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...
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Public Library of Science (PLoS)
2021-01-01
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| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0249791&type=printable |
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| author | Nicola Sweeney Blair Merrick Rui Pedro Galão Suzanne Pickering Alina Botgros Harry D Wilson Adrian W Signell Gilberto Betancor Mark Kia Ik Tan John Ramble Neophytos Kouphou Sam Acors Carl Graham Jeffrey Seow Eithne MacMahon Stuart J D Neil Michael H Malim Katie Doores Sam Douthwaite Rahul Batra Gaia Nebbia Jonathan D Edgeworth |
| author_facet | Nicola Sweeney Blair Merrick Rui Pedro Galão Suzanne Pickering Alina Botgros Harry D Wilson Adrian W Signell Gilberto Betancor Mark Kia Ik Tan John Ramble Neophytos Kouphou Sam Acors Carl Graham Jeffrey Seow Eithne MacMahon Stuart J D Neil Michael H Malim Katie Doores Sam Douthwaite Rahul Batra Gaia Nebbia Jonathan D Edgeworth |
| author_sort | Nicola Sweeney |
| collection | DOAJ |
| 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 | Article |
| id | doaj-art-2e399c613b574b219ea8a3ec333a2c1b |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2021-01-01 |
| publisher | Public Library of Science (PLoS) |
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| spelling | doaj-art-2e399c613b574b219ea8a3ec333a2c1b2025-08-20T03:46:20ZengPublic Library of Science (PLoS)PLoS ONE1932-62032021-01-01164e024979110.1371/journal.pone.0249791Clinical 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.Nicola SweeneyBlair MerrickRui Pedro GalãoSuzanne PickeringAlina BotgrosHarry D WilsonAdrian W SignellGilberto BetancorMark Kia Ik TanJohn RambleNeophytos KouphouSam AcorsCarl GrahamJeffrey SeowEithne MacMahonStuart J D NeilMichael H MalimKatie DooresSam DouthwaiteRahul BatraGaia NebbiaJonathan D EdgeworthDuring 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.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0249791&type=printable |
| spellingShingle | Nicola Sweeney Blair Merrick Rui Pedro Galão Suzanne Pickering Alina Botgros Harry D Wilson Adrian W Signell Gilberto Betancor Mark Kia Ik Tan John Ramble Neophytos Kouphou Sam Acors Carl Graham Jeffrey Seow Eithne MacMahon Stuart J D Neil Michael H Malim Katie Doores Sam Douthwaite Rahul Batra Gaia Nebbia Jonathan D Edgeworth 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. PLoS ONE |
| 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 |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0249791&type=printable |
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