An assessment of a new diagnostic indirect enzyme immunoassay for the detection of anti-Mycoplasma pneumoniae IgM

American Journal of Clinical Pathology
N Cimolai, A C Cheong

Abstract

A new and rapid IgM enzyme immunoassay (EIA)(Immuno Well, Gen-Bio, San Diego, CA) was evaluated for its ability to accurately establish a serodiagnosis for acute Mycoplasma pneumoniae infection. Case definitions were established with the combination of complement fixation (CF) serology, IgM anti-P1 immunoblotting, and clinical and other laboratory data. In an asymptomatic population of 52 children and adults, the EIA was positive for 3.9%. For 17 serum pairs for which there was evidence of a greater than or equal to 4-fold rise in CF titer, 5 acute sera (29.4%) and 14 convalescent sera (82.3%) were positive. In applying the assay to sera that were acquired from a prospective study of childhood infection where the positive case definition was maintained for 22.3% of patients, the sensitivity, specificity, positive predictive value, and negative predictive value for the EIA was 90.5%, 93.2%, 79.2%, and 97.1%, respectively. When the EIA results of a "low-positive," as defined by the manufacturer, were excluded from the positive group, the respective values were 81.0%, 97.3%, 89.5%, and 94.7%. The accuracy of this new assay will be influenced by the prevalence of true illness in the populations to which it may be applied.

Citations

May 12, 2006·Journal of Medical Microbiology·Esaki Muthu ShankarUsha Anand Rao
Sep 11, 2004·Clinical and Diagnostic Laboratory Immunology·Deborah F TalkingtonW Lanier Thacker
May 26, 2017·Clinical Microbiology Reviews·Ken B WaitesT Prescott Atkinson
Mar 11, 2004·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·F de OryJ M Echevarría
Dec 21, 2004·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·P A CsángóR D Hess

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