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Published February 3, 2021 | Version v1
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Comparative evaluation of ten lateral flow immunoassays to detect SARS-CoV-2 antibodies

Creators

  • 1. Liverpool School of Tropical Medicine
  • 2. University of Edinburgh
  • 3. Royal Liverpool University Hospital
  • 4. University of Liverpool
  • 5. Imperial College London

Description

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.

Notes

Funding provided by: Medical Research Council
Crossref Funder Registry ID: http://dx.doi.org/10.13039/501100000265
Award Number: MC_PC_19059

Funding provided by: Wellcome Trust
Crossref Funder Registry ID: http://dx.doi.org/10.13039/100010269
Award Number: 215091/Z/18/Z,220764/Z/20/Z

Funding provided by: Bill and Melinda Gates Foundation
Crossref Funder Registry ID: http://dx.doi.org/10.13039/100000865
Award Number: OPP1209135

Funding provided by: National Institute for Health Research
Crossref Funder Registry ID: http://dx.doi.org/10.13039/501100000272
Award Number: 200907,200927,IS-BRC-1215-20013,CO-CIN-01

Funding provided by: Liverpool Experimental Cancer Medicine Centre
Crossref Funder Registry ID:
Award Number: C18616/A25153

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Additional details

Related works

Is cited by
10.12688/wellcomeopenres.16522.1 (DOI)