Performance of rapid antigen tests in identifying Omicron BA.4 and BA.5 infections in South Africa.

Autor: Samsunder N; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa., Lustig G; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa., de Vos M; FIND, Geneva, Switzerland., Ngcapu S; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa; Department of Medical Microbiology, University of KwaZulu-Natal, Durban, South Africa., Giandhari J; KwaZulu-Natal Research Innovation and Sequencing Platform, Durban, South Africa., Tshiabuila D; KwaZulu-Natal Research Innovation and Sequencing Platform, Durban, South Africa., San EJ; KwaZulu-Natal Research Innovation and Sequencing Platform, Durban, South Africa., Lewis L; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa., Kharsany AB; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa; Department of Medical Microbiology, University of KwaZulu-Natal, Durban, South Africa., Cawood C; Epicentre AIDS Risk Management (Pty) Limited, Durban, South Africa., de Oliveira T; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa; KwaZulu-Natal Research Innovation and Sequencing Platform, Durban, South Africa; Centre for Epidemic Response and Innovation, School of Data Science and Computational Thinking, Stellenbosch University, Stellenbosch, South Africa; Department of Global Health, University of Washington, Seattle, United States of America., Abdool Karim Q; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa; Department of Epidemiology, Columbia University, New York City, United States of America., Abdool Karim S; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa; Department of Epidemiology, Columbia University, New York City, United States of America., Escadafal C; FIND, Geneva, Switzerland., Naidoo K; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa; MRC-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit, Doris Duke Medical Research Institute, University of KwaZulu-Natal, South Africa., Sivro A; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa; Department of Medical Microbiology, University of KwaZulu-Natal, Durban, South Africa; JC Wilt Infectious Disease Research Centre, National Microbiology laboratory, Public Health Agency of Canada, Winnipeg, MB, Canada. Electronic address: aida.sivro@caprisa.org.
Jazyk: angličtina
Zdroj: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology [J Clin Virol] 2023 Aug; Vol. 165, pp. 105498. Date of Electronic Publication: 2023 Jun 02.
DOI: 10.1016/j.jcv.2023.105498
Abstrakt: Background: Concerns around accuracy and performance of rapid antigen tests continue to be raised with the emergence of new SARS-CoV-2 variants.
Objective: To evaluate the performance of two widely used SARS-CoV-2 rapid antigen tests during BA.4/BA.5 SARS-CoV-2 wave in South Africa (May - June 2022).
Study Design: A prospective field evaluation compared the SARS-CoV-2 Antigen Rapid test from Hangzhou AllTest Biotech (nasal swab) and the Standard Q COVID-19 Rapid Antigen test from SD Biosensor (nasopharyngeal swab) to the Abbott RealTime SARS-CoV-2 assay (nasopharyngeal swab) on samples collected from 540 study participants.
Results: Overall 28.52% (154/540) were SARS-CoV-2 RT-PCR positive with median cycle number value of 12.30 (IQR 9.30-19.40). Out of the 99 successfully sequenced SARS-CoV-2 positive samples, 18 were classified as BA.4 and 56 were classified as BA.5. The overall sensitivities of the AllTest SARS-CoV-2 Ag test and Standard Q COVID-19 Ag test were 73.38% (95% CI 65.89-79.73) and 74.03% (95% CI 66.58-80.31) and their specificities were 97.41% (95% CI 95.30-98.59) and 99.22% (95% CI 97.74-99.74) respectively. Sensitivity was >90% when the cycle number value was <20. The sensitivity of both rapid tests was >90% in samples infected with Omicron sub-lineage BA.4 and BA.5.
Conclusion: Accuracy of tested rapid antigen tests that target the nucleocapsid SARS-CoV-2 protein, were not adversely affected by BA.4 and BA.5 Omicron sub-variants.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Antigen rapid diagnostic tests were provided by FIND, the global alliance for diagnostics, and FIND was involved in the study design development. CE and MdV are employees of FIND. The rest of the authors declare no conflict of interests.
(Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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