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...

Trichomoniasis is a significant sexually transmitted disease (STD) in the spectrum of public health and primary care because of its association with agents such as human immunodeficiency virus and Neisseria gonorrhoeae. However, its true significance may be underestimated due to diagnostic modalities that exhibit poor sensitivity. A total of 1,086 genital specimens from two urban emergency departments, a suburban urgent-care facility, and a metropolitan outpatient physician group were subjected to transcription-mediated amplification-based Trichomonas vaginalis analyte-specific-reagent (ASR) testing (Gen-Probe, Inc.). The rate of positive molecular ASR results (14.5%) doubled that of direct saline preparation (7.0%; P < 0.0002). Analogous increases were observed at one emergency department and within the outpatient physician group (P < 0.0002). No significant increase in the rate of positive molecular ASR results was observed from the facilities that encountered a lower frequency of black/African American patients. While positive T. vaginalis findings via direct saline preparation did not have a significant association with concomitant Chlamydia trachomatis or N. gonorrhoeae infection overall, a positive T. vaginalis ASR result was a better predictor of concomitant C. trachomatis or N. gonorrhoeae infection (odds ratios of 2.34 and 4.46, respectively; P < 0.0001). The increased rate of positive T. vaginalis ASR results was observed in both point-of-care (P ‫؍‬ 0.02 versus direct saline preparation) and laboratory (P ‫؍‬ 0.003) testing. Highly sensitive T. vaginalis molecular ASR not only transcends issues of specimen integrity and microscopic acumen but also has an increased ability to predict the likelihood of additional STDs in defined populations.In spite of the discovery of Trichomonas vaginalis nearly 175 years ago and documentation of its inhabitation of the female urogenital tract and the male urinary tract in the late 1800s, pathogenicity was not ascribed to this agent until the European literature of the 20th century (19). Reports have since shown the significance of antecedent T. vaginalis infection, especially in human immunodeficiency virus coinfection (22, 37), acquisition (21), and transmission (17, 23); in pregnancy-related complications (10, 43); and in associations with pelvic inflammatory disease (16) and Neisseria gonorrhoeae infection (16,24). T. vaginalis is currently thought to be responsible for approximately 50% of all curable infections worldwide (5); worldwide estimates of annual trichomoniasis incidence have reached 180 million cases (42).While the aforementioned data may be of tremendous significance, trichomoniasis prevalence rates, both worldwide and in the United States, are thought to be grossly underestimated. Schwebke and Burgess (32) hypothesize that the variable sensitivity of T. vaginalis diagnostic testing contributes partially to these artificially low statistics. Direct examination of genital saline collections continues to serve as a common basis for laboratory detection...

bRecent literature has reported increased accuracy of Trichomonas vaginalis transcription-mediated amplification (TMA)-based analyte-specific reagent (ASR) testing in female populations. A retrospective investigation assessed 7,277 female first-void urine, cervical, or vaginal specimens submitted from a high-prevalence sexually transmitted infection (STI) community to characterize prevalence of disease etiologies. The most common STI phenotype reflected detection of solely T. vaginalis (54.2% of all health care encounters that resulted in STI detection). In females with detectable T. vaginalis, codetection of Chlamydia trachomatis and Neisseria gonorrhoeae occurred in 7.8% and 2.7% of health care encounters, respectively. The mean age of women with detectable T. vaginalis (30.6) was significantly higher than those for women with C. trachomatis or N. gonorrhoeae (22.3 and 21.6, respectively; P < 0.0001). T. vaginalis was the predominant sexually transmitted agent in women over the age of 20 (P < 0.0002). C. trachomatis was the most commonly detected agent in females under the age of 21, particularly from cervical specimens. However, first-void urine detection rates for T. vaginalis and C. trachomatis within this age demographic demonstrated no difference (P ‫؍‬ 0.92). While overall and cervical specimen-derived detection of T. vaginalis within African American majority geographical locales outweighed that within majority Caucasian geographical regions (P < 0.004), this difference was not noted with first-void urine screening (P ‫؍‬ 0.54). Health care professionals can consider TMA-based T. vaginalis screening for a wide age range of patients; incorporation of first-void urine specimens into screening algorithms can potentiate novel insight into the epidemiology of trichomoniasis.

