| Journal: | Memorias do Instituto Oswaldo Cruz |
| Database: | PERIÓDICA |
| System number: | 000459472 |
| ISSN: | 0074-0276 |
| Authors: | Fontana Maurell, Marcela1 Motta, Fernando do Couto2 Arruda, Monica Barcellos1 Cardoso, Pedro1 Ribeiro, Marisa1 Andrade, Elisabete1 Godoy, Daniela T1 Costa, Elaine1 Rocha, Daniele1 Resende, Paola Cristina2 Siqueira, Marilda Agudo M.T2 Brindeiro, Rodrigo1 Alvarez, Patrícia1 |
| Institutions: | 1Fundacao Oswaldo Cruz, Instituto de Tecnologia de Imunobiologicos Bio-Manguinhos, Rio de Janeiro. Brasil 2Fundacao Oswaldo Cruz, Instituto Oswaldo Cruz, Rio de Janeiro. Brasil |
| Year: | 2023 |
| Volumen: | 118 |
| Country: | Brasil |
| Language: | Inglés |
| Document type: | Artículo |
| Approach: | Experimental, aplicado |
| English abstract | The prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern (VOCs) has changed unevenly over time around the world. Although whole genome sequencing is the gold standard for virus characterisation, the discovery of alpha VOC causing spike gene target failure (SGTF) result, when tested using an reverse transcription real-time polymerase chain reaction (RT-qPCR) assay, has provided a simple tool for tracking the frequencies of variants. OBJECTIVES The aim of this study was to investigate if a multiplex RT-qPCR assay (BioM 4Plex VOC) could be used to detect SARS-CoV-2 and to perform a VOC screening test in a single reaction tube. Here, we present the multicentre study evaluating this assay. METHODS Twelve laboratories have participated in the multicentre study. The BioM 4Plex VOC was distributed to them with detailed instructions of how to perform the test. They were asked to test the BioM 4Plex VOC in parallel with their routine Commercial SARS-CoV-2 diagnostic assay. Additionally, they were requested to select SARS-CoV-2-positive samples with genome sequenced and lineage definition according to PANGO lineage classification. FINDINGS The BioM 4Plex VOC and commercial RT-PCR assay are equally effective in detecting SARS-CoV-2. Results revealed a specificity of 96.5-100% [95% confidence interval (CI)], a sensitivity of 99.8-100% (95% CI), and an accuracy of 99.8-100% (95% CI). A 99% concordance rate was found between results from the BioM 4Plex VOC and that from available genome sequencing data. MAIN CONCLUSIONS The BioM 4Plex VOC provides an effective solution to detect SARS-CoV-2 infections and screening for VOCs in a single reaction. It is a straightforward method to help us monitor the frequency and distribution of VOCs and develop strategies to better cope with the pandemics |
| Disciplines: | Medicina |
| Keyword: | Neumología, Virus, Diagnóstico, SARS-CoV-2, COVID-19, Variantes virales, Vigilancia epidemiológica |
| Keyword: | Pneumology, Virus, Diagnosis, SARS-CoV-2, COVID-19, Viral variants, Epidemiological surveillance |
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