Mycoplasma genitalium is now recognized as a possible cause of several idiopathic sexually transmitted disease (STD) syndromes. However, due to the difficulty of culture of this fastidious bacterium, nucleic acid amplification tests (NAATs) are necessary for its detection in patient specimens. In the current study we compared a newly developed research-only transcription-mediated amplification (TMA) assay (Gen-Probe Incorporated) to our in-house DNA-based PCR assay for detection of M. genitalium. The relative performance characteristics of these two NAATs were assessed with genital specimens from 284 women and 352 men reporting to an STD clinic in Seattle, WA. Among the women, M. genitalium was detected by the TMA and PCR assays in 36 (13%) and 39 (14%) vaginal swab specimens, respectively ( ‫؍‬ 0.923); 26 (9%) and 23 (8%) cervical swab specimens, respectively ( ‫؍‬ 0.843); and 25 (9%) and 28 (10%) urine specimens, respectively ( ‫؍‬ 0.687). Among the M. genitalium-positive women, the relative sensitivities of detection for the TMA and PCR assays were 84% and 91%, respectively, for vaginal swab specimens; 60% and 53%, respectively, for cervical swab specimens; and 58% and 65%, respectively, for urine specimens. By using an infected patient (a woman positive at any site by TMA assay and at any site by PCR) as a proxy for a "gold standard," the specificities of detection were >99.5% for both the TMA and the PCR assays. Among the men, M. genitalium was detected in 24 urine specimens (6.8%) by the TMA assay, 26 (7.4%) urine specimens by PCR assay, and 32 urine specimens (9%) by either test ( ‫؍‬ 0.791). We conclude that the M. genitalium TMA and PCR assays are highly specific and that vaginal swab specimens are the most sensitive specimen type for the detection of M. genitalium in women.Mycoplasma genitalium was first isolated from urethral exudates from two men with urethritis in 1981 (38), yet the isolation and culture of this fastidious organism are extremely difficult and time-consuming. Although culture techniques for M. genitalium have improved in the last two decades (20), efficient isolation and cultivation of this organism remain elusive (2,20), and thus, identification of infected individuals has relied on the use of PCR tests (16,36). The application of M. genitalium-specific PCR tests has allowed studies that assess reproductive tract disease in men and women, including urethritis, cervicitis, endometritis, and pelvic inflammatory disease (7,14,16,19,25,27,36,37), suggesting a disease spectrum similar to those caused by Chlamydia trachomatis and Neisseria gonorrhoeae. Detection of DNA from this organism by PCR in fallopian tube tissue from a woman with salpingitis (8) and the association of M. genitalium with tubal factor infertility by serologic tests (6) suggest an even broader range of disease associations and sequelae for this emerging pathogen. These results are particularly disconcerting, considering that M. genitalium has been detected in 1% of young adults in the U.S. general population, a preval...

Background Neisseria gonorrhoeae and Chlamydia trachomatis are characterized by different risk factors, thus control strategies for each also differ. In contrast, risk factors for Mycoplasma genitalium have not been well characterized. Methods Between 2000 and 2006, 1090 women ages 14 to 45 attending the Public Health-Seattle & King County Sexually Transmitted Diseases Clinic in Seattle, WA, underwent clinical examination and computer-assisted survey interview. M. genitalium was detected by transcription mediated amplification from self-obtained vaginal swab specimens. C. trachomatis and N. gonorrhoeae were detected by culture from cervical swab specimens. Results Prevalent M. genitalium infection was detected in 84 women (7.7%), C. trachomatis in 63 (5.8%), and N. gonorrhoeae in 26 (2.4%). Age <20 and nonwhite race were associated with increased risk for all 3 organisms. In addition, risk for M. genitalium was higher for women with a black partner (adjusted odds ratio [AOR]: 3.4; 95% confidence interval = 1.83–6.29), those never married (AOR: 2.6; 1.08–6.25), using Depo-Provera (AOR: 2.3; 1.19–4.46), and smoking (AOR: 1.7; 1.03–2.83). Drug use, history of STI in the past year, ≤high school education, meeting and having intercourse the same day, anal sex, douching, and hormonal contraception were associated with N. gonorrhoeae or C. trachomatis, but not with M. genitalium. Number of partners was not associated with any of the 3 organisms. Conclusions The limited number of risk factors for prevalent infection common to all 3 pathogens suggests that M. genitalium may circulate in different sexual networks than N. gonorrhoeae or C. trachomatis. The predominance of sociodemographic risk factors for M. genitalium, rather than high-risk sexual behaviors, suggests broad-based testing may be the most effective control strategy.

Although not statistically significant, this study indicates that mailed rescreening could be a successful method to increase rescreening rates.