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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.
Bezerra, Matheus Filgueira; Amorim Silva, Lilian Caroliny; Pessoa-E-Silva, Rômulo; Lino, Gisele; Zimmer Dezordi, Soares Filipe; Barbosa de Lima, Gustavo; Emídio de Lima, Raul; Campos, Tulio L; Docena, Cassia; Bruno de Oliveira, Anderson; Galdino da Rocha Pitta, Maira; de Assis da Silva Santos, Francisco; Pereira, Michelly; Wallau, Gabriel Luz; Santos Paiva, Marcelo Henrique.
  • Bezerra MF; Departamento de Microbiologia, Instituto Aggeu Magalhães, Fiocruz, Recife, Brazil.
  • Amorim Silva LC; Núcleo de Plataforma Tecnológica, Instituto Aggeu Magalhães, Fiocruz, Recife, Brazil.
  • Pessoa-E-Silva R; Núcleo de Pesquisa em Inovação Terapêutica, Recife, Brazil.
  • Lino G; Gerência de Vigilância Epidemiológica, Secretaria Municipal de Saúde, Caruaru, Brazil.
  • Zimmer Dezordi SF; Departamento de Entomologia, Instituto Aggeu Magalhães, Fiocruz, Recife, Brazil.
  • Barbosa de Lima G; Núcleo de Plataforma Tecnológica, Instituto Aggeu Magalhães, Fiocruz, Recife, Brazil.
  • Emídio de Lima R; Núcleo de Plataforma Tecnológica, Instituto Aggeu Magalhães, Fiocruz, Recife, Brazil.
  • Campos TL; Núcleo de Bioinformática, Instituto Aggeu Magalhães, Fiocruz, Recife, Brazil.
  • Docena C; Núcleo de Plataforma Tecnológica, Instituto Aggeu Magalhães, Fiocruz, Recife, Brazil.
  • Bruno de Oliveira A; Gerência de Vigilância Epidemiológica, Secretaria Municipal de Saúde, Caruaru, Brazil.
  • Galdino da Rocha Pitta M; Núcleo de Pesquisa em Inovação Terapêutica, Recife, Brazil.
  • de Assis da Silva Santos F; Centro Acadêmico do Agreste (CAA), Núcleo de Ciências da Vida, Caruaru, Brazil.
  • Pereira M; Núcleo de Pesquisa em Inovação Terapêutica, Recife, Brazil; Departamento de Fisiologia e Farmacologia - UFPE, Recife, Brazil.
  • Wallau GL; Departamento de Entomologia, Instituto Aggeu Magalhães, Fiocruz, Recife, Brazil; Núcleo de Bioinformática, Instituto Aggeu Magalhães, Fiocruz, Recife, Brazil; Department of Arbovirology, Bernhard Nocht Institute for Tropical Medicine, WHO Collaborating Center for Arbovirus and Hemorrhagic Fever Refe
  • Santos Paiva MH; Departamento de Entomologia, Instituto Aggeu Magalhães, Fiocruz, Recife, Brazil; Centro Acadêmico do Agreste (CAA), Núcleo de Ciências da Vida, Caruaru, Brazil. Electronic address: marcelo.paiva@fiocruz.br.
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.
Keywords

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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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