Search

Background: The decision to use a particular test to diagnose patients presenting with symptoms of vaginitis and/or STI is based primarily on the prevailing standards of care in the clinic at which the patient evaluation takes place. As a result, laboratory testing of vaginal samples for these patients often involves either an STI or a vaginitis test, but rarely both options simultaneously, which complicates the diagnosis and management of concurrent infections., Methods: Using de-identified remnant vaginal specimens from symptomatic patients previously tested for STI ( Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV)) with the Becton Dickinson (BD) CTGCTV2 assay for BD MAX System, positivity for bacterial vaginosis (BV) and Candida spp (associated with vulvovaginal candidiasis (VVC)) were evaluated using the molecular-based BD MAX Vaginal Panel., Findings: The rate of STI/BV co-infection was 79.4% (227/286) in this symptomatic population, while that of STI/VVC was 27.0% (77/285). Women diagnosed with any one of the three STIs tested had an OR 2.86 (95% CI, 1.99, 4.11; p<0.0001) for a concurrent BV infection and OR 0.96 (95% CI, 0.67, 1.37; p=0.8085) for infection with Candida species., Conclusion: Our results suggest that women being tested for STI have a high prevalence of co-infection with BV and a lower, although appreciable, prevalence of co-infection with VVC. The detection of co-occurring vaginal infections can be facilitated by molecular testing using a single sample., Competing Interests: Competing interests: BVDP: Author’s institution received funding from BD Life Sciences for the conduct of this study and has also received study funding from Abbott, Cepheid, Cue, Hologic, MagIC, Rheonix and Roche. BVDP receives consulting fees and/honoraria from Abbott Rapid Diagnostics and Roche Molecular. SK, SP, VP and ET-C are employees of BD and own BD shares. PD and CA: no conflicts of interest., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Objectives: We aimed to investigate the early natural history of Trichomonas vaginalis in men recently testing positive for this infection by a nucleic acid amplification test (NAAT). We hypothesised that 50% of men would spontaneously resolve their infection (in the absence of treatment) on repeat T. vaginalis NAAT., Methods: Men ages ≥18 years at the Jefferson County Health Department Sexual Health Clinic testing positive for T. vaginalis by NAAT during standard-of-care (SOC) within the past 30 days and presenting to the clinic for treatment were approached. At enrolment, participants completed a questionnaire, provided urine for repeat T. vaginalis NAAT, and were treated with 2 g oral metronidazole. Those with a repeat positive enrolment NAAT were seen for a 4-week test-of-cure (TOC) visit. At TOC, men provided urine for repeat NAAT. We determined the proportion of men with spontaneous resolution of T. vaginalis and evaluated predictors of spontaneous resolution. In those with a repeat positive enrolment T. vaginalis NAAT, we evaluated the proportion with persistent infection at TOC as a secondary outcome., Results: Between October 2021 and January 2023, 53 men with a recent positive SOC T. vaginalis NAAT were approached; 37 (69.8%) participated. The mean participant age was 32.9 years (SD 9.9); all identified as Black. The majority (97.3%) reported sex with women only; 35.1% reported sex with >1 partner in the last month. At enrolment, 26/37 (70.3%) had a repeat positive T. vaginalis NAAT in the absence of treatment after an average of 8.4 days (SD 5.9). Sexual partner gender, number of recent sexual partners, genital symptoms, unprotected sex with any partner and recent antibiotic use were not associated with spontaneous resolution. Of the 26 men attending a TOC visit, 17 (65.4%) returned and all except one (94.1%) were cured., Conclusion: Most men do not spontaneously clear T. vaginalis infection during early repeat testing., Competing Interests: Competing interests: OVG has received research grant support from NIH, Abbott Molecular, Gilead Sciences, Visby and Moderna, served on a scientific advisory board for Scynexis, and done consulting for El Sevier, GSK, Abbott Molecular and Thermo Fisher for which she received honoraria. CAM has received research grant support to her institution from NIH/NIAID, Lupin Pharmaceuticals, Gilead Sciences, Visby Medical and Abbott Molecular. She also reports honorarium and/or consulting fees from Scynexis, Cepheid, BioNTech, BioMed Diagnostics, Visby Medical, Elsevier, UpToDate, Abbott Molecular and Roche. All other authors have no relevant interests to disclose., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: In 2016, WHO estimated 376 million new cases of the four main curable STIs: gonorrhoea, chlamydia, trichomoniasis and syphilis. Further, an estimated 290 million women are infected with human papillomavirus. STIs may lead to severe reproductive health sequelae. Low-income and middle-income countries carry the highest global burden of STIs. A large proportion of urogenital and the vast majority of