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

Abstract

AbstractAccurate 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‐like collection 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 DBS technique with semiautomated processing for large scale analysis.