SARS-CoV-2 antibodies rapid tests: a valuable epidemiological tool in challenging settings

Abstract

Background: During the last year, mass screening campaigns have been carried out to identify immunological response to SARS-CoV-2 and establish a possible seroprevalence. The obtained results gained new importance with the beginning of SARS-CoV-2 vaccination campaign, as the lack of doses has persuaded several countries to introduce different policies for individuals who had a history of COVID 19. LFAs may represent an affordable tool to support population screening in LMICs, where diagnostic tests are lacking, and epidemiology is still widely unknown. However, LFAs have demonstrated a wide range of performance and the question of which one could be more valuable in these settings still remains. Methods: We evaluated the performance of 11 LFAs in detecting SARS-CoV-2 infection, analysing samples collected from 350 subjects. In addition, samples from 57 health care workers collected at 21-24 days after the first dose of Pfizer-BioNTech vaccine were also evaluated. Findings: LFAs demonstrated a wide range of specificity (92.31% to 100%) and sensitivity (50 to 100%). The analysis of serum samples post vaccination was used to describe the most suitable tests to detect IgG response against S protein RBD. History of TB therapy was identified as a potential factor affecting the specificity of LFAs. Conclusions: This analysis identified which LFAs represent a valuable tool not only for the detection of prior SARS-CoV-2 infection, but also to detect IgG elicited in response to vaccination. These results demonstrated that different LFAs may have different applications and the possible risks of their use in high TB burden settings.

Updated Clinical Evaluation of the CLUNGENE® Rapid COVID-19 Antibody Test

“…In addition, the ability of the CLUNGENE ® antibody test to detect antibodies to the coronavirus's spike protein's receptor binding domain means it has the potential to assess the efficacy of most vaccines, as well as convalescent plasma therapy [32]. Countries in Europe are now using antibody testing to determine if a second COVID-19 vaccine dose is required if a patient has a prior infection based on a positive antibody test [33].…”