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

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.

Reviewing methods of deep learning for diagnosing COVID-19, its variants and synergistic medicine combinations

“…When utilized related to symptomatology, a determination of contamination might be conceivable. Fast antigen test using anti-CoV antibodies rather than immobilized viral antigen, allowing for a more easy assessment of the current disease [ 151 ].…”

An update on lateral flow immunoassay for the rapid detection of SARS-CoV-2 antibodies

“…A very recent study assessed the sensitivity of eight LFIAs in post-vaccinated individuals and found that the sensitivity increased from dose one to dose two in six out of eight LFIAs [127] . Three tests detecting anti-spike antibodies achieved 100% sensitivity at dose two, compared with a chemiluminescent microparticle immunoassay [127] .…”

“…A very recent study assessed the sensitivity of eight LFIAs in post-vaccinated individuals and found that the sensitivity increased from dose one to dose two in six out of eight LFIAs [127] . Three tests detecting anti-spike antibodies achieved 100% sensitivity at dose two, compared with a chemiluminescent microparticle immunoassay [127] . Another recent study showed that a LFIA (Humasis®, Anyang, South Korea) was able to detect anti-spike antibodies in plasma samples of vaccinated subjects with an accuracy comparable to ELISA, and the strength of label bands correlated with antibody concentrations, although effective protection against infection was not assessed [128] .…”