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Trichomonas vaginalis infection in males has been largely uncharacterized. Past reports indicated increased susceptibility to other sexually transmitted infection (STI) agents such as human immunodeficiency virus and Neisseria gonorrhoeae with concurrent T. vaginalis infection. This warrants a more thorough review of male T. vaginalis incidence. A retrospective 3-year investigation of transcription-mediated amplification (TMA)-based urethral swab and first-void urine screening for T. vaginalis within a regional health care system was performed to address T. vaginalis prevalence in males. Of 622 total samples tested, 6.6% were positive for T. vaginalis. Delineation of all specimens by ZIP code of patient residence revealed 11 predominant ZIP codes with respect to testing volume and detection rates. Within these 11 ZIP codes, representing 78.3% of total testing volume, urine was the preferred specimen source compared to urethral swabs. Seven of these 11 ZIP codes contained majority African American populations. The aggregate T. vaginalis detection rate trended higher than that of the remaining four ZIP codes, which were comprised primarily of Caucasian populations (8.9% versus 5.0%, respectively; P ‫؍‬ 0.15). The average age of a T. vaginalis-infected male (39.9 years) was significantly greater than those for Chlamydia trachomatis or N. gonorrhoeae (27.6 and 25.9 years, respectively; P < 0.001). Given the significant rate of T. vaginalis detection, with age distribution analogous to that reported in females, TMA-based detection of T. vaginalis can be a routine constituent within a comprehensive STI screening panel for males in high-prevalence STI communities.

A total of 7,899 specimens submitted for live clinical Trichomonas vaginalis analyte-specific reagent (ASR) screening from 2008 to 2010 were audited on the basis of patient gender, specimen source, molecular Neisseria gonorrhoeae and Chlamydia trachomatis results, and relative light unit (RLU) data yielded by T. vaginalis ASR. Only 1.4% of the screening was ordered by emergency department clinicians. The screening volume in 2010 was 126% higher than that in 2008. The proportions of annual female and male screening remained consistent throughout the 3-year interval (ϳ92 and 8%, respectively). Although 71.8 and 9.5% of screening was performed on endocervical and vaginal specimens, respectively, over the 3-year period, no significant difference was noted in the T. vaginalis detection rates (8.9 and 8.6%, P ‫؍‬ 0.85). Increased T. vaginalis detection was derived from female urine specimens (12.6%) compared to female genital swabs (P ‫؍‬ 0.0004). The proportion of female urine screening increased during the 3-year interval (P < 0.0002). T. vaginalis detection rate in males was 6.6%, with no difference between urethral and urine T. vaginalis detection (P ‫؍‬ 0.53). The mean RLU value for 714 positive specimens was 3,971,441; analogous values for each female specimen source and combined male source testing showed no variance (P > 0.29). Combined-gender T. vaginalis detection rate (9.1%) was significantly greater than those of C. trachomatis (5.9%) and N. gonorrhoeae (1.5%; P < 0.0002). Equivocal results presented at a rate of 0.4%. T. vaginalis ASR is an increasingly utilized assay that yields higher detection rates than other sexually transmitted infection etiologies in this community subacute care setting.

Transcription-mediated amplification (TMA) enhances detection of Neisseria gonorrhoeae and Chlamydia trachomatis from rectal and pharyngeal sources. The utility of TMA for detection of Trichomonas vaginalis has recently been described. We report on the performance of TMA for detection of sexually transmitted infection (STI) agents from extraurogenital sources, with a focus on T. vaginalis. Within a 21-month interval, 1,314 consecutive male patient encounters at an STI clinic resulted in collection of 2,408 specimens for C. trachomatis, N. gonorrhoeae, and T. vaginalis TMA screening. A total of 471 encounters were managed with a single specimen collection (94.9% urine), with 12.7% positive for at least one STI agent. This detection percentage increased to 14.4% with collection of specimens from two sources and to 20.3% with collection from three sources (P ‫؍‬ 0.03 versus single-source sampling). A total of 44.4% of encounters were managed by collection of urine and pharyngeal specimens and 19.1% by the addition of a third (rectal) collection. While procurement of urine and rectal specimens resulted in greater detection of C. trachomatis (6.1% and 11.3% rates, respectively) than of other STI agents, 858 pharyngeal specimens yielded a 2.9% T. vaginalis detection rate compared with 2.1% for N. gonorrhoeae and 1.6% for C. trachomatis. All T. vaginalis pharyngeal detections were confirmed by TMA-based alternative target testing. A total of 38.1% of T. vaginalis-positive pharyngeal specimens were derived from symptomatic patient encounters. A total of 85.7% of males with T. vaginalis-positive pharyngeal collections indicated strictly heterosexual preference. Additional specimen source sampling is necessary to make STI screening comprehensive. Incorporation of extraurogenital sources into assessment for T. vaginalis detection may identify additional symptomatic and asymptomatic male STI carriers.