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. 2023 Feb 23;23(1):110.
doi: 10.1186/s12879-023-08033-1.

Evaluation of eight lateral flow tests for the detection of anti-SARS-CoV-2 antibodies in a vaccinated population

Caitlin Greenland-Bews  1 , Rachel L Byrne  1 , Sophie I Owen  1   2 , Rachel L Watkins  1 , Daisy Bengey  1 , Kate Buist  1 , Karina Clerkin  1 , Camille Escadafal  3 , Lorna S Finch  1 , Susan Gould  1 , Emanuele Giorgi  4 , Andy Hodgkinson  5 , Larysa Mashenko  1 , Darren Powell  5 , Helen R Savage  1 , Caitlin R Thompson  1 , Lance Turtle  6 , Jahanara Wardale  1 , Dominic Wooding  1 , Thomas Edwards  1 , Ana Cubas Atienzar  1 , Emily R Adams  7   8
Affiliations

Evaluation of eight lateral flow tests for the detection of anti-SARS-CoV-2 antibodies in a vaccinated population

Caitlin Greenland-Bews et al. BMC Infect Dis. .

Abstract

Background: Rapid determination of an individual's antibody status can be beneficial in understanding an individual's immune response to SARS-CoV-2 and for initiation of therapies that are only deemed effective in sero-negative individuals. Antibody lateral flow tests (LFTs) have potential to address this need as a rapid, point of care test.

Methods: Here we present a proof-of-concept evaluation of eight LFT brands using sera from 95 vaccinated individuals to determine sensitivity for detecting vaccination generated antibodies. Samples were analysed on eight different brands of antibody LFT and an automated chemiluminescent microparticle immunoassay (CMIA) that identifies anti-spike antibodies which was used as our reference standard.

Results: All 95 (100%) participants tested positive for anti-spike antibodies by the chemiluminescent microparticle immunoassay (CMIA) reference standard post-dose two of their SARS-CoV-2 vaccine: BNT162b2 (Pfizer/BioNTech, n = 60), AZD1222 (AstraZeneca, n = 31), mRNA-1273 (Moderna, n = 2) and Undeclared Vaccine Brand (n = 2). Sensitivity increased from dose one to dose two in six out of eight LFTs with three tests achieving 100% sensitivity at dose two in detecting anti-spike antibodies.

Conclusions: These tests are demonstrated to be highly sensitive to detect raised antibody levels in vaccinated individuals. RDTs are low cost and rapid alternatives to ELISA based systems.

Keywords: Antibody; COVID-19; Diagnostics; Serology; Vaccination.

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Conflict of interest statement

Emily Adams is Director of Epidemics and NTDs at GADx, UK, Sophie Owen is Clinical Affairs Officer at GADx, UK. GADx tests were not evaluated in this publication. There are no other competing interests to declare for the authors of this paper.

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