Evaluation of 12 Commercial Tests and the Complement Fixation Test for Mycoplasma pneumoniae -Specific Immunoglobulin G (IgG) and IgM Antibodies, with PCR Used as the “Gold Standard”

• DOI: 10.1128/jcm.43.5.2277-2285.2005
• Publication Date: 2005-05-04T22:33:14Z
• Authors: Matthias F. C. Be...; Kristien Dirven; Alje P. van Dam; Kate E. Templeton; Eric C. J. Claas; Herman Goossens
• Keywords: Complement fixation test; Gold standard (test); Immunoglobulin M; Latex fixation test; Mycoplasmataceae

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