Abstract
Mycoplasma pneumoniae is a particularly important pathogen that causes community acquired pneumonia in children. In this study, a rapid test was developed to diagnose M. pneumoniae by using a colloidal gold-based immuno-chromatographic assay which targets a region of the P1 gene. 302 specimens were analyzed by the colloidal gold assay in parallel with real-time PCR. Interestingly, the colloidal gold assay allowed M. pneumoniae identification, with a detection limit of 1 × 103 copies/ml. 76 samples were found to be positive in both real-time PCR and the colloidal gold assay; two specimens positive in real-time PCR were negative in the rapid colloidal gold assay. The specificity and sensitivity of the colloidal gold assay were 100% and 97.4%, respectively. These findings indicate that the newly developed immuno-chromatographic antigen assay is a rapid, sensitive and specific method for identifying M. pneumoniae, with potential clinical application in the early diagnosis of Mycoplasma pneumoniae infection.
Highlights
Our results showed that M. pneumoniae was identified correctly by the colloidal gold assay with no cross-reactions found between M. pneumoniae and other pathogens (Data not shown)
M. pneumoniae is a common pathogen of primary atypical pneumonia and other respiratory infectious diseases[14,15]
Miyashita et al reported a diagnostic sensitivity of only 60% that of real-time PCR for a commercial rapid antigen kit (Asahi Kasei Pharma Co., Tokyo, Japan)[20]
Summary
To assess the sensitivity of the colloidal gold assay, standard M. pneumoniae was quantified by real-time PCR and submitted to serial 10-fold dilutions to obtain 101 to 107 copies/ml. The 76 specimens positive in the colloidal gold assay were in real-time PCR; the corresponding patients were admitted to the hospital with a disease course of 5–10 days. P = 0.000) between the colloidal gold assay and real-time PCR, indicating a high specificity for the newly developed method.
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