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Real-life evaluation of a rapid antigen test (DPP SARS-CoV-2 Antigen) for COVID-19 diagnosis of primary healthcare patients, in the context of the Omicron-dominant wave in Brazil.

Authors :
Bezerra MF
Silva LCA
Pessoa-E-Silva R
Soares GL
Dezordi FZ
Lima GB
Lima RE
Campos TL
Docena C
Oliveira AB
Pitta MGDR
Santos FADS
Pereira M
Wallau GL
Paiva MHS
Source :
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases [Clin Microbiol Infect] 2023 Mar; Vol. 29 (3), pp. 392.e1-392.e5. Date of Electronic Publication: 2022 Nov 12.
Publication Year :
2023

Abstract

Objectives: We aimed to investigate the real-life performance of the rapid antigen test in the context of a primary healthcare setting, including symptomatic and asymptomatic individuals that sought diagnosis during an Omicron infection wave.<br />Methods: We prospectively accessed the performance of the DPP SARS-CoV-2 Antigen test in the context of an Omicron-dominant real-life setting. We evaluated 347 unselected individuals (all-comers) from a public testing centre in Brazil, performing the rapid antigen test diagnosis at point-of-care with fresh samples. The combinatory result from two distinct real-time quantitative PCR (RT-qPCR) methods was employed as a reference and 13 samples with discordant PCR results were excluded.<br />Results: The assessment of the rapid test in 67 PCR-positive and 265 negative samples revealed an overall sensitivity of 80.5% (CI 95% = 69.1%-89.2%), specificity of 99.2% (CI 95% = 97.3%-99.1%) and positive/negative predictive values higher than 95%. However, we observed that the sensitivity was dependent on the viral load (sensitivity in Ct < 31 = 93.7%, CI = 82.8%-98.7%; Ct > 31 = 47.4%, CI = 24.4%-71.1%). The positive samples evaluated in the study were Omicron (BA.1/BA.1.1) by whole-genome sequencing (n = 40) and multiplex RT-qPCR (n = 17).<br />Conclusions: Altogether, the data obtained from a real-life prospective cohort supports that the rapid antigen test sensitivity for Omicron remains high and underscores the reliability of the test for COVID-19 diagnosis in settings with high disease prevalence and limited PCR testing capability.<br /> (Copyright © 2022 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Details

Language :
English
ISSN :
1469-0691
Volume :
29
Issue :
3
Database :
MEDLINE
Journal :
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
Publication Type :
Academic Journal
Accession number :
36375745
Full Text :
https://doi.org/10.1016/j.cmi.2022.11.003