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Molecular-based assays demonstrate excellent sensitivity for the detection of vaginitis causes. Here, the high-throughput BD Vaginal Panel for BD COR System (VP-COR) performance was compared to that of the predicate, BD MAX Vaginal Panel for BD MAX System (VP-MAX). Clinical or contrived samples were used to determine the agreement between VP-COR and VP-MAX. Acceptance criteria for VP-COR agreement were as follows: bacterial vaginosis (BV) required a positive percent agreement (PPA) point estimate of ≥95% and a negative percent agreement (NPA) point estimate of ≥98%; Candida group, Candida glabrata , Candida krusei , and Trichomonas vaginalis (TV) required a PPA and NPA point estimate of ≥95% [with lower bound of 95% confidence interval (95% CI) ≥90%]. PPA was 99.5% (95% CI: 97.5-100) and 97.9% (95% CI: 96.5-98.8) for BV contrived ( n = 516) and BV clinical ( n = 1,050) specimens, respectively. For the Candida group (clinical; n = 724), C. glabrata (contrived; n = 544), C. krusei (contrived; n = 522), and TV (clinical; n = 702), PPA was 99.4% (95% CI: 98.0-99.9), 100% (95% CI: 97.9-100), 100% (95% CI: 97.6-100), and 99.7% (95% CI: 98.3-100), respectively; the lowest lower bound CI value was 97.6%. NPA was >95% for BV contrived and BV clinical specimens. For the Candida group, C. glabrata , C. krusei , and TV, NPA was ≥98.9%; the lowest lower bound CI value was 97.3%. These results demonstrate the equivalent performance of the VP-COR assay when compared to VP-MAX.IMPORTANCEVaginitis is common among women of reproductive age, resulting in around 10 million office visits a year. Diagnosis is often difficult due to its multiple causes-including bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis-as well as variation in symptom presentation. Typically, cases are identified with a combination of symptomology, medical history, physical examination, and office- or laboratory-based testing. These traditional techniques involve subjective elements and demonstrate varying sensitivity and specificity. Inaccurate or delayed diagnosis leads to continued symptoms, repeat visits, inappropriate treatment, and unnecessary costs. Alternatively, the use of molecular-based assays increases sensitivity for the detection of vaginitis causes. With the validation of the vaginal panel molecular assay on COR (a high-throughput platform), a workflow can be streamlined in high-demand laboratories while providing high sensitivity for vaginitis detection., Competing Interests: E.S. and E.L. are employees of the study sponsor, Becton, Dickinson and Company, BD Life Sciences–Diagnostic Solutions. W.G. and S.N.T. received research funding as part of this study.

Recurrent vaginitis is a leading reason for visiting a gynaecologist, with bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) being the most common diagnoses. Reasons and mechanisms behind their recurrent nature are poorly understood. We conducted a genome-wide association study (GWAS) to find possible genetic risk factors for recurrent vaginitis using data from a large population-based biobank, the Estonian Biobank. The study included 6870 cases (at least two episodes of vaginitis) and 5945 controls (no vaginitis episodes). GWAS approach included single marker and gene-based analyses, followed by functional annotation of associated variants and candidate gene mapping.In single marker analysis, one statistically significant (P = 7.8 × 10 -9 ) variant rs1036732378 was identified on chromosome 10. The gene-based association analysis identified one gene, KRT6A, that exceeded the recommended significance threshold (P = 2.6 × 10 -6 ). This is a member of the keratin protein family and is expressed during differentiation in epithelial tissues.Functional mapping and annotation of genetic associations by using adjusted significance level identified 22 potential risk loci that may be associated with recurrent vaginitis phenotype. Comparison of our results with previous studies provided nominal support for LBP (associated with immune response to vaginal bacteria) and PRKCH genes (possible role in keratinocyte differentiation and susceptibility to candidiasis).In conclusion, this study is the first highlighting a potential role of the vaginal epithelium in recurrent vaginitis., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: none., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Infectious vaginitis is one of the most prevalent conditions affecting women of reproductive age with significant clinical consequences. Bacterial vaginosis (BV), vulvo-vaginal candidiasis (VVC), and trichomoniasis (TV) are the main etiologies. Unfortunately, there is limited data on the prevalence and associated risk factors, especially in sub-saharan Africa. This study, thus, determined the prevalence and risk factors of infectious vaginitis among women seeking reproductive health services at a Marie-stopes health facility in urban areas of Kampala, Uganda., Methods: A cross-sectional study with 361 participants was conducted from July to October 2021. Data on risk factors and infection were collected via a structured questionnaire and laboratory analysis of vaginal swabs, respectively, with data analysis performed using Stata version 14.0 college station, Texas 77,845 US., Results: The ages of participants ranged from 18 to 49 years, with a mean age of 29.53 years. Overall, 58.45% were infected, of whom 33.24% had VVC, 24.93% had BV, and 0.28% had TV. Bivariate analysis revealed that women with pruritus (COR: 3.057, 95% CI: 1.940-4.819), pregnancy (COR: 4.914, 95% CI: 1.248-19.36), antibiotic use (COR: 1.592, 95% CI: 1.016-2.494), douching (COR: 1.719, 95% CI: 1.079-2.740), and multiple partners (COR: 1.844, 95% CI: 1.079-2.904) were more likely to have VVC, whereas having higher education status (University; Vocational) (COR: 0.325, 95% CI: 0.134-0.890; COR: 0.345, 95% CI: 0.116-0.905) reduced the risk. On the other hand, women with a smelly discharge (COR: 1.796, 95% CI: 1.036-3.110), IUD use (COR: 1.868, 95% CI: 1.039-3.358), and antibiotic use (COR: 1.731, 95% CI: 1.066-2.811) were more likely to have BV. Multivariable analysis identified pruritus (AOR: 2.861, 95% CI: 1.684-4.863) as the only independent predictor for VVC., Conclusion: Results indicate a high prevalence of infection among these women; therefore regular screening and treatment is recommended to curb the high rate of infection. More studies on risk factors of infection are recommended., (© 2023. The Author(s).)

Purpose: Nonspecific vaginitis is a distinct clinical entity with particular microscopic and immunologic features. There is currently no standard of care for women with nonspecific vaginitis. The aim of our study was to assess the change in vaginal symptoms score after 3 months of treatment with an intravaginal medical device in participants with abnormal vaginal discharge and specific signs and symptoms. As secondary objectives, the study analyzed other clinical and microscopic features, such as vaginal discharge aspect, change in vaginal pH, change in vaginal microbiome, and vaginal inflammation., Methods: The study population included 47 participants with symptomatic vulvovaginitis, distinct from candidiasis, trichomoniasis, or bacterial vaginosis. The study design included 2 research sites from Romania. The treatment protocol consisted of 1 ovule per day inserted intravaginally during 15 consecutive days. The total study duration was 3 months., Findings: The intravaginal medical device had a positive impact on the vaginal symptoms score for 72.34% of the study participants. Topical administration of the ovules balanced vaginal pH values and significantly reduced signs of inflammation between study visits., Implications: This intravaginal medical device had curative effects that support its use as a stand-alone treatment in women with nonspecific vaginitis. A second clinical investigation is ongoing to evaluate the clinical efficacy of the device in postoperative care of cervical and vaginal wounds traumatic or secondary to surgical interventions., Clinicaltrials: gov identifier: NCT04735705., Competing Interests: Declaration of Competing Interest MDX Research was involved in the study design, site selection, collection, statistical analysis, and preparation of the manuscript. The authors have indicated that they have no other conflicts of interest regarding the content of this article., (Copyright © 2023. Published by Elsevier Inc.)

