Clinical Laboratory Assessment of Mycoplasma genitalium Transcription-Mediated Amplification Using Primary Female Urogenital Specimens

Abstract

Following analysis of primary cervix, vagina, and first-void female urine specimens for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis via commercial transcription-mediated amplification (TMA), residual material was subjected to Mycoplasma genitalium research-use-only TMA. Representation within a 2,478-specimen retrospective study set was established by comparison to a 6-month audit of clinical C. trachomatis TMA (12,999 specimens) on the basis of the C. trachomatis detection rate, specimen source distribution, clinic location, and age. M. genitalium was detected in 282 (11.4%) patients. This rate was higher than those seen with T. vaginalis (9.0%; P ‫؍‬ 0.005), C. trachomatis (6.2%), and N. gonorrhoeae (1.4%). Positive M. genitalium results were confirmed by repeat testing or alternative-target TMA at a rate of 98.7%. The mean age of the M. genitalium-infected females (24.7 years) was lower than that of the T. vaginalis-infected females (mean, 30.1 years; P < 0.0001) and higher than that of the C. trachomatis-infected females (mean, 23.8 years; P ‫؍‬ 0.003). Of 566 patient encounters positive for at least one sexually transmitted infection (STI), 35.9% exhibited sole detection of M. genitalium (P < 0.0004 versus sole detection of other STI agents) and 26.1% were solely positive for T. vaginalis (P < 0.0002 versus C. trachomatis). The M. genitalium and T. vaginalis detection rates among 755 patients at urban emergency departments were 14.6% and 13.0%, respectively (P ‫؍‬ 0.37). A 10.0% M. genitalium detection rate from other facilities exceeded that of T. vaginalis (7.2%; P ‫؍‬ 0.004). Incorporation of M. genitalium TMA into comprehensive testing programs would detect M. genitalium in a significant proportion of females, particularly those in outpatient obstetrics and gynecology (OB/GYN) settings. T he sexually transmitted infection (STI) agentMycoplasma genitalium has historically had a role of pathogenicity in male nongonococcal urethritis (1). Recent evidence has implicated the bacterium in clinically significant disease in females (2, 3). Additional studies suggest that M. genitalium infection promotes HIV acquisition (4-6) and virus shedding (7,8). Moreover, in a recent meta-analysis, Lis et al. (9) reported significant associations between M. genitalium infection and cervicitis, pelvic inflammatory disease, preterm birth, and spontaneous abortion.Until recently, a lack of reliable testing options has curtailed laboratory diagnosis of M. genitalium infection. Culture and serologic modalities have been limited by sensitivity and/or cross-reactivity with other mycoplasmas (1) and are becoming supplanted by molecular diagnostics, largely on a research basis. PCR-based assays have correlated M. genitalium DNA burden with clinical condition (10, 11) and treatment efficacy (12) in males. Quantitative molecular analysis has sought to study progression of genital disease in females (13). In the realm of laboratory diagnosis, initial studies of target capture-based transcription-mediated amp...

Mycoplasma genitalium Prevalence, Coinfection, and Macrolide Antibiotic Resistance Frequency in a Multicenter Clinical Study Cohort in the United States

“…genitalium genomic DNA targets (3, 4) and transcription-mediated amplification (TMA) for detection of M. genitalium 16S rRNA (5–7) has increased our understanding of the epidemiology of M. genitalium, as well as associations between M.…”

Molecular Diagnostics Update for the Emerging (If Not Already Widespread) Sexually Transmitted Infection Agent Mycoplasma genitalium: Just About Ready for Prime Time

“…Moreover, a recent report suggests that inclusion of multiple analytes and specimen source collections significantly increases detection of STI carrier status (33). Further investigations may be necessary to indicate targeted demographics (20,(28)(29)(30) should a fully comprehensive screening approach not be advocated in a given locale. Consideration of M. genitalium molecular diagnostics within an STI screening algorithm may ultimately realize public health benefits and improved clinical management.…”

“…A community-wide study (with broad demographic and acuity-of-illness coverage) in the same U.S. high-prevalence STI community assessed M. genitalium ASR using 2,478 residual female specimens submitted for routine laboratory screening of C. trachomatis, N. gonorrhoeae, and T. vaginalis (29). The M. genitalium detection rate was 11.4% and exceeded those of the other STI agents (P Յ 0.005).…”

Expansion of Comprehensive Screening of Male Sexually Transmitted Infection Clinic Attendees with Mycoplasma genitalium and Trichomonas vaginalis Molecular Assessment: a Retrospective Analysis

“…Previous data revealed that repeat TMA analysis performed the same as alternative target testing for confirmation of STI agent detection (19,20). In general, specificity of M. genitalium ASR within a female acute and subacute population was demonstrated by 98.8% concordance between results from M. genitalium ASR and alternative target testing (21). In conclusion, procurement of rectal, pharyngeal, and urine specimens increases overall identification of male STI carrier status.…”