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

J Med Virol. 2023 May;95(5):e28765. doi: 10.1002/jmv.28765.

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-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.

Keywords: COVID-19; SARS-CoV-2; antibody detection; dried blood spot.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Viral
  • COVID-19* / diagnosis
  • Dried Blood Spot Testing
  • Enzyme-Linked Immunosorbent Assay
  • Humans
  • Prospective Studies
  • SARS-CoV-2
  • Sensitivity and Specificity

Substances

  • Antibodies, Viral