Purpose: Vaginitis is caused by bacterial vaginosis (BV), Candida vaginitis (CV) and Trichomonas vaginalis (TV). This retrospective study evaluates the performance of the Aptima CV/TV, and BV assays on the automated Panther system., Methods: Two hundred forty-two multitest swabs were tested on the CV/TV assay and 422 on the BV assay. Positive and negative percent agreement (PPA, NPA) of the Candida glabrata (CG), Candida species group (CSG), TV and BV targets were calculated using a modified gold standard, with review of Gram smear and the usage of the Allplex Vaginitis Screening Assay to resolve discrepancies., Results: The PPA and NPA were respectively 98.4% and 95.9% for BV, 100% and 95.4% for CSG, 100% and 99% for CG, and 100% and 100% for TV, and when compared to consensus results., Conclusion: The CV/TV and BV assays surpassed the acceptance criteria threshold of 95%, and proved to be an excellent alternative to conventional testing., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Trichomoniasis (TV), bacterial vaginosis (BV), and vulvovaginal candidiasis (VVC) are the most common causes of vaginitis. This study investigated the prevalence of these diagnoses, their associated factors, and the appropriateness of the empirical treatment. From March 25, 2019, to June 17, 2022, 429 women with symptoms or signs of vaginitis were enrolled in a hospital in northern Taiwan with 438 episodes of vaginitis. Vaginal swabs were collected for Gram's staining, in vitro cultures for Trichomonas vaginalis, bacteria, and yeasts, and multiplex PCR assay for TV, BV, and VVC. Their empirical treatments were recorded. Factors associated with different etiologies of vaginitis were sought in multivariable logistic regression models. The prevalence of TV, BV, and VVC were 2.1%, 22.8%, and 21.7%, respectively, while coinfections of BV and VVC, TV and BV, TV and VVC, and triple infection occurred in 5.0%, 0.2%, 0.2%, and 0.7%, respectively. Multivariable analyses revealed that having multiple sexual partners was associated with TV and BV (adjusted odds ratio [aOR] 9.756 and 3.246, respectively), while menopausal women were less likely to have VVC (aOR 0.184). Moreover, dysuria was associated with TV (aOR 4.981), vaginal itch and pelvic pain with VVC (aOR 3.223 and 0.425, respectively), and discharge pH > 4.5 with BV (aOR 1.767). Other clinical symptoms and pelvic examination features had limited value for differential diagnosis. Among the 78 empirical antifungal and metronidazole prescriptions, 55.2% were ineffective or unnecessary. Our study highlights the importance to integrate appropriate diagnostic tools into the clinical care of women with vaginitis. IMPORTANCE Vaginal complaints are widespread among women and are associated with emotional, physical, and economic burdens with challenges in their diagnosis and management. In this survey, we identified that 40% of vaginitis in Taiwan was caused by either trichomoniasis, bacterial vaginosis, vulvovaginal candidiasis, or a combination of these infections. Our data suggested that typical physical findings appeared infrequently among women with these infections and their empirical treatments were frequently inappropriate. Our findings highlighted the importance of integrating proper diagnostic tools into clinical practice to improve the diagnosis and management of vaginitis, as recommended by national and international guidelines., Competing Interests: The authors declare no conflict of interest.

Objective: To analyze the vaginal microecological status of vaginitis population and non-vaginitis population of gynecological female outpatients. Methods: A total of 30 265 women who visited the gynecological outpatient clinic of Beijing Obstetrics and Gynecology Hospital from December 2018 to December 2020 completed vaginal microecological examination. After removing the follow-up patients, 23 181 women were divided into group with symptoms and signs of vaginitis (6 697 cases) and group without symptoms and signs of vaginitis (16 484 cases), according to whether the women with symptoms and signs of vaginitis or not. And the vaginal microecological status of the two groups was compared and analyzed. Results: (1) The total detection rate of vaginitis in the initial women was 34.87% (8 083/23 181), of which 46.10% (3 087/6 697) in group with symptoms and signs of vaginitis and 30.31% (4 996/16 484) in group without symptoms and signs of vaginitis, nearly 1/3 of the gynecological outpatients without signs and symptoms of vaginitis had vaginitis. (2) Among the types of simple vaginitis, vulvovaginal candidiasis (VVC) was the most frequent in group with symptoms and signs of vaginitis (16.01%, 1 072/6 697), followed by aerobic vaginitis (AV; 12.83%, 859/6 697), with significant differences compared with group without symptoms and signs of vaginitis (all P <0.001). There were no statistical differences between the two groups of bacterial vaginosis (BV) and trichomonal vaginitis (TV), indicating that BV and TV were more likely to be neglected (all P >0.05). (3) The proportion of various combinations of vaginitis among 2 632 cases of mixed vaginitis were, in descending order: BV+AV, VVC+AV, BV+AV+VVC, AV+TV, AV+TV+BV, BV+VVC. (4) Microecological analysis of 15 098 cases diagnosed with non-vaginitis had normal flora (including those with normal flora and those with normal flora but decreased function) in 14 013 cases (92.81%, 14 013/15 098), abnormal flora in 429 cases (2.84%, 429/15 098) and the BV intermediate in 656 cases (4.34%, 656/15 098); this indicated that the vast majority of the microecological tests were normal in the vaginal microbiota of those without vaginitis. Conclusions: Microecological examination could diagnose multiple pathogenic infections at once, and is especially important as a guide for the definitive diagnosis of mixed vaginitis and vaginitis with atypical clinical symptoms. Vaginal infections such as BV and TV that are easily overlooked should be concerned.

In this prospective, observational, method comparison clinical study, the Xpert Xpress MVP test (MVP) was evaluated using both clinician-collected (CVS) and self-collected vaginal swabs (SVS) collected in a clinical setting. The study was conducted at 12 sites, including point-of-care (POC) settings, from geographically diverse locations in the United States. Participants were biologically female patients ≥ 14 years old with signs and/or symptoms of vaginitis/vaginosis. MVP test results for BV were compared to the BD MAX Vaginal Panel (BDVP). Results for Candida group and Candida glabrata and Candida krusei targets (species not differentiated) were assessed relative to yeast culture followed by mass spectrometry for species identification. Trichomonas vaginalis (TV) results were compared relative to a composite method that included results from the BDVP and InPouch TV culture. The investigational test demonstrated high positive percent agreement ranging from 93.6 to 99.0%, and negative percent agreement ranging from 92.1% to 99.8% for both CVS and SVS specimens, indicating it may be a valuable tool for the diagnosis of vaginitis/vaginosis in laboratory and POC settings.

Vaginal symptoms are one of the most common reasons women consult with physicians and can significantly impact quality of life. The differential diagnosis of vaginal discharge includes physiologic discharge, vaginitis, cervicitis, and pelvic inflammatory disease (PID). Vaginitis is inflammation of the vagina, most commonly caused by bacterial vaginosis (BV), vulvovaginal candidiasis, and trichomoniasis infections. Cervicitis is an inflammation of the cervix and typically caused by Chlamydia trachomatis and Neisseria gonorrhoeae. PID is infection of the female upper genital tract, involving the uterus, fallopian tubes, ovaries, and/or pelvic peritoneum and usually caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and bacterial vaginosis-associated pathogens. A pelvic exam should be performed for any woman presenting with vaginal discharge to confirm the diagnosis and rule out an upper tract infection. BV and vulvovaginal candidal infections only require treatment if symptomatic and do not require partner therapy, whereas treatment and partner therapy is recommended for sexually transmitted illnesses, such as trichomoniasis, chlamydia and gonorrhea. Vaginitis may be uncomfortable, but rarely leads to serious long-term consequence, but pelvic inflammatory disease can lead to serious long-term sequelae, including increased risk for ectopic pregnancy, infertility, and chronic pelvic pain., (Copyright © 2022 Elsevier Inc. All rights reserved.)

This study aimed to determine the prevalence of and risk factors associated with BV(bacterial vaginosis, BV), VVC (vulvovaginal candidiasis, VVC) and TV (trichomonal vaginitis, TV) among non-pregnant women. Among 770 women included in analyses, surveyed using a questionnaire and subsequently diagnosed with BV, VVC and TV via Gram staining and vaginal swab microscopy. Vaginal infections were prevalent in 31.30%, with BV being the most prevalent (21.35%). Single-variable analysis revealed that an age of 20-29 years (odds ratio [OR] = 2.31, 95% CI: 1.24-4.29; p  = .007) and lack of education (OR = 0.50, 95% CI: 0.28-0.89; p  = .018) were significantly associated with BV. However, an age of 30-39 years was significantly associated with VVC (OR = 2.12, 95% CI: 1.03-4.38; p  = .038). Multivariable analysis confirmed that miscarriage was an independent predictor of BV and VVC. Miscarriage was significantly associated with the incidence of BV and VVC (OR = 1.680, 95% CI: 1.146-2.462; p  = .011 and OR = 2.04, 95% CI: 1.30-3.20; p  = .002, respectively). In conclusion, BV appears to be the predominant cause of vaginitis, risk factors for vaginitis include age and level of education and miscarriage.IMPACT STATEMENT What is already known on this subject? Inflammation of the vagina, or vaginitis, is caused by various infectious and non-infectious factors. The most common causes of infectious vaginitis are BV, VVC and TV. Kunming located at the southwestern border of China, However, there is still no systematic research investigating the status of vaginitis infection in Yunnan Province. Therefore, the present study aimed to determine the prevalence of these vaginal infections; BV, VVC, and TV, among women of childbearing age, and to assess the prevalence of vaginal infections and the associated risk factors. What do the results of this study add? In our study we found that vaginal infections were prevalent in 31.30% of reproductive-age women, with BV being the most prevalent (21.35%). We believe that our study makes a significant contribution to the literature because we report that BV appears to be the predominant cause of vaginitis, followed by VVC and TV. Risk factors for vaginitis include age, miscarriage and level of education. What are the implications of these findings for clinical practice and/or further research? This study aimed to determine the prevalence of these vaginal infections, BV, VVC and TV, and to assess the prevalence of vaginal infections and the associated risk factors. Health education interventions are recommended to raise women's awareness of vaginitis and its prevention.

