Performance of two rapid antigen tests against SARS-CoV-2 in neighborhoods of socioeconomic vulnerability from a middle-income country.

Autor: Zeballos D; Instituto de Saúde Coletiva, Universidade Federal da Bahia, Salvador, Bahia, Brazil., Magno L; Instituto de Saúde Coletiva, Universidade Federal da Bahia, Salvador, Bahia, Brazil.; Departamento de Ciências da Vida, Universidade do Estado da Bahia, Salvador, Bahia, Brazil., Aranha Rossi T; Departamento de Ciências da Vida, Universidade do Estado da Bahia, Salvador, Bahia, Brazil., Soares F; Instituto de Saúde Coletiva, Universidade Federal da Bahia, Salvador, Bahia, Brazil., Pinto Junior JA; Departamento de Estatística, Universidade Federal Fluminense, Niterói, Rio de Janeiro, Brazil., Ferreira O; Laboratório de Virologia Molecular, Instituto de Biologia, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil., Carvalho Dos Santos C; Departamento de Análises Clínicas e Toxicológicas, Faculdade de Farmácia, Universidade Federal da Bahia, Salvador, Bahia, Brazil., Reis JN; Departamento de Análises Clínicas e Toxicológicas, Faculdade de Farmácia, Universidade Federal da Bahia, Salvador, Bahia, Brazil., Torres TS; Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil., Veloso VG; Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil., Dourado I; Instituto de Saúde Coletiva, Universidade Federal da Bahia, Salvador, Bahia, Brazil.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2024 Jun 21; Vol. 19 (6), pp. e0298579. Date of Electronic Publication: 2024 Jun 21 (Print Publication: 2024).
DOI: 10.1371/journal.pone.0298579
Abstrakt: Background: As new and improved antigen-detecting rapid diagnostic tests for SARS-CoV-2 infection (Ag-RDT) continue to be developed, assessing their diagnostic performance is necessary to increase test options with accurate and rapid diagnostic capacity especially in resource-constrained settings. This study aimed to assess the performance of two Ag-RDTs in a population-based study.
Methods: We conducted a diagnostic accuracy study in neighborhoods with high socioeconomic vulnerability in Salvador-Brazil, including individuals aged ≥12 years old who attended primary health services, between July and December 2022, with COVID-19 symptoms or who had been in contact with a confirmed case. Two Ag-RDTs were compared in parallel using reverse transcription polymerase chain reaction (RT-PCR) as reference standard, the PanbioTM COVID-19 Ag test (Abbott®) and Immuno-Rapid COVID-19 Ag (WAMA Diagnostic®). Sensitivity, specificity, positive (PPV) and negative predictive values (NPV) were calculated.
Results: For the Abbott test the sensitivity was 52.7% (95% CI: 44.3% - 61.0%), specificity 100% (95% CI: 98.7% - 100%), PPV 100% (95% CI: 95.4% - 100%) and NPV 80.4% (95% CI: 75.9% - 84.4%). For the WAMA test, the sensitivity was 53.4% (95% CI: 45.0% - 61.6%), specificity 100% (95% CI: 98.7% - 100%), PPV 100% (95% CI: 95.4% - 100%) and NPV 80.7% (95% CI: 76.2% - 84.6%). Sensitivity for the group with Cycle Threshold (CT) <24 was 82.3% (95%CI: 72.1-90.0, n = 83) for PanbioTM COVID-19 Ag test and 87.3% (95%CI: 77.9-93.8, n = 83) for Immuno-Rapid COVID-19 Ag test.
Conclusion: Sensitivity for both Ag-RDT was lower than reported by manufacturers. In the stratified analysis, sensitivity was higher among those with lower CT values <24. Specificity was high for both rapid antigen tests. Both Ag-RDT showed to be useful for rapid diagnostic of potential cases of COVID-19. Negative results must be assessed carefully according to clinical and epidemiological information.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright: © 2024 Zeballos et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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