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Related Experiment Video

Updated: Oct 10, 2025

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COVID-19 Antibody Detection and Assay Performance Using Red Cell Agglutination.

Kshitij Srivastava1, Kamille A West1, Valeria De Giorgi1

  • 1Department of Transfusion Medicine, NIH Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.

Microbiology Spectrum
|December 8, 2021
PubMed
Summary

A new red blood cell-based assay (C-19 kodecytes) effectively detects SARS-CoV-2 antibodies. This scalable method shows high sensitivity and specificity, offering a promising tool for widespread COVID-19 antibody screening.

Keywords:
C19-kodecyteCOVID-19SARS-CoV-2assay evaluationcolumn agglutination techniquered cell agglutination

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Area of Science:

  • Immunology
  • Virology
  • Medical Diagnostics

Background:

  • Serologic screening for SARS-CoV-2 antibodies is crucial for understanding infection dynamics and immunity.
  • Existing antibody tests vary in performance and accessibility.
  • Red blood cell-based assays offer a novel approach for antibody detection.

Purpose of the Study:

  • To evaluate the analytical performance of a novel red blood cell-based assay (C-19 kodecytes) for detecting SARS-CoV-2 antibodies.
  • To compare the C-19 kodecyte assay against established serologic and virus neutralization assays.
  • To assess the scalability and practical application of the C-19 kodecyte assay in a clinical laboratory setting.

Main Methods:

  • Red blood cells were labeled with SARS-CoV-2 spike protein peptides to create C-19 kodecytes.
  • The C-19 kodecyte assay was used to test plasma from 140 COVID-19 convalescent donors and 275 healthy controls.
  • Assay performance was compared with a virus neutralizing assay and two commercial chemiluminescent antibody tests (Total and IgG assays).

Main Results:

  • The C-19 kodecyte assay demonstrated a sensitivity of 92.8% and a specificity of 96.3%.
  • It showed almost perfect agreement with the Total assay (Cohen's kappa = 0.90).
  • The assay is easily scalable and adaptable to existing blood typing laboratory platforms.

Conclusions:

  • The C-19 kodecyte assay is a reliable and accurate method for SARS-CoV-2 antibody detection.
  • Its high sensitivity and specificity meet FDA requirements for emergency use authorization.
  • The assay's scalability and use of routine equipment make it suitable for population-wide screening and implementation in hospital blood banks worldwide.