Simple, sensitive, specific self-sampling assay secures SARS-CoV-2 antibody signals in sero-prevalence and post-vaccine studies

Sci Rep. 2022 Feb 3;12(1):1885. doi: 10.1038/s41598-022-05640-x.

Abstract

At-home sampling is key to large scale seroprevalence studies. Dried blood spot (DBS) self-sampling removes the need for medical personnel for specimen collection but facilitates specimen referral to an appropriately accredited laboratory for accurate sample analysis. To establish a highly sensitive and specific antibody assay that would facilitate self-sampling for prevalence and vaccine-response studies. Paired sera and DBS eluates collected from 439 sero-positive, 382 sero-negative individuals and DBS from 34 vaccine recipients were assayed by capture ELISAs for IgG and IgM antibody to SARS-CoV-2. IgG and IgM combined on DBS eluates achieved a diagnostic sensitivity of 97.9% (95%CI 96.6 to 99.3) and a specificity of 99.2% (95% CI 98.4 to 100) compared to serum, displaying limits of detection equivalent to 23 and 10 WHO IU/ml, respectively. A strong correlation (r = 0.81) was observed between serum and DBS reactivities. Reactivity remained stable with samples deliberately rendered inadequate, (p = 0.234) and when samples were accidentally damaged or 'invalid'. All vaccine recipients were sero-positive. This assay provides a secure method for self-sampling by DBS with a sensitivity comparable to serum. The feasibility of DBS testing in sero-prevalence studies and in monitoring post-vaccine responses was confirmed, offering a robust and reliable tool for serological monitoring at a population level.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Viral / blood*
  • Biomarkers / blood
  • COVID-19 / diagnosis*
  • COVID-19 / epidemiology*
  • COVID-19 / immunology
  • COVID-19 / virology
  • COVID-19 Testing / methods*
  • COVID-19 Vaccines / immunology
  • Dried Blood Spot Testing / methods*
  • Feasibility Studies
  • Female
  • Humans
  • Immunoglobulin G / blood*
  • Immunoglobulin M / blood*
  • Male
  • SARS-CoV-2 / immunology*
  • Sensitivity and Specificity
  • Seroepidemiologic Studies
  • Specimen Handling / methods*

Substances

  • Antibodies, Viral
  • Biomarkers
  • COVID-19 Vaccines
  • Immunoglobulin G
  • Immunoglobulin M