A point-of-care lateral flow assay for neutralising antibodies against SARS-CoV-2
A point-of-care lateral flow assay for neutralising antibodies against SARS-CoV-2
Abstract As vaccines against SARS-CoV-2 are now being rolled out, a better understanding of immunity to the virus; whether through infection, or passive or active immunisation, and the durability of this protection is required. This will benefit from the ability to measure SARS-CoV-2 immunity, ideally with rapid turnaround and without the need for laboratory-based testing. Current rapid point-of-care (POC) tests measure antibodies (Ab) against the SARS-CoV-2 virus, however, these tests provide no information on whether the antibodies can neutralise virus infectivity and are potentially protective, especially against newly emerging variants of the virus. Neutralising Antibodies (NAb) are emerging as a strong correlate of protection, but most current NAb assays require many hours or days, samples of venous blood, and access to laboratory facilities, which is especially problematic in resource-limited settings. We have developed a lateral flow POC test that can measure levels of RBD-ACE2 neutralising antibodies from whole blood, with a result that can be determined by eye (semi-quantitative) or on a small instrument (quantitative), and results show high correlation with microneutralisation assays. This assay also provides a measure of total anti-RBD antibody, thereby providing evidence of exposure to SARS-CoV-2 or immunisation, regardless of whether NAb are present in the sample. By testing samples from immunised macaques, we demonstrate that this test is equally applicable for use with animal samples, and we show that this assay is readily adaptable to test for immunity to newly emerging SARS-CoV-2 variants. Lastly, using a cohort of vaccinated humans, we demonstrate that our whole-blood test correlates closely with microneutralisation assay data (R2 =0.75, p<0.0001), and that fingerprick whole blood samples are sufficient for this test. Accordingly, the COVID-19 NAb-test? device described here can provide a rapid readout of immunity to SARS-CoV-2 at the point of care.
Wines Bruce D.、Godfrey Dale I.、Rowntree Louise C.、Bond Katherine、McQuilten Zoe、Juno Jennifer A.、Purcell Damian F.J.、Kedzierska Katherine、Nguyen Thi H.O.、Tan Hyon-Xhi、Gherardin Nicholas A.、Zheng Shuning、Grimley Samantha L.、Mordant Francesca L.、Ciula Marcin、Hogarth P. Mark、Fulford Thomas S.、Subbarao Kanta、Kent Stephen J.、Cheng Allen C.、Drummer Heidi E.、Van Huy、Li Fan、Anderson David A.、Williamson Deborah A.、Wheatley Adam K.、Doolan Denise L.、Center Rob J.、Redmond Samuel
Immune therapies Laboratory, Burnet Institute||Department of Immunology and Pathology, Central Clinical School||Department of Clinical Pathology, The University of MelbourneDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne||Australian Research Council Centre of Excellence in Advanced Molecular Imaging, University of MelbourneDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, MelbourneDepartment of Microbiology, Royal Melbourne HospitalDepartment of Epidemiology and Preventive Medicine, Monash UniversityDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, MelbourneDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, MelbourneDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, MelbourneDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, MelbourneDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, MelbourneDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne||Australian Research Council Centre of Excellence in Advanced Molecular Imaging, University of MelbourneBurnet InstituteDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, MelbourneDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, MelbourneDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, MelbourneImmune therapies Laboratory, Burnet Institute||Department of Immunology and Pathology, Central Clinical School||Department of Clinical Pathology, The University of MelbourneDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, MelbourneDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne||WHO Collaborating Centre for Reference and Research on Influenza at the Peter Doherty Institute for Infection and ImmunityDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne||Melbourne Sexual Health Centre and Department of Infectious Diseases, Alfred Hospital and Central Clinical School, Monash University||Australian Research Council Centre for Excellence in Convergent Bio-Nano Science and Technology, University of MelbourneDepartment of Epidemiology and Preventive Medicine, Monash UniversityDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne||Burnet Institute||Department of Microbiology, Monash UniversityBurnet InstituteBurnet InstituteBurnet InstituteDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne||Department of Microbiology, Royal Melbourne HospitalDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne||Melbourne Sexual Health Centre and Department of Infectious Diseases, Alfred Hospital and Central Clinical School, Monash UniversityAustralian Institute of Tropical Health & Medicine, James Cook UniversityDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne||Burnet InstituteDepartment of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne
医学研究方法预防医学基础医学
Wines Bruce D.,Godfrey Dale I.,Rowntree Louise C.,Bond Katherine,McQuilten Zoe,Juno Jennifer A.,Purcell Damian F.J.,Kedzierska Katherine,Nguyen Thi H.O.,Tan Hyon-Xhi,Gherardin Nicholas A.,Zheng Shuning,Grimley Samantha L.,Mordant Francesca L.,Ciula Marcin,Hogarth P. Mark,Fulford Thomas S.,Subbarao Kanta,Kent Stephen J.,Cheng Allen C.,Drummer Heidi E.,Van Huy,Li Fan,Anderson David A.,Williamson Deborah A.,Wheatley Adam K.,Doolan Denise L.,Center Rob J.,Redmond Samuel.A point-of-care lateral flow assay for neutralising antibodies against SARS-CoV-2[EB/OL].(2025-03-28)[2025-05-23].https://www.medrxiv.org/content/10.1101/2021.04.12.21255368.点此复制
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