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Objectives Mycoplasma pneumoniae  is one of the common causative pathogens of community-acquired respiratory tract infections mainly in children and young adults. Rapid and accurate diagnostic techniques for identifying the causative pathogen would be useful for initiating treatment with an appropriate antibiotic. The purpose of the present study was to evaluate the sensitivity and specificity of a novel immunochromatographic assay using silver amplification technology using FUJI DRI-CHEM IMMUNO AG2 and FUJI DRI-CHEM IMMUNO AG cartridge Myco (FUJIFILM Co., Tokyo, Japan) for detection of  M. pneumoniae . Methods Throat swab samples were collected from 170 pediatric patients who were diagnosed with bronchitis or pneumonia. The silver amplification immunochromatographic (SAI) assay was performed using these samples and the results were compared with those of real-time PCR. The time required for the SAI assay is approximately 20 min (5 min for sample preparation and 15 min for waiting time after starting the assay). Results The sensitivity and specificity of the SAI assay for detection of  M. pneumoniae  were 85.2 and 99.1%, respectively, and the assay showed positive and negative predictive values of 98.1 and 92.3%, respectively, compared with the results of real-time PCR. The diagnostic accuracy was 94.1%. Conclusions FUJI DRI-CHEM IMMUNO AG2 and FUJI DRI-CHEM IMMUNO AG cartridge Myco are appropriate for clinical use. The optimal timing of this assay is five days or more after the onset of  M. pneumoniae  infection. However, PCR or other molecular methods are superior, especially with regard to sensitivity and negative predictive value.

journal of laboratory medicine

Evaluation of a novel immunochromatographic assay using silver amplification technology for detection of  Mycoplasma pneumoniae  from throat swab samples in pediatric patients