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Background:Solana® (Quidel) is a new rapid (<40 min.) point-of-care (POC) test for qualitative detection ofTrichomonas vaginalis(TV) DNA. The assay has two steps: 1) specimen preparation, and 2) amplification and detection using isothermal Helicase-Dependent Amplification (HDA). The objective was to demonstrate the performance of Solana for vaginal swabs and female urines based on comparison to wet mount and TV culture. Performance was also compared to the Aptima-TV assay. Methods:Urine and four clinician-collected vaginal swabs were collected. The first two were used for FDA composite reference (wet mount; InPouch TV Culture). The third swab was used for Solana. Sensitivity/specificity were based on the reference method. A specimen was considered positive if either test was positive. The fourth swab was for Aptima-TV. Results:Vaginal swabs and urines were obtained from 501 asymptomatic and 543 symptomatic women. Prevalence of TV by was 11.5%. For swabs, Solana® demonstrated high sensitivity and specificity from asymptomatic (100%/98.9%) and symptomatic (98.6%/98.5%) women, as well as for urines from asymptomatic (98.0%/98.4%) and symptomatic (92.9%/97.9%) women, compared to the reference method. Compared to Aptima-TV, the sensitivity/specificity was 89.7%/99.0% for swabs and 100%/98.9% for urines. Conclusion:The Solana® assay performed well compared to the reference assays. [ABSTRACT FROM PUBLISHER]

Bacterial vaginosis (BV) is the most common cause of vaginal infection, yet its pathogenesis remains controversial. Although it has never been proven to be a sexually transmitted diseases the epidemiological evidence favoring this is quite robust. Although BV is characterized by its polymicrobial nature, it is highly likely that the inciting organism is Gardnerella vaginalis. [ABSTRACT FROM AUTHOR]

Background. Nongonococcal urethritis (NGU) is a common chlamydia-associated syndrome in men; however, Trichomonas vaginalis and Mycoplasma genitalium are associated with its etiology and should be considered in approaches to therapy. We sought to determine whether the addition of tinidazole, an anti-trichomonal agent, to the treatment regimen would result in higher cure rates than those achieved with treatment with doxycycline or azithromycin alone. A secondary aim was to compare the efficacy of doxycycline therapy and with that of azithromycin therapy. Methods. Randomized, controlled, double-blinded phase IIB trial of men with NGU. Participants were randomized to receive doxycycline plus or minus tinidazole or azithromycin plus or minus tinidazole and were observed for up to 45 days. Results. The prevalences of Chlamydia trachomatis, M. genitalium, and T. vaginalis were 43%, 31%, and 13%, respectively. No pathogens were identified in 29%of participants. Clinical cure rates at the first follow-up visit were 74.5% (111 of 149 patients) for doxycycline-containing regimens and 68.6% (107 of 156 patients) for azithromycin-containing regimens. By the final visit, cure rates were 49% (73 of 149 patients) for doxycycline-containing regimens and 43.6% (68 of 156 patients) for azithromycin-containing regimens. There were no significant differences in clinical response rates among the treatment arms. However, the chlamydia clearance rate was 94.8% (55 of 58 patients) for the doxycycline arm and 77.4% (41 of 53 patients) for the azithromycin arm (P = .011), and the M. genitalium clearance rate was 30.8% (12 of 39 patients) for the doxycycline arm and 66.7% (30 of 45 patients) for the azithromycin arm (P = .002). Conclusions. Addition of tinidazole to the treatment regimen did not result in higher cure rates but effectively eradicated trichomonas. Clinical cure rates were not significantly different between patients treated with doxycycline and those treated with azithromycin; however, doxycycline had significantly better efficacy against Chlamydia, whereas azithromycin was superior to doxycycline for the treatment of M. genitalium. [ABSTRACT FROM AUTHOR]