Vulvovaginal candidiasis (VVC), a common cause of vaginitis, affects 75% of women in their lifetime. In Kenya, vaginitis/VVC is managed using the vaginal discharge syndrome guidelines. We assessed how frequently healthcare workers consider the diagnosis of vaginitis/VVC in symptomatic women, and adherence to the syndromic guidelines, outpatient records at Nairobi City County health facilities, of non-pregnant symptomatic females aged ≥15 years were abstracted. Descriptive statistics were applied, and analysis of determinants of practice determined using multivariable logistic regression models. Of 6,516 patients, 4,236 (65%) (inter-facility range 11-92%) had vaginitis of which 1,554 (37%) were considered VVC (inter-facility range 0-99%). Vaginitis was associated with facility, adjusted odds ratio (aOR) 2.80 (95% confidence interval (CI) 1.64-4.76) and aOR 0.03 (95% CI 0.02-0.04); and month, aOR 0.33 (95% CI 0.25-0.43). Vaginal examination was in 53% (inter-facility range 0-98%). Adherence to syndromic treatment was 56% (inter-facility range 0-83%), better with older patients (aOR 7.73, 95% CI 3.31-18.07). Vaginitis and VVC are commonly diagnosed in symptomatic patients in Nairobi; adherence to the syndromic guidelines is low and differs across the health facilities. Interventions to improve adherence are needed.

Background: In a randomized controlled trial of 2 g (single-dose) metronidazole (MTZ) versus 500 mg twice daily for 7 days (multidose) for Trichomonas vaginalis treatment, multidose was superior. We examined if the effect was similar by select clinical factors to determine if treatment recommendations could be targeted., Methods: The primary outcome was T. vaginalis repeat infection at test-of-cure (TOC) 4 weeks after completion of therapy. Analyses were stratified by T. vaginalis history, baseline genital symptoms, and concurrent diagnosis of bacterial vaginosis (BV) per Nugent score at baseline., Results: Women who returned for TOC (n = 540) were included. At baseline, 52.9% had a self-reported history of T. vaginalis; 79.3%, genital symptoms; 5.8%, a gonorrhea diagnosis; and 47.5%, BV. During follow-up, 97.4% took all MTZ as instructed and 34.5% had interval condomless sex with a baseline partner. At TOC, 14.8% tested positive for T. vaginalis. In stratified analysis, women randomized to single-dose MTZ had a higher rate of TOC T. vaginalis positivity than those randomized to multidose if they were symptomatic at baseline (21.4% vs. 10.8%, P = 0.003) or had a reported history of T. vaginalis (24.1% vs. 12.6%, P = 0.01). Test-of-cure T. vaginalis positivity was higher for women receiving a single dose (18.9%) versus multidose (10.8%), irrespective of baseline BV status (P > 0.06). In multivariable analysis, only a history of T. vaginalis and single-dose MTZ were independently associated with a positive TOC for T. vaginalis., Conclusions: Although multidose MTZ is recommended for all women with T. vaginalis, it is especially important for women with a T. vaginalis history and, given high posttreatment infection rates, a TOC should be performed., Competing Interests: Conflict of Interest and Sources of Funding: C.A.M. is a consultant for Lupin Pharmaceuticals, BioFire Diagnostics, Cepheid, and PhagoMed. She has also received research funding support from Lupin Pharmaceuticals and Abbott Molecular as well as speaker honoraria from Abbott Molecular, Cepheid, Roche Diagnostics, and Becton Dickinson. L.A.M. has received honoraria for his role as a consultant to Gilead Sciences, ViiV Healthcare, Roche, and Merck. He has received research grants from Gilead Sciences, ViiV Healthcare/GSK, Janssen, Binx Health (Atlas Genetics), Becton Dickinson, Rheonix, Click Diagnostics, Roche, Evofem, Westat, and Lupin Pharmaceuticals. R.A.L. has conducted clinical trials for Cepheid and Hologic and is a consultant for Roche and Merck. N.S., D.H.M., and P.K. have nothing to disclose., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)

Objective:  To determine the concordance between the clinical diagnosis of women with abnormal vaginal discharge (AVD) and laboratory results using molecular detection and observation of the vaginal microbiota., Methods:  Cross-sectional study conducted in 2018 in Temuco, Chile. A total of 25 midwives from 12 health centers participated. A total of 125 women > 18 years old, volunteers, were recruited. The sample of the posterior vaginal fornix was obtained by speculoscopy. Characteristics of the discharge and of the external and internal genitalia were observed. Gram staining was used to observe vaginal microbiota, blastoconidia and pseudohyphae, and polymerase chain reaction was used for the detection of Trichomonas vaginalis and Candida albicans . The Cohen kappa coefficient was used in the concordance analysis., Results:  Out of a total of 125 women with AVD, 85.6% consulted spontaneously and 14.4% were diagnosed clinically during a routine check-up. Absolute concordance was significant ( p  = 0.0012), with an agreement of 13.6%. The relative concordance was significant, but fair for bacterial vaginosis (Kappa = 0.21; p  = 0.003) and candidiasis (Kappa = 0.22; p  = 0.001), and slight for trichomoniasis (Kappa = 0.14; p  = 0.009). The percentage of coincidence of the diagnoses (single or mixed) by laboratory and midwives was: bacterial vaginosis 63.2% (12/19), candidiasis 36.5% (27/74), and trichomoniasis 12.5% (4/32). There was 20% coinfection. A total of 36% of the clinical diagnoses of AVD had negative laboratory tests., Conclusion:  The vulvovaginitis conditions candidiasis and trichomoniasis appear to be overdiagnosed, and bacterial vaginosis appears to be underdiagnosed by the clinical diagnosis when compared with the laboratory diagnosis. The low concordance obtained shows the importance of complementing the clinical diagnosis with a laboratory study of AVD, particularly in women with failed treatments and/or coinfections with unspecific and varying signs and symptoms., Competing Interests: The authors have no conflict of interests to declare., (Federação Brasileira de Ginecologia e Obstetrícia. This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).)

Background: Although vaginal symptoms are common, diagnosis of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis (TV) is not standardized. Diagnostic approaches and appropriateness of treatment were evaluated for women with symptoms of vaginitis who were seeking care at community practice sites., Methods: Three hundred three symptomatic women, across 8 University of Pittsburgh Medical Center-affiliated clinics, were evaluated per standard office-based practice. Four of 5 vaginal swabs (1 cryopreserved) were collected for a US Food and Drug Administration-authorized nucleic acid amplification test (NAAT) for vaginitis/vaginosis diagnosis; Nugent scoring (BV); yeast culture (VVC); and a second NAAT (for TV). Two hundred ninety women had evaluable samples. Medical record extraction facilitated verification of treatments prescribed within 7 days of the index visit and return visit frequency within 90 days., Results: Women had a mean age of 29.4 ± 6.5 years, 90% were not pregnant, 79% were of white race, and 38% reported vaginitis treatment within the past month. Point-of-care tests, including vaginal pH (15%), potassium hydroxide/whiff (21%), and wet mount microscopy (17%), were rarely performed. Of the 170 women having a laboratory-diagnosed cause of vaginitis, 81 (47%) received 1 or more inappropriate prescriptions. Of the 120 women without BV, TV, or VVC, 41 (34%) were prescribed antibiotics and/or antifungals. Among women without infectious vaginitis, return visits for vaginitis symptoms were more common among women treated empirically compared to those not receiving treatment (9/41 vs 5/79, P = .02)., Conclusions: Within a community practice setting, 42% of women having vaginitis symptoms received inappropriate treatment. Women without infections who received empiric treatment were more likely have recurrent visits within 90 days., Clinical Trials Registration: NCT03151928., (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.)

Gardnerella vaginalis (GV) and Trichomonas vaginalis (TV) infections have been proposed as risk factors for persistence or progression of low-grade precancerous cervical lesions (CIN1/L-SIL). However, their role is still undefined. We aimed to assess if GV and TV infections affect the risk of persistence/progression of CIN1/L-SIL. A retrospective cohort study was performed to assess the risk of CIN1/L-SIL persistence or progression, persistence alone and progression alone in patients with GV and/or TV infections (GV + and/or TV+), only GV (GV+), only TV (TV+), or GV and TV coinfections compared to patients without these infections. Relative risk (RR) with 95 % confidence intervals (CI) was adopted (significant p-value>0.05). Two hundred and seventy patients were included. RR for CIN1/L-SIL persistence or progression was 1.63 in GV + and/or TV+ (p = 0.02), 1.99 in GV+ (p = 0.0008), 0.25 in TV+ (p = 0.32), 1.78 in coinfection (p = 0.26). RR for persistence was 1.55 in GV + and/or TV+ (p = 0.1), 2.179 in GV+ (p = 0.0013), 0.32 in TV+ (p = 0.41), 0.45 in coinfection (p = 0.55). RR for progression was 1.92 in GV + and/or TV+ (p = 0.22), 1.34 in GV+ (p = 0.68), 1.16 in TV+ (p = 0.91), 8.39 in coinfection (p = 0.0002). In conclusion, GV infection may be a risk factor for CIN1/L-SIL persistence. TV infection alone does not significantly affect the risk of persistence or progression of such lesions, while it may greatly increase the risk of progression when associated with GV infection., (Copyright © 2020 Elsevier GmbH. All rights reserved.)

