In:
PLOS ONE, Public Library of Science (PLoS), Vol. 16, No. 4 ( 2021-4-7), p. e0249791-
Kurzfassung:
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.
Materialart:
Online-Ressource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0249791
DOI:
10.1371/journal.pone.0249791.g001
DOI:
10.1371/journal.pone.0249791.g002
DOI:
10.1371/journal.pone.0249791.g003
DOI:
10.1371/journal.pone.0249791.s001
DOI:
10.1371/journal.pone.0249791.s002
DOI:
10.1371/journal.pone.0249791.s003
DOI:
10.1371/journal.pone.0249791.s004
DOI:
10.1371/journal.pone.0249791.s005
DOI:
10.1371/journal.pone.0249791.s006
DOI:
10.1371/journal.pone.0249791.r001
DOI:
10.1371/journal.pone.0249791.r002
DOI:
10.1371/journal.pone.0249791.r003
DOI:
10.1371/journal.pone.0249791.r004
DOI:
10.1371/journal.pone.0249791.r005
DOI:
10.1371/journal.pone.0249791.r006
Sprache:
Englisch
Verlag:
Public Library of Science (PLoS)
Publikationsdatum:
2021
ZDB Id:
2267670-3
