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.
Clin Microbiol Infect
; 2022 Nov 11.
Article
in English
| MEDLINE | ID: covidwho-2252061
ABSTRACT
OBJECTIVES:
We aimed to investigate the real-life performance of the rapid antigen test (RAT) in the context of a primary healthcare setting, including symptomatic and asymptomatic individuals that sought diagnostic during a Omicron infection wave.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 center in Brazil, performing the RAT diagnosis at point-of-care with fresh samples. The combinatory result from two distinct RT-qPCR methods was employed as reference and 13 samples with discordant PCR results were excluded.RESULTS:
The assessment of the rapid test in 67 PCR-positive and 265 negative samples revealed an overall sensitivity of 80.5% (CI95% = 69.1 - 89.2%), specificity of 99.2% (CI95% = 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).CONCLUSIONS:
Altogether, the data obtained from a real-life prospective cohort supports that the RAT 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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Type of study:
Cohort study
/
Diagnostic study
/
Experimental Studies
/
Observational study
/
Prognostic study
Topics:
Variants
Country/Region as subject:
South America
/
Brazil
Language:
English
Journal subject:
Communicable Diseases
/
Microbiology
Year:
2022
Document Type:
Article
Affiliation country:
J.cmi.2022.11.003
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