The purpose was to evaluate whether probiotics can increase the effectiveness of antimicrobial therapy. Ninety women with Trichomonas vaginalis (TV) in the presence BV were included in the study of regimens for therapy combination with metronidazole and vaginal probiotics. For 7 days, the probiotics group patients received metronidazole at 500 mg twice a day and 1 capsule of probiotic Gynophilus® vaginally twice a day; the placebo group patients in addition to metronidazole received a placebo instead of a probiotic. For the next 7 days, patients in both groups in order restore normal microflora were given the probiotics vaginally. Before the treatment, on the 4th, 8th, and 15th day of therapy complaints, pH and redox potential of the vaginal fluid were recorded, TV detection culturally, microflora of the vagina with the qPCR-RT and microscopically. Adding probiotics to traditional therapy of TV in the presence of BV increased the likelihood of cure from TV (88.6 and 42.9% in the probiotic and placebo groups, respectively) and from BV (63.6 and 11.9%, respectively). We have found that the addition of probiotics to antimicrobial therapy causes the decrease in the inflammatory response and significant changes in the vagina's physicochemical parameters (decreased of the pH values, increased of the redox potential) already on the fourth day of the therapy. The changes in the metronidazole's antimicrobial action implementation when a probiotic is added are the reason of increasing the TV therapy's effectiveness in the BV presence.

Vaginitis is one of the most common causes of patient visits to gynecologists, primary care providers, and urgent care centers. However, many women leave without a clear diagnosis or experience recurrent symptoms despite treatment. The 3 most common etiologies of vaginitis are trichomonas, bacterial vaginosis, and vulvovaginal candidiasis, which account for an estimated 70% of cases. The remaining 30% may be related to other causes of vaginitis, including atrophic vaginitis, desquamative inflammatory vaginitis, and vaginal erosive disease. The purpose of this review is to describe the noncandidal causes of acute and recurrent vaginitis, with the goal of improving the likelihood of accurate diagnosis as well as efficient and effective therapy. We excluded candidal vaginitis from our review because there was a recently published review on this topic in the Journal. The clinical presentation and evaluation of patients with symptoms of vaginitis can be triaged into 1 of 2 diagnostic pathways: noninflammatory and inflammatory vaginitis. The most common noninflammatory cause is bacterial vaginosis. Features such as irritation, purulent discharge, and the presence of polymorphonuclear neutrophils are more suggestive of an inflammatory process. Trichomoniasis is the most common cause of inflammatory vaginitis. Other well-described forms of inflammatory vaginitis include atrophic vaginitis, desquamative inflammatory vaginitis, and erosive disease. We present a review of the pathogenesis, symptoms, examination findings, diagnostic testing, and treatment for each of these causes of noncandidal vaginitis., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis. Patient- and clinician-collected vaginal-swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima Candida/Trichomonas vaginitis (CV/TV) assays. The results were compared to Nugent (plus Amsel for intermediate Nugent) scores for BV, Candida cultures and DNA sequencing for VVC, and a composite of NAAT and culture for T. vaginalis The prevalences of infection were similar for clinician- and patient-collected samples: 49% for BV, 29% for VVC due to the Candida species group, 4% for VVC due to Candida glabrata , and 10% for T. vaginalis Sensitivity and specificity estimates for the investigational tests in clinician-collected samples were 95.0% and 89.6%, respectively, for BV; 91.7% and 94.9% for the Candida species group; 84.7% and 99.1% for C. glabrata ; and 96.5% and 95.1% for T. vaginalis Sensitivities and specificities were similar in patient-collected samples. In a secondary analysis, clinicians' diagnoses, in-clinic assessments, and investigational-assay results were compared to gold standard reference methods. Overall, the investigational assays had higher sensitivity and specificity than clinicians' diagnoses and in-clinic assessments, indicating that the investigational assays were more predictive of infection than traditional diagnostic methods. These results provide clinical-efficacy evidence for two in vitro diagnostic NAATs that can detect the main causes of vaginitis., (Copyright © 2020 Schwebke et al.)

Objectives: Self-collected vaginal swabs can facilitate diagnosis of vaginal discharge (VD) in resource-limited settings, provided reliability of the method is established. The aim of this study was to evaluate the concordance between self-collected and physician-collected vaginal swabs for aetiological diagnosis of VD and to determine the prevalence of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and trichomonas vaginitis (TV)., Methods: A total of 550 females (median age: 32 years; range: 18-45 years) attending two sexually transmitted infection/reproductive tract infection (STI/RTI) clinics with VD from January 2015 to May 2016 were included in the study after obtaining written informed consent. Swabs were self-collected by patients after instructions and subsequently by a physician under speculum examination. Samples were processed for standard bedside tests, Gram staining, wet mount and culture (gold standard) according to the national guidelines. Concordance between the two methods was determined by the Cohen's kappa value., Results: BV, VVC and TV were diagnosed in 79 (14.4%), 144 (26.2%) and 3 (0.5%) patients, respectively. VVC coexisted with BV in 58 (10.5%) patients. There was no coinfection of TV with BV or VVC. Candida albicans was isolated in 84 (58.3%) VVC cases. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of self-collected swabs for diagnosing BV was 91.1%, 100%, 100% and 98.5%, respectively, while for the C. albicans VVC and TV, sensitivity, specificity, PPV and NPV all were 100% as compared with physician-collected swabs. Highly concordant results were obtained between two methods by the Kappa values of 0.95 (BV), 0.99 (VVC) and 1.0 (TV)., Conclusion: The comparative performance of self-collected and physician-collected vaginal swabs establishes self-collection of samples for BV, VVC and TV as a viable alternative tool in the management of STIs/RTIs, especially in peripheral and resource-constrained settings. This would be effective in implementing the diagnostic approaches for STIs/RTIs in community-based surveillance studies at national or regional level and therefore strengthening the National STI/RTI Control Programme., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Vaginitis is a common complaint, diagnosed either empirically or using Amsel's criteria and wet mount microscopy. This study sought to determine characteristics of an investigational test (a molecular test for vaginitis), compared to reference, for detection of bacterial vaginosis, Candida spp., and Trichomonas vaginalis Vaginal specimens from a cross-sectional study were obtained from 1,740 women (≥18 years old), with vaginitis symptoms, during routine clinic visits (across 10 sites in the United States). Specimens were analyzed using a commercial PCR/fluorogenic probe-based investigational test that detects bacterial vaginosis, Candida spp., and Trichomonas vaginalis Clinician diagnosis and in-clinic testing (Amsel's test, potassium hydroxide preparation, and wet mount) were also employed to detect the three vaginitis causes. All testing methods were compared to the respective reference methods (Nugent Gram stain for bacterial vaginosis, detection of the Candida gene its2 , and Trichomonas vaginalis culture). The investigational test, clinician diagnosis, and in-clinic testing were compared to reference methods for bacterial vaginosis, Candida spp., and Trichomonas vaginalis The investigational test resulted in significantly higher sensitivity and negative predictive value than clinician diagnosis or in-clinic testing. In addition, the investigational test showed a statistically higher overall percent agreement with each of the three reference methods than did clinician diagnosis or in-clinic testing. The investigational test showed significantly higher sensitivity for detecting vaginitis, involving more than one cause, than did clinician diagnosis. Taken together, these results suggest that a molecular investigational test can facilitate accurate detection of vaginitis., (Copyright © 2018 Schwebke et al.)

Objective: To assess the effectiveness of the WHO syndromic algorithm in the management of vaginal discharge among women of reproductive age in Dakar., Methods: Cross-sectional study of consecutive female patients (aged 18-49 years) presenting with vaginal symptoms at six selected study sites in Dakar; of these, 276 patients were included in the analysis. Vaginal and cervical swab samples were collected and analysed to establish an aetiological diagnosis of any infection. Syndrome-based diagnosis was compared with the laboratory results to evaluate its accuracy based on sensitivity, specificity and positive and negative predictive values. The degree of agreement between the two approaches was assessed using the Cohen's kappa concordance analysis., Results: Overall prevalence of vaginal infections was 56.9% (157/276); 5.4% (15/276) of the patients had cervical infection. Using the syndromic approach, 51% of patients were correctly managed for Trichomonas vaginalis (TV)/Gardnerella vaginalis (GV); 61% for Candida albicans (CA) and 54% for Chlamydia trachomatis (CT)/Neisseria gonorrhoea (NG) infections. Consequently, 31% of patients with TV/GV, 51% with CA and 53% with CT/NG infections would have missed treatment. Further, the kappa value was <0.20, indicating that there was no agreement or only slight agreement between the syndromic approach and laboratory-based diagnosis., Conclusion: This study highlights the limitations of the applicability of the WHO syndromic approach in settings with low prevalence of sexually transmitted infections (STIs) and calls for affordable and accurate rapid tests for STIs., (© 2018 John Wiley & Sons Ltd.)