extragenital non-viral STI cases are asymptomatic. Screening key populations and early and accurate diagnosis are important to provide correct treatment and to control the spread of STIs. This article paints a picture of the state of technology of STI point-of-care testing (POCT) and its implications for health system integration., Methods: The material for the STI POCT landscape was gathered from publicly available information, published and unpublished reports and prospectuses, and interviews with developers and manufacturers., Results: The development of STI POCT is moving rapidly, and there are much more tests in the pipeline than in 2014, when the first STI POCT landscape analysis was published on the website of WHO. Several of the available tests need to be evaluated independently both in the laboratory and, of particular importance, in different points of care., Conclusion: This article reiterates the importance of accurate, rapid and affordable POCT to reach universal health coverage. While highlighting the rapid technical advances in this area, we argue that insufficient attention is being paid to health systems capacity and conditions to ensure the swift and rapid integration of current and future STI POCT. Unless the complexity of health systems, including context, institutions, adoption systems and problem perception, are recognised and mapped, simplistic approaches to policy design and programme implementation will result in poor realisation of intended outcomes and impact., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Using mathematical modelling, we have previously shown that the prevalence of infection with Trichomonas vaginalis (TV) is likely to increase in the general population in Australia with the transition from Pap smear-based cervical screening to human papillomavirus (HPV) DNA testing. Here we use the existing model to estimate the level of supplemental testing required to maintain TV control., Methods: A compartmental mathematical model describing the transmission of TV in the general heterosexual population in Australia was used to evaluate the impact of a range of screening scenarios on TV prevalence over time following the transition to HPV DNA testing for cervical screening. Scenarios considered were the inclusion of a TV test with the HPV test and the addition of TV testing to routine chlamydia testing conducted in primary care., Results: Our modelling suggests that with sufficient coverage, inclusion of TV testing with routine chlamydia screening in general practice, TV prevalence can be reduced over time, but at the current reported coverage will gradually increase following the transition to HPV testing. Inclusion of TV testing with HPV testing in the cervical screening programme is preferable to no supplemental testing but is considerably less effective in controlling TV., Conclusions: These findings support the inclusion of TV testing with routine chlamydia testing of young people., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Trichomonas vaginalis ( TV) infection is the most common non-viral STI globally and can result in adverse pregnancy outcomes and exacerbated HIV acquisition/transmission. Nucleic acid amplification tests (NAATs) are the most sensitive diagnostic tests, with high specificity, but TV NAATs are rarely used in Brazil. We investigated the TV prevalence and compared the performance of the US Food and Drug Association-cleared Aptima TV assay with microscopy (wet mount and Gram-stained) and culture for TV detection in women in Pelotas, Brazil in an observational study., Methods: From August 2015 to December 2016, 499 consecutive asymptomatic and symptomatic sexually active women attending a Gynaecology and Obstetrics Outpatient Clinic were enrolled. Vaginal fluid and swab specimens were collected and wet mount microscopy, Gram-stained microscopy, culture and the Aptima TV assay performed., Results: The median age of enrolled women was 36.5 years (range: 15-77). The majority were white, had a steady sexual partner and low levels of education. The TV detection rate was 4.2%, 2.4%, 1.2% and 0% using the Aptima TV assay, culture, wet mount microscopy and Gram-stained microscopy, respectively. The sensitivity of culture and wet mount microscopy was only 57.1% (95% CI 36.5 to 75.5) and 28.6% (95% CI 13.8 to 50.0), respectively., Conclusions: A 4.2% positivity rate of T. vaginalis was found among women in Pelotas, Brazil and the routine diagnostic test (wet mount microscopy) and culture had low sensitivities. More sensitive diagnostic tests (NAATs) and enhanced testing of symptomatic and asymptomatic at-risk women are crucial to mitigate the transmission of TV infection, TV-associated sequelae and enhanced HIV acquisition and transmission., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Variable use of new molecular assays, asymptomatic infections and a lack of population data mean that the population burden of Trichomonas vaginalis is uncertain. We investigated the age-specific prevalence of T. vaginalis within the sexually active British general population