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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; Godfrey, Dale I.
  • Fulford TS; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Van H; Burnet Institute, Melbourne, Victoria, Australia.
  • Gherardin NA; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia; Australian Research Council Centre of Excellence in Advanced Molecular Imaging, University of Melbourne, Melbourne, Victoria, Australia.
  • Zheng S; Burnet Institute, Melbourne, Victoria, Australia.
  • Ciula M; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Drummer HE; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia; Burnet Institute, Melbourne, Victoria, Australia; Department of Microbiology, Monash University, Australia.
  • Redmond S; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Tan HX; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Boo I; Burnet Institute, Melbourne, Victoria, Australia.
  • Center RJ; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia; Burnet Institute, Melbourne, Victoria, Australia.
  • Li F; Burnet Institute, Melbourne, Victoria, Australia.
  • Grimley SL; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Wines BD; Immune therapies Laboratory, Burnet Institute, Melbourne, VIC, Australia,; Department of Immunology and Pathology, Central Clinical School, Monash University, Melbourne, VIC, Australia; Department of Clinical Pathology, The University of Melbourne, Parkville, VIC, Australia.
  • Nguyen THO; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Mordant FL; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Ellenberg P; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Rowntree LC; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Kedzierski L; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Cheng AC; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
  • Doolan DL; Australian Institute of Tropical Health & Medicine, James Cook University, Cairns, Queensland, Australia.
  • Matthews G; Kirby Institute, University of NSW, Sydney, NSW, Australia.
  • Bond K; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia; Department of Microbiology, Royal Melbourne Hospital, Melbourne, Australia.
  • Hogarth PM; Immune therapies Laboratory, Burnet Institute, Melbourne, VIC, Australia,; Department of Immunology and Pathology, Central Clinical School, Monash University, Melbourne, VIC, Australia; Department of Clinical Pathology, The University of Melbourne, Parkville, VIC, Australia.
  • McQuilten Z; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
  • Subbarao K; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia; WHO Collaborating Centre for Reference and Research on Influenza at the Peter Doherty Institute for Infection and Immunity.
  • Kedzierska K; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Juno JA; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Wheatley AK; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia; Melbourne Sexual Health Centre and Department of Infectious Diseases, Alfred Hospital and Central Clinical School, Monash University, Melbourn
  • Kent SJ; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia; Melbourne Sexual Health Centre and Department of Infectious Diseases, Alfred Hospital and Central Clinical School, Monash University, Melbourn
  • Williamson DA; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia; Department of Microbiology, Royal Melbourne Hospital, Melbourne, Australia.
  • Purcell DFJ; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Anderson DA; Burnet Institute, Melbourne, Victoria, Australia. Electronic address: david.anderson@burnet.edu.au.
  • Godfrey DI; Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia; Australian Research Council Centre of Excellence in Advanced Molecular Imaging, University of Melbourne, Melbourne, Victoria, Australia. Elect
EBioMedicine ; 74: 103729, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1555409
ABSTRACT

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 140) 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.

FUNDING:

Support was received from the Victorian Operational Infrastructure Support Program and the Australian Government Department of Health. This work was supported by grants from the Department of Health and Human Services of the Victorian State Government; the ARC (CE140100011, CE140100036), the NHMRC (1113293, 2002317 and 1116530), and Medical Research Future Fund Awards (2005544, 2002073, 2002132). Individual researchers were supported by an NHMRC Emerging Leadership Level 1 Investigator Grants (1194036), NHMRC APPRISE Research Fellowship (1116530), NHMRC Leadership Investigator Grant (1173871), NHMRC Principal Research Fellowship (1137285), NHMRC Investigator Grants (1177174 and 1174555) and NHMRC Senior Principal Research Fellowships (1117766 and 1136322). Grateful support was also received from the A2 Milk Company and the Jack Ma Foundation.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Point-of-Care Systems / Antibodies, Neutralizing / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Cohort study / Observational study / Prognostic study Topics: Vaccines / Variants Limits: Animals / Humans Country/Region as subject: Oceania Language: English Journal: EBioMedicine Year: 2021 Document Type: Article Affiliation country: J.ebiom.2021.103729

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Point-of-Care Systems / Antibodies, Neutralizing / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Cohort study / Observational study / Prognostic study Topics: Vaccines / Variants Limits: Animals / Humans Country/Region as subject: Oceania Language: English Journal: EBioMedicine Year: 2021 Document Type: Article Affiliation country: J.ebiom.2021.103729