Background: Syndromic management of sexually transmissible infections is commonly used in resource-poor settings for the management of common STIs; abnormal vaginal discharge (AVD) flowcharts are used to identify and treat cervical infection including Neisseria gonorrhoea and Chlamydia trachomatis. A systematic review and meta-analysis was undertaken to measure the diagnostic test performance of AVD flowcharts, including both World Health Organization (WHO)- and locally-adapted AVD flowcharts., Methods: A systematic search of multiple electronic databases was conducted to locate eligible studies published between 1991 and 2014. Flowcharts were categorised into one of 14 types based on: 1) use of WHO guidelines or locally-adapted versions; 2) use of risk assessment, clinical examination or both; and 3) symptomatic entry. Summary diagnostic performance measures calculated included summary sensitivity, summary specificity and diagnostic odds ratio., Results: Thirty-six studies, including data on 99 flowcharts, were included in the review. Summary sensitivity estimates for WHO flowcharts ranged from 41.2 to 43.6%, and for locally adapted flowcharts from 39.5 to 74.8%. Locally adapted flowcharts performed slightly better than the WHO flowcharts. A difference in performance was not observed between use of risk assessment or clinical examination. The AVD flowchart performed slightly better when it was not restricted to symptomatic women only., Conclusions: There was considerable variation in the performance of the AVD flowchart but overall it was a poor diagnostic tool regardless of whether risk assessment or clinical examination was included, or whether the flowchart was WHO or locally developed. Many women were treated unnecessarily and many women with cervical infection were not detected. We caution against their continued use for management of cervical infection.

Utility of syndromic case management (SCM) in women visiting obstetrics & gynecology department needs to be evaluated as it is subjective and imperfect. Consequently, antibiotic resistance has accelerated along with increased risk of infection to the partners. To understand the effectiveness and/or inadequacies of SCM, 11000 women were recruited and examined by clinicians for infection by Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), Bacterial vaginosis (BV) and others. Amongst these patients, 1797 (16.3%) reported vaginal discharge (VD). Other symptoms included: vaginitis (97%), cervicitis (75%), genital ulcers (60%), abnormal vaginal discharge (55%) and lower abdominal pain (48%). The patients were treated for single or co-infections using pre-packed National Aids Control Program III STI/RTI Kits. However, based on PCR diagnostics, 1453/1797 (81%) subjects were uninfected for NG/TV/CT. Amongst 344 (19%) infected patients, 257 (75%) carried infection with single pathogen (TV/NG/CT) while 87/344 (25%) were co-infected with multiple pathogens. Prevalence of TV, NG & CT was 4%, 7% and 8% respectively. Co-infection with CT + NG was highest, 51% (44/87), whereas, co-infection with CT + TV was 21% and NG + TV was 18% while co-infection with all three pathogens was 1.3%. We conclude that SCM is imprecise and successful intervention requires accurate and confirmatory diagnostic approach.

Objectif: Analyser les données probantes et formuler des recommandations quant au dépistage et à la prise en charge de la candidose vulvovaginale, de la trichomonase et de la vaginose bactérienne., Issues: Parmi les issues évaluées, on trouve l'efficacité de l'antibiothérapie, les taux de guérison en ce qui concerne les infections simples et compliquées, et les implications de ces pathologies pendant la grossesse. RéSULTATS: La littérature publiée a été récupérée par l'intermédiaire de recherches menées dans MEDLINE, EMBASE, CINAHL et The Cochrane Library en juin 2013 au moyen d'un vocabulaire contrôlé (p. ex. « vaginitis », « trichomoniasis », « vaginal candidiasis ») et de mots clés (p. ex. « bacterial vaginosis », « yeast », « candidiasis », « trichomonas vaginalis », « trichomoniasis », « vaginitis », « treatment ») appropriés. Les résultats ont été restreints aux analyses systématiques, aux essais comparatifs randomisés / essais cliniques comparatifs et aux études observationnelles. Aucune restriction n'a été appliquée en matière de date, mais les résultats ont été limités aux documents rédigés en anglais ou en français. Les recherches ont été mises à jour de façon régulière et intégrées à la directive clinique jusqu'en mai 2014. La littérature grise (non publiée) a été identifiée par l'intermédiaire de recherches menées dans les sites Web d'organismes s'intéressant à l'évaluation des technologies dans le domaine de la santé et d'organismes connexes, dans des collections de directives cliniques et auprès de sociétés de spécialité médicale nationales et internationales., Valeurs: La qualité des résultats est évaluée au moyen des critères décrits par le Groupe d'étude canadien sur les soins de santé préventifs (Tableau 1). DéCLARATIONS SOMMAIRES: RECOMMANDATIONS., (Copyright © 2016. Published by Elsevier Inc.)

Background: This review aimed to synthesize and analyze the diagnostic accuracy and the likelihood of providing correct treatment of the syndromic approach Vaginal Discharge Flowchart in managing cervical infections caused by Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), and vaginal infections caused by Trichomonas vaginalis (TV) and Bacterial vaginosis (BV) and Candida albicans. This review will inform updating the WHO 2003 guidelines on Vaginal Discharge syndromic case management., Methods: A systematic review was conducted on published studies from 01-01-2000 to 30-03-2015 in multiple databases. Studies evaluating the diagnostic accuracy and validation of the WHO Vaginal Discharge Flowchart were included. Validation parameters including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and the 95% confidence intervals for the different types of the flowchart were taken as outcomes, re-calculated, and analysed using a fixed model meta-analysis for data pooling. The level of agreement between the index and reference test were determined by the Cohen's Kappa co-efficiency test. Each individual study was assessed on quality using the QUADAS-2 tool., Findings: The search yielded 2,845 studies of which 16 met the eligibility criteria for final analysis. The diagnostic performance to identify cervical infections was low and resulted in a high proportion of over and missed treatment. The four flowcharts had a sensitivity between 27.37% in history and risk assessment and 90.13% with microscopy, with the inverse in specificity rates. The treatment performances between the flowcharts were inconsistent. The same applies to the use of vaginal discharge flowchart for treating vaginal infections. For vaginal infections the vaginal discharge flowchart had a good performance in flowchart 3 with 91.68% of sensitivity; 99.97% specificity; 99.93% PPV and 0.02% who missed their treatment and 8.32% of women who were over treated by the vaginal discharge flowchart., Conclusion: The vaginal discharge flowchart should focus on management of vaginal infection. It could be used as an intermediate approach for cervical infections for sex workers until a point of care test is available in resource poor settings., Competing Interests: The authors have declared that no competing interests exist.

Purpose: To estimate the prevalence of bacterial vaginosis (BV), candidiasis and trichomoniasis and compare the findings of physical examination of the vaginal secretion with the microbiological diagnosis obtained by cytology study of a vaginal smear using the Papanicolaou method., Methods: A cross-sectional study of 302 women aged 20 to 87 years, interviewed and submitted to a gynecology test for the evaluation of vaginal secretion and collection of a cytology smear, from June 2012 to May 2013. Sensitivity analyses were carried out and specificity, positive predictive value (PPV) and negative predictive value (NPV) with their respective 95%CI were determined to assess the accuracy of the characteristics of vaginal secretion in relation to the microbiological diagnosis of the cytology smear . The kappa index (k) was used to assess the degree of agreement between the clinical features of vaginal secretion and the microbiological findings obtained by cytology. RESULTS The prevalence of BV, candidiasis and trichomoniasis was 25.5, 9.3 and 2.0%, respectively. The sensitivity, specificity, PPV and NPV of the clinical characteristics of vaginal secretion for the cytological diagnosis of BV were 74, 78.6, 54.3 and 89.9%, respectively. The sensitivity, specificity, PPV and the NPV of the clinical characteristics of vaginal secretion for the cytological diagnosis of candidiasis were 46.4, 86.2, 25.5 and 94%, respectively. The correlation between the clinical evaluation of vaginal secretion and the microbiological diagnosis of BV, candidiasis and trichomoniasis, assessed by the kappa index, was 0.47, 0.23 and 0.28, respectively. CONCLUSION The most common cause of abnormal vaginal secretion was BV. The clinical evaluation of vaginal secretion presented amoderate to weak agreement with the microbiological diagnosis, indicating the need for complementary investigation of the clinical findings of abnormal vaginal secretion.

Objective: To review the evidence and provide recommendations on screening for and management of vulvovaginal candidiasis, trichomoniasis, and bacterial vaginosis., Outcomes: OUTCOMES evaluated include the efficacy of antibiotic treatment, cure rates for simple and complicated infections, and the implications of these conditions in pregnancy., Evidence: Published literature was retrieved through searches of MEDLINE, EMBASE, CINAHL, and The Cochrane Library in June 2013 using appropriate controlled vocabulary (e.g., vaginitis, trichomoniasis, vaginal candidiasis) and key words (bacterial vaginosis, yeast, candidiasis, trichomonas vaginalis, trichomoniasis, vaginitis, treatment). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date limits, but results were limited to English or French language materials. Searches were updated on a regular basis and incorporated in the guideline to May 2014. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, and national and international medical specialty societies., Values: The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). Summary Statements 1. Vulvovaginal candidiasis affects 75% of women at least once. Topical and oral antifungal azole medications are equally effective. (I) 2. Recurrent vulvovaginal candidiasis is defined as 4 or more episodes per year. (II-2) 3. Trichomonas vaginalis is a common non-viral sexually transmitted infection that is best detected by antigen testing using vaginal swabs collected and evaluated by immunoassay or nucleic acid amplification test. (II-2) 4. Cure rates are equal at up to 88% for trichomoniasis treated with oral metronidazole 2 g once or 500 mg twice daily for 7 days. Partner treatment, even without screening, enhances cure rates. (I-A) 5. Current evidence of the efficacy of alternative therapies for bacterial vaginosis (probiotics, vitamin C) is limited. (I) Recommendations 1. Following initial therapy, treatment success of recurrent vulvovaginal candidiasis is enhanced by maintenance of weekly oral fluconazole for up to 6 months. (II-2A) 2. Symptomatic vulvovaginal candidiasis treated with topical azoles may require longer courses of therapy to be resolved. (1-A) 3. Test of cure following treatment of trichomoniasis with oral metronidazole is not recommended. (I-D) 4. Higher-dose therapy may be needed for treatment-resistant cases of trichomoniasis. (I-A) 5. In pregnancy, treatment of symptomatic Trichomonas vaginalis with oral metronidazole is warranted for the prevention of preterm birth. (I-A) 6. Bacterial vaginosis should be diagnosed using either clinical (Amsel's) or laboratory (Gram stain with objective scoring system) criteria. (II-2A) 7. Symptomatic bacterial vaginosis should be treated with oral metronidazole 500 mg twice daily for 7 days. Alternatives include vaginal metronidazole gel and oral or vaginal clindamycin cream. (I-A) 8. Longer courses of therapy for bacterial vaginosis are recommended for women with documented multiple recurrences. (I-A).

