Comparative evaluation of ten lateral flow immunoassays to detect SARS-CoV-2 antibodies



Garrod, Gala, Owen, Sophie, Baillie, Kenneth, Baldwin, Lisa, Brown, Lottie, Byrne, Rachel, Cubas-Atienzar, Ana, Cuevas, Luis, Fraser, Alice, Fletcher, Thomas ORCID: 0000-0002-3712-415X
et al (show 13 more authors) (2021) Comparative evaluation of ten lateral flow immunoassays to detect SARS-CoV-2 antibodies.

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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 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.

Item Type: Article
Uncontrolled Keywords: ISARIC4C Investigators
Depositing User: Symplectic Admin
Date Deposited: 25 Feb 2021 15:34
Last Modified: 25 Mar 2021 18:10
DOI: 10.12688/wellcomeopenres.16522.1
Open Access URL: https://wellcomeopenresearch.org/articles/6-18/v1
URI: https://livrepository.liverpool.ac.uk/id/eprint/3115967