Evaluation of a novel direct RT-LAMP assay for the detection of SARS-CoV-2 from saliva samples in asymptomatic individuals

Large scale screening of health care workers and the general population for asymptomatic COVID-19 infection requires modalities that are amenable to testing at scale while retaining acceptable levels of sensitivity and specificity. This study evaluated a novel COVID-19 Direct-RT LAMP assay using sal...

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Autores principales: Brown, Benjamin, O'Hara, Robert William, Guiver, Malcolm, Davies, Emma, Birtles, Andrew, Farooq, Hamzah, Verma, Arpana, Guo, Hui, Hayden, Katharine, Machin, Nicholas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Published by Elsevier Ltd. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8942569/
https://www.ncbi.nlm.nih.gov/pubmed/35345440
http://dx.doi.org/10.1016/j.jcvp.2022.100074
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author Brown, Benjamin
O'Hara, Robert William
Guiver, Malcolm
Davies, Emma
Birtles, Andrew
Farooq, Hamzah
Verma, Arpana
Guo, Hui
Hayden, Katharine
Machin, Nicholas
author_facet Brown, Benjamin
O'Hara, Robert William
Guiver, Malcolm
Davies, Emma
Birtles, Andrew
Farooq, Hamzah
Verma, Arpana
Guo, Hui
Hayden, Katharine
Machin, Nicholas
author_sort Brown, Benjamin
collection PubMed
description Large scale screening of health care workers and the general population for asymptomatic COVID-19 infection requires modalities that are amenable to testing at scale while retaining acceptable levels of sensitivity and specificity. This study evaluated a novel COVID-19 Direct-RT LAMP assay using saliva samples in asymptomatic individuals by comparison to RT-PCR. Additional studies were performed using VTM collected from routine diagnostic testing. Analytical sensitivity was determined for Direct RT-LAMP assay using the WHO International Standard. Finally, quantified results from RT-PCR testing of 9177 nose and throat swabs obtained from routine diagnostic testing were used to estimate the sensitivity of Direct RT-LAMP using the limit of detection curve obtained from the analytical sensitivity data. Results from saliva testing demonstrated a sensitivity of 40.91% and a specificity of 100% for Direct RT-LAMP. The sensitivity and specificity for nose and throat swabs were 44.85% and 100% respectively. The 95% limit of detection (LOD) for Direct RT-LAMP was log 7.13 IU/ml (95% 6.9–7.5). The estimated sensitivity for Direct-RT LAMP based on the results of 9117 nose and throat swabs was 34% and 45% for saliva and VTM respectively. The overall diagnostic sensitivity of Direct RT-LAMP was low compared to RT-PCR. Testing of nose and throat swabs and estimating the sensitivity based on a large cohort of clinical samples demonstrated similar results. This study highlights the importance of utilising the prospective collection of samples from the intended target population in the assessment of diagnostic sensitivity.
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spelling pubmed-89425692022-03-24 Evaluation of a novel direct RT-LAMP assay for the detection of SARS-CoV-2 from saliva samples in asymptomatic individuals Brown, Benjamin O'Hara, Robert William Guiver, Malcolm Davies, Emma Birtles, Andrew Farooq, Hamzah Verma, Arpana Guo, Hui Hayden, Katharine Machin, Nicholas J Clin Virol Plus Article Large scale screening of health care workers and the general population for asymptomatic COVID-19 infection requires modalities that are amenable to testing at scale while retaining acceptable levels of sensitivity and specificity. This study evaluated a novel COVID-19 Direct-RT LAMP assay using saliva samples in asymptomatic individuals by comparison to RT-PCR. Additional studies were performed using VTM collected from routine diagnostic testing. Analytical sensitivity was determined for Direct RT-LAMP assay using the WHO International Standard. Finally, quantified results from RT-PCR testing of 9177 nose and throat swabs obtained from routine diagnostic testing were used to estimate the sensitivity of Direct RT-LAMP using the limit of detection curve obtained from the analytical sensitivity data. Results from saliva testing demonstrated a sensitivity of 40.91% and a specificity of 100% for Direct RT-LAMP. The sensitivity and specificity for nose and throat swabs were 44.85% and 100% respectively. The 95% limit of detection (LOD) for Direct RT-LAMP was log 7.13 IU/ml (95% 6.9–7.5). The estimated sensitivity for Direct-RT LAMP based on the results of 9117 nose and throat swabs was 34% and 45% for saliva and VTM respectively. The overall diagnostic sensitivity of Direct RT-LAMP was low compared to RT-PCR. Testing of nose and throat swabs and estimating the sensitivity based on a large cohort of clinical samples demonstrated similar results. This study highlights the importance of utilising the prospective collection of samples from the intended target population in the assessment of diagnostic sensitivity. Published by Elsevier Ltd. 2022-06 2022-03-24 /pmc/articles/PMC8942569/ /pubmed/35345440 http://dx.doi.org/10.1016/j.jcvp.2022.100074 Text en Crown Copyright © 2022 Published by Elsevier Ltd. 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
Brown, Benjamin
O'Hara, Robert William
Guiver, Malcolm
Davies, Emma
Birtles, Andrew
Farooq, Hamzah
Verma, Arpana
Guo, Hui
Hayden, Katharine
Machin, Nicholas
Evaluation of a novel direct RT-LAMP assay for the detection of SARS-CoV-2 from saliva samples in asymptomatic individuals
title Evaluation of a novel direct RT-LAMP assay for the detection of SARS-CoV-2 from saliva samples in asymptomatic individuals
title_full Evaluation of a novel direct RT-LAMP assay for the detection of SARS-CoV-2 from saliva samples in asymptomatic individuals
title_fullStr Evaluation of a novel direct RT-LAMP assay for the detection of SARS-CoV-2 from saliva samples in asymptomatic individuals
title_full_unstemmed Evaluation of a novel direct RT-LAMP assay for the detection of SARS-CoV-2 from saliva samples in asymptomatic individuals
title_short Evaluation of a novel direct RT-LAMP assay for the detection of SARS-CoV-2 from saliva samples in asymptomatic individuals
title_sort evaluation of a novel direct rt-lamp assay for the detection of sars-cov-2 from saliva samples in asymptomatic individuals
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8942569/
https://www.ncbi.nlm.nih.gov/pubmed/35345440
http://dx.doi.org/10.1016/j.jcvp.2022.100074
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