Are Lessons Learned in Setting Cut Points for Detection of Anti-Drug Antibodies Also Useful in Serology Assays for Robust Detection of SARS-CoV-2 Reactive Antibodies?

AAPS J. 2020 Oct 6;22(6):127. doi: 10.1208/s12248-020-00510-8.
No abstract available

Keywords: COVID-19; cut point; diagnostics; immunogenicity; serology; statistics.

Publication types

  • Comparative Study

MeSH terms

  • Antibodies / blood
  • Antibodies, Viral / blood*
  • Antibodies, Viral / immunology
  • Antigens, Viral / immunology*
  • Betacoronavirus / immunology*
  • COVID-19
  • COVID-19 Testing
  • Clinical Laboratory Techniques / methods*
  • Coronavirus Infections / diagnosis*
  • Drug Hypersensitivity / blood
  • Drug Hypersensitivity / diagnosis
  • Endpoint Determination / methods*
  • Endpoint Determination / standards
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Enzyme-Linked Immunosorbent Assay / standards
  • False Negative Reactions
  • False Positive Reactions
  • Humans
  • Normal Distribution
  • Pandemics*
  • Pneumonia, Viral / diagnosis*
  • Point-of-Care Testing
  • Reproducibility of Results
  • SARS-CoV-2
  • Sensitivity and Specificity
  • Spike Glycoprotein, Coronavirus / immunology*

Substances

  • Antibodies
  • Antibodies, Viral
  • Antigens, Viral
  • Spike Glycoprotein, Coronavirus
  • spike protein, SARS-CoV-2