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While machine learning (ML) has shown great promise in medical diagnostics, a major challenge is that ML models do not always perform equally well among ethnic groups. This is alarming for women's health, as there are already existing health disparities that vary by ethnicity. Bacterial Vaginosis (BV) is a common vaginal syndrome among women of reproductive age and has clear diagnostic differences among ethnic groups. Here, we investigate the ability of four ML algorithms to diagnose BV. We determine the fairness in the prediction of asymptomatic BV using 16S rRNA sequencing data from Asian, Black, Hispanic, and white women. General purpose ML model performances vary based on ethnicity. When evaluating the metric of false positive or false negative rate, we find that models perform least effectively for Hispanic and Asian women. Models generally have the highest performance for white women and the lowest for Asian women. These findings demonstrate a need for improved methodologies to increase model fairness for predicting BV. [ABSTRACT FROM AUTHOR]

Vaginitis is a common gynecological problem, nevertheless, its clinical evaluation is often insufficient. This study evaluated the performance of an automated microscope for the diagnosis of vaginitis, by comparison of the investigated test results to a composite reference standard (CRS) of wet mount microscopy performed by a specialist in vulvovaginal disorders, and related laboratory tests. During this single-site cross-sectional prospective study, 226 women reporting vaginitis symptoms were recruited, of which 192 samples were found interpretable and were assessed by the automated microscopy system. Results showed sensitivity between 84.1% (95%CI: 73.67–90.86%) for Candida albicans and 90.9% (95%CI: 76.43–96.86%) for bacterial vaginosis and specificity between 65.9% (95%CI: 57.11–73.64%) for Candida albicans and 99.4% (95%CI: 96.89–99.90%) for cytolytic vaginosis. These findings demonstrate the marked potential of machine learning-based automated microscopy and an automated pH test of vaginal swabs as a basis for a computer-aided suggested diagnosis, for improving the first-line evaluation of five different types of infectious and non-infectious vaginal disorders (vaginal atrophy, bacterial vaginosis, Candida albicans vaginitis, cytolytic vaginosis, and aerobic vaginitis/desquamative inflammatory vaginitis). Using such a tool will hopefully lead to better treatment, decrease healthcare costs, and improve patients' quality of life. [ABSTRACT FROM AUTHOR]

Bacterial vaginosis (BV) is a common gynaecological condition. Diagnosis of BV is typically based on Amsel criteria, Nugent score and/or bacterial culture. In this study, these conventional methods and two CE-IVD marked quantitative real-time (q)PCR assays were compared with microbiota analysis for the diagnosis of BV. Eighty women were evaluated for BV during two sequential hospital visits by Amsel criteria, Nugent score, culture, the AmpliSens® Florocenosis/Bacterial vaginosis-FRT PCR kit (InterLabService, Moscow, Russia), and the BD MAX™ Vaginal Panel (BD Diagnostics, MD, USA). Microbiota analysis based on amplicon sequencing of the 16S ribosomal RNA gene was used as reference test. The microbiota profile of 36/115 (31%) included cases was associated with BV. Based on microbiota analysis, the sensitivity of detecting BV was 38.9% for culture, 61.15% for Amsel criteria, 63.9% for Nugent score and the BD MAX assay, and 80.6% for the AmpliSens assay, while the specificity of all methods was ≥ 92.4%. Microbiota profiles of the cases with discrepant results between microbiota analysis and the diagnostic methods were variable. All five diagnostic methods missed BV positive cases with a relatively high abundance of the genus Alloscardovia, Bifidobacterium, or Dialister, which were categorised as unspecified dysbiosis by the AmpliSens assay. Compared to Amsel criteria, Nugent score, culture, and the BD MAX assay, the AmpliSens assay was most in agreement with microbiota analysis, indicating that currently, the AmpliSens assay may be the best diagnostic method available to diagnose BV in a routine clinical setting. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the BD MAX™ vaginal panel in the diagnosis of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis by comparing it with conventional methods: (i) combination of Hay criteria and presence of clue cells with predominant growth of Gardnerella vaginalis, (ii) yeast culture, and (iii) combination of culture, wet mount microscopic examination, and an alternative molecular assay. One thousand vaginal samples of women ≥ 14 years were analyzed; 5% of the samples belonged to pregnant women. 19.3% were classified as BV, in 33.6% yeasts were recovered and in 1.5% TV was detected. For BV, sensitivity and specificity were of 89.8% and 96.5%, respectively; for VVC, sensitivity and specificity were of 97.4% and 96.8%, respectively, and for T. vaginalis, the sensitivity and specificity were of 100%. The BD MAX™ vaginal panel is highly sensitive and specific and simplifies the identification of infectious vaginitis. [ABSTRACT FROM AUTHOR]