to inform testing strategies., Methods: Britain's third National Survey of Sexual Attitudes and Lifestyle (Natsal-3) is a probability sample survey of 15 162 individuals aged 16-74 years, undertaken during 2010-2012. Urine from 4386 participants aged 16-44 years reporting ≥1 lifetime sexual partner was tested for T. vaginalis using in-house real-time PCR., Results: Urinary T. vaginalis was detected in seven women and no men providing urine samples, giving a weighted prevalence estimate of 0.3% (95% CI 0.1% to 0.5%) in sexually experienced women aged 16-44 years. Of the seven women with T. vaginalis detected, four were of black or mixed ethnicity (prevalence 2.7% (0.9% to 7.7%) in this group) and five reported recent partners of black or mixed ethnicity. Six of the women reported symptoms, and five reported sexual health clinic attendance in the past 5 years (prevalence in those reporting clinic attendance: 1.0% (0.4% to 2.3%)). The prevalence of a self-reported history of T. vaginalis (past 5 years) was 0.1% (0.0% to 0.2%) in women and 0.0% (0.0% to 0.2%) in men aged 16-44 years., Conclusions: Our British population prevalence estimates indicate that T. vaginalis is a rare infection. These data support policies that restrict asymptomatic screening for T. vaginalis and suggest deployment of molecular tests should be focused within clinical settings and guided by symptoms and local demography., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Objectives: Trichomonas vaginalis (TV) is the most common curable STI worldwide and is associated with increased risk of HIV acquisition and serious reproductive morbidities. The prevalence of TV infection is very low in Australian cities, and this is thought to be at least partly due to incidental detection and treatment of TV in women participating in the cervical cytology screening programme. In 2017, the national cervical screening programme will transition to a new model based on testing for high-risk (HR) human papillomavirus (HPV), with a reduced frequency and commencement at an older age. We model the potential impact of this transition on TV prevalence in Australia., Methods: A mathematical model was developed to describe the transmission of TV in the general population and used to evaluate scenarios that capture the switch from cytology-based screening to HR HPV testing. Under these scenarios, individuals with asymptomatic TV who test negative for HR HPV will remain undiagnosed and untreated. We estimate the change in TV prevalence expected to occur due to the switch from cytology to HR HPV testing and changes to the frequency and age at commencement of screening., Results: Our results suggest that with the transition to HR HPV testing, TV prevalence may increase from the current ~0.4% to 2.8% within 20 years if TV testing coverage is not increased and HR HPV prevalence does not decline further. If HR HPV prevalence continues to decline at its current rate with ongoing vaccination, TV prevalence is predicted to increase to 3.0% within this time frame., Conclusions: Our modelling suggests that in a setting like Australia, where TV can be detected incidentally through cytology-based cervical screening, a transition to HPV testing is likely to result in increasing TV prevalence over time unless additional measures are implemented to increase TV testing and treatment., Competing Interests: Competing interests: BBH reports grants from the National Health and Medical Research Council during the conduct of the study; CPR reports personal fees from The Kirby Institute during the conduct of the study; MGL reports grants from Boehringer Ingelhiem, Gilead Sciences, Merck Sharp & Dohme, Bristol-Myers Squibb, Janssen-Cilag, ViiV HealthCare, and personal fees from Gilead Sciences, Sirtex, outside the submitted work; DGR reports grants from the National Health and Medical Research Council during the conduct of the study; RJG, BD and JSH have nothing to disclose., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: Advancing the field of point-of-care testing (POCT) for STIs can rapidly and substantially improve STI control and prevention by providing targeted, essential STI services (case detection and screening). POCT enables definitive diagnosis and appropriate treatment in a single visit and home and community-based testing., Methods: Since 2014, the WHO Department of Reproductive Health and Research, in collaboration with technical partners, has completed four landscape analyses of promising diagnostics for use at or near the point of patient care to detect syphilis, Neisseria gonorrhoeae , Chlamydia trachomatis , Trichomonas vaginalis and the human papillomavirus. The analyses comprised a literature review and interviews. Two International Technical Consultations on STI POCTs (2014 and 2015) resulted in the development of target product profiles (TPP). Experts in STI microbiology, laboratory diagnostics, clinical management, public health and epidemiology participated in the consultations with representation from all WHO regions., Results: The landscape analysis