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An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour

datacite.subject.fosCiências Médicas
datacite.subject.sdg03:Saúde de Qualidade
dc.contributor.authorDoria, Gonçalo
dc.contributor.authorClemente, Carla
dc.contributor.authorCoelho, Eduardo
dc.contributor.authorColaço, João
dc.contributor.authorCrespo, Rui
dc.contributor.authorSemikhodskii, Andrei
dc.contributor.authorMansinho, Helder
dc.contributor.authorDinis, Magno
dc.contributor.authorCarvalho, Maria Fernanda
dc.contributor.authorCasmarrinha, Manuela
dc.contributor.authorSamina, Cátia
dc.contributor.authorVidal, Ana Cristina
dc.contributor.authorDelarue, Francisca
dc.contributor.authorGraúdo, Susana
dc.contributor.authorSantos, Ana Catarina
dc.contributor.authorPeças, David
dc.contributor.authorCarreira, Olga
dc.contributor.authorMarques, Raquel
dc.contributor.authorGaspar, Carina
dc.contributor.authorFlores, Orfeu
dc.date.accessioned2025-10-22T10:28:10Z
dc.date.available2025-10-22T10:28:10Z
dc.date.issued2022-10
dc.description.abstractObjectives: The performance of a new point-of-care CE-IVD-marked isothermal lab-on-phone COVID-19 assay was assessed in comparison to a gold standard real-time reverse transcriptase–PCR method. Methods: The study was conducted following a nonprobability sampling of ≥16-year-old volunteers from three different laboratories, using direct mouthwash (N = 24) or nasopharyngeal (N = 191) clinical samples. Results: The assay demonstrated 95.19% sensitivity and 100% specificity for detection of SARS-CoV-2 in direct nasopharyngeal crude samples and 78.95% sensitivity and 100% specificity in direct mouthwash crude samples. It also successfully detected currently predominant SARS-CoV-2 variants of concern (Beta B.1.351, Delta B.1.617.2, and Omicron B.1.1.529) and demonstrated to be inert against potential cross-reactions of other common respiratory pathogens that cause infections that present similar symptoms to COVID-19. Conclusion: This lab-on-phone pocket-sized assay relies on an isothermal amplification of SARS-CoV-2’s N and E genes, taking just 50 minutes from sample to result, with only 2 minutes of hands-on time. It presents good performance when using direct nasopharyngeal crude samples, enabling a low-cost, real-time, rapid, and accurate identification of SARS-CoV-2 infections at the point of care, which is important for both clinical management and population screening, as a tool to break the chain of transmission of COVID-19 pandemic, especially in low-resources environments.eng
dc.identifier.citationGonçalo Doria, Carla Clemente, Eduardo Coelho, João Colaço, Rui Crespo, Andrei Semikhodskii, Helder Mansinho, Magno Dinis, Maria Fernanda Carvalho, Manuela Casmarrinha, Cátia Samina, Ana Cristina Vidal, Francisca Delarue, Susana Graúdo, Ana Catarina Santos, David Peças, Olga Carreira, Raquel Marques, Carina Gaspar, Orfeu Flores, An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour, International Journal of Infectious Diseases, Volume 123, 2022, Pages 1-8. https://doi.org/10.1016/j.ijid.2022.07.042
dc.identifier.doi10.1016/j.ijid.2022.07.042
dc.identifier.issn1201-9712
dc.identifier.urihttp://hdl.handle.net/10400.26/59339
dc.language.isoeng
dc.peerreviewedyes
dc.publisherElsevier
dc.relation.hasversionhttps://doi.org/10.1016/j.ijid.2022.07.042
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectSARS-CoV-2
dc.subjectCOVID-19
dc.subjectPoint-of-care testing
dc.subjectNucleic acid amplification techniques
dc.subjectLAMP assay
dc.subjectReal-time PCR
dc.titleAn isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 houreng
dc.typecontribution to journal
dspace.entity.typePublication
oaire.citation.endPage8
oaire.citation.startPage1
oaire.citation.titleInternational Journal of Infectious Diseases
oaire.citation.volume123
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85

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