection for SARS-CoV-2 by lateral flow assay: a national systematic evaluation of sensitivity and specificity for mass-testing”. EClinical Medicine 36 (2021): 100924.
  6. S. Food and Drug Administration. In vitro diagnostics EUAs (2020).
  7. Agency PaMD. “PMDA’s effort to combat COVID-19 (2020).
  8. Porte L., et al. “Evaluation of novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples”. International Journal of Infectious Diseases 99 (2020): 328-333.
  9. Diao B., et al. “Diagnossis of acute respiratory syndrome coronavirus 2 infection by detection of nucleocapsid protein”. Med Rxiv (2020).
  10. Lambert-Niclot S., et al. “Evaluation of a rapid diagnostic assay for detection of SARS-CoV-2 antigen in nasopharyngeal swabs”. Journal of Clinical Microbiology8 (2020).
  11. Mertens P., et al. “Development and potential usefulness of the COVID-19 Ag Respi-Strip Diagnostic Assay in a pandemic context”. Frontiers in Medicine 7 (2020): 225.
  12. Blairon L., et al. “Large-scale, molecular and serological SARS-CoV-2 screening of healthcare workers in a 4-site public hospital in Belgium after COVID-19 outbreak”. Journal of Infection (2020).
  13. Mak GC., et al. “Evaluation of rapid antigen test for detection of SARS-CoV-2 virus. Journal of Clinical Virology: the official publication of the Pan American Society for”. Clinical Virology 129 (2020): 104500.
  14. Nagura-Ikeda M., et al. “Clinical evaluation of self-collected saliva by Rt-qPCR, direct RT-qPCR, RT-LAMP, and a rapid antigen test to diagnose COVID-19”. Journal of Clinical Microbiology (2020).
  15. Omi K., et al. “SARS-CoV-2 qRT-PCR Ct value distribution in Japan and possible utility of rapid antigen testing kit”. Med Rxiv (2020).
  16. Scohy A., et al. “Low performance of rapid antigen detection test as frontline yesting for COVID-19 diagnosis”. Journal of Clinical Virology 129 (2020): 104455.
  17. Weitzel T., et al. “Head-to-head comparison of four antigen-based rapid detection tests for the diagnosis of SARS-CoV-2 in respiratory samples”. Bio Rxiv (2020).
  18. Weiss A., et al. “Spatial and temporal dynamics of SARS-CoV-2 in COVID-19 patients: a systematic review and meta-analysis”. EBio Medicine (2020): 58.
  19. Arons MM., et al. “Pre-symptomatic SARS-CoV-2 infections and transmission in a skilled nursing facility”. The New England Journal of Medicine22 (2020): 2081-2090.
  20. Dinnes J., et al. “Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection”. Cochrane Database of Systematic Reviews 8 (2020).
  21. Kweon OJ., et al. “Evaluation of rapid SARS-CoV-2 antigen tests, AFIAS COVID-19 Ag and ichroma COVID-19 Ag, with serial nasopharyngeal specimens from COVID-19 patients”. PLoS ONE4 (2021): e0249972.
  22. Stohr JJJM., et al. “Self-testing for the detection of SARS-CoV-2 infection with rapid antigen tests”. Med Rxiv (2021).
  23. Hayer J., et al. “Real-world clinical performance of commercial SARS-CoV-2 repid antigen tests in suspected COVID-19: a systematic meta-analysis of available data as of November 20, 2020”. International Journal of Infectious Diseases 108 (2021): 592-602.
Citation: Attapon Cheepsattayakorn., et al. “Rapid Antigen Testing for Detection of SARS-CoV-2 (COVID-19) Infection”. EC Microbiology 17.9 (2021): 18-20.

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