Background. Bacterial vaginosis (BV) is the most common cause of vaginitis worldwide. Currently recommended treatments have poor efficacy and are associated with high rates of BV recurrence. We examined whether a longer duration of treatment with metronidazole or combination therapy with metronidazole and azithromycin would enhance the cure rates for BV. In addition, we examined factors other than drug therapy associated with cure. Methods. Women with symptomatic BV (defined by a modified Amsel criteria) were enrolled in a 4-arm study that compared metronidazole for 7 days versus 14 days, plus or minus azithromycin on days 1 and 3. Data regarding interim behaviors were also obtained, as were vaginal specimens for Gram staining. Results. At the first follow-up visit (7 days after the completion of therapy), there was a significant difference in cure rates among patients who received 7 days of metronidazole therapy, compared with those who received 14 days of therapy, combined across azithromycin therapy (P = .0003). There was no effect associated with azithromycin therapy. There were no differences in cure rates between any of the treatment groups at 21 days after completion of therapy. Abstinence or protected sex, refraining from douching, and a lower baseline Nugent score for the vaginal Gram stain were all significantly associated with cure. Conclusions. Cure rates for BV were significantly improved by 14 days of metronidazole treatment (compared with 7 days of treatment), but the effects were not sustained, suggesting that relapse or reinfection occurred. Combination therapy with the addition of azithromycin had no benefit. Lower baseline Nugent scores—presumably reflecting less complex vaginal flora—were significantly associated with cure, as was refraining from unprotected sex and from douching. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate whether an elevated vaginal leucocyte count in women with bacterial vaginosis (BV) predicts the presence of vaginal or cervical infections, and to assess the relation of vaginal WBC counts to clinical manifestations.Methods: We retrospectively analysed the relation of vaginal leucocyte counts to vaginal and cervical infections and to clinical manifestations in non-pregnant women diagnosed with BV at an STD clinic visit.Results: Of 296 women with BV studied, the median age was 24 years and 81% were African-American. Elevated vaginal leucocyte counts were associated with objective signs of vaginitis and cervicitis and also predicted candidiasis (OR 7.9, 95% CI 2.2 to 28.9), chlamydia (OR 3.1, 95% CI 1.4 to 6.7), gonorrhoea (OR 2.7, 95% CI 1.3 to 5.4), or trichomoniasis (OR 3.4, 95% CI 1.6 to 7.3). In general, as a screening test for vaginal or cervical infections, vaginal leucocyte count had moderate sensitivities and specificities, low positive predictive values, and high negative predictive values.Conclusions: An elevated vaginal leucocyte count in women with BV was a strong predictor of vaginal or cervical infections. Vaginal leucocyte quantification may provide an alternative approach to assessing need for empirical therapy for chlamydia and gonorrhoea, particularly in resource-limited high STD risk settings that provide syndromic management. [ABSTRACT FROM AUTHOR]

Background: Little is known about infection rates for human immunodeficiency virus (HIV) and other diseases that can be transmitted sexually in Bangladeshi women who may be at intermediate levels of risk--that is, women who are not commercial sex workers (CSWs) but whose sexual contacts may include men at high risk for STD. This study examines HIV/hepatitis/STD and other genital tract infections in women living near Tejgaon truck stand in Dhaka, Bangladesh.Methods: This population based study was conducted from January to December 1998. A random sample of 384 women provided urine and blood samples and participated in an interview; 261 of them also had a physical examination in which vaginal and cervical specimens were taken. Laboratory tests included PCR on urine and cervical swabs for gonorrhoea and chlamydia, culture for trichomoniasis, serology tests for syphilis, herpes simplex 2, hepatitis B, C, D, HIV1, HIV2, and clinical diagnoses of other genital tract infections.Results: None of the participants tested positive for HIV. In the 261 women who had a physical examination, trichomoniasis was detected in 19.5%, chlamydia in 3.4%, gonorrhoea in 5.4%, bacterial vaginosis in 37.2%, and candidiasis in 10%. In the full sample of 384 women, with tests of urine and blood, prevalence of infection with chlamydia, gonorrhoea, syphilis, and herpes simplex 2 was detected in 0%, 6.3%, 5.7%, and 32% respectively. Almost 50% of the subjects had ever been exposed to hepatitis B, 3.6% were currently infective, 1.6% had hepatitis C, and none had hepatitis D.Conclusion: The high prevalence of certain of these infectious diseases indicates the need to implement prevention interventions with these women and, perhaps more importantly, with their male partners. Qualitative research is needed to provide insights into their sexual behaviour and the contexts in which high risk behaviours occur. [ABSTRACT FROM AUTHOR]

BACKGROUND AND OBJECTIVES: Although women attending STD clinics are at high risk for cervical cancer, most STD programmes do not include Papanicolaou (Pap) smears in their routine screening procedures. Concerns regarding reliability of this test in a population with a high rate of active infection are often raised. The objective of this study was to analyse the associations between STD diagnosis/clinical syndromes and unsatisfactory and abnormal Pap smears. METHODS: Retrospective analysis of Pap results and medical records from women attending an inner city STD programme. RESULTS: Of the 1202 patients analysed, 3.2% had squamous intraepithelial lesions (SIL) and 3.5% had smears which were unsatisfactory because of the thickness of the specimen. There were no associations between STD diagnoses and SIL; however, the presence of cervical inflammation was significantly associated with SIL. Pap smears which were unsatisfactory because they were too thick were also associated with the clinical finding of cervical inflammation. CONCLUSIONS: The presence of active infection did not preclude the detection of SIL on Pap smears. The percentage of unsatisfactory smears resulting from inflammation was low. [ABSTRACT FROM PUBLISHER]

Although human immunodeficiency virus (HIV) rates are increasing rapidly in Asia, a full understanding of the extent of other sexually transmitted diseases (STDs) in many of these areas is lacking. There have been anecdotes of rising rates of STDs in Mongolia, a country thus far relatively unaffected by HIV. To further the understanding of STDs, a prevalence study was conducted in the STD clinic in Ulaanbaatar, the capital and largest city in Mongolia. Among 260 patients, the prevalence of gonorrhoea, chlamydia and syphilis was 31.1%, 8.1% and 8.6% respectively for males and 10.3%, 9.9% and 6.0% for females. Sixty-seven per cent of females had trichomoniasis and 19.7% of males had non-gonococcal urethritis (NGU). Forty-two per cent of gonococcal isolates had plasmid mediated resistance to penicillin, and chromosomal resistance to penicillin, tetracycline, and ciprofloxacin was documented. No patients were infected with HIV. STDs are a significant problem in Mongolia. Improved control efforts are urgently needed to prevent the emergence of HIV. [ABSTRACT FROM AUTHOR]

The cause of bacterial vaginosis remains controversial. The two leading hypotheses are that Gardnerella vaginalis is the specific aetiologic agent versus the polymicrobial hypothesis that G. vaginalis acts in concert with other bacteria, principally anaerobes, to produce the disease. Here we reassess the prevailing polymicrobial hypothesis, finding it conceptually problematical. No host initiating factors as postulated have been identified, nor is there conclusive evidence that G. vaginalis lacks diagnostic specificity for the disease. The polymicrobial hypothesis, presupposing a unique disruption of vaginal microecology, is inconsistent with the epidemiological profile of the syndrome, which is that of a sexually transmitted disease. The epidemiological and clinical similarities between bacterial vaginosis and trichomoniasis suggest a similar pathogenetic process; i.e., primary causation by a specific agent, with secondary anaerobic activation and resultant amine production. [ABSTRACT FROM AUTHOR]

Summarizes findings of tests for chlamydial and gonococcal infections administered to incarcerated women in several United States cities. The feasibility of screening in correctional facilities; The prevalence of these infections among screened women; Editorial note from the US Centers for Disease Control and Prevention.