Evidence map›Paper›PMID 34871960›Full record

ArticleEBioMedicine2021

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

Thomas S Fulford, Huy Van, Nicholas A Gherardin, Shuning Zheng, Marcin Ciula, Heidi E Drummer, Samuel Redmond, Hyon-Xhi Tan, Irene Boo, Rob J Center and 23 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in EBioMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
2.1field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 44 citations in OpenAlex.

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  18. Evaluation of a rapid semiquantitative lateral flow assay for the prediction of serum neutralizing activity against SARS-CoV-2 variants.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

33 authors at 6 institutions in 1 country.

Thomas S FulfordDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Huy VanBurnet Institute, Melbourne, Victoria, Australia.
Nicholas A GherardinDepartment 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.
Shuning ZhengBurnet Institute, Melbourne, Victoria, Australia.
Marcin CiulaDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Heidi E DrummerDepartment 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.
Samuel RedmondDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Hyon-Xhi TanDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Irene BooBurnet Institute, Melbourne, Victoria, Australia.
Rob J CenterDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia; Burnet Institute, Melbourne, Victoria, Australia.
Fan LiBurnet Institute, Melbourne, Victoria, Australia.
Samantha L GrimleyDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Bruce D WinesImmune 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.
Thi H O NguyenDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Francesca L MordantDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Paula EllenbergDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Louise C RowntreeDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Lukasz KedzierskiDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Allen C ChengDepartment of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Denise L DoolanAustralian Institute of Tropical Health & Medicine, James Cook University, Cairns, Queensland, Australia.
Gail MatthewsKirby Institute, University of NSW, Sydney, NSW, Australia.
Katherine BondDepartment 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.
P Mark HogarthImmune 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.
Zoe McQuiltenDepartment of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Kanta SubbaraoDepartment 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.
Katherine KedzierskaDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Jennifer A JunoDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Adam K WheatleyDepartment 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, Melbourne, Victoria, Australia.
Stephen J KentDepartment 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, Melbourne, Victoria, Australia; Australian Research Council Centre for Excellence in Convergent Bio-Nano Science and Technology, University of Melbourne, Melbourne, Victoria, Australia.
Deborah A WilliamsonDepartment 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.
Damian F J PurcellDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
David A AndersonBurnet Institute, Melbourne, Victoria, Australia. Electronic address: david.anderson@burnet.edu.au.
Dale I GodfreyDepartment 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. Electronic address: godfrey@unimelb.edu.au.
The University of Melbourne · AUBurnet Institute · AUAustralian Institute of Tropical Health and Medicine · AUAustralian Research Council · AUPeter Doherty Institute · AUThe Royal Melbourne Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAs 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.

methodsWe 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.

findingsWe 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.

interpretationTaken together, the COVID-19 NAb-test

fundingSupport 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.

Indexed as

Point-of-Care SystemsAnimalsAntibodies, NeutralizingAntibodies, ViralAustraliaCOVID-19COVID-19 Serological TestingCOVID-19 VaccinesHumansMacacaNeutralization TestsSARS-CoV-2VaccinationAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesLateral flow assayNeturalising antibodiesPoint of care testSARS-CoV-2

Identifiers

PMID34871960
PMCPMC8641961
OpenAlexW4226063743

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.