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Clinical utility of targeted SARS-CoV-2 serology testing to aid the diagnosis and management of suspected missed, late or post-COVID-19 infection syndromes: Results from a pilot service implemented during the first pandemic wave
During the first wave of the global COVID-19 pandemic the clinical utility and indications for SARS-CoV-2 serological testing were not clearly defined. The urgency to deploy serological assays required rapid evaluation of their performance characteristics. We undertook an internal validation of a CE...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8026061/ https://www.ncbi.nlm.nih.gov/pubmed/33826651 http://dx.doi.org/10.1371/journal.pone.0249791 |
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author | Sweeney, Nicola Merrick, Blair Pedro Galão, Rui Pickering, Suzanne Botgros, Alina Wilson, Harry D. Signell, Adrian W. Betancor, Gilberto Tan, Mark Kia Ik Ramble, John Kouphou, Neophytos Acors, Sam Graham, Carl Seow, Jeffrey MacMahon, Eithne Neil, Stuart J. D. Malim, Michael H. Doores, Katie Douthwaite, Sam Batra, Rahul Nebbia, Gaia Edgeworth, Jonathan D. |
author_facet | Sweeney, Nicola Merrick, Blair Pedro Galão, Rui Pickering, Suzanne Botgros, Alina Wilson, Harry D. Signell, Adrian W. Betancor, Gilberto Tan, Mark Kia Ik Ramble, John Kouphou, Neophytos Acors, Sam Graham, Carl Seow, Jeffrey MacMahon, Eithne Neil, Stuart J. D. Malim, Michael H. Doores, Katie Douthwaite, Sam Batra, Rahul Nebbia, Gaia Edgeworth, Jonathan D. |
author_sort | Sweeney, Nicola |
collection | PubMed |
description | During the first wave of the global COVID-19 pandemic the clinical utility and indications for SARS-CoV-2 serological testing were not clearly defined. The urgency to deploy serological assays required rapid evaluation of their performance characteristics. We undertook an internal validation of a CE marked lateral flow immunoassay (LFIA) (SureScreen Diagnostics) using serum from SARS-CoV-2 RNA positive individuals and pre-pandemic samples. This was followed by the delivery of a same-day named patient SARS-CoV-2 serology service using LFIA on vetted referrals at central London teaching hospital with clinical interpretation of result provided to the direct care team. Assay performance, source and nature of referrals, feasibility and clinical utility of the service, particularly benefit in clinical decision-making, were recorded. Sensitivity and specificity of LFIA were 96.1% and 99.3% respectively. 113 tests were performed on 108 participants during three-week pilot. 44% participants (n = 48) had detectable antibodies. Three main indications were identified for serological testing; new acute presentations potentially triggered by recent COVID-19 e.g. pulmonary embolism (n = 5), potential missed diagnoses in context of a recent COVID-19 compatible illness (n = 40), and making infection control or immunosuppression management decisions in persistently SARS-CoV-2 RNA PCR positive individuals (n = 6). We demonstrate acceptable performance characteristics, feasibility and clinical utility of using a LFIA that detects anti-spike antibodies to deliver SARS-CoV-2 serology service in adults and children. Greatest benefit was seen where there is reasonable pre-test probability and results can be linked with clinical advice or intervention. Experience from this pilot can help inform practicalities and benefits of rapidly implementing new tests such as LFIAs into clinical service as the pandemic evolves. |
format | Online Article Text |
id | pubmed-8026061 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-80260612021-04-15 Clinical utility of targeted SARS-CoV-2 serology testing to aid the diagnosis and management of suspected missed, late or post-COVID-19 infection syndromes: Results from a pilot service implemented during the first pandemic wave Sweeney, Nicola Merrick, Blair Pedro Galão, Rui Pickering, Suzanne Botgros, Alina Wilson, Harry D. Signell, Adrian W. Betancor, Gilberto Tan, Mark Kia Ik Ramble, John Kouphou, Neophytos Acors, Sam Graham, Carl Seow, Jeffrey MacMahon, Eithne Neil, Stuart J. D. Malim, Michael H. Doores, Katie Douthwaite, Sam Batra, Rahul Nebbia, Gaia Edgeworth, Jonathan D. PLoS One Research Article During the first wave of the global COVID-19 pandemic the clinical