TY - DATA
AU - Garrod, Gala
AU - Owen, Sophie
AU - Baillie, J. Kenneth
AU - Baldwin, Lisa
AU - Brown, Lottie
AU - Byrne, Rachel
AU - Cubas-Atienzar, Ana I.
AU - Cuevas, Luis E.
AU - Fraser, Alice
AU - Fletcher, Thomas
AU - Goodwin, Lynsey
AU - Kay, Grant
AU - Kontogianni, Konstantina
AU - Mason, Jenifer
AU - Openshaw, Peter J.M.
AU - Menzies, Stefanie
AU - Moore, Shona C.
AU - Semple, Malcolm G.
AU - Taylor, Joseph M.
AU - Turtle, Lance C.W.
AU - Williams, Christopher J.
AU - Adams, Emily R.
AU - ISARIC4C Investigators
PY - 2021
DA - February
TI - Comparative evaluation of ten lateral flow immunoassays to detect SARS-CoV-2 antibodies
VL - 6
IS - 18
DO - https://doi.org/10.12688/wellcomeopenres.16522.1
AB - 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 pre-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 settings.
PB - Wellcome Open Research
UR - https://www.research.ed.ac.uk/en/datasets/eb4edb47-ff0c-4299-9df7-8488cef4a3a8
KW - Coronavirus (COVID-19)
ER