Trichomoniasis is a common sexually transmitted disease associated with preterm birth, low birth weight, and increased susceptibility to infection with other pathogenic sexually transmitted microorganisms. Nucleic acid amplification tests for Trichomonas vaginalis have improved sensitivity for detecting infected individuals compared to existing culture-based methods. This prospective, multicenter U.S. clinical trial evaluated the performance of the automated Aptima T. vaginalis assay for detecting T. vaginalis in 1,025 asymptomatic and symptomatic women. Vaginal swab, endocervical swab, ThinPrep PreservCyt, and urine specimens were collected. Subject infection status was determined by wet-mount microscopy and culture. Aptima T. vaginalis assay performance was determined for each specimen type by comparison to subject infection status. Of 933 subjects analyzed, 59.9% were symptomatic. Aptima T. vaginalis clinical sensitivity and specificity were, respectively, 100% and 99.0% for vaginal swabs, 100% and 99.4% for endocervical swabs, 100% and 99.6% in ThinPrep samples, and 95.2% and 98.9% in urine specimens. Aptima T. vaginalis performance levels were similar in asymptomatic and symptomatic subjects. This study validates the clinical performance of the Aptima T. vaginalis assay for screening asymptomatic and symptomatic women for T. vaginalis infection.Trichomoniasis, a common sexually transmitted disease (STD) caused by the protozoan Trichomonas vaginalis, affects approximately 180 million persons per year worldwide, making it the most common nonviral STD agent in the world. An estimated 7.4 million new cases occur annually in the United States (1), and the disease has an overall prevalence of 3.1% (24). Both women and men can be infected, although symptoms are more common in women. Symptomatic women have a diffuse, malodorous, yellow-green vaginal discharge with vulvar irritation which may be confused with bacterial vaginosis. Infected men may temporarily have urethral irritation, mild discharge, or slight burning after urination or ejaculation (5). Many infections do not produce symptoms and when left untreated may lead to preterm birth, low birth weight, and pelvic inflammatory disease (5). T. vaginalis infection also increases susceptibility to infection with HIV (14,22,23). Effective and inexpensive antibiotic therapy for T. vaginalis infection is readily available, and detection and treatment of T. vaginalis in symptomatic or asymptomatic women with a high risk of STD are important to prevent disease acquisition, transmission, and associated complications.Currently, the gold standard for the diagnosis of T. vaginalis infection is culture; however, the sensitivity of commercially available culture has been reported to be 75% to 89% compared to amplified methods (13,20). Tests with improved sensitivity are needed to diagnose this prevalent STD. The Aptima Trichomonas vaginalis assay, an FDA-cleared, fully automated nucleic acid amplification test, has demonstrated high sensitivity and specificity compared to c...

In female sexually transmitted infection (STI) clinic attendees, Mycoplasma genitalium (MG) was more frequently detected using vaginal (53/73) versus endocervical (43/73) specimens. In women without other STIs, MG detection (N=44) was associated with age≤ 22 years (odds ratio (OR) 2.53, P=0.006) and clinical evidence of cervicitis (OR 2.11, P=0.03).

Testing remnant Aptima specimens from women infected with Chlamydia trachomatis detected 13.4% (53/396) with Mycoplasma genitalium compared with 5.4% (22/406) in matched C. trachomatis-negative women. Overall, 9.4% (provincial ranges of 3-20%) were infected with M. genitalium and resistance mediating mutations were found in 47.3% (26/55) to macrolides and 1.9% (1/53) to fluoroquinolones by sequencing.

Urinary meatal swabs compared with urine showed higher infection rates for Mycoplasma genitalium (15.3% vs 12.6%, P = 0.035), Chlamydia trachomatis (11.3% vs 9.3%, P = 0.039), Neisseria gonorrhoeae (1.4% vs 1.1%, P = 1.00), Trichomonas vaginalis (8.0% vs 1.7%, P < 0.001), and high-risk human papillomavirus (5.9% vs 3.4%, P = 0.078) respectively.

