Clinical validation of novel dried blood spot based collecting device using serum separation for measuring SARS-CoV-2 antibodies.

Abstract

Accurate surveillance of coronavirus disease 2019 (COVID-19) incidence includes large-scale antibody testing of the population. Current testing methods require collection of venous blood samples by a healthcare worker, or dried blood spot (DBS) collection using finger prick, however this might have some logistic and processing limitations. We investigated the performance of the Ser-Col device for detecting severe acute respiratory syndrome coronavirus-2(SARS-CoV-2) antibodies using a finger prick: DBS-likecollection system that includes a lateral flow paper for serum separation and allows for automated large scale analysis.For this prospective study, adult patients with moderate to severe COVID-19 were included 6 weeks post-symptom onset. Healthy, adult volunteers were included as a negative control group. Venous blood and capillary blood using the Ser-Col device were collected and the Wantai SARS-CoV-2 total antibody ELISA was performed on all samples.We included 50 subjects in the study population and 49 in the control group. Results obtained with venous blood versus Ser-Col capillary blood showed 100% sensitivity (95% CI: 0.93-1.00) and 100% specificity (95% CI: 0.93-1.00).Our study shows the feasibility of SARS-CoV-2 total antibody screening using a standardized DBStechnique with semiautomated processing for large scale analysis.