Abstract
This study investigated the performance of a rapid point-of-care antibody test, the BioMedomics COVID-19 IgM/IgG Rapid Test, in comparison with a high-quality, validated, laboratory-based platform, the Roche Elecsys Anti-SARS-CoV-2 assay. Serological testing was conducted on 709 individuals. Concordance metrics were estimated. Logistic regression was used to assess associations with seropositivity. SARS-CoV-2 seroprevalence was 63.5% (450/709; 95% CI 59.8%-67.0%) using the BioMedomics assay and 71.9% (510/709; 95% CI 68.5%-75.2%) using the Elecsys assay. There were 60 discordant results between the two assays, all of which were seropositive in the Elecsys assay, but seronegative in the BioMedomics assay. Overall, positive, and negative percent agreements between the two assays were 91.5% (95% CI 89.2%-93.5%), 88.2% (95% CI 85.1%-90.9%), and 100% (95% CI 98.2%-100%), respectively, with a Cohen’s kappa of 0.81 (95% CI 0.78–0.84). Excluding specimens with lower (Elecsys) antibody titers, the agreement improved with overall, positive, and negative percent concordance of 94.4% (95% CI 92.3%-96.1%), 91.8% (95% CI 88.8%-94.3%), and 100% (95% CI 98.2%-100%), respectively, and a Cohen’s kappa of 0.88 (95% CI 0.85–0.90). Logistic regression confirmed better agreement with higher antibody titers. The BioMedomics COVID-19 IgM/IgG Rapid Test demonstrated good performance in measuring detectable antibodies against SARS-CoV-2, supporting the utility of such rapid point-of-care serological testing to guide the public health responses and vaccine prioritization.
Highlights
Coronavirus disease 2019 (COVID-19), caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to present a global challenge, leading to health, social, and economic burdens [1]
Seroprevalence of SARS-CoV-2-IgG in this sample was estimated at 63.5% (450/709; 95% confidence interval (CI) 59.8%-67.0%) using the BioMedomics assay and at 71.9% (510/709; 95% CI 68.5%-75.2%) using the Elecsys assay
Seroprevalence of SARS-CoV-2-IgM was estimated at 8.5% (60/709; 95% CI 6.5%-10.8%), measured only using the BioMedomics assay
Summary
Coronavirus disease 2019 (COVID-19), caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to present a global challenge, leading to health, social, and economic burdens [1]. The wave predominantly affected the craft and manual workers who constitute just over half of Qatar’s total population [2]. Seroprevalence in this part of the population was measured at about 60% following this wave [5, 6]. Following this epidemic wave, Qatar’s public health authorities expanded serological testing for SARS-CoV-2 antibodies, for both healthcare and research purposes [6–8]. Antibody status was deliberated as one of the criteria for COVID-19 vaccine prioritization [9], and for a waiver of the quarantine requirement for international travelers [10]
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