Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2021
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
_version_ 1783675604583841792
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
work_keys_str_mv AT sweeneynicola clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT merrickblair clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT pedrogalaorui clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT pickeringsuzanne clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT botgrosalina clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT wilsonharryd clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT signelladrianw clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT betancorgilberto clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT tanmarkkiaik clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT ramblejohn clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT kouphouneophytos clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT acorssam clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT grahamcarl clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT seowjeffrey clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT macmahoneithne clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT neilstuartjd clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT malimmichaelh clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT dooreskatie clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT douthwaitesam clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT batrarahul clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT nebbiagaia clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave
AT edgeworthjonathand clinicalutilityoftargetedsarscov2serologytestingtoaidthediagnosisandmanagementofsuspectedmissedlateorpostcovid19infectionsyndromesresultsfromapilotserviceimplementedduringthefirstpandemicwave