Affiliation:
1. Department of Medical Microbiology, Center of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands
2. Department of Microbiology, University of Antwerp, Antwerp, Belgium
Abstract
ABSTRACT
Serology and nucleic acid amplification are the main diagnostic tools for the diagnosis of
Mycoplasma pneumoniae
infection. Since no reference standard is generally accepted, serologic assays for
M. pneumoniae
have not been evaluated on a broad scale. In this study, 12 commercially available serologic assays (for immunoglobulin G [IgG] and IgM) and the complement fixation test (CFT) were evaluated by using
M. pneumoniae
DNA detection by real-time PCR as the “gold standard.” The assays tested were Platelia EIA (Bio-Rad), SeroMP EIA (Savyon), Serion classic EIA (Virion/Serion), Biotest EIA (Biotest), Ridascreen EIA (r-Biopharm), AniLabsystems EIA (Labsystems), Novum EIA (Novum Diagnostica), Diagnosys EIA (MP products), Genzyme/Virotech EIA, ImmunoWell EIA (Genbio), ImmunoCard EIA (Meridian), and SerodiaMycoII microparticle agglutination (Fujirebio). Serum samples (
n
= 46) from 27 PCR-positive patients with a known first day of disease and sera (
n
= 33) from PCR-negative controls were obtained from prospective studies of acute lower respiratory tract infections. Additionally, control sera (
n
= 63) from patients with acute viral or bacterial respiratory infections other than those caused by
M. pneumoniae
were tested. The results showed low specificities for both the Novum and the ImmunoCard IgM assays. The IgM assays with the best performances in terms of sensitivity and specificity were AniLabsystems (77% and 92%, respectively), SeroMP (71% and 88%, respectively), and CFT (65% and 97%, respectively). Good receiver operating characteristic areas under the curve were found for CFT (0.94), the Platelia assay (0.87), and the AniLabsystems assay (0.85). We conclude that there are few commercial serologic assays for the detection of
M. pneumoniae
infections with appropriate performances in terms of sensitivity and specificity and that PCR has become increasingly important for the diagnosis of
M. pneumoniae
infections in defined groups of patients.
Publisher
American Society for Microbiology
Cited by
169 articles.
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