[Validation of the Kit for Detecting Mycoplasma Genitalium from the Male Urethritis]

Mycoplasma genitalium is one of the pathogenic microorganisms in male urethritis as a sexually transmitted infection (STI). M.genitalium is detected in the urine specimens of 15-25% male patients with urethritis. The emergence of macrolide- or fluoroquinolone-resistant M.genitalium has become a serious problem in the treatment of male urethritis worldwide, but there is no commercial-based detecting kits accepted by the national insurance in Japan. In this study, we tested the validity of a molecular kit for detecting seven microorganisms related to STI (Anyplex™ II STI-7 Detection which detects Neisseria gonorrhoeae, Chlamydia trachomatis, M.genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum, Trichomonas vaginalis) produced by Seegene company in Korea. Seventeen M.genitalium strains were used to determine the detection limit of M.genitalium. M.genitalium DNA samples were extracted from M.genitalium strains and the diluted DNA samples were reacted to detect M.genitalium by the Anyplex™ II STI-7 Detection. The detection limit was determined as the maximum dilution of DNA samples and the number of M.genitalium DNA copies calculated. In this study, the minimum DNA copies to detect M.genitalium by the Anyplex™ II STI-7 Detection was determined to be around 50 per reaction. The detection rates of M.genitalium in urine specimens were compared between MgPa gene PCR and the Anyplex™ II STI-7 Detection. The positive and negative concordant rates were high as 96.4% (27/28) and 98.6% (71/72), respectively. The validity of the kit for detecting seven microorganisms related to STI (Anyplex™ II STI-7 Detection) was high and thought to be useful for clinical uses.