Endometriosis is a benign gynecologic disease characterized by the presence of ectopic endometrium and associated with inflammation and immune abnormalities. However, the molecular basis for endometriosis is not well understood. To address this issue, the present study examined the expression of high-mobility group box (HMGB) 1 in menstrual blood to investigate its role in the ectopic growth of human endometriotic stromal cells (ESCs). A total of 139 patients were enrolled in this study; 84 had endometriosis and 55 were nonendometriotic gynecological patients (control). The HMGB1 levels in various fluids were measured by enzyme-linked immunosorbent assay. Expression of receptor for advanced glycation end products (RAGE) in eutopic and ectopic endometrium was assessed by immunohistochemistry, and RAGE and vascular endothelial growth factor (VEGF) messenger RNA expression in HMGB1- and lipopolysaccharide (LPS)-treated ESCs was evaluated by real-time polymerase chain reaction. The HMGB1 concentration was higher in menstrual blood than in serum or peritoneal fluid (P < .001 for both). RAGE was expressed in both normal and ectopic endometrium. Administration of 1000 ng/mL HMGB1 or coadministration of 100 ng/mL HMGB1 and 100 ng/mL LPS induced VEGF production in ESCs relative to the control (P < .05). These results suggest that menstrual fluid has naturally high levels of HMGB1 and may promote endometriosis following retrograde menstruation when complexed with other factors such as LPS by inducing inflammation and angiogenesis. [ABSTRACT FROM AUTHOR]

Bacterial vaginosis (BV), candidiasis, and trichomoniasis were the three established types of vaginal conditions until aerobic vaginitis (AV) was defined in the early 2000s. We sought to study the prevalence of abnormal vaginal flora (AVF) with inflammation in our hospital and to correlate it with AV. We prospectively collected vaginal smear specimens originated from symptomatic women who were examined at Iaso Obstetrics, Gynecology and Children's Hospital of Athens from April 2014 until September 2015. Amsel's criteria were used for the diagnosis of BV. The presence of leukocytes and lactobacillary grade were evaluated to classify a condition as AVF with inflammation; subsequently, bacterial cultures were performed. A total of 761 women were included. Five hundred and seventy-nine women were diagnosed with candidiasis, BV, trichomoniasis, or other types of vaginitis in which no pathogenic bacterial growth occurred in cultures. One hundred and eighty-two women (23.9 %) were diagnosed with AVF with inflammation (116 non-pregnant, 66 pregnant). Escherichia coli was the most common pathogen among these women (non-pregnant: 45.7 %, pregnant: 34.8 %). Other common pathogens were Group-B- Streptococcus (non-pregnant: 20.7 %, pregnant: 22.7 % respectively), Enterococcus faecalis (14.7 %, 18.2 %), and Klebsiella pneumoniae (6.9 %, 12.1 %). The prevalence of AVF with inflammation may be high. Since inflammation criteria were applied, most cases of BV were eliminated and the majority of cases of AVF are AV. Therefore, clinicians should include AV in the differential diagnosis of vaginitis, while microbiologists should take into account the growth of aerobic bacteria in vaginal cultures originating from women with microscopic findings of AV. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate a real-time PCR-based technique to quantify bacteria associated with aerobic vaginitis (AV) as a potential test.Methods: Vaginal samples from 100 women were tested by wet-mount microscopy, gram stain and quantitative real-time PCR targeting Enterobacteriacea, Staphylococcus spp., Streptococcus spp., Enterococcus spp., Escherichia coli, Streptococcus agalactiae, S. aureus; Lactobacillus spp. AV diagnosis obtained by wet-mount microscopy was used as reference.Results: Some level of AV was diagnosed in 23 (23.7 %) cases. Various concentrations of Enterobacteriacea, Staphylococcus spp., Streptococcus spp. were detected an all patients. Enterococcus spp. were detected in 76 (78.3 %) cases. Summarized concentrations of aerobes were tenfold higher in AV-positive compared to AV-negative cases [7.30lg vs 6.06lg (p = 0.02)]. Concentrations of aerobes in severe, moderate and light AV cases did not vary significantly (p = 0.14). Concentration of lactobacilli was 1000-fold lower in AV-positive cases compared to normal cases (5.3lg vs 8.3lg, p < 0.0001). Streptococcus spp. dominated in the majority of AV-positive cases [19/22 (86.4 %) samples]. The relation of high loads of aerobes to the low numbers of Lactobacilli are a reliable marker for the presence of AV and could substitute microscopy as a test.Conclusions: PCR may be a good standardized substitution for AV diagnosis in settings where well-trained microscopists are lacking. [ABSTRACT FROM AUTHOR]

