| Author | Yoshikawa, Andre Akira Gonzaga | |
| Author | Cardoso, Sabrina Fernandes | |
| Author | Eslabão, Lívia Budziarek | |
| Author | Pinheiro, Iara Carolini | |
| Author | Campos, Priscila Regina Valverde | |
| Author | Caminha, Gisele | |
| Author | Bruna Romero, Oscar | |
| Author | Medeiros, Leandro | |
| Author | Pitaluga, Luísa Damazio Rona | |
| Author | Pitaluga, André Nobrega | |
| Access date | 2024-10-16T16:42:59Z | |
| Available date | 2024-10-16T16:42:59Z | |
| Document date | 2024 | |
| Citation | YOSHIKAWA, Andre Akira Gonzaga et al. Point-of-care testing for COVID-19: a simple two-step molecular diagnostic development and validation during the SARS-CoV-2 pandemic. Memórias do Instituto Oswaldo Cruz, v. 119, n. e230236, p. 1-8, 4 Oct. 2024. | |
| ISSN | 0074-0276 | |
| URI | https://www.arca.fiocruz.br/handle/icict/66557 | |
| Description | Produção científica do Laboratório de Biologia Molecular de Parasitos e Vetores. | pt_BR |
| Sponsorship | FIOCRUZ (VPPIS-005-FIO-20-2-45 - to André Nobrega Pitaluga as a member of the grant team), SPK Solutions / ENGIE / Ministério Público do Trabalho - SC (to André Nobrega Pitaluga and Luísa Damazio Rona Pitaluga), Welcome Trust (grant 207486/Z/17/Z - to Luísa Damazio Rona Pitaluga as a member of the grant team), CNPq (to Oscar Bruna Romero). | |
| Language | eng | en_US |
| Publisher | Fiocruz/IOC | |
| Rights | open access | |
| Title | Point-of-care testing for COVID-19: a simple two-step molecular diagnostic development and validation during the SARS-CoV-2 pandemic | en_US |
| Type | Article | |
| DOI | 10.1590/0074-02760230236 | |
| Abstract | BACKGROUND: During the coronavirus disease 19 (COVID-19) pandemic, diagnostic testing of the general population proved challenging due to limitations of the gold-standard diagnostic procedure using reverse transcription real-time polymerase chain reaction (RT-qPCR) for large-scale testing on the centralised model, especially in low-resource areas. OBJECTIVES: To address this, a point-of-care (PoC) diagnostic protocol for COVID-19 was developed, providing fast, reliable, and affordable testing, particularly for low-mid develop areas. METHODS: The PoC diagnostic process combines a simple paper-based RNA extraction method housed within a 3D-printed plastic device with a colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay. Nasopharyngeal/oropharyngeal swabs (NOS) and saliva samples were tested between 2020 and 2021, with the assistance of Santa Catarina’s State Health Secretary, Brazil. FINDINGS: The developed diagnostic protocol showed a limit of detection of 9,900 copies and an overall diagnostic specificity of 98% for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from 1,348 clinical analysed samples. The diagnostic sensitivity was 95% for NOS samples, 85% for early morning saliva, and 69% for indiscriminate saliva. MAIN CONCLUSIONS: In conclusion, the developed device successfully extracted SARS-CoV-2 viral RNA from swabs and saliva clinical samples. When combined with colorimetric RT-LAMP, it provides results within 45 min using minimal resources, thus delivering a diagnostic kit protocol that is applicable in large-scale sampling. | en_US |
| Affilliation | Universidade Federal de Santa Catarina. Centro de Ciências Biológicas. Departamento de Biologia Celular, Embriologia e Genética. Florianópolis, SC, Brasil. | |
| Affilliation | Universidade Federal de Santa Catarina. Centro de Ciências Biológicas. Departamento de Biologia Celular, Embriologia e Genética. Florianópolis, SC, Brasil / Governo de Santa Catarina. Secretaria da Saúde. Diretoria de Vigilância Epidemiológica. Florianópolis, SC, Brasil. | |
| Affilliation | Universidade Federal de Santa Catarina. Centro de Ciências Biológicas. Departamento de Microbiologia, Imunologia e Parasitologia. Florianópolis, SC, Brasil. | |
| Affilliation | Universidade Federal de Santa Catarina. Centro de Ciências Biológicas. Departamento de Biologia Celular, Embriologia e Genética. Florianópolis, SC, Brasil. | |
| Affilliation | Prefeitura de Florianópolis. Secretaria Municipal de Saúde. Florianópolis, SC, Brasil. | |
| Affilliation | Laboratório Central de Saúde Pública de Santa Catarina. Florianópolis, SC, Brasil. | |
| Affilliation | Universidade Federal de Santa Catarina. Centro de Ciências Biológicas. Departamento de Microbiologia, Imunologia e Parasitologia. Florianópolis, SC, Brasil. | |
| Affilliation | Instituto Federal de Educação, Ciência e Tecnologia de Santa Catarina. Florianópolis, SC, Brasil. | |
| Affilliation | Universidade Federal de Santa Catarina. Centro de Ciências Biológicas. Departamento de Biologia Celular, Embriologia e Genética. Florianópolis, SC, Brasil / Conselho Nacional de Desenvolvimento Científico e Tecnológico. Instituto Nacional de Ciência e Tecnologia em Entomologia Molecular. Rio de Janeiro, RJ, Brasil. | |
| Affilliation | Conselho Nacional de Desenvolvimento Científico e Tecnológico. Instituto Nacional de Ciência e Tecnologia em Entomologia Molecular. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Biologia Molecular de Parasitos e Vetores. Rio de Janeiro, RJ, Brasil. | |
| Subject | COVID-19 | en_US |
| Subject | SARS-CoV-2 | en_US |
| Subject | Point-of-care molecular diagnostic | en_US |
| Subject | RT-LAMP | en_US |
| e-ISSN | 1678-8060 | |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
| xmlui.metadata.dc.subject.ods | 09 Indústria, inovação e infraestrutura | |
| xmlui.metadata.dc.subject.ods | 17 Parcerias e meios de implementação | |
