Comparison of a novel chemiluminescence immunoassay with the passive agglutination method for the diagnosis of Mycoplasma pneumoniae infection in children

Abstract Objective The purpose of this study was to evaluate a newly developed chemiluminescence immunoassay (CLIA) and compare it to passive agglutination (PA) for the diagnosis of pneumonia caused by Mycoplasma pneumoniae in children. Method A total of 291 children suspected of M. pneumoniae infections were enrolled. Serum samples were obtained from routine diagnostic requests, and specific antibodies were simultaneously detected by PA and CLIA. Cohen's kappa was used to assess the agreement between the PA and CLIA assays, multivariate logistic regression analysis was used to evaluate risk factors for the discordance between the PA and CLIA assays. Results The positive rate was 62.2% (181/291) for PA and 61.2% (178/291) for CLIA (P = 0. 08). The specificity, sensitivity, negative, and positive predictive values of CLIA for M. pneumoniae infection were 80.09%, 86.7%, 78.8%, and 88.2%, respectively, with the PA test considered as the diagnostic standard. The correlation of the CLIA and PA assays was 76.8%, and the Kappa coefficient was 0.80. Significant correlations were found between the PA titers and the results of MP-IgM (R = 0.88, P  Conclusions A high degree of consistency was found between the PA and CLIA methods in detecting M. pneumoniae infections. CLIA is a reliable and rapid method and might be a promising alternative assay to PA for the diagnosis of M. pneumoniae infections.