INTRODUCTION
Mycoplasmas are members of the class Mollicutes. They are very small free-living bacteria usually ranging from 0.3–0.5 μm in size. Mycoplasma genitalium and Mycoplasma hominis and the two ureaplasma species Ureaplasma urealyticum (previously known as U. urealyticum biovar) and Ureaplasma parvum (previously known as U. urealyticum biovar) are commonly found in the human urogenital tract.
M. genitalium is found in 1–3% of sexually active men and women in population-based studies.
M. genitalium is a common cause of urethritis in men and women, and causes cervicitis and upper genital tract infection in women.
M. genitalium has been strongly and uniformly associated with non-gonococcal urethritis (NGU) in more than 30 studies, and has been detected in the urethra of 15–25% of men with symptomatic NGU compared to about 5–10% of those without this disease. In studies that evaluated the association with non-chlamydial NGU (NCNGU), the association has generally been stronger, showing that M. genitalium and C. trachomatis act as separate causes of NGU. In several studies, M. genitalium has been found in more than one third of men with NCNGU. Among sexual health clinic populations, approximately 90% of M. genitalium-infected men have microscopic signs of urethritis and almost three quarters report symptoms. Several clinical studies have shown a strong correlation between M. genitalium and persistent or recurrent NGU, particularly in the context of using doxycycline for syndromic treatment for NGU.
All currently available diagnostic reagents use nucleic acid assays.

PRINCIPLE
StrongStep®Mycoplasma genitalium Antigen Rapid Test has been designed to detect M. genitalium antigen through visual interpretation of color development in the internal strip. The membrane was immobilized with monoclonal anti- M. genitalium antibodies on the test region. During the test, the specimen is allowed to react with colored monoclonal anti- M. genitalium antibodies colored particals conjugates, which were precoated on the conjugate pad of the test. The mixture then moves on the membrane by capillary action, and interact with reagents on the membrane. If there were enough M. genitalium antigen in specimens, a colored band will form at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.