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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| Veröffentlicht in: | PloS one 2021-04, Vol.16 (4), p.e0249791-e0249791 |
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| creator | 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 |
| 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. |
| doi_str_mv | 10.1371/journal.pone.0249791 |
| format | Article |
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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.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0249791</identifier><identifier>PMID: 33826651</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adult ; Antibodies ; Antibody response ; Biology and life sciences ; Coronaviruses ; COVID-19 ; COVID-19 - blood ; COVID-19 - complications ; COVID-19 - diagnosis ; COVID-19 - epidemiology ; COVID-19 Serological Testing ; Data analysis ; Diagnosis ; Editing ; Electronic systems ; Epidemics ; Female ; Genetic aspects ; Humans ; Immunology ; Infections ; Infectious diseases ; Laboratories ; Lighting ; Male ; Medical diagnosis ; Medicine and Health Sciences ; Methodology ; Microorganisms ; Mitigation ; Pandemics ; Physiological aspects ; Public health ; Research and Analysis Methods ; SARS-CoV-2 - metabolism ; Serology ; Severe acute respiratory syndrome ; Severe acute respiratory syndrome coronavirus 2 ; Syndrome ; United Kingdom ; Viral diseases ; Viral infections</subject><ispartof>PloS one, 2021-04, Vol.16 (4), p.e0249791-e0249791</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Sweeney et al. 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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. 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Database</collection><collection>Engineering Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Advanced Technologies & Aerospace Database</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sweeney, Nicola</au><au>Merrick, Blair</au><au>Pedro Galão, Rui</au><au>Pickering, Suzanne</au><au>Botgros, Alina</au><au>Wilson, Harry D</au><au>Signell, Adrian W</au><au>Betancor, Gilberto</au><au>Tan, Mark Kia Ik</au><au>Ramble, John</au><au>Kouphou, Neophytos</au><au>Acors, Sam</au><au>Graham, Carl</au><au>Seow, Jeffrey</au><au>MacMahon, Eithne</au><au>Neil, Stuart J D</au><au>Malim, Michael H</au><au>Doores, Katie</au><au>Douthwaite, Sam</au><au>Batra, Rahul</au><au>Nebbia, Gaia</au><au>Edgeworth, Jonathan D</au><au>Nagler, Michael</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2021-04-07</date><risdate>2021</risdate><volume>16</volume><issue>4</issue><spage>e0249791</spage><epage>e0249791</epage><pages>e0249791-e0249791</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>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.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>33826651</pmid><doi>10.1371/journal.pone.0249791</doi><tpages>e0249791</tpages><orcidid>https://orcid.org/0000-0002-7774-3836</orcidid><orcidid>https://orcid.org/0000-0001-6428-7707</orcidid><orcidid>https://orcid.org/0000-0003-3368-5053</orcidid><orcidid>https://orcid.org/0000-0002-5507-1725</orcidid><orcidid>https://orcid.org/0000-0002-4945-8640</orcidid><orcidid>https://orcid.org/0000-0002-6061-6064</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2021-04, Vol.16 (4), p.e0249791-e0249791 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2509588170 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Public Library of Science (PLoS); PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adult Antibodies Antibody response Biology and life sciences Coronaviruses COVID-19 COVID-19 - blood COVID-19 - complications COVID-19 - diagnosis COVID-19 - epidemiology COVID-19 Serological Testing Data analysis Diagnosis Editing Electronic systems Epidemics Female Genetic aspects Humans Immunology Infections Infectious diseases Laboratories Lighting Male Medical diagnosis Medicine and Health Sciences Methodology Microorganisms Mitigation Pandemics Physiological aspects Public health Research and Analysis Methods SARS-CoV-2 - metabolism Serology Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Syndrome United Kingdom Viral diseases Viral infections |
| 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 |
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