The purpose of this investigation was to evaluate the impact of the vaginal milieu on the presence of abnormal Pap smears and a positive human papilloma virus (HPV) test. A cross-sectional study was conducted between June 2014 and May 2015, evaluating the vaginal discharge by fresh wet mount microscopy and comparing these data with Pap smear findings. Wet mount slides were scored for bacterial vaginosis (BV), aerobic vaginitis (AV), presence of Candida and Trichomonas vaginalis. Cytologic evaluation was done on all Pap smears according to the Bethesda criteria. The cobas© HPV Test (Roche) was performed for HPV detection. A total of 622 cases were evaluated. The mean age of the patients was 41.6 ± 10.65 years (range 21-75). Eighty-three women (13.3 %) had a cytology result worse than low-grade squamous intraepithelial lesion (LSIL). When comparing this group with the one with normal or minor [atypical squamous cells of undetermined significance (ASC-US) or LSIL] Pap smear abnormalities, there were no differences in the presence of Candida (32.5 % vs. 33.2 %, p = 1.0), absence of lactobacilli (38.6 % vs. 32.5 %, p = 0.32) or BV (20.5 % vs. 13.2 %, p = 0.09). On the other hand, moderate or severe inflammation (msI) (41.0 % vs. 28.8 %, p = 0,04), moderate or severe AV (msAV) (16.9 % vs. 7.2 %, p = 0.009) and msAV/BV (37.3 % vs. 20.0 %, p = 0.001) were more common in women with such major cervical abnormalities. No significant association was found between deviations of the vaginal milieu and high-risk HPV infection. The presence of msI or msAV, but not BV, is independently associated with an increased risk of major cervical cytological abnormalities, but not with HPV infection. [ABSTRACT FROM AUTHOR]

Purpose: A new CE-marked portable desktop ion mobility spectrometer (VGTest) was used for detection of malodorous biogenic amines indicative of bacterial vaginosis (BV). This study aimed to assess the performance of this testing method for the first time in a routine ambulatory care clinic and to determine the relative levels of biogenic amines in vaginal fluid of BV. Methods: Vaginal and cervical swabs ( n = 57) were surveyed for infections. Cases of BV ( n = 18) confirmed positive according to 'Amsel' criteria and normal controls ( n = 39) showing no infection under clinical examination and testing negative in wet mount microscopy were included in the IMS analysis. Results: The trimethylamine (TMA) content in vaginal fluid of the BV-positive cases, AUC/AUC [mean 0.215 (range 0.15-0.35)] was significantly higher than normal controls [mean 0.06 (range 0.048-0.07)] p < 0.0001. The putrescine (1,4-diaminobutane, PUT) and cadaverine (1,5-diaminopentane, CAD) of BV-positive cases were above controls at borderline significance. The AUC/AUC ratios correlated neither with AUC/AUC nor AUC/AUC among BV-positive patients. In contrast, among normal controls all the biogenic amines were at a low level and the linear regression analysis revealed striking positive correlations of AUC/AUC with AUC/AUC ( p < 0.05) and AUC/AUC ( p < 0.001). The test shows 83 % sensitivity and 92 % specificity at a cut-off of AUC/AUC = 0.112 and AUC of receiver operator characteristic = 0.915 (0.81-0.97, 95 % CI). Conclusions: VGTest-IMS is accurate and feasible for point-of-care testing of BV in the ambulatory care setting. Further evaluations are in progress to assess the utility of VGTest-IMS for differential diagnosis of candidosis, non-BV infection and common inflammatory conditions. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the feasibility of using self-collected vaginal specimens for the quantitative real-time polymerase chain reaction (qPCR) assays of bacterial vaginosis (BV)-