Comparison of the analytical sensitivity of COVID-19 rapid antigen tests in Australia and Canada.

Autor: Toft CJ; College of Public Health, Medical and Veterinary Sciences, James Cook University, Douglas, Queensland, Australia., Stocks BB; Metrology, National Research Council Canada, 1200 Montreal Road, Ottawa, Ontario, K1A 0R6, Canada. Electronic address: bradley.stocks@nrc-cnrc.gc.ca., Schaeffer PM; College of Public Health, Medical and Veterinary Sciences, James Cook University, Douglas, Queensland, Australia. Electronic address: patrick.shaeffer@jcu.edu.au.
Jazyk: angličtina
Zdroj: Talanta [Talanta] 2024 Aug 01; Vol. 275, pp. 126147. Date of Electronic Publication: 2024 Apr 23.
DOI: 10.1016/j.talanta.2024.126147
Abstrakt: Rapid testing has become an indispensable strategy to identify the most infectious individuals and prevent the transmission of SARS-CoV-2 in vulnerable populations. As such, COVID-19 rapid antigen tests (RATs) are being manufactured faster than ever yet lack relevant comparative analyses required to inform on absolute analytical sensitivity and performance, limiting end-user ability to accurately compare brands for decision making. To date, more than 1000 different COVID-19 RATs are commercially available in the world, most of which detect the viral nucleocapsid protein (NP). Here, we examine and compare the analytical sensitivity of 26 RATs that are readily available in Canada and/or Australia using two NP reference materials (RMs) - a fluorescent NP-GFP expressed in bacterial cells and NCAP-1 produced in a mammalian expression system. Both RMs generate highly comparable results within each RAT, indicating minimal bias due to differing expression systems and final buffer compositions. However, we demonstrate orders of magnitude differences in analytical sensitivities among distinct RATs, and find little correlation with the median tissue culture infectious dose (TCID 50 ) assay values reported by manufacturers. In addition, two COVID-19/Influenza A&B combination RATs were evaluated with influenza A NP-GFP. Finally, important logistics considerations are discussed regarding the robustness, ease of international shipping and safe use of these reference proteins. Taken together, our data highlight the need for and practicality of readily available, reliable reference proteins for end-users that will ensure that manufacturers maintain batch-to-batch quality and accuracy of RATs. They will aid international public health and government agencies, as well as health and aged care facilities to reliably benchmark and select the best RATs to curb transmission of future SARS-CoV-2 and influenza outbreaks.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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