identified diagnostic tests that are either available on the market, to be released in the near future or in the pipeline. The TPPs specify 28 analytical and operational characteristics of POCTs for use in different populations for surveillance, screening and case management. None of the tests that were identified in the landscape analysis met all of the targets of the TPPs., Conclusion: More efforts of the global health community are needed to accelerate access to affordable quality-assured STI POCTs, particularly in low- and middle-income countries, by supporting the development of new diagnostic platforms as well as strengthening the validation and implementation of existing diagnostics according to internationally endorsed standards and the best available evidence., Competing Interests: Competing interests: None declared., (© World Health Organization 2017. Licensee BMJ Publishing Group Limited. This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (https://creativecommons.org/licenses/by/3.0/igo), which permits use, distribution,and reproduction for non-commercial purposes in any medium, provided the original work is properly cited. In any reproduction of this article there should not be any suggestion that WHO or this article endorse any specific organization or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article’s original URL.)

Objectives: Trichomonas vaginalis is the most prevalent curable STI worldwide and has been associated with adverse health outcomes and increased HIV-1 transmission risk. We conducted a cross-sectional analysis among couples to assess how characteristics of both individuals in sexual partnerships are associated with the prevalence of male and female T. vaginalis infection., Methods: African HIV-1 serodiscordant heterosexual couples were concurrently tested for trichomoniasis at enrolment into two clinical trials. T. vaginalis testing was by nucleic acid amplification or culture methods. Using Poisson regression with robust standard errors, we identified characteristics associated with trichomoniasis., Results: Among 7531 couples tested for trichomoniasis, 981 (13%) couples contained at least one infected partner. The prevalence was 11% (n=857) among women and 4% (n=319) among men, and most infected individuals did not experience signs or symptoms of T. vaginalis . Exploring concordance of T. vaginalis status within sexual partnerships, we observed that 61% (195/319) of T. vaginalis -positive men and 23% (195/857) of T. vaginalis -positive women had a concurrently infected partner. In multivariable analysis, having a T. vaginalis -positive partner was the strongest predictor of infection for women (relative risk (RR) 4.70, 95% CI 4.10 to 5.38) and men (RR 10.09, 95% CI 7.92 to 12.85). For women, having outside sex partners, gonorrhoea, and intermediate or high Nugent scores for bacterial vaginosis were associated with increased risk of trichomoniasis, whereas age 45 years and above, being married, having children and injectable contraceptive use were associated with reduced trichomoniasis risk. Additionally, women whose male partners were circumcised, had more education or earned income had lower risk of trichomoniasis., Conclusions: We found that within African HIV-1 serodiscordant heterosexual couples, the prevalence of trichomoniasis was high among partners of T. vaginalis -infected individuals, suggesting that partner services could play an important role identifying additional cases and preventing reinfection. Our results also suggest that male circumcision may reduce the risk of male-to-female T. vaginalis transmission., Competing Interests: Competing interests: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Objective: The social context of poverty is consistently linked to Trichomonas vaginalis infection, yet few studies regarding T. vaginalis have been conducted exclusively among low-income individuals. We identified social determinants of health associated with prevalent T. vaginalis infection among homeless and unstably housed adult women., Methods: Between April and October of 2010, we conducted cross-sectional T. vaginalis screening and behavioural interviews in an existing cohort of San Francisco homeless and unstably housed women. Data were analysed using multivariable logistical regression., Results: Among 245 study participants, the median age was 47 years and 72% were of non-Caucasian race/ethnicity. T. vaginalis prevalence was 12%, compared to 3% in the general population, and 33% of infected individuals reported no gynaecological symptoms. In adjusted analysis, the odds of T. vaginalis infection were lower among persons older than 47 years, the population median (OR=0.14, 95% CI 0.04 to 0.38), and higher among those reporting recent short-term homeless shelter stays (OR=5.36, 95% CI 1.57 to 18.26). Race and income did not reach levels of significance. Sensitivity analyses indicated that testing all women who report recent unprotected sex would identify more infections than testing those who report gynaecological symptoms (20/30 vs 10/30; p=0.01)., Conclusions: