Evaluation of six commercially available kits using purified heterophile antigen for the rapid diagnosis of infectious mononucleosis compared with Epstein-Barr virus-specific serology

Clin Diagn Virol. 1996 Oct;7(1):17-21. doi: 10.1016/s0928-0197(96)00245-0.

Abstract

Background: Novel commercial kits based on antibody reactivity to purified heterophile antigens have recently been introduced for the diagnosis of Epstein-Barr (EB) virus-associated infectious mononucleosis (IM). It is important to determine possible improvements in the performance and reliability of such tests for the diagnosis of IM.

Objective: To evaluate the reliability of six commercially available kits for the rapid diagnosis of IM in comparison to EB-virus-specific serology.

Study design: In total, 100 sera, 53 from patients with serologically verified primary EB virus infection and 47 from EB-virus-immune or -susceptible patients, were used to evaluate the six rapid test kits: Monolatex, Mono-Latex, Mono-Lex (latex agglutination-based kits), Mono-Plus, IM-Check and Clearview IM (solid-phase-based kits). EB-virus-specific serologies including detection of viral capsid antigen IgM and IgG and EB nuclear antigen-1 IgG, were used as reference methods.

Results: Compared with the reference methods, the sensitivities and specificities of the heterophile antibody test kits were 70-92% and 96-100%, respectively. IM-Check had a low sensitivity and was difficult to read. The remaining kits performed well.

Conclusion: Monolatex, Mono-Latex, Mono-Lex, Mono-Plus and Clearview IM can be recommended for the confirmation of EB-virus-associated infectious mononucleosis. Clearview IM combined a high sensitivity and specificity with very simple one-step solid-phase-based procedure.

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral / blood*
  • Antibodies, Viral / immunology
  • Antigens, Heterophile / immunology*
  • Antigens, Viral / immunology*
  • Child
  • Child, Preschool
  • Evaluation Studies as Topic
  • Herpesvirus 4, Human / immunology
  • Herpesvirus 4, Human / isolation & purification*
  • Humans
  • Infectious Mononucleosis / blood
  • Infectious Mononucleosis / immunology
  • Infectious Mononucleosis / virology*
  • Middle Aged
  • Reagent Kits, Diagnostic*
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Antibodies, Viral
  • Antigens, Heterophile
  • Antigens, Viral
  • Reagent Kits, Diagnostic