No abstract

Mycorrhizal fungi are transplanted into exotic habitats to aid in agriculture and land restoration. However, different taxa have different effects on hosts, and little is known about their survival or spread. The fate of arbuscular mycorrhizal fungi was examined in a reciprocal transplant experiment of a single host shrub species, Artemisia tridentata subspecies tridentata between two semiarid sites. The sites were located near Reno, Nevada, and San Diego, California, in the western United States. The experiment was a complete factorial design: two plant populations, A. tridentata ssp. tridentata from the Reno and the San Diego sites, and five fungal treatments (Acaulospora elegans from San Diego, Scutellospora calospora from Reno, a whole‐soil inoculum from San Diego, a whole‐soil inoculum from Reno, and uninoculated soil). Based on fluorescein isothiocyanate‐labeled antiserum studies, neither fungus declined over three growing seasons at the site of origin with the plant population of origin. Survival of the fungi always declined in association with the exotic host population and at the exotic site. Spore density of fungi that had been inoculated was generally very low. However, when significant differences between treatments were observed, spore density of the fungus was higher in association with plants that had been inoculated with it than with uninoculated plants, and the fungus had higher survivorship in the site and with the host of its origin. Both fungi usually sporulated more often under inoculated than uninoculated host plants. Over three growing seasons, both A. elegans and S. calospora survived in their sites of origin and in the exotic location with both plant populations. The fungi spread throughout the root systems and between plants of the different treatments. These results show that, while there was higher survival by the arbuscular mycorrhizal fungi at the site and with the host of origin, these fungi survived and spread for at least three growing seasons, although they declined significantly at the exotic site and with exotic hosts.

SurePath specimens from women referred to colposcopy were treated with Aptima Transfer Solution (ATS) before testing in Aptima HPV (AHPV) and Aptima HPV 16, 18/45 (AHPV-GT) assays. Untreated SurePath specimens were tested with the cobas HPV test. PreservCyt specimens were assessed for cytology and tested with AHPV. High-grade cervical intraepithelial neoplasia lesions served as the reference standard. Excellent agreement (95.5%; k=0.91) was observed for ATS-treated SurePath specimens between Tigris and Panther systems and between the PreservCyt and ATS-treated SurePath specimens (91.1%, k=0.81) with the AHPV assay on Tigris. Agreement between the AHPV and cobas assays with SurePath specimens was substantial (89.9%, k=0.80). AHPV sensitivity for CIN2+(n=147) was 91.2% for SurePath and PreservCyt. Cobas HPV sensitivity was 93.9% for SurePath specimens. AHPV testing of SurePath specimens was more specific (59.4%) than cobas (54.7%) (p<0.001). Detection and genotyping showed similar absolute and relative risks. ATS-treated SurePath specimens tested with AHPV and AHPV-GT assays showed similar performance with greater specificity than cobas HPV on SurePath specimens. Similar overall results were seen using a CIN3 disease endpoint.

Mycoplasma genitalium is a sexually transmitted bacterium linked to adverse sexual and reproductive health outcomes in women and men. M. genitalium is difficult to culture, and in the absence of validated amplified molecular methods for diagnosis of infection, there is no reference standard available for use as a comparator for the validation of new M. genitalium diagnostic tests. We evaluated the analytical and clinical performance of three transcription-mediated amplification (TMA) tests for M. genitalium, each targeting unique rRNA sequences, for use as a composite comparator for clinical validation of the Aptima Mycoplasma genitalium (AMG) assay, an in vitro diagnostic (IVD) TMA test that targets 16 s rRNA of M. genitalium. Analytical sensitivity, specificity, and strain inclusivity of all four TMA tests were determined using nine laboratory strains of M. genitalium and 56 nontarget bacteria, protozoa, and viruses. Analytical sensitivity of the tests for M. genitalium ranged from 0.017 to 0.040 genome equivalents/ml. None of the nontarget organisms evaluated cross-reacted with any test. A composite comparator reference standard consisting of the 3 alternate (Alt) TMA tests was used to evaluate the clinical performance of the AMG assay by testing residual vaginal swab, female urine, and male urine specimens obtained from 1,400 adult subjects from three U.S. clinical sites. Using this reference standard to establish infected specimen status, the sensitivity, specificity, and overall agreement of the AMG IVD assay were 100%, 99.9%, and 99.9%, respectively. These results demonstrate the utility of molecular composite reference standard methodology for the clinical validation of future IVD tests for this organism.