The prevalence of T. vaginalis is high among homeless and unstably housed adult women, over one-third of infected individuals have no gynaecological symptoms, and correlates of infection differ from those reported in the general population. Targeted screening and treatment among impoverished women reporting recent unprotected sex, particularly young impoverished women and all women experiencing short-term homelessness, may reduce complications related to this treatable infection., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Objective: We evaluated agreement in diagnoses for bacterial vaginosis (BV), Trichomonas vaginalis (TV) and vulvovaginal candidiasis (VVC) between clinicians examining the patient and performing diagnostic tests versus a clinician with access only to the patient's history and diagnostic findings from self-obtained vaginal swabs (SOVS)., Design: Women presenting with vaginal discharge to a sexually transmitted infections clinic provided SOVS for evaluation and completed the study and qualitative questionnaires. A clinician then obtained a history and performed speculum and bimanual examinations. Participants' history and diagnostic test results from SOVS were provided to a masked non-examining clinician who rendered independent diagnoses. Overall agreement in diagnoses and κ statistics was calculated., Results: The prevalence of infections among the 197 participants was 63.4% (BV), 19% (TV) and 14% (VVC). The per cent agreement between the examining and non-examining clinician for the diagnoses of BV was 68.5%, 90.9% for TV and 91.9% for VVC. Of the 105 women diagnosed with BV by the examining clinician, 34 (32%) were missed by the non-examining clinician. The non-examining clinician missed 13 (48%) of 27 women and 12 (34%) of 35 women treated for VVC and TV, respectively. Four women who all presented with abdominal pain were diagnosed with pelvic inflammatory disease., Conclusions: Tests from SOVS and history alone cannot be used to adequately diagnose BV, TV and VVC in women presenting with symptomatic vaginal discharge. Cost benefits from eliminating the speculum examination and using only tests from SOVS may be negated by long-term costs of mistreatment.

Objectives: To compare self-collected vaginal swab (SCVS) types and first-catch urine (FCU) to diagnose Trichomonas vaginalis using analyte-specific reagents designed to be used in a transcription-mediated amplification assay., Methods: A total of 241 women (group A) collected a FCU and a SCVS using a dacron swab (APTIMA collection kit). A second group of 289 women (group B) collected two SCVS using one dacron swab and one nylon-flocked swab., Results: Of 75 young women (street youth) determined to be infected with T vaginalis only seven reported symptoms of vaginal discharge or irritation. Using a cutoff of 50,000 relative light units, the sensitivity and specificity was 97.2% and 97.6%, respectively for dacron SCVS compared with 41.7% and 100% for FCU in group A; 92.3% and 98.8% for dacron SCVS and 92.3% and 99.2% for flocked-nylon SCVS in group B. The assay tested 96 samples in 6 h., Conclusions: Dacron and nylon-flocked SCVS performed equally well and significantly better than FCU using analyte-specific reagents in the APTIMA transcription-mediated amplification assay. Either swab type could be used for self-collection.

Objectives: Trichomonas vaginalis (TV) has a low profile in urban sexually transmitted infection (STI) clinics in many developed countries. The objective of this study was to determine the true prevalence of TV in an Australian urban sexual health setting using sensitive molecular diagnostic techniques., Methods: A cross-sectional study investigating the aetiology of cervicitis in women attending two urban sexual health clinics in Sydney, Australia, enrolled 356 consecutive eligible women from 2006 to 2008. The diagnostic yield from the standard clinical practice of discretionary high vaginal wet preparation microscopy in women with suspicious vaginal discharge was compared with universal use of nested PCR for TV of cervical samples., Results: TV was detected by PCR in 17/356 women (4.8%, 95% CI 2.8 to 7.5%), whereas only four cases (1.1%, 95% CI 0.3 to 2.8%) were detected by discretionary wet preparation microscopy. Eleven of the 17 women (p=0.003) were of culturally and linguistically diverse background. Additionally, cervicitis was found to be significantly associated with TV, RR 1.66 (1.14 to 2.42), p=0.034., Conclusions: Traditional TV-detection methods underestimate TV prevalence in urban Australia. The TV prevalence of 4.8% by PCR testing in this study exceeds previously reported urban Australian TV rates of <1%. An increase in trichomoniasis-associated adverse reproductive outcomes and enhanced HIV transmission poses a salient public health threat. Accordingly, TV warrants a higher profile in urban STI clinic settings in developed countries, and we suggest that priority be given to development of standardised molecular TV detection techniques and that these become part of routine STI testing.

