Accurate point-of-care serology tests for COVID-19

PLoS One. 2021 Mar 16;16(3):e0248729. doi: 10.1371/journal.pone.0248729. eCollection 2021.

Abstract

Background: As COVID-19 vaccines become available, screening individuals for prior COVID-19 infection and vaccine response in point-of-care (POC) settings has renewed interest. We prospectively screened at-risk individuals for SARS-CoV-2 spike and nucleocapsid protein antibodies in a POC setting to determine if it was a feasible method to identify antibody from prior infection.

Methods: Three EUA-approved lateral flow antibody assays were performed on POC finger-stick blood and compared with serum and a CLIA nucleocapsid antibody immunoassay. Variables including antibody class, time since PCR, and the assay antigen used were evaluated.

Results: 512 subjects enrolled, of which 104 had a COVID-19 history and positive PCR. Only three PCR-positive subjects required hospitalization, with one requiring mechanical ventilation. The POC results correlated well with the immunoassay (93-97% sensitivity) and using serum did not improve the sensitivity or specificity.

Conclusions: Finger-stick, POC COVID-19 antibody testing was highly effective in identifying antibody resulting from prior infections in mildly symptomatic subjects. Using high-complexity serum immunoassays did not improve the screening outcome. Almost all individuals with COVID-19 infection produced detectable antibodies to the virus. POC antibody testing is useful as a screen for prior COVID-19 infection, and should be useful in assessing vaccine response.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antibodies, Viral / blood
  • COVID-19 / diagnosis*
  • COVID-19 / virology
  • COVID-19 Serological Testing
  • Female
  • Humans
  • Immunoassay
  • Immunoglobulin G / blood
  • Immunoglobulin M / blood
  • Male
  • Middle Aged
  • Nucleocapsid / immunology
  • Point-of-Care Systems*
  • Reagent Kits, Diagnostic
  • SARS-CoV-2 / immunology
  • SARS-CoV-2 / isolation & purification
  • Sensitivity and Specificity
  • Young Adult

Substances

  • Antibodies, Viral
  • Immunoglobulin G
  • Immunoglobulin M
  • Reagent Kits, Diagnostic