Modified ARCHITECT® serologic assays enable plasma-level performance from dried blood spot samples

Biotechniques. 2022 Oct;73(4):193-203. doi: 10.2144/btn-2022-0082. Epub 2022 Oct 14.

Abstract

Dried blood spots (DBSs) provide an alternative sample input for serologic testing. We evaluated DBSs for the ARCHITECT® hepatitis B surface antigen (HBsAg) NEXT, hepatitis B e-antigen (HBeAg), anti-hepatitis B core antigen (anti-HBc II), HIV antigen/antibody (Ag/Ab) Combo and AdviseDx SARS-CoV-2 IgG II assays. Assay performance with DBSs was assessed with or without assay modification and compared with on-market assay with plasma samples. DBS stability was also determined. HBsAg NEXT and HIV Ag/Ab Combo assays using DBSs showed sensitivity and specificity comparable to that of on-market assays. Modified HBeAg, anti-HBc II and SARS-CoV-2 IgG II DBS assays achieved performance comparable to on-market assays. Use of DBSs as input for high-throughput serologic assays is expected to have significant implications for improving population surveillance and increasing access to diagnostic testing.

Keywords: HBV; HBeAg; HBsAg NEXT; HIV Ag/Ab combo; SARS-CoV-2; anti-HBc II; dried blood spots; serology.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19* / diagnosis
  • HIV Infections* / diagnosis
  • Hepatitis B Antibodies
  • Hepatitis B Surface Antigens
  • Hepatitis B e Antigens
  • Humans
  • Immunoglobulin G
  • SARS-CoV-2
  • Sensitivity and Specificity

Substances

  • Hepatitis B Surface Antigens
  • Hepatitis B e Antigens
  • Hepatitis B Antibodies
  • Immunoglobulin G