Evaluation of the Abbott ARCHITECT™ cytomegalovirus IgM/IgG, rubella IgM/IgG, and syphilis treponemal antibodies enzyme immunoassays in a mother and child health center population

Diagn Microbiol Infect Dis. 2019 Jul;94(3):231-235. doi: 10.1016/j.diagmicrobio.2018.12.017. Epub 2019 Jan 17.

Abstract

This study evaluated the concordance of Architect™ chemiluminescent microparticle immunoassays with Captia™ ELISA for cytomegalovirus (CMV) IgM and IgG, with Enzygnost™ and Captia™ ELISA for rubella IgM and IgG and with Trep-Sure™ ELISA for syphilis treponemal antibodies in a mixed pediatric and obstetrical population. Total agreement between assays and Kappa statistic value were 82.5% (95% CI: 75.6-87.7) and 0.65 (95% CI: 0.54-0.77) for CMV IgM, 82.8% (95% CI: 76.7-87.6) and 0.65 (95% CI: 0.55-0.75) for CMV IgG, 89.2% (95% CI: 82.9-93.4) and 0.56 (95% CI: 0.36-0.75) for rubella IgM, 88.6% (95% CI: 82.9-92.6) and 0.74 (95% CI: 0.63-0.84) for rubella IgG, and 97.9% (95% CI: 94.5-99.4) and 0.89 (95% CI: 0.79-1.00) for syphilis treponemal antibodies. This study demonstrates that the Architect™ chemiluminescent microparticle immunoassays correlate well with other FDA-approved ELISA assays in this specific population.

Keywords: Chemiluminescent microparticle immunoassay; Congenital infection; Cytomegalovirus; Enzyme-linked immunosorbent assay; Rubella; Syphilis.

Publication types

  • Evaluation Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Bacterial / blood*
  • Antibodies, Viral / blood*
  • Child
  • Child, Preschool
  • Cytomegalovirus Infections / diagnosis*
  • Diagnostic Tests, Routine / methods*
  • Female
  • Humans
  • Immunoenzyme Techniques / methods*
  • Immunoglobulin G / blood
  • Immunoglobulin M / blood
  • Infant
  • Infant, Newborn
  • Luminescent Measurements
  • Male
  • Middle Aged
  • Rubella / diagnosis*
  • Syphilis / diagnosis*
  • Young Adult

Substances

  • Antibodies, Bacterial
  • Antibodies, Viral
  • Immunoglobulin G
  • Immunoglobulin M