Evaluation of five commercial enzyme immunoassays for the detection of human cytomegalovirus-specific IgM antibodies in the absence of a commercially available gold standard

Clin Chem Lab Med. 2001 Jan;39(1):62-70. doi: 10.1515/CCLM.2001.014.

Abstract

In the recent years the number of commercially available immunoassays for the detection of human cytomegalovirus (HCMV)-specific immunoglobulin M (IgM) antibodies has rapidly increased. The aim of the present study was to evaluate five commercial immunoassays for the serological diagnosis of HCMV-infection. These methods, namely the IMx CMV IgM assay, the AxSYM CMV IgM assay (both Abbott), the Gull CMV IgM, the CMV-IgM-ELA test PCS Medac and the Biotest Anti-HCMV recombinant IgM ELISA, were compared for their diagnostic effectiveness and interference with substances eventually producing cross-reactions with HCMV-IgM (Epstein-Barr-virus (EBV)-IgM, rheumatoid factor (RF)). In addition, repeated measurements on samples from kidney and heart transplant recipients with active HCMV infection were examined to compare the temporal development of the HCMV-IgM measured with the five assay systems. Since there is no commercially available gold standard, it was assumed that the true classification, of whether the patient sample is HCMV-IgM positive or negative, was unknown. Hence sensitivity and specificity were assessed based on a maximum likelihood approach using a "latent class" model. The cross-reactions were quantified by a Bayesian statistical model using prior information for the expected prevalences in the EBV-IgM and rheumatoid factor sample groups. The results of the study demonstrated that there are great differences in sensitivity and specificity as well as in cross-reactions with EBV-IgM and RF between the tested ELISAs.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antibodies / immunology*
  • Blotting, Western
  • Child
  • Child, Preschool
  • Cytomegalovirus / immunology*
  • Cytomegalovirus Infections / diagnosis
  • Enzyme-Linked Immunosorbent Assay / instrumentation
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Female
  • Heart Transplantation
  • Humans
  • Immunoenzyme Techniques / methods*
  • Immunoglobulin G / metabolism
  • Immunoglobulin M / immunology*
  • Kidney Transplantation
  • Likelihood Functions
  • Male
  • Middle Aged
  • Models, Statistical
  • Pregnancy
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Transplantation

Substances

  • Antibodies
  • Immunoglobulin G
  • Immunoglobulin M