Open AccessEvaluation of the Virclia ® automated chemiluminescent immunoassay system for diagnosing pneumonia caused by Mycoplasma pneumoniae
Author(s) -
Ortiz de la Tabla Victoria,
Berruezo Marta,
García Payá Elena,
Fernández Marta,
García José Alberto,
Masiá Mar,
Gutiérrez Félix
Publication year - 2018
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.22431
Subject(s) - mycoplasma pneumoniae , medicine , receiver operating characteristic , serology , immunoassay , pneumonia , chemiluminescent immunoassay , immunology , mycoplasma pneumonia , gastroenterology , antibody
Background Mycoplasma pneumoniae is considered an important etiologic agent of community‐acquired pneumonia ( CAP ) in outpatients. We aimed to evaluate the diagnostic accuracy of a quick automated chemiluminescent immunoassay ( CLIA ) for M. pneumoniae in a population‐based prospective study of CAP . Methods A total of 137 outpatients diagnosed with CAP were included in the study. Acute‐ and convalescent phase sera were analyzed for IgG and IgM to M. pneumoniae with both CLIA (VirClia ® ) and ELISA immunoassays. Conventional serological criteria by quantitative ELISA were considered as reference standard. Sensitivity and specificity of the assay were assessed with the construction of receiver operating characteristic ( ROC ) curves, and the kappa index was used to evaluate the accuracy of the IgG and IgM determinations in the acute phase. Results Thirty‐eight patients were diagnosed with pneumonia by M. pneumoniae . ROC curves for IgG and IgM of convalescent and acute phase (C/A) quotients by the CLIA and ELISA assays were comparable. Specifically, for the CLIA , the best C/A quotient for IgG was 2.617 (sensitivity, 94.9%; specificity, 99.9%), and for IgM 1.400 (sensitivity, 65.8%; specificity, 100%). Regarding the acute phase, the best diagnostic accuracy for the CLIA was obtained with an IgG index of 1.120 (sensitivity, 89.5%; specificity, 73.7%). The CLIA was very simple to execute and required a minimum sample handling. Conclusion The accuracy of the Virclia ® assay for the diagnosis of M. pneumoniae infection in outpatients with CAP was equivalent to the quantitative ELISA . The CLIA was quicker to perform and displayed better analytic workability than conventional ELISA .