Objective: To compare a TaqMan-based real-time polymerase chain reaction (PCR) with conventional PCR, culture, and wet-mount microscopy for the diagnosis of trichomoniasis in women., Methods: Vaginal swabs from 119 women were tested for Trichomonas vaginalis by wet mount and culture. Paired vaginal lavage and urine specimens were tested by conventional and real-time PCR., Results: Using an expanded "gold standard", defined as a positive culture result using vaginal swabs and/or a positive PCR test using TVK3/7 primers, the overall prevalence of T vaginalis in the study population was 65.5% (78/119). The detection rate of T vaginalis was 65.5% (78/119) and 36.9% (44/119) by conventional PCR using vaginal washings and urine specimens, respectively; 68.9% (82/119) by real-time PCR using vaginal washings and 61.3% (73/119) by real-time PCR using urine specimens. The sensitivities of conventional PCR using vaginal washings and urine and real-time PCR using vaginal washings and urine, compared with the gold standard were 100%, 56.4%, 100% and 76.7%, and the specificities of these tests were 100%, 97.6%, 82.9% and 97%, respectively., Conclusions: The real-time PCR test proved to be significantly more sensitive than culture and wet-mount microscopy, although its specificity was slightly lower than these tests. In addition, it was more sensitive, rapid and less time consuming than conventional PCR for the detection of T vaginalis.

Objectives: To compare the performance of three diagnostic methods for Trichomonas vaginalis infection-latex agglutination, saline wet mount, and culture., Methods: Vaginal swabs from 3807 women attending antenatal clinics were tested for the presence of T vaginalis by latex agglutination. All positives and the following two negatives were tested by wet preparation and culture., Results: The prevalence of infection by latex agglutination was 5.4%. Using an expanded gold standard based on the wet mount and culture results, the sensitivity of the latex agglutination test was 98.8% (95% CI 95.9 to 99.9) and specificity was 92.1 (89.2 to 94.5). The kappa index for test agreement was 0.93 for latex and culture and 0.88 for latex and wet preparation., Conclusion: The latex agglutination test is a highly sensitive test for detecting T vaginalis infection. It is a simple rapid test and has the potential for use in screening and diagnostic settings.

Objectives: DNA amplification techniques have become widely used for the diagnosis of sexually transmitted infections. For the detection of Trichomonas vaginalis, PCR techniques are not yet widely used despite the publication of several assays. The sensitivity and specificity of five independent primer sets were determined on self collected vaginal specimens obtained from female commercial sex workers., Methods: Self collected specimens were obtained from symptomatic and asymptomatic women attending a female sex workers clinic in Abidjan, Côte d'Ivoire. Two vaginal specimens were collected, the first one was processed for culture and the second was processed for PCR analysis. PCR techniques for trichomonads were performed, using the primers as reported by Riley (TVA5/TVA6), Kengne (TVK3/TVK7), Madico (BTUB 9/BTUB 2), Shiao (IP1/IP2), and Mayta (TV1/TV2). An EIA amplicon detection method was designed for each of the primer sets., Results: True positive specimens were defined as culture positive and/or two positive PCR results with EIA amplicon detection in any combination. According to this definition a prevalence of 20% was obtained compared to 7% obtained by culture. The PCR primer set TVK3/TVK7 gave the highest sensitivity (89.2%). Poor sensitivities were obtained with the primer sets TV1/TV2 (60.2%) and TVA5/TVA6 (63.9%). PCR showed a sensitivity improvement of 2.4% up to 12% when EIA was used for amplicon detection., Conclusions: Overall, the sensitivities of the different PCR assays resulting from this study were lower than those previously described. These findings could be the result of the nature of the specimen population and suggests a strain variability.

