Diagnostic sensitivity of a rapid antigen test for the detection of Mycoplasma pneumoniae: Comparison with real-time PCR.

A rapid antigen kit for the detection of the Mycoplasma pneumoniae ribosomal protein L7/L12 using an immunochromatographic assay, Ribotest Mycoplasma, became available in Japan in 2013. To determine the sensitivity of Ribotest compared with real-time polymerase chain reaction (PCR), we prospectively performed these two tests simultaneously in adolescent and adult patients with community-acquired pneumonia (CAP). In addition, we retrospectively analyzed the theoretical sensitivity of Ribotest using M. pneumoniae PCR-positive specimens from previous studies. In prospective study, 118 CAP cases were enrolled, and 16 cases were diagnosed as M. pneumoniae pneumonia; eight cases were PCR-positive, one case was culture positive, and all cases demonstrated a four-fold increase in antibody titer. Ribotest was positive in 15 cases; five cases were PCR positive and 10 cases were PCR negative. For the PCR was control test, the sensitivity, specificity, and overall agreement with Ribotest were 62.5%, 90.9%, and 88.9%, respectively. In the retrospective study, we used 1110 M. pneumoniae PCR-positive specimens, which are collected from pediatric patients with respiratory tract infection who visited 65 institutions throughout Japan. Using a cut-off level for the Ribotest of 8.3 × 10(4) copy/mL in transport medium, 667 (60.0%) specimens were theoretically positive. In conclusion, our prospective and retrospective results demonstrated that the diagnostic sensitivity of Ribotest compared with PCR was not high, at approximately 60%. Thus, treatment decisions about M. pneumoniae pneumonia should be based on clinical findings such as Japanese Respiratory Society scoring system and not on Ribotest results alone.