Jill S. Huppert

Rapid Antigen Testing Compares Favorably with Transcription-Mediated Amplification Assay for the Detection of Trichomonas vaginalis in Young Women

BACKGROUND Diagnosis of Trichomonas vaginalis (TV) infection is limited by imperfect testing methods. Newer tests, such as rapid antigen and nucleic acid amplification tests, are often compared with culture, which is not widely used but is more sensitive than wet mount. We assessed the sensitivity and specificity of 4 tests for the identification of TV using 3 statistical approaches. METHODS Sexually active adolescent women aged 14-21 years (n=330) were recruited from a teen health center and emergency department. Vaginal swabs were tested for TV using wet mount, culture (InPouch TV; Biomed Diagnostics), rapid antigen testing (OSOM TV; Genzyme Diagnostics), and transcription-mediated amplification testing (TMA; APTIMA TV analyte specific reagents; Gen-Probe). RESULTS TV was detected in 61 participants (18.5%). Compared with a composite reference standard (i.e., any TV test with positive results), the sensitivities of wet mount, culture, rapid antigen testing, and TMA were 50.8%, 75.4%, 82%, and 98.4%, respectively. Using latent class analysis, the sensitivity of wet mount (56%) was significantly lower than that of other tests, and the sensitivities of culture and rapid antigen testing were similar (83% and 90%, respectively); specificity was 100% for each of these 3 methods. TMA had a sensitivity of 98.2% and a specificity of 98%. Tests performed equally well regardless of whether the participant had bleeding or other infections. The sensitivities of the rapid antigen test and TMA were comparable (92.5% and 97.5%, respectively) in women who had vaginal symptoms. CONCLUSIONS Wet mount alone is insufficient for the reliable diagnosis of TV infection in women. TMA and rapid antigen tests are highly sensitive and specific, and both are superior to wet mount. Rapid antigen testing is equivalent to culture, and it compares favorably with the sensitivity of TMA for the detection of TV.

Use of an Immunochromatographic Assay for Rapid Detection of Trichomonas vaginalis in Vaginal Specimens

ABSTRACT Trichomonas vaginalis infection is estimated to be the most widely prevalent nonviral sexually transmitted infection in the world. Wet-mount microscopy is the most common diagnostic method, although it is less sensitive than culture. The OSOM Trichomonas Rapid Test (Genzyme Diagnostics, Cambridge, Mass.) (referred to here as OSOM) is a new point-of-care diagnostic assay for T. vaginalis that uses an immunochromatographic capillary flow (dipstick) assay and provides results in 10 min. The purpose of this study was to determine the test characteristics of OSOM compared to those of a composite reference standard (CRS) comprised of wet-mount microscopy and T. vaginalis culture. This multicenter cross-sectional study enrolled sexually active women ≥18 years of age who presented with symptoms of vaginitis, exposure to T. vaginalis, or multiple sexual partners. Vaginal-swab specimens were obtained for T. vaginalis culture, wet mount, and rapid testing. The prevalence of T. vaginalis in this sample was 23.4% (105 of 449) by the CRS. The sensitivity and specificity of OSOM vaginal-swab specimens were 83.3 and 98.8%, respectively, while wet mount had a sensitivity and specificity of 71.4 and 100%, respectively, compared to the CRS. OSOM performed significantly better than wet mount (P = 0.004) and detected T. vaginalis in samples that required 48 to 72 h of incubation prior to becoming culture positive. The performance of the rapid test was not affected by the presence of coinfections with chlamydia and gonorrhea. The OSOM Trichomonas Rapid Test is a simple, objective test that can be expected to improve the diagnosis of T. vaginalis, especially where microscopy and culture are unavailable.

Mycoplasma genitalium detected by transcription-mediated amplification is associated with Chlamydia trachomatis in adolescent women.

Objectives: The clinical significance of Mycoplasma genitalium (MG) infection in adolescent women is poorly understood. We compared the prevalence of MG with that of other sexually transmitted organisms such as Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) and assessed the associations of MG with sexual behaviors, genitourinary symptoms, physical and laboratory findings. Study Design: Women aged 14 to 21 years (n = 331) were recruited from an urban medical center. The subjects’ sexual behaviors, genitourinary symptoms, and physical findings were recorded. Endocervical swabs were collected for CT and NG testing and vaginal swabs for wet mount, Gram stain, TV and MG testing. MG infection was identified by nucleic acid amplification using a transcription-mediated amplification assay. Results: MG was detected in 74 (22.4%), CT in 79 (24.4%), TV in 60 (18.2%), and NG in 35 (10.7%) subjects. MG infection was not associated with vaginal symptoms, physical evidence of cervicitis, or findings on wet mount or Gram stain. In logistic regression, variables positively associated with MG were current CT [odds ratio (OR), 2.3; 95% confidence interval (CI), 1.4–4.4] and recent sexual contact (≤7 days) (OR, 2.0; CI, 1.1–3.2). Dysuria (OR, 0.44; CI, 0.2–0.96) and use of hormonal contraception (OR, 0.55; CI, 0.3–1.0) were negatively associated with MG infection. Conclusion: In adolescent women, MG infection was as common as chlamydial infection and trichomoniasis and more common than gonorrhea. MG was associated with CT and recent sexual contact but not with vaginal symptoms or signs of cervicitis.

