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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

OBJECTIVES: 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...

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Autores principales: Doria, Gonçalo, Clemente, Carla, Coelho, Eduardo, Colaço, João, Crespo, Rui, Semikhodskii, Andrei, Mansinho, Helder, Dinis, Magno, Carvalho, Maria Fernanda, Casmarrinha, Manuela, Samina, Cátia, Vidal, Ana Cristina, Delarue, Francisca, Graúdo, Susana, Santos, Ana Catarina, Peças, David, Carreira, Olga, Marques, Raquel, Gaspar, Carina, Flores, Orfeu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9307284/
https://www.ncbi.nlm.nih.gov/pubmed/35878801
http://dx.doi.org/10.1016/j.ijid.2022.07.042
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author Doria, Gonçalo
Clemente, Carla
Coelho, Eduardo
Colaço, João
Crespo, Rui
Semikhodskii, Andrei
Mansinho, Helder
Dinis, Magno
Carvalho, Maria Fernanda
Casmarrinha, Manuela
Samina, Cátia
Vidal, Ana Cristina
Delarue, Francisca
Graúdo, Susana
Santos, Ana Catarina
Peças, David
Carreira, Olga
Marques, Raquel
Gaspar, Carina
Flores, Orfeu
author_facet Doria, Gonçalo
Clemente, Carla
Coelho, Eduardo
Colaço, João
Crespo, Rui
Semikhodskii, Andrei
Mansinho, Helder
Dinis, Magno
Carvalho, Maria Fernanda
Casmarrinha, Manuela
Samina, Cátia
Vidal, Ana Cristina
Delarue, Francisca
Graúdo, Susana
Santos, Ana Catarina
Peças, David
Carreira, Olga
Marques, Raquel
Gaspar, Carina
Flores, Orfeu
author_sort Doria, Gonçalo
collection PubMed
description OBJECTIVES: 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.
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spelling pubmed-93072842022-07-25 An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour Doria, Gonçalo Clemente, Carla Coelho, Eduardo Colaço, João Crespo, Rui Semikhodskii, Andrei Mansinho, Helder Dinis, Magno Carvalho, Maria Fernanda Casmarrinha, Manuela Samina, Cátia Vidal, Ana Cristina Delarue, Francisca Graúdo, Susana Santos, Ana Catarina Peças, David Carreira, Olga Marques, Raquel Gaspar, Carina Flores, Orfeu Int J Infect Dis Article OBJECTIVES: 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. The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. 2022-10 2022-07-22 /pmc/articles/PMC9307284/ /pubmed/35878801 http://dx.doi.org/10.1016/j.ijid.2022.07.042 Text en © 2022 The Authors Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Doria, Gonçalo
Clemente, Carla
Coelho, Eduardo
Colaço, João
Crespo, Rui
Semikhodskii, Andrei
Mansinho, Helder
Dinis, Magno
Carvalho, Maria Fernanda
Casmarrinha, Manuela
Samina, Cátia
Vidal, Ana Cristina
Delarue, Francisca
Graúdo, Susana
Santos, Ana Catarina
Peças, David
Carreira, Olga
Marques, Raquel
Gaspar, Carina
Flores, Orfeu
An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour
title An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour
title_full An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour
title_fullStr An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour
title_full_unstemmed An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour
title_short An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour
title_sort isothermal lab-on-phone test for easy molecular diagnosis of sars-cov-2 near patients and in less than 1 hour
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9307284/
https://www.ncbi.nlm.nih.gov/pubmed/35878801
http://dx.doi.org/10.1016/j.ijid.2022.07.042
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