Objective: To examine the diagnostic performance of self obtained low vaginal swabs (SOLVS) and polymerase chain reaction (PCR) techniques in the diagnosis of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) infection in a variety of clinical practice settings in remote north western Australia., Design: A cross sectional field study of microbiological collection techniques in women undergoing gynaecological investigation in remote settings performed by a variety of practitioner types over 10 months., Participants and Setting: 349 women from remote towns and communities in the Kimberley region of north west Western Australia having gynaecological examinations for clinical reasons, well women screening, antenatal screening, and sexual health examinations., Results: The overall prevalence of infection in the study population based on any positive conventional sample was 9.2%, 7.6%, and 16.1% for CT, NG, and TV respectively. The detection rates for CT and NG by SOLVS were 89% and 96% respectively, compared with 79% and 91% for endocervical swabs and 79% and 83% for first void urine. SOLVS had a sensitivity of 93% for TV detection, equal to that of clinician obtained low vaginal swabs. None of these differences reached statistical significance. A combination of SOLVS and first void urine detected 96% of the CT cases, 100% of the NG cases, and 96% of TV cases., Conclusions: Self obtained low vaginal swabs are an acceptable, simple and sensitive diagnostic sample for the detection of CT, NG, and TV, and have particular applications in remote clinical practice and as a screening technique.

Objective: To evaluate the validity of different algorithms for the diagnosis of gonococcal and chlamydial infections among pregnant and non-pregnant women consulting health services for vaginal discharge in Nairobi, Kenya., Methods: Cross sectional study among 621 women with complaints of vaginal discharge in three city council clinics between April and August 1997. Women were interviewed and examined for symptoms and signs of sexually transmitted infections (STIs). Specimens were obtained for laboratory diagnosis of genital infections, HIV, and syphilis. The data were used to evaluate the Kenyan flow chart as well as several other generated algorithms., Results: The mean age was 24 years and 334 (54%) were pregnant. The overall prevalence rates were: 50% candidiasis, 23% trichomoniasis, 9% bacterial vaginosis, 7% gonorrhoea, 9% chlamydia, 7% syphilis, and 22% HIV. In non-pregnant women, gonococcal and chlamydial infection was significantly associated with (1) demographic and behavioural risk markers such as being single, younger than 20 years, multiple sex partners in the previous 3 months; (2) symptom fever; and (3) signs including presence of yellow or bloody vaginal discharge, cervical mucopus, cervical erythema, and friability. Among pregnant women only young age, dysuria, and fever were significantly associated with cervical infection. However, none of these variables was either sensitive or specific enough for the diagnosis of cervical infection. Several algorithms were generated and applied to the study data. The algorithm including risk markers performed slightly better than the current Kenyan algorithm., Conclusion: STIs form a major problem in the Nairobi area and should be addressed accordingly. None of the tested algorithms for the treatment of vaginal discharge would constitute a marked improvement of the existing flow chart. Hence, better detection tools for the specific aetiology of vaginal discharge are urgently needed.

Objectives: (i) To determine the microbial aetiologies of vaginal discharge in STD clinic and antenatal clinic (ANC) attenders; (ii) to evaluate the performance and costs of a new WHO algorithm for the detection of gonococcal and chlamydial infections in women complaining of vaginal discharge and/or genital itching, using a risk assessment., Methods: Two groups were enrolled: (i) 395 consecutive female patients attending a hospital outpatient clinic complaining of genital discharge or itching; and (ii) 628 consecutive pregnant women reporting at an urban ANC these symptoms. Patients were interviewed by a nurse, who applied the WHO risk score. They were then referred to the study room for interview concerning the same and other risk factors, examined, and sampled for Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), and Candida albicans (CA). Sensitivity, specificity, positive predictive value, overtreatment and correct treatment rates, and cost of drugs per true case treated were estimated., Results: The prevalence of NG and/or CT infections was 11.4% and 8% at the STD clinic and the ANC respectively. The most prevalent pathogens were CA (38% at both clinics) and TV (25% at the STD clinic and 34% at the ANC). The sensitivity of the WHO algorithm for NG and/or CT was 62% at the STD clinic and 46% at the ANC, and the specificities were 64% and 84% respectively. The operational feasibility of the method was good. The cost of drugs per true case treated in applying the risk assessment approach was $3.5 among nonpregnant women and $5.0 among pregnant women. This compared favourably with respective costs of $8.8 and $25.0 in applying the syndromic management alone., Conclusions: The WHO risk assessment algorithm for the diagnosis of NG and/or CT infections among women complaining of genital discharge can considerably reduce overtreatment of NG and/or CT in both pregnant and non-pregnant women, but in this study it failed to identify 38% of non-pregnant and 54% of pregnant women with these infections. The elements of the risk score may need adjustment in different settings.

