Comparison of chemiluminescence immunoassay, enzyme-linked immunosorbent assay and passive agglutination for diagnosis of Mycoplasma pneumoniae infection.

Objective: This study aimed to compare the performance of chemiluminescence immunoassay (CLIA), enzyme-linked immunosorbent assay (ELISA), and passive agglutination (PA) method in detecting Mycoplasma pneumoniae (MP) infection.

Methods: This study enrolled a total of 280 patients who were consecutively seen at the Nanfang Hospital of the Southern Medical University in Guangdong Province, China, between August and December 2016. Serum was collected and examined by CLIA, ELISA, and PA, respectively.

Results: There were 180 positive (64.3%) and 100 negative cases (35.7%) by PA, 184 positive (65.7%) and 96 negative cases (34.3%) by CLIA MP-immunoglobulin (Ig) M, 89 positive (31.8%) and 191 negative cases (68.2%) by CLIA MP-IgG, 196 positive (70%) and 84 negative cases (30%) by ELISA MP-IgM, and 114 positive (40.7%) and 166 negative cases (59.3%) by ELISA MP-IgG. Patients were allocated to two groups based on PA results. In PA-negative group (≤1:40), the positive rates of MP-IgM by CLIA were 22.8% and 51.2% and by ELISA were 33.3% and 53.5%, respectively. In the PA-positive group (1:80 to ≥1:1,280), MP-IgM negative cases showed a decreasing trend: 40%, 18%, 14.3%, 10%, and 6.7% (CLIA), and 43.3%, 8%, 14.3%, 5%, and 6.7% (ELISA). The consistency between CLIA/ELISA MP-IgM, -IgG, and -IgG+MP-IgM was >92% for negative cases and >75% for positive cases, resulting in an overall consistency rate >88%. The kappa coefficients were 0.804, 0.763, and 0.806, respectively.

Conclusion: CLIA and ELISA have a higher sensitivity compared with PA. CLIA has a high concordance with ELISA. Moreover, CLIA has a higher specificity and sensitivity for the detection of IgM and IgG and should be used for the clinical diagnosis of MP infection.