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BIBTEX RIS

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

2022; Elsevier BV; Volume: 29; Issue: 3 Linguagem: Inglês

10.1016/j.cmi.2022.11.003

ISSN

1469-0691

Autores

Matheus Filgueira Bezerra, Lílian Caroliny Amorim Silva, Rômulo Pessoa-e-Silva, Gisele Lino Soares, Filipe Zimmer Dezordi, Gustavo Barbosa de Lima, Raul Emídio de Lima, Túlio de Lima Campos, Cássia Docena, Anderson Bruno de Oliveira, Maíra Galdino da Rocha Pitta, Francisco de Assis da Silva Santos, Michelly Cristiny Pereira, Gabriel Luz Wallau, Marcelo Henrique Santos Paiva,

Tópico(s)

Biosensors and Analytical Detection

Resumo

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.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.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).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.

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