A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study

dc.creatorFontana-Maurell, Marcela
dc.creatorMotta, Fernando do Couto
dc.creatorBarcelos, Monica Arruda
dc.creatorCardoso, Pedro
dc.creatorRibeiro, Marisa
dc.creatorAndrade, Elisabete
dc.creatorGodoy, Daniela T.
dc.creatorCosta, Elaine
dc.creatorRocha, Daniele
dc.creatorSiqueira, Marilda Agudo M. T.
dc.creatorBrindeiro, Rodrigo
dc.creatorAlvarez, Patricia
dc.date2023-02-12T13:42:50Z
dc.date2023-02-12T13:42:50Z
dc.date2023
dc.date.accessioned2023-09-26T20:32:25Z
dc.date.available2023-09-26T20:32:25Z
dc.identifierFONTANA-Maurell, Marcela et al. A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro , v. 118, 220202, p. 1 -31, 2023.
dc.identifier0074-0276
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/57026
dc.identifier10.1590/0074-02760220202
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8859127
dc.descriptionThe Collaborative Study Group: Adriano Abbud, Claudio Tavares Sacchi, Karoline Rodrigues Campos (Adolfo Lutz Institute); Ana Flávia Mendonça, Luiz Augusto Pereira (Central Laboratory - Goiás); Jaqueline Pegoretti Goulart, Anna Clara Gregório Có (Central Laboratory - Espírito Santo); Lidio Gonçalves Lima Neto, Hivylla Lorrana dos Santos Ferreira (Central Laboratory - Maranhão); Maria do Carmo Debur, Guilherme Nardi Becker (Central Laboratory - Paraná); Tatiana Schaffer Gregianini, Richard Steiner Salvato (Central Laboratory - Rio Grande do Sul); Sandra Bianchini Fernandes, Darcita Buerger Rovaris (Central Laboratory - Santa Catarina); Andreia Santos Costa, Márcia Socorro Pereira Cavalcante (Central Laboratory - Amapá); Mirleide Cordeiro dos Santos, Luana Soares Barbagelata (Evandro Chagas Institute); Yasmin Santos Freitas Macêdo, Tiago Gräf (Fundação Oswaldo Cruz. Instituto Gonçalo Muniz. Salvador, BA, Brasil); Fabio Miyajima, Carlos Leonardo de Aragão Araujo, Joaquim Cesar do Nascimento Sousa Junior (Fundação Oswaldo Cruz. Fiocruz Ceará. Fortaleza, CE, Brasil).
dc.descriptionBackground: The prevalence of 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 characterization, the discovery of alpha VOC causing spike gene target failure (SGTF) result, when tested using an 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 multicenter study evaluating this assay. Methods: Twelve laboratories have participated in the multicenter 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.
dc.formatapplication/pdf
dc.languageeng
dc.relationhttps://www.arca.fiocruz.br/handle/icict/57809
dc.rightsopen access
dc.subjectCOVID-19
dc.subjectDiagnóstico SARS-CoV-2
dc.subjectVariantes de Preocupação
dc.subjectVigilância epidemiológica
dc.subjectSARS-CoV-2 diagnosis
dc.subjectVariants of Concern
dc.subjectEpidemiological surveillance
dc.subjectCOVID-19
dc.titleA straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study
dc.typePreprint


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