Lipschutz ulcers: evaluation and management of acute genital ulcers in women

Acute genital ulcers are painful and distressing to women and perplexing to the providers who care for them. The differential diagnosis includes sexually and nonsexually transmitted infections, autoimmune conditions, drug reactions, and local manifestations of systemic illness. However, in many cases, no causative agent is identified, and lesions are classified as idiopathic aphthosis. In the setting of fever and acute onset of genital ulcers in girls and women, the term Lipschutz ulcers has been used to describe ulcers associated with an immunologic reaction to a distant source of infection or inflammation. The aims of this article are to review the differential diagnosis and pathogenesis of acute genital ulcers, to offer an evaluation and classification scheme, and to discuss treatment options for the dermatologist who cares for women and girls with vulvar ulcers.

Perceptions of an ideal point-of-care test for sexually transmitted infections - A qualitative study of focus group discussions with medical providers

Background A point-of-care test (POCT) for sexually transmitted infections (STIs), which offers immediate diagnosis resulting in patients receiving diagnosis and treatment in a single visit, has the ability to address some of the STI control needs. However, needs assessment from STI experts and end users about currently available STI POCTs and their future new development has not been evaluated since World Health Organization Sexually Transmitted Diseases Diagnostics Initiative was formed over 15 years ago. Therefore, our objective was to explore the perceptions of the ideal types of STI POCT for use in health care settings. Methodology/Principal Findings A qualitative study, encompassing eight focus groups, was conducted from March 2008 through April 2009. Participants included 6 STD clinic directors, 63 clinicians, and 7 public health/laboratory/epidemiology professionals in the STI field. Discussion topics included currently available POCT, perceived barriers to using POCT in clinics, priority STI for the development of new POCT, and characteristics of the ideal POCT. All discussions were recorded and transcribed verbatim. Themes raised as barriers for current POCT included complexity, long time frames of the so-called “rapid” test, multiple time-driven steps, requiring laboratory technician, difficulty in reading result, interruption of workflow, unreliability, and invasiveness. Chlamydia trachomatis was identified as the priority organism for development of a new STI POCT. Themes indicated for the ideal POCT included rapid turnaround (up to 20 minutes), ease of use, non-invasive, accurate (preferred sensitivity and specificity in the range of high 90s), Clinical Laboratory Improvement Amendments (CLIA)-waived, user-friendly (for both patients and staff), compact, durable, and sturdy. Conclusions/Significance Focus group discussions with STI experts and professionals highlighted chlamydia as the top priority pathogen for POCT development, and identified the qualities of new POCT for STIs. Participants endorsed ease of use, rapid turnaround and high accuracy as essential characteristics of an ideal POCT.

Stepwise Diagnosis of Trichomonas vaginalis Infection in Adolescent Women

ABSTRACT The objective of this study was to examine the effects of clinical factors and of the type and timing of a secondary test in improving the sensitivity of Trichomonas vaginalis detection in young women over that of a wet mount alone. For this purpose, sexually active adolescent women (n = 345) were recruited from a hospital teen clinic or emergency department. Following an interview and a pelvic exam, four primary T. vaginalis tests (wet mount, culture, a rapid test, and a nucleic acid amplification test [NAAT]) were performed on vaginal swabs. If the wet-mount result was negative, two secondary tests (culture and a rapid test) were performed on the used wet-mount swab and saline. A positive result by any of the four primary tests was considered a true T. vaginalis-positive result. The prevalence of T. vaginalis was 18.8% overall and 8.8% in the 307 wet-mount-negative women. There was 100% concordance between primary and secondary rapid tests. Secondary culture was 80% sensitive compared to primary culture. The likelihood of a positive rapid test increased with increasing time between specimen collection and testing. A wet mount followed by a rapid test was the most sensitive strategy using two tests (86.4%; confidence interval [CI], 75.3 to 93.4%). Limiting secondary testing to those with multiple partners resulted in a lower sensitivity (73.9%; CI, 61.5 to 84%) that was not significantly better than that of the wet mount alone (58.5%; CI, 45.6 to 70.6%). We conclude that a rapid test can be delayed or performed on a used swab with no loss of sensitivity. Until a NAAT for T. vaginalis is commercially available, a stepwise approach using an additional rapid test for wet-mount-negative women is recommended for adolescent women regardless of clinical factors.

