Validation of dried blood spot sample modifications to two commercially available COVID-19 IgG antibody immunoassays

Bioanalysis. 2021 Jan;13(1):13-28. doi: 10.4155/bio-2020-0289. Epub 2020 Dec 15.

Abstract

Aim: Coronavirus disease 2019 antibody testing often relies on venous blood collection, which is labor-intensive, inconvenient and expensive compared with finger-stick capillary dried blood spot (DBS) collection. The purpose of our work was to determine if two commercially available anti-severe acute respiratory syndrome coronavirus 2 enzyme-linked immunosorbent assays for IgG antibodies against spike S1 subunit and nucleocapsid proteins could be validated for use with DBS. Materials & methods: Kit supplied reagents were used to extract DBS, and in-house DBS calibrators were included on every run. Results: Positive/negative concordance between DBS and serum was 100/99.3% for the spike S1 subunit assay and 100/98% for the nucleocapsid assay. Conclusion: Validation of the DBS Coronavirus disease 2019 IgG antibody assays demonstrated that serum and DBS can produce equivalent results with minimal kit modifications.

Keywords: COVID-19; DBS; ELISA; IgG; SARS-CoV-2; antibody; dried blood spot; filter paper; pandemic.

Publication types

  • Validation Study

MeSH terms

  • Antibodies, Viral / chemistry
  • Antigens, Viral / blood
  • Antigens, Viral / immunology
  • COVID-19 / blood
  • COVID-19 / diagnosis*
  • COVID-19 / immunology
  • COVID-19 / virology
  • COVID-19 Testing / standards*
  • Coronavirus Nucleocapsid Proteins / blood
  • Coronavirus Nucleocapsid Proteins / immunology
  • Dried Blood Spot Testing / standards*
  • Enzyme-Linked Immunosorbent Assay / standards*
  • Female
  • Humans
  • Immunoglobulin G / chemistry
  • Male
  • Middle Aged
  • Phosphoproteins / blood
  • Phosphoproteins / immunology
  • Reagent Kits, Diagnostic / standards
  • Reproducibility of Results
  • SARS-CoV-2 / immunology*
  • Sensitivity and Specificity
  • Spike Glycoprotein, Coronavirus / blood
  • Spike Glycoprotein, Coronavirus / immunology

Substances

  • Antibodies, Viral
  • Antigens, Viral
  • Coronavirus Nucleocapsid Proteins
  • Immunoglobulin G
  • Phosphoproteins
  • Reagent Kits, Diagnostic
  • Spike Glycoprotein, Coronavirus
  • nucleocapsid phosphoprotein, SARS-CoV-2
  • spike protein, SARS-CoV-2