Accuracy of four lateral flow immunoassays for anti SARS-CoV-2 antibodies: a head-to-head comparative study.
COVID-19
Lateral flow devices
Rapid testing
Seroepidemiology
Serosurveillance
Journal
EBioMedicine
ISSN: 2352-3964
Titre abrégé: EBioMedicine
Pays: Netherlands
ID NLM: 101647039
Informations de publication
Date de publication:
Jun 2021
Jun 2021
Historique:
received:
01
03
2021
revised:
30
04
2021
accepted:
12
05
2021
pubmed:
8
6
2021
medline:
2
7
2021
entrez:
7
6
2021
Statut:
ppublish
Résumé
SARS-CoV-2 antibody tests are used for population surveillance and might have a future role in individual risk assessment. Lateral flow immunoassays (LFIAs) can deliver results rapidly and at scale, but have widely varying accuracy. In a laboratory setting, we performed head-to-head comparisons of four LFIAs: the Rapid Test Consortium's AbC-19 We observed a clear trade-off between sensitivity and specificity: the IgG band of the SureScreen device and the AbC-19 The estimates of sensitivity and specificity can be used to adjust for test error rates when using these devices to estimate the prevalence of antibody. If tests were used to determine whether an individual has SARS-CoV-2 antibodies, in an example scenario in which 20% of individuals have antibodies we estimate around 5% of positive results on the most specific device would be false positives. Public Health England.
Sections du résumé
BACKGROUND
BACKGROUND
SARS-CoV-2 antibody tests are used for population surveillance and might have a future role in individual risk assessment. Lateral flow immunoassays (LFIAs) can deliver results rapidly and at scale, but have widely varying accuracy.
METHODS
METHODS
In a laboratory setting, we performed head-to-head comparisons of four LFIAs: the Rapid Test Consortium's AbC-19
FINDINGS
RESULTS
We observed a clear trade-off between sensitivity and specificity: the IgG band of the SureScreen device and the AbC-19
INTERPRETATION
CONCLUSIONS
The estimates of sensitivity and specificity can be used to adjust for test error rates when using these devices to estimate the prevalence of antibody. If tests were used to determine whether an individual has SARS-CoV-2 antibodies, in an example scenario in which 20% of individuals have antibodies we estimate around 5% of positive results on the most specific device would be false positives.
FUNDING
BACKGROUND
Public Health England.
Identifiants
pubmed: 34098341
pii: S2352-3964(21)00207-3
doi: 10.1016/j.ebiom.2021.103414
pmc: PMC8176919
pii:
doi:
Substances chimiques
Antibodies, Viral
0
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
103414Subventions
Organisme : Wellcome Trust
Pays : United Kingdom
Informations de copyright
Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest JS and KP report financial activities on behalf of WHO in 2018 and 2019 in evaluation of several other rapid test kits. MH declares unrelated and unrestricted speaker fees and travel expenses in last 3 years from MSD and Gillead. JD has received grants from Merck, Novartis, Pfizer and AstraZeneca and personal fees and non-financial support from Pfizer Population Research Advisory Panel. Outside of this work, RB and EL perform meningococcal contract research on behalf of PHE for GSK, Pfizer and Sanofi Pasteur. All other authors declare no conflicts of interest.