Background: Genital tract infection is associated with preterm birth (before 37 weeks' gestation). Screening for infections during pregnancy may therefore reduce the numbers of babies being born prematurely. However, screening for infections may have some adverse effects, such as increased antibiotic drug resistance and increased cost of treatment., Objectives: To assess the effectiveness of antenatal lower genital tract infection screening and treatment programs for reducing preterm birth and subsequent morbidity., Search Methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2014), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2014, Issue 7) and reference lists of retrieved reports., Selection Criteria: We included all published and unpublished randomised controlled trials in any language that evaluated any described methods of antenatal lower genital tract infection screening compared with no screening., Data Collection and Analysis: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked for accuracy., Main Results: One study (4155 women at less than 20 weeks' gestation) met the inclusion criteria. The intervention group (2058 women) received infection screening and treatment for bacterial vaginosis, trichomonas vaginalis and candidiasis; the control group (2097 women) also received screening, but the results of the screening program were not revealed and women received routine antenatal care. The rate of preterm birth before 37 weeks' gestation was significantly lower in the intervention group (3% versus 5% in the control group) with a risk ratio (RR) of 0.55 (95% confidence interval (CI) 0.41 to 0.75; the evidence for this outcome was graded as of moderate quality). The incidence of preterm birth for infants with a weight equal to or below 2500 g (low birthweight) and infants with a weight equal to or below 1500 g (very low birthweight) were significantly lower in the intervention group than in the control group (RR 0.48, 95% CI 0.34 to 0.66 and RR 0.34; 95% CI 0.15 to 0.75, respectively; both graded as moderate quality evidence). Based on a subset of costs for preterm births of < 1900 g, the authors reported that for each of those preterm births averted, EUR 60,262 would be saved., Authors' Conclusions: There is evidence from one trial that infection screening and treatment programs for pregnant women before 20 weeks' gestation reduce preterm birth and preterm low birthweight. Infection screening and treatment programs are associated with cost savings when used for the prevention of preterm birth. Future trials should evaluate the effects of different types of infection screening programs.

Objective: To evaluate the ability of collecting the Affirm VP-III test sample using the residual vaginal discharge found on the speculum., Methods and Methods: One hundred nine symptomatic women (≥18 y) participated in this study. During pelvic examination, vaginal fluid was collected onto 3 swabs for office-based diagnostic tests and Affirm (referred to as Affirm-R). A fourth swab was used to collect residual vaginal discharge from the speculum, followed by Affirm testing (referred to as Affirm-RVD). Sensitivity, specificity, and Cohen κ agreement for office-based diagnostic tests and Affirm-RVD were determined against Affirm-R., Results: Complete results were available for 99 samples. Cohen κ agreement between Affirm-RVD and Affirm-R was 0.66 (p<.0001) for Gardnerella vaginalis, 0.81 (p<.0001) for Candida species, and 1.0 (p<.0001) for Trichomonas vaginalis. Affirm-RVD sensitivity, specificity, and positive and negative predictive values were 73.8%, 91.2%, 86.1%, and 82.5% for G. vaginalis; 84.2%, 96.3%, 84.2%, and 96.3% for Candida species; and 100%, 100%, 100%, and 100% for T. vaginalis, respectively. Cohen κ agreement between office-based diagnostic tests and Affirm-R was 0.16 (p=.141) for G. vaginalis, 0.46 (p<.0001) for Candida species, and 0.55 (p<.0001) for T. vaginalis., Conclusions: The Affirm VP-III sample collected from the residual vaginal discharge found on the speculum after performing office-based diagnostic tests can produce comparable results to traditionally collected sample.

Objective: Cervical cancer is one of the most common malignancies worldwide, yet it is preventable by population screening. In a previous study, we confirmed the feasibility of utilizing whole slide imaging (WSI) of cell block (CB) preparations to overcome the limitations of digitizing cytologic samples. In this study, we evaluated the accuracy of WSI in identifying various organisms and nonneoplastic findings., Study Design: A total of 335 WS images from Pap CB preparations were analyzed using the Aperio system. The test performance characteristics of ThinPrep (TP) and WSI samples were compared for adequacy, for the presence of bacterial vaginosis (BV), fungi, Trichomonas vaginalis (TV) and herpes simplex virus (HSV) and for nonneoplastic findings., Results: The WSI samples contained optimal material from all preparations. BV was diagnosed in 33 WSI versus 36 TP samples. Budding yeasts and/or pseudohyphal forms were noted in 18 WSI versus 19 TP samples. TV organisms (10 of 11 samples) and 1 HSV case were accurately identified in the WSI and TP samples. Squamous metaplasia, keratosis and reactive/reparative and inflammatory changes were easily identified by WSI., Conclusions: The concept of WSI from Pap CB preparations is potentially feasible for adoption. Digital remote web-based technology eliminates the need for an individual on site, saving time and resources., (© 2014 S. Karger AG, Basel.)

Aim of the Work: Examine clinical characteristics of aerobic vaginitis and mixed infection for the purpose of better diagnostic accuracy and treatment efficiency., Materials and Methods: Prospective research has been conducted at Clinic for Gynecology and Obstetrics, Department for Microbiology and Pathology at Polyclinic for laboratory diagnostic and Gynecology and Obstetrics Department at Health Center Sapna. Examination included 100 examinees with the signs of vaginitis., Examination Consisted of: anamnesis, clinical, gynecological and microbiological examination of vaginal smear., Results: The average age of the examinees was 32,62±2,6. Examining vaginal smears of the examinees with signs of vaginitis in 96% (N-96) different microorganisms have been isolated, while in 4% (N-4) findings were normal. AV has been found in 51% (N-51) of the examinees, Candida albicans in 17% (N-17), BV in 15% (N-15), Trichomonas vaginalis in 13% (N-13). In 21% (N-21) AV was diagnosed alone while associated with other agents in 30% (N-30). Most common causes of AV are E. coli (N-55) and E. faecalis (N-52). AV and Candida albicanis have been found in (13/30, 43%), Trichomonas vaginalis in (9/30, 30%) and BV (8/30, 26%). Vaginal secretion is in 70,05% (N-36) yellow coloured, red vagina wall is recorded in 31,13% (N-16) and pruritus in 72,54% (N-37). Increased pH value of vagina found in 94,10% (N-48). The average pH value of vaginal environment was 5,15±0,54 and in associated presence of AV and VVC, TV and BV was 5,29±0,56 which is higher value considering presence of AV alone but that is not statistically significant difference (p>0,05). Amino-odor test was positive in 29,94% (N-15) of associated infections. Lactobacilli are absent, while leukocytes are increased in 100% (N-51) of the examinees with AV., Conclusion: AV is vaginal infection similar to other vaginal infections. It is important to be careful while diagnosing because the treatment of AV differentiates from treatment of other vaginitis.

A commercially available, nonamplified, nucleic acid probe-based test system (BD Affirm VPIII) was compared with nucleic acid amplification (NAA)-based assays for determining the etiology of vaginitis in a cohort of 323 symptomatic women. First, a semiquantitative, multiplexed PCR assay (BV-PCR) and the Affirm VPIII Gardnerellavaginalis test were compared with a unified bacterial-vaginosis (BV) reference standard incorporating both Nugent Gram stain scores and Amsel clinical criteria. In the evaluable population of 305 patients, BV-PCR was 96.9% (191/197) sensitive and 92.6% specific (100/108) for BV, while Affirm VPIII was 90.1% sensitive (179/197) and 67.6% specific (73/108). Second, a multiplexed PCR assay detecting Candida albicans and Candida glabrata (CAN-PCR) was compared with the Affirm VPIII Candida test using a reference standard for vulvovaginal candidiasis (VVC) of yeast culture plus exclusion of alternate vaginitis etiologies. In the population evaluated (n = 102), CAN-PCR was 97.7% sensitive (42/43) and 93.2% specific (55/59) and Affirm VP III was 58.1% sensitive (25/43) and 100% specific (59/59) for VVC. Finally, the results of a commercial NAA test (GenProbe Aptima Trichomonas vaginalis assay; ATV) for T. vaginalis were compared with the Affirm VPIII Trichomonas vaginalis test. In the absence of an independent reference standard for trichomonal vaginitis (TV), a positive result in either assay was deemed to represent true infection. In the evaluable cohort of 388 patients, the sensitivity of ATV was 98.1% (53/54) versus 46.3% (25/54) for Affirm VPIII. The diagnostic accuracy of the combined NAA-based test construct was approximately 20 to 25% higher than that of the Affirm VPIII when modeled in populations with various prevalences of infectious vaginitis.

