Analytical performance evaluation of the Elecsys Epstein-Barr virus immunoassay panel

Diagn Microbiol Infect Dis. 2021 Nov;101(3):115443. doi: 10.1016/j.diagmicrobio.2021.115443. Epub 2021 May 29.


We evaluated the analytical performance of the Elecsys® Epstein-Barr virus (EBV) immunoassay panel for the in vitro detection of EBV immunoglobulin M (IgM), EBV viral capsid antigen immunoglobulin G (VCA IgG), and EBV nuclear antigen immunoglobulin G (EBNA IgG). Relative sensitivity/specificity were assessed using 1,734 human blood samples (1,068 residual samples from routine EBV testing; 467 presumed acute infection; 199 presumed seronegative) tested with the Elecsys EBV and 2 comparator panels (ARCHITECT EBV; Liaison EBV). EBV infection status was defined by majority approach. The three panels demonstrated comparable relative sensitivities/specificities, ranging between values (%) of 98.3-99.5 / 96.9-97.4 (EBV IgM); 96.3-98.4 / 98.4-98.7 (EBV VCA IgG); and 98.1-99.5 / 99.1-99.5 (EBV EBNA IgG). The Elecsys EBV IgM assay demonstrated superior analytical specificity in samples containing potential interferents. Utilizing the Elecsys EBV panel for the EBNA-first approach showed 97.5% overall agreement versus the majority approach in samples with clear EBV status.

Keywords: Epstein-Barr virus; Immunoassay; Sensitivity; Serology; Specificity.

Publication types

  • Evaluation Study

MeSH terms

  • Antibodies, Viral / blood*
  • Antigens, Viral / immunology
  • Capsid Proteins / immunology
  • Epstein-Barr Virus Infections / diagnosis*
  • Epstein-Barr Virus Infections / immunology
  • Epstein-Barr Virus Nuclear Antigens / immunology
  • Herpesvirus 4, Human / immunology*
  • Humans
  • Immunoassay / methods
  • Immunoassay / standards*
  • Immunoglobulin G / blood
  • Immunoglobulin M / blood
  • Reagent Kits, Diagnostic / standards*
  • Sensitivity and Specificity


  • Antibodies, Viral
  • Antigens, Viral
  • Capsid Proteins
  • Epstein-Barr Virus Nuclear Antigens
  • Epstein-Barr viral capsid antigen
  • Immunoglobulin G
  • Immunoglobulin M
  • Reagent Kits, Diagnostic