Objectives: (1) To compare the effectiveness of two clinical protocols for the management of vaginal discharge in the situations where no laboratory facilities are available but speculum examination is possible and where basic laboratory facilities are available. (2) To determine clinical and simple laboratory indicators for diagnosis of patients with vaginal discharge in the local setting., Design: Alternate allocation of subjects to one of two management protocols., Subjects: Women presenting to university gynaecology outpatients department with a complaint of vaginal discharge., Methods: Subjects were alternately allocated management according to one of two protocols: one without (group A) and one with (group B) immediate access to results of basic laboratory tests. Full clinical assessment including speculum examination and microbiological assessment for infection with gonorrhoea, chlamydia, candida, trichomonas, and bacterial vaginosis was performed on all women. Follow up assessment of clinical and microbiological response was performed 1-2 weeks later., Results: At initial assessment, both groups were similar in all respects except that more group B women had inflammation of the vulva. The prevalences of various conditions were: candidiasis 22%, bacterial vaginosis 38%, trichomoniasis 4%, chlamydia 4%, gonorrhoea 0.4%. There was no association between any demographic characteristic and diagnosis of cause of the discharge. Both protocols resulted in clinically and statistically significant improvements for women with candidiasis, bacterial vaginosis, and trichomoniasis. There were no clinically important differences in outcomes between the two protocols. The sensitivities and specificities of various indicators were: curd-like vaginal discharge for candidiasis, 72% and 100%; homogeneous vaginal discharge for bacterial vaginosis or trichomoniasis, 94% and 88%; absent or scanty lactobacilli for bacterial vaginosis, 99% and 68%; > 20% clue cells for bacterial vaginosis, 81% and 99%; visible endocervical mucopus for chlamydia or gonorrhoea, 36% and 86%; microscopic endocervical mucopus for chlamydia or gonorrhoea, 64% and 69%., Conclusions: Both protocols were equally effective in managing women with abnormal vaginal discharge. Simple clinical indicators for candidiasis, bacterial vaginosis, or trichomonas as in protocol A are sufficiently sensitive and specific for use in situations with no laboratory support. A modification to protocol A could increase detection of bacterial vaginosis at basic health service level. Further work is needed to identify appropriate indicators for infection with chlamydia or gonorrhoea.

Objectives: Trichomonas vaginalis is the most common STD worldwide and the infection has been linked with an increased risk of HIV transmission. We present a detailed comparison between conventional collection and testing methods and the polymerase chain reaction (PCR) tampon test for T vaginalis., Methods: Women were tested for the presence of T vaginalis by PCR analysis of a tampon specimen and by conventional methods which included one or more of the following: culture and microscopy from a high vaginal swab (HVS) or endocervical swab (ECS), and microscopy of a Papanicolaou (Pap) smear., Results: T vaginalis was detected in 51/590 (8.6%) conventional tests and 93/590 (15.8%) tampon specimens. Retesting of all tampon PCR positive specimens confirmed 89/93 (95.7%) tests. Using the tampon PCR as the reference, the sensitivities of the different conventional sampling and testing methods for the detection of T vaginalis were 8.3% (5/60) for ECS microscopy or culture, 31% (13/42) for HVS microscopy or culture, 52.8% (19/36) for HVS directly inoculated into Trichomonas medium and 59.4% (38/64) for Pap smear., Conclusions: No conventional test in the remote setting has comparable sensitivity to PCR. The Pap smear is the next most sensitive, but requires a speculum examination. The use of PCR will allow inclusion of T vaginalis into STD screening programmes in both developed (lower prevalence) and developing (higher prevalence) countries.