1. 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
- Author
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Neophytos Kouphou, Nicola Sweeney, Alina Botgros, Blair Merrick, Sam Douthwaite, Sam Acors, Adrian W. Signell, Gilberto Betancor, Rahul Batra, Rui Pedro Galão, Harry Wilson, Mark Kia Ik Tan, Jeffrey Seow, Michael H. Malim, Carl Graham, Gaia Nebbia, Jonathan D. Edgeworth, Eithne MacMahon, Katie J. Doores, John Ramble, Suzanne Pickering, and Stuart J. D. Neil
- Subjects
Male ,RNA viruses ,0301 basic medicine ,Viral Diseases ,Pulmonology ,Coronaviruses ,Physiology ,Biochemistry ,Serology ,Medical Conditions ,0302 clinical medicine ,Immune Physiology ,Pandemic ,Epidemiology ,Medicine and Health Sciences ,Infection control ,Enzyme-Linked Immunoassays ,Medical diagnosis ,Pathology and laboratory medicine ,Virus Testing ,Immune System Proteins ,Multidisciplinary ,Syndrome ,Medical microbiology ,3. Good health ,Pulmonary embolism ,Infectious Diseases ,Viruses ,Medicine ,Female ,SARS CoV 2 ,Pathogens ,Research Article ,Adult ,medicine.medical_specialty ,SARS coronavirus ,Science ,Immunology ,MEDLINE ,Context (language use) ,Research and Analysis Methods ,Microbiology ,Antibodies ,COVID-19 Serological Testing ,Respiratory Disorders ,03 medical and health sciences ,Diagnostic Medicine ,medicine ,Humans ,Immunoassays ,Intensive care medicine ,Pandemics ,Biology and life sciences ,SARS-CoV-2 ,business.industry ,Organisms ,Viral pathogens ,COVID-19 ,Proteins ,Covid 19 ,medicine.disease ,Microbial pathogens ,030104 developmental biology ,Respiratory Infections ,Immunologic Techniques ,business ,030217 neurology & neurosurgery - 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.
- Published
- 2021