BibTex format
@unpublished{Tedder:2021:10.2139/ssrn.3739821,
author = {Tedder, RS and Parker, E and Sureda-Vives, M and Fernandez, N and Randell, P and Marchesin, F and Katsanovskaja, K and Harvey, R and Lilley, A and Harris, BHL and Zuhair, M and Fertleman, M and Ijaz, S and Dicks, S and Short, C-E and Quinlan, R and Taylor, GP and McKay, P and Hu, K and Rosa, A and Roustan, C and Zuckerman, M and El, Bouzidi K and Cooke, G and Flower, B and Moshe, M and Elliott, P and Spencer, AJ and Lambe, T and Gilbert, SC and Kingston, H and Baillie, JK and Openshaw, P and Semple, M and Cherepanov, P and McLure, M},
doi = {10.2139/ssrn.3739821},
publisher = {Elsevier BV},
title = {Detection and quantification of antibody to SARS-CoV-2 receptor binding domain provides enhanced sensitivity, specificity and utility},
url = {http://dx.doi.org/10.2139/ssrn.3739821},
year = {2021}
}
RIS format (EndNote, RefMan)
TY - UNPB
AB - Background: Accurate and sensitive detection of antibody to SARS-CoV-2 remains an essential component of the pandemic response. Measuring antibody that predicts neutralising activity and the vaccine response is an absolute requirement for laboratory-based confirmatory and reference activity.Methods: The viral receptor binding domain (RBD) constitutes the prime target antigen for neutralising antibody. A double antigen binding assay (DABA) provides the most sensitive format. It has been exploited in a novel hybrid manner employing an S1 solid-phase preferentially presenting RBD once solid-phase bound, coupled with a labelled RBD conjugate, used in a two-step sequential assay.Findings: This assay showed a specificity of 100% on 825 pre COVID-19 samples and a potential sensitivity of 99.6% on 276 recovery samples, predicting quantitatively the presence of neutralising antibody determined by pseudo-type neutralisation and by plaque reduction. Anti-RBD is also measurable in ferrets immunised with ChadOx1 nCoV-19 vaccine. The early response at presentation with illness, elevated responsiveness with disease severity, detection of asymptomatic seroconversion and persistence after the loss of antibody to the nucleoprotein (anti-NP) are all documented.Trial Registration: The ISARIC WHO CCP-UK study was registered at https://www.isrctn.com/ISRCTN66726260 and designated an Urgent Public Health Research Study by NIHR.Interpretation: The hybrid DABA displays the attributes necessary for an antibody test to be used in both clinical and reference serology. It allows the neutralising antibody response to be inferred early in infection and potentially in vaccine recipients. It is also of sufficient sensitivity to be used to provide serological confirmation of prior infection and provides a more secure measure for seroprevalence studies in the population generally than does anti-NP based on the Architect platform.Funding: This work is variously supported by grants from: the National I
AU - Tedder,RS
AU - Parker,E
AU - Sureda-Vives,M
AU - Fernandez,N
AU - Randell,P
AU - Marchesin,F
AU - Katsanovskaja,K
AU - Harvey,R
AU - Lilley,A
AU - Harris,BHL
AU - Zuhair,M
AU - Fertleman,M
AU - Ijaz,S
AU - Dicks,S
AU - Short,C-E
AU - Quinlan,R
AU - Taylor,GP
AU - McKay,P
AU - Hu,K
AU - Rosa,A
AU - Roustan,C
AU - Zuckerman,M
AU - El,Bouzidi K
AU - Cooke,G
AU - Flower,B
AU - Moshe,M
AU - Elliott,P
AU - Spencer,AJ
AU - Lambe,T
AU - Gilbert,SC
AU - Kingston,H
AU - Baillie,JK
AU - Openshaw,P
AU - Semple,M
AU - Cherepanov,P
AU - McLure,M
DO - 10.2139/ssrn.3739821
PB - Elsevier BV
PY - 2021///
TI - Detection and quantification of antibody to SARS-CoV-2 receptor binding domain provides enhanced sensitivity, specificity and utility
UR - http://dx.doi.org/10.2139/ssrn.3739821
UR - https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3739821
ER -