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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.
2022
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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. |
format | Online Article Text |
id | pubmed-9307284 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. |
record_format | MEDLINE/PubMed |
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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