utility and indications for SARS-CoV-2 serological testing were not clearly defined. The urgency to deploy serological assays required rapid evaluation of their performance characteristics. We undertook an internal validation of a CE marked lateral flow immunoassay (LFIA) (SureScreen Diagnostics) using serum from SARS-CoV-2 RNA positive individuals and pre-pandemic samples. This was followed by the delivery of a same-day named patient SARS-CoV-2 serology service using LFIA on vetted referrals at central London teaching hospital with clinical interpretation of result provided to the direct care team. Assay performance, source and nature of referrals, feasibility and clinical utility of the service, particularly benefit in clinical decision-making, were recorded. Sensitivity and specificity of LFIA were 96.1% and 99.3% respectively. 113 tests were performed on 108 participants during three-week pilot. 44% participants (n = 48) had detectable antibodies. Three main indications were identified for serological testing; new acute presentations potentially triggered by recent COVID-19 e.g. pulmonary embolism (n = 5), potential missed diagnoses in context of a recent COVID-19 compatible illness (n = 40), and making infection control or immunosuppression management decisions in persistently SARS-CoV-2 RNA PCR positive individuals (n = 6). We demonstrate acceptable performance characteristics, feasibility and clinical utility of using a LFIA that detects anti-spike antibodies to deliver SARS-CoV-2 serology service in adults and children. Greatest benefit was seen where there is reasonable pre-test probability and results can be linked with clinical advice or intervention. Experience from this pilot can help inform practicalities and benefits of rapidly implementing new tests such as LFIAs into clinical service as the pandemic evolves. Public Library of Science 2021-04-07 /pmc/articles/PMC8026061/ /pubmed/33826651 http://dx.doi.org/10.1371/journal.pone.0249791 Text en © 2021 Sweeney et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Sweeney, Nicola Merrick, Blair Pedro Galão, Rui Pickering, Suzanne Botgros, Alina Wilson, Harry D. Signell, Adrian W. Betancor, Gilberto Tan, Mark Kia Ik Ramble, John Kouphou, Neophytos Acors, Sam Graham, Carl Seow, Jeffrey MacMahon, Eithne Neil, Stuart J. D. Malim, Michael H. Doores, Katie Douthwaite, Sam Batra, Rahul Nebbia, Gaia Edgeworth, Jonathan D. Clinical utility of targeted SARS-CoV-2 serology testing to aid the diagnosis and management of suspected missed, late or post-COVID-19 infection syndromes: Results from a pilot service implemented during the first pandemic wave |
title | Clinical utility of targeted SARS-CoV-2 serology testing to aid the diagnosis and management of suspected missed, late or post-COVID-19 infection syndromes: Results from a pilot service implemented during the first pandemic wave |
title_full | Clinical utility of targeted SARS-CoV-2 serology testing to aid the diagnosis and management of suspected missed, late or post-COVID-19 infection syndromes: Results from a pilot service implemented during the first pandemic wave |
title_fullStr | Clinical utility of targeted SARS-CoV-2 serology testing to aid the diagnosis and management of suspected missed, late or post-COVID-19 infection syndromes: Results from a pilot service implemented during the first pandemic wave |
title_full_unstemmed | Clinical utility of targeted SARS-CoV-2 serology testing to aid the diagnosis and management of suspected missed, late or post-COVID-19 infection syndromes: Results from a pilot service implemented during the first pandemic wave |
title_short | Clinical utility of targeted SARS-CoV-2 serology testing to aid the diagnosis and management of suspected missed, late or post-COVID-19 infection syndromes: Results from a pilot service implemented during the first pandemic wave |
title_sort | clinical utility of targeted sars-cov-2 serology testing to aid the diagnosis and management of suspected missed, late or post-covid-19 infection syndromes: results from a pilot service implemented during the first pandemic wave |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8026061/ https://www.ncbi.nlm.nih.gov/pubmed/33826651 http://dx.doi.org/10.1371/journal.pone.0249791 |
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