Tools
Tools
Garrod, Gala, Owen, Sophie 
ORCID: https://orcid.org/0000-0002-0458-2357, Baillie, J. Kenneth, Baldwin, Lisa, Brown, Lottie, Byrne, Rachel, CubasAtienzar, Ana, Cuevas, Luis ORCID: https://orcid.org/0000-0002-6581-0587, Fraser, Alice, Fletcher, Tom, Goodwin, Lynsey, Kay, Grant Alistair, Kontogianni, Konstantina, Mason, Jenifer, Openshaw, Peter J.M., Menzies, Stefanie ORCID: https://orcid.org/0000-0002-9273-9296, Moore, Shona C., Semple, Malcolm G., Taylor, Joseph, Turtle, Lance C.W., Williams, Chris and Adams, Emily ORCID: https://orcid.org/0000-0002-0816-2835
(2021)
'Comparative evaluation of ten lateral flow immunoassays to detect SARS-CoV-2 antibodies'. Wellcome Open Research, Vol 6, Issue 18.
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Abstract
Background: Rapid mobilisation from industry and academia
following the outbreak of the novel coronavirus, severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2), led to the
development and availability of SARS-CoV-2 lateral flow
immunoassays (LFAs). High quality LFAs are urgently needed at the
point of care to add to currently available diagnostic tools. In this
study, we provide evaluation data for ten LFAs suitable for use at the
point of care.
Methods: COVID-19 positive patients (N=45), confirmed by reverse
transcription – quantitative polymerase chain reaction (RT-qPCR), were
recruited through the International Severe Acute Respiratory and
Emerging Infection Consortium - Coronavirus Clinical Characterisation
Consortium (ISARIC4C) study. Sera collected from patients with
influenza A (N=20), tuberculosis (N=5), individuals with previous
flavivirus exposure (N=21), and healthy sera (N=4), collected preOpen Peer Review
Reviewer Status AWAITING PEER REVIEW
Any reports and responses or comments on the
article can be found at the end of the article.
Page 1 of 9
Wellcome Open Research 2021, 6:18 Last updated: 01 FEB 2021
pandemic, were used as negative controls. Ten LFAs manufactured or
distributed by ASBT Holdings Ltd, Cellex, Fortress Diagnostics,
Nantong Egens Biotechnology, Mologic, NG Biotech, Nal von Minden
and Suzhou Herui BioMed Co. were evaluated.
Results: Compared to RT-qPCR, sensitivity of LFAs ranged from 87.0-
95.7%. Specificity against pre-pandemic controls ranged between
92.0-100%. Compared to IgG ELISA, sensitivity and specificity ranged
between 90.5-100% and 93.2-100%, respectively. Percentage
agreement between LFAs and IgG ELISA ranged from 89.6-92.7%.
Inter-test agreement between LFAs and IgG ELISA ranged between
kappa=0.792-0.854.
Conclusions: LFAs may serve as a useful tool for rapid confirmation of
ongoing or previous infection in conjunction with clinical suspicion of
COVID-19 in patients attending hospital. Impartial validation prior to
commercial sale provides users with data that can inform best use
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