Expedited Partner Therapy for Adolescents Diagnosed with Chlamydia or Gonorrhea: A Position Paper of the Society for Adolescent Medicine

Chlamydia and gonorrhea, the most frequently reported sexually transmitted infections (STIs), present substantial public health challenges among adolescents. Although these infections are easily treated with antibiotics, many adolescents are reinfected within 3–6 months, usually because their partners remain untreated. The standard approaches to notifying and treating a partner of an STI-infected patient are patient referral, whereby the patient notifies his/her partners to seek care, and provider referral, whereby the provider or public health disease intervention specialist notifies the partner and directs him/her toward treatment. These methods rely on the accuracy of the disclosed partner information as well as other limitations, such as compliance and staffing resources. Another approach to partner notification is expedited partner therapy (EPT), treating sex partners without requiring a prior clinical evaluation. In randomized trials, EPT has reduced the rates of persistent or recurrent gonorrhea and chlamydia infection; however, its routine use is limited by concerns related to liability, cost, compliance, and missed opportunities for prevention counseling. The Society for Adolescent Medicine (SAM) recommends that providers who care for adolescents should do the following: use EPT as an option for STI care among chlamydiaor gonorrheainfected heterosexual males and females who are unlikely or unable to otherwise receive treatment; through SAM and AAP chapters, collaborate with policy makers to remove EPT legal barriers and facilitate reimbursement; and collaborate with health departments for implementation assistance.

Trichomoniasis in teens: an update.

PURPOSE OF REVIEW Trichomoniasis, caused by the protozoa Trichomonas vaginalis, is one of the oldest sexually transmitted infections. Since the advent of more accurate diagnostic tests, the epidemiology and consequences of infection with T. vaginalis can be described more precisely. This review will highlight new diagnostic methods, the epidemiology of trichomoniasis, and discuss the merits of improved screening for this pathogen in adolescent women. RECENT FINDINGS Interest in trichomoniasis has renewed due to evidence that trichomoniasis is more common than gonorrhea in adolescent women, is often asymptomatic, may persist for several months, and may be confused with bacterial vaginosis. In addition, trichomoniasis is linked to pelvic inflammatory disease and can increase ones susceptibility to viruses such as herpes, human papillomavirus, andHIV. SUMMARY Clinicians who use better diagnostic methods and offer more widespread testing will identify more infections and reduce the epidemic of this easily treated infection. Early diagnosis provides the opportunity to reduce transmission and potentially prevent future complications.

Point-of-Care Testing for Sexually Transmitted Infections Increases Awareness and Short-Term Abstinence in Adolescent Women

PURPOSE To evaluate the effect of point-of-care (POC) testing for sexually transmitted infections (STIs) on reported awareness of test results and STI risk-reduction behaviors in adolescents. METHODS Adolescent and young adult women aged 14-21 years were recruited from the Emergency Department or Teen Health Clinic for this longitudinal study and were tested for STIs. Baseline demographics, risk behaviors, treatment, POC tests (wet mount and rapid antigen tests for Trichomonas vaginalis), and other STI test results (available 24-48 hours postvisit) were measured. These were compared to subjects report of test results, abstinence, partner discussion, and partner testing during a postvisit telephone contact. RESULTS Of 294 subjects, 155 (53%) were contacted: 65 (42%) had a positive STI test result; 28 (43%) were POC positive; and 52 (33.5%) believed their STI results were positive. A positive POC test result increased the proportion of subjects aware of being positive for an STI (89 vs 21%, p < .01). Postvisit, 62% reported abstinence, 82% discussed testing with her partner, and 48% reported partner testing. Predictors of abstinence included a positive POC test result (adjusted odds ratio (AOR) = 4.6, confidence interval (CI) = 1.5-13.6, prior abstinence of >14 days (AOR = 3.9, CI = 1.7-9.0), and black race (AOR = 3.5, CI = 1.2-9.7). Women who believed their STI results were positive were more likely to report partner discussion (odds ratio [OR] = 3.0, CI = 1.0-8.8) and partner testing (OR = 5.1, CI = 2.4-11.2). CONCLUSIONS Awareness of STI results increases with POC testing. Effective communication of results can increase patient understanding and compliance with risk reduction strategies, which may affect the STI epidemic.

Urinary Tract Infection and Chlamydia Infection in Adolescent Females

STUDY OBJECTIVE To examine whether clinical or laboratory findings could distinguish Chlamydia trachomatis (CT) from urinary tract infection (UTI) among adolescent females in whom providers tested for both. DESIGN, SETTING, PARTICIPANTS A laboratory database at an urban teen health center was reviewed to identify females who had both urine culture and ligase chain reaction (LCR) test for CT ordered at the same visit. History and physical findings were abstracted from the medical record. There were 81 visits with retrievable laboratory results and chart documentation. MAIN OUTCOME MEASURES UTI was defined as >1000 colony-forming units on culture, and CT was defined as positive LCR test. Pearsons Chi-squared test was used to assess strength of the hypothesized associations. RESULTS UTI was diagnosed in 20 (24%) and CT in 18 (22%) of 82 visits. Concurrent CT was diagnosed in 6 of 20 subjects with UTI. Symptoms and physical signs did not differentiate UTI from CT. Positive urinary nitrites were associated with UTI, but did not exclude CT. Similarly, wet prep evidence of trichomonas or white blood cells was associated with CT, but did not exclude UTI. Clinical diagnosis of CT or UTI was 50% sensitive and 70% specific. CONCLUSIONS Adolescent females who are screened for both CT and UTI have high rates of concurrent disease. Urinary or vaginal symptoms do not differentiate well between these infections. Clinical diagnosis is imprecise, suggesting that adolescent females with vaginal or urinary symptoms should be tested for both CT and UTI.