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

被引：29

作者：

Fulford, Thomas S. ^{[1
]}

Van, Huy ^{[2
]}

Gherardin, Nicholas A. ^{[1
,3
]}

Zheng, Shuning ^{[2
]}

Ciula, Marcin ^{[1
]}

Drummer, Heidi E. ^{[1
,2
,4
]}

Redmond, Samuel ^{[1
]}

Tan, Hyon-Xhi ^{[1
]}

Boo, Irene ^{[2
]}

Center, Rob J. ^{[1
,2
]}

Li, Fan ^{[2
]}

Grimley, Samantha L. ^{[1
]}

Wines, Bruce D. ^{[5
,6
,7
]}

Nguyen, Thi H. O. ^{[1
]}

Mordant, Francesca L. ^{[1
]}

Ellenberg, Paula ^{[1
]}

Rowntree, Louise C. ^{[1
]}

Kedzierski, Lukasz ^{[1
]}

Cheng, Allen C. ^{[8
]}

Doolan, Denise L. ^{[9
]}

Matthews, Gail ^{[10
]}

Bond, Katherine ^{[1
,11
]}

Hogarth, P. Mark ^{[5
,6
,7
]}

McQuilten, Zoe ^{[8
]}

Subbarao, Kanta ^{[1
,12
]}

Kedzierska, Katherine ^{[1
]}

Juno, Jennifer A. ^{[1
]}

Wheatley, Adam K. ^{[1
,13
,14
,15
]}

Kent, Stephen J. ^{[1
,13
,14
,15
,16
]}

Williamson, Deborah A. ^{[1
,11
]}

Purcell, Damian F. J. ^{[1
]}

Anderson, David A. ^{[2
]}

Godfrey, Dale, I ^{[1
,3
]}

机构：

[1] Univ Melbourne Peter Doherty Inst Infect & Immun, Dept Microbiol & Immunol, Melbourne, Vic, Australia

[2] Burnet Inst, Melbourne, Vic, Australia

[3] Univ Melbourne, Australian Res Council Ctr Excellence Adv Mol Ima, Melbourne, Vic, Australia

[4] Monash Univ, Dept Microbiol, Melbourne, Vic, Australia

[5] Burnet Inst, Immune Therapies Lab, Melbourne, Vic, Australia

[6] Monash Univ, Cent Clin Sch, Dept Immunol & Pathol, Melbourne, Vic, Australia

[7] Univ Melbourne, Dept Clin Pathol, Parkville, Vic, Australia

[8] Monash Univ, Dept Epidemiol & Prevent Med, Melbourne, Vic, Australia

[9] James Cook Univ, Australian Inst Trop Hlth & Med, Cairns, Qld, Australia

[10] Univ NSW, Kirby Inst, Sydney, NSW, Australia

[11] Royal Melbourne Hosp, Dept Microbiol, Melbourne, Vic, Australia

[12] Peter Doherty Inst Infect & Immun, WHO Collaborating Ctr Reference & Res Influenza, Melbourne, Vic, Australia

[13] Monash Univ, Melbourne Sexual Hlth Ctr, Melbourne, Vic, Australia

[14] Monash Univ, Dept Infect Dis, Alfred Hosp, Melbourne, Vic, Australia

[15] Monash Univ, Cent Clin Sch, Melbourne, Vic, Australia

[16] Univ Melbourne, Australian Res Council Ctr Excellence Convergent, Melbourne, Vic, Australia

来源：

EBIOMEDICINE | 2021年 / 74卷

基金：

英国医学研究理事会; 澳大利亚研究理事会; 澳大利亚国家健康与医学研究理事会;

关键词：

SARS-CoV-2; Neturalising antibodies; Lateral flow assay; Point of care test; RESPIRATORY SYNDROME CORONAVIRUS; BINDING;

D O I：

10.1016/j.ebiom.2021.103729

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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-test (TM) device described here provides a rapid readout of NAb based protection to SARS-CoV-2 at the point of care. (C) 2021 Published by Elsevier B.V.

引用

页数：16

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