A point-of-care lateral flow assay for neutralising antibodies against SARS-CoV-2

Fulford, Thomas S., Van, Huy, Gherardin, Nicholas A., Zheng, Shuning, Ciula, Marcin, Drummer, Heidi E., Redmond, Samuel, Tan, Hyon-Xhi, Boo, Irene, Center, Rob J., Li, Fan, Grimley, Samantha L., Wines, Bruce D., Nguyen, Thi H.O., Mordant, Francesca L., Ellenberg, Paula, Rowntree, Louise C., Kedzierski, Lukasz, Cheng, Allen C., Doolan, Denise L., Matthews, Gail, Bond, Katherine, Hogarth, P. Mark, McQuilten, Zoe, Subbarao, Kanta, Kedzierska, Katherine, Juno, Jennifer A., Wheatley, Adam K., Kent, Stephen J., Williamson, Deborah A., Purcell, Damian F.J., Anderson, David A., and Godfrey, Dale I. (2021) A point-of-care lateral flow assay for neutralising antibodies against SARS-CoV-2. EBioMedicine, 74. p. 103729.

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Background: As vaccines against SARS-CoV-2 are now being rolled out, a better understanding of immunity to the virus, whether from infection, or passive or active immunisation, and the durability of this protection is required. This will benefit from the ability to measure antibody-based protection to SARS-CoV-2, ideally with rapid turnaround and without the need for laboratory-based testing.

Methods: We have developed a lateral flow POC test that can measure levels of RBD-ACE2 neutralising antibody (NAb) from whole blood, with a result that can be determined by eye or quantitatively on a small instrument. We compared our lateral flow test with the gold-standard microneutralisation assay, using samples from convalescent and vaccinated donors, as well as immunised macaques.

Findings: We show a high correlation between our lateral flow test with conventional neutralisation and that this test is applicable with animal samples. We also show that this assay is readily adaptable to test for protection to newly emerging SARS-CoV-2 variants, including the beta variant which revealed a marked reduction in NAb activity. Lastly, using a cohort of vaccinated humans, we demonstrate that our whole-blood test correlates closely with microneutralisation assay data (specificity 100% and sensitivity 96% at a microneutralisation cutoff of 1:40) and that fingerprick whole blood samples are sufficient for this test.

Interpretation: Taken together, the COVID-19 NAb-testTM device described here provides a rapid readout of NAb based protection to SARS-CoV-2 at the point of care.

Item ID: 72689
Item Type: Article (Research - C1)
ISSN: 2352-3964
Keywords: SARS-CoV-2, Neturalising antibodies, Lateral flow assay, Point of care test
Copyright Information: © 2021 Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/
Funders: Australian Research Council (ARC), National Health and Medical Research Council (NHMRC)
Projects and Grants: ARC CE140100011, ARC CE140100036, NHMRC 1113293, NHMRC 2002317, NHMRC 1116530, NHMRC 1194036, NHMRC 1116530, NHMRC 173871, NHMRC 1137285, NHMRC 1177174, NHMRC 1174555, NHMRC 1117766, NHMRC 1136322
Date Deposited: 01 Mar 2022 01:08
FoR Codes: 32 BIOMEDICAL AND CLINICAL SCIENCES > 3207 Medical microbiology > 320705 Medical virology @ 100%
SEO Codes: 20 HEALTH > 2001 Clinical health > 200101 Diagnosis of human diseases and conditions @ 100%
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