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.

Vaginal symptoms are one of the leading reasons that women visit their health care providers. Women often self-diagnose and may treat themselves inappropriately. This article describes the etiology, risk factors, symptoms, diagnosis, and treatment of the 3 most common vaginal infections: bacterial vaginosis, trichomoniasis, and vulvovaginal candidiasis., (© 2012 by the American College of Nurse-Midwives.)

Objective: To determine of the prevalence of Bacterial Vaginosis, Candida sp, mixed infections (Bacterial Vaginosis + Candida sp), Trichomonas Vaginalis, Actinomyces sp in Ankara, Turkey and analyze whether there is seasonal variation in these infectious agents., Methods: A retrospective study on the results of 23298 cervical cytology examinations of patients which were performed in Fatih University Faculty of Medicine, Pathology Laboratory in Ankara, Turkey from January 2007 to July 2011. Patients were included in the study if a Pap smear was performed for any reason., Results: The prevalence of Bacterial Vaginosis, Candida sp, mixed infections (Bacterial Vaginosis + Candida sp), Trichomonas Vaginalis, Actinomyces sp was 7.76%, 2.81%, 0.32%, 0.13%, and 0.27%, respectively A seasonal variation was not observed in the prevalence of any of the infectious agents (p>0.05)., Conclusion: We conclude that cervical cytology is well suited for diagnosis of cervical infections. Bacterial vaginosis appears to be the predominant cause of vaginitis.

Objective: To compare diagnosis of bacterial vaginosis according to the Amsel criteria with measurement by ion mobility spectrometry (IMS) of the biogenic amines that are present in vaginal discharge fluid., Study Design: Duplicate samples of vaginal fluid were collected from 115 unselected and consecutive patients in a vaginitis clinic in Detroit. All samples were evaluated using Amsel criteria and the results were compared with the diagnosis based on the IMS results., Results: The incidence rate of vaginal infections was assessed on the basis of both tests and the frequency of BV was found to be 17.4%. The sensitivity and specificity for bacterial vaginosis diagnosis using IMS determination were 95.5% and 98.9%, respectively, with an accuracy of 94.4%., Conclusions: The results show that IMS may be used to rapidly diagnose this common vaginal infection with high accuracy., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Genital malodor is a common distressing complaint that brings a woman to her physician's office. Vaginal infections, primarily bacterial vaginosis and trichomoniasis, still remain the commonest causes and are relatively easy to diagnose and treat. However, in approximately one third of women who present with malodor, no cause is identified. Although data on the management of vaginal discharge are extensive, the management of genital odor beyond common vaginal infections remains poorly studied. This presents a frustrating situation for both the patient and her physician. Often, patients resort to home remedies and over-the-counter preparations, which, while providing short-term relief for some women, almost never address the cause and, in some cases, can exacerbate symptoms. In this review, we have attempted to consolidate the known and documented causes of genital malodor including the nonvaginal causes and provide case studies that will help clinicians understand the possible settings for the various causes. We also provide an algorithm for the management of this symptom beyond vaginal infections.

Objective: The aim of this study was to determine the role of Papanicolaou (pap) smears in the diagnosis of lower genital tract infections., Materials and Methods: A retrospective study was planned by reviewing charts of patients for trichomonas vaginalis, bacterial vaginosis, actinomyces, candida and nonspecific vaginitis., Results: Charts of 9,080 patients were reviewed and 1,733 women had a diagnosis of lower genital tract infection in the pap smear or had had a clinically treated lower genital tract infection. Only 33.5%, 30.4%, 43.3%, and 0% of patients with bacterial vaginosis, trichomonas vaginalis, candida and actinomyces, respectively on pap smear were diagnosed and treated clinically. Postmenopausal patients had a higher rate of trichomonas vaginalis infection and a lower rate of candida infection when compared to women of the reproductive age group. Patients using an intrauterine device for contraception had a statistically significantly increased rate of trichomonas vaginalis and candida infection when compared to women using other contraceptive methods or those who were not using any contraception., Conclusions: Finding trichomonas vaginalis, bacterial vaginosis and actinomyces infections in pap smears might be considered an indication for treatment without performing other diagnostic tests. Treatment of asymptomatic infections can prevent complications in selected patients. Candida can be a commensal bacteria in the vagina, therefore asymptomatic patients may not require treatment. Detection of a higher rate of trichomonas vaginalis and candida infection in IUD users shows that IUDs can increase the risk of vaginal infections and associated complications.

Bacterial vaginosis, trichomoniasis, and vulvovaginal candidiasis are the most common infectious causes of vaginitis. Bacterial vaginosis occurs when the normal lactobacilli of the vagina are replaced by mostly anaerobic bacteria. Diagnosis is commonly made using the Amsel criteria, which include vaginal pH greater than 4.5, positive whiff test, milky discharge, and the presence of clue cells on microscopic examination of vaginal fluid. Oral and topical clindamycin and metronidazole are equally effective at eradicating bacterial vaginosis. Symptoms and signs of trichomoniasis are not specific; diagnosis by microscopy is more reliable. Features of trichomoniasis are trichomonads seen microscopically in saline, more leukocytes than epithelial cells, positive whiff test, and vaginal pH greater than 5.4. Any nitroimidazole drug (e.g., metronidazole) given orally as a single dose or over a longer period resolves 90 percent of trichomoniasis cases. Sex partners should be treated simultaneously. Most patients with vulvovaginal candidiasis are diagnosed by the presence of vulvar inflammation plus vaginal discharge or with microscopic examination of vaginal secretions in 10 percent potassium hydroxide solution. Vaginal pH is usually normal (4.0 to 4.5). Vulvovaginal candidiasis should be treated with one of many topical or oral antifungals, which appear to be equally effective. Rapid point-of-care tests are available to aid in accurate diagnosis of infectious vaginitis. Atrophic vaginitis, a form of vaginitis caused by estrogen deficiency, produces symptoms of vaginal dryness, itching, irritation, discharge, and dyspareunia. Both systemic and topical estrogen treatments are effective. Allergic and irritant contact forms of vaginitis can also occur.

The role of emergency nurse practitioners (ENPs) is constantly changing as their caseloads expand, from comprising patients with minor injuries and ailments to comprising those with more complex medical and surgical conditions. This article discusses three common gynaecological infections with which women may present to emergency departments: vulvovaginal candidiasis, bacterial vaginosis and trichomoniasis. Knowledge of these conditions, and of how to obtain accurate histories and conduct brief patient examinations, is needed if ENPs are to diagnose and provide treatment for them.

Background: The WHO introduced the syndromic management to help in the control of STIs in resource-poor settings. This needs to be adapted to local settings taking into consideration the prevalence of the various organisms causing STIs. This has given rise to a need to validate the algorithm. The study aimed to correlate the syndromic management treatment algorithm for vaginal discharge with the aetiological diagnosis based on laboratory investigations. Specifically, the sensitivity, specificity and positive predictive values of the syndromic management against a gold standard laboratory diagnosis were evaluated., Methods: A total of 195 consecutive patients presenting to the study sites with vaginal discharge were enrolled in the study. Information on sociodemographic data was obtained with the aid of questionnaires. Samples were taken and examined for candida, trichomonas, bacterial vaginosis (BV), chlamydia and gonorrheal infections, after speculum and vaginal examinations., Results: The sensitivity and positive predictive values (PPV) of the syndromic management in detecting vaginal infections performed better than corresponding values for cervicitis. The algorithm for cervicitis improved on addition of speculum examination (36% and 32.1% for sensitivity and PPV respectively)., Conclusion: The study shows that the syndromic diagnosis for vaginal discharge fares better for vaginitis, especially with addition of speculum examination. The application of syndromic diagnosis for cervicitis resulted in omission of patients who had evidence of cervical infections by bacteriologic examination.

This study identifies the prevalence of vaginal flora alterations in low-risk pregnant women and their association with reported symptoms and gynecological exams. This quantitative, descriptive, cross-sectional study was conducted in public primary care service units in Botucatu, SP, Brazil from 2006 to 2008 with 289 pregnant women from a stratified sample obtained by sampling by care unit. Tests of vaginal content were performed using Gram's method and testing for Trichomonas vaginalis using Diamond's medium. The prevalence of altered vaginal flora was 49.5%, of which bacterial vaginosis (20.7%), vaginal candidiasis (11.8%) and intermediate flora (11.1%) were the most frequent, not considering associations. Results revealed a high prevalence of vaginal flora alterations with little relation to symptoms, but in agreement with findings from the gynecological exams. Considering undesirable maternal and perinatal outcomes and feasible laboratory practices, the establishment of a routine for diagnosing vaginal flora alterations in low-risk pregnant women is suggested.

Objective: To determine the prevalence and risk factors of vaginitis in the Tibetan area of Sichuan Province in China., Study Design: Between September and October 2007, 397 women were surveyed with a questionnaire and diagnosed with bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and trichomoniasis by Gram stain and microscopy of vaginal swabs., Results: The prevalence of BV, VVC, and trichomoniasis was 51.6%, 6.5%, and 2.5%, respectively. Multivariate logistic modeling showed that risk factors associated with having vaginitis due to any of the three infections were older age and Tibetan ethnicity., Conclusion: BV appears to be the predominant cause of vaginitis, followed by VVC, and trichomoniasis. Risk factors for vaginitis include being more than 49 years old and of Tibetan ethnicity., (Copyright 2010 Elsevier Ireland Ltd. All rights reserved.)

Background & Objective: In India, National AIDS Control Organization (NACO) introduced syndromic approach to treat patients with abnormal vaginal discharge without a need for laboratory tests. Simple tools like pH test and Whiff test can be done without high expertise, microscope and even speculum. This can improve diagnostic value of syndromic approach of abnormal vaginal discharge. The present study was conducted to evaluate sensitivity and specificity of pH test and Whiff test in diagnosis of abnormal vaginal discharge, considering microscopic diagnosis as gold standard., Methods: This prospective hospital-based study included 564 women with abnormal vaginal discharge. All women were subjected to gynaecological examination, pH test and Whiff test. The findings were compared with microscopic examination. Statistical analysis was done by calculating proportions, percentage, sensitivity and specificity., Results: Vaginitis was diagnosed in 301 (53.37%) women. Bacterial vaginosis (BV) was the commonest type of vaginitis (39.01%). Cervical erosion was the second most common cause (17.91%) and physiological discharge was the third (14.36%). pH >or= 4.5 and positive Whiff test had sensitivity of 94.09 per cent and specificity 87.5 per cent in diagnosing BV. Similarly pH < 4.5 and positive or negative Whiff test had sensitivity of 83.72 per cent in diagnosing candidiasis., Interpretation & Conclusion: pH test and Whiff test can improve diagnostic value of speculum examination where microscope facilities are not available.

Objective: Bacterial vaginosis (BV) and Trichomonas vaginalis infection (TV) have been associated with adverse birth outcomes and increased risk for HIV. We compare the performance of simple inexpensive point-of-care (POC) tests to laboratory diagnosis and syndromic management of BV and TV in poor settings., Methods: Between November 2005 and March 2006, 898 sexually active women attending two reproductive health clinics in Mysore, India were recruited into a cohort study investigating the relationship between vaginal flora and HSV-2 infection. Participants were interviewed and screened for reproductive tract infections. Laboratory tests included serology for HSV-2; cultures for TV, Candida sp., and Neisseria gonorrhoeae; Gram stains; and two POC tests: vaginal pH; and Whiff test., Results: Of the 898 participants, 411 [45.7%, 95% confidence interval (95% CI): 42.4-49.0%] had any laboratory diagnosed vaginal infection. BV was detected in 165 women (19.1%, 95%CI: 16.5-21.9%) using Nugent score. TV was detected in 76 women (8.5%, 95%CI: 6.7-10.4%) using culture. Among the entire study population, POC correctly detected 82% of laboratory diagnosed BV cases, and 83% of laboratory diagnosed TV infections. Among women with complaints of vulval itching, burning, abnormal vaginal discharge, and/or sores (445/898), POC correctly detected 83% (60 of 72 cases) of laboratory diagnosed BV cases vs. 40% (29 of 72 cases) correctly managed using the syndromic approach (P < 0.001). Similarly, POC would have detected 82% (37 of 45 cases) of TV cases vs. 51% (23 of 45 cases) correctly managed using the syndromic approach (P = 0.001)., Conclusions: In the absence of laboratory diagnostics, POC is not only inexpensive and practical, but also significantly more sensitive than the syndromic management approach, resulting in less overtreatment. .

Background: Vaginal discharge is very common problem among females. Alteration in balance of normal vaginal organisms can cause the overgrowth of the bacteria that creates vaginal discharge. It is common among sexually active women yet there still remain gaps in our knowledge of this infectious disorder., Objective: To evaluate the frequency of bacterial vaginosis (BV), vaginal candidiasis (VC), vaginal trichomoniasis and Group B streptococcus in women complaining of vaginal discharge in our setup., Method: A total of 100 women of reproductive age group with the complaint of vaginal discharge were included in the study. After filling proforma patients were examined by speculum examination and two high vaginal swabs (HVS) were collected aseptically from each patient. One swab was used for making wet mount for clue cells, pus cells and for motility of Trichomonas vaginalis. The other swab was used to check pH and Amine test. The growth was confirmed by Gram staining in each case., Results: Gardnerrella vaginalis were isolated in 28%, Group B streptococcus in 5% and T. vaginolis in 4% of women., Conclusion: Gardnerella vaginalis causing BV is the most common cause of vaginal discharge in otherwise healthy women of reproductive age group in our setup.

FemPure is a kit for the rapid diagnosis of vaginitis by Trichomonas vaginalis, Candida spp., and Gardnerella vaginalis, based on aggregation of latex particles joined to specific antibodies. The validation of the method involved the parameters specificity, detection limit, robustness, clinical sensitivity, and clinical specificity. Also, samples analyzed in parallel by the validated test and other recognized tests conducted by external laboratory were included. The method was specific for the 3 infectious agents, and no cross-reaction with other microorganisms usually present in vaginal exudates. The detection limit > or =1 x 10(6) CFU/mL for Candida albicans and G. vaginalis avoids the detection of concentrations considered normal flora, whereas T. vaginalis was detected until 1 x 10(5) cells/mL. Values of clinical sensitivity > or =80% and clinical specificity > or =90% and concordance > or =90% were found between samples evaluated in parallel by different methods. Robustness showed that the test can be used in laboratories with different management systems; its simple implementation without equipment allows the use in primary health care areas.

Objective: The objective of the study was to assess effects of male circumcision on female genital symptoms and vaginal infections., Study Design: Human immunodeficiency virus (HIV)-negative men enrolled in a trial were randomized to immediate or delayed circumcision (control arm). Genital symptoms, bacterial vaginosis (BV), and trichomonas were assessed in HIV-negative wives of married participants. Adjusted prevalence risk ratios (adjPRR) and 95% confidence intervals (CIs) were assessed by multivariable log-binomial regression, intent-to-treat analyses., Results: A total of 783 wives of control and 825 wives of intervention arm men were comparable at enrollment. BV at enrollment was higher in control (38.3%) than intervention arm spouses (30.5%, P = .001). At 1 year follow-up, intervention arm wives reported lower rates of genital ulceration (adjPRR, 0.78; 95% CI, 0.63-0.97), but there were no differences in vaginal discharge or dysuria. The risk of trichomonas was reduced in intervention arm wives (adjPRR, 0.52; 95% CI, 0.05-0.98), as were the risks of any BV (adjPRR, 0.60; 95% CI, 0.38-0.94) and severe BV (prevalence risk ratios, 0.39; 95% CI, 0.24-0.64)., Conclusion: Male circumcision reduces the risk of ulceration, trichomonas, and BV in female partners.

Objective: To estimate the accuracy of the clinical diagnosis of the three most common causes of acute vulvovaginal symptoms (bacterial vaginosis, candidiasis vaginitis, and trichomoniasis vaginalis) using a traditional, standardized clinical diagnostic protocol compared with a DNA probe laboratory standard., Methods: This prospective clinical comparative study had a sample of 535 active-duty United States military women presenting with vulvovaginal symptoms. Clinical diagnoses were made by research staff using a standardized protocol of history, physical examination including pelvic examination, determination of vaginal pH, vaginal fluid amines test, and wet-prep microscopy. Vaginal fluid samples were obtained for DNA analysis. The research clinicians were blinded to the DNA results., Results: The participants described a presenting symptom of abnormal discharge (50%), itching/irritation (33%), malodor (10%), burning (4%), or others such as vulvar pain and vaginal discomfort. According to laboratory standard, there were 225 cases (42%) of bacterial vaginosis, 76 cases (14%) of candidiasis vaginitis, 8 cases (1.5%) of trichomoniasis vaginalis, 87 cases of mixed infections (16%), and 139 negative cases (26%). For each single infection, the clinical diagnosis had a sensitivity and specificity of 80.8% and 70.0% for bacterial vaginosis, 83.8% and 84.8% for candidiasis vaginitis, and 84.6% and 99.6% for trichomoniasis vaginalis when compared with the DNA probe standard., Conclusion: Compared with a DNA probe standard, clinical diagnosis is 81-85% sensitive and 70-99% specific for bacterial vaginosis, Candida vaginitis, and trichomoniasis. Even under research conditions that provided clinicians with sufficient time and materials to conduct a thorough and standardized clinical evaluation, the diagnosis and, therefore, subsequent treatment of these common vaginal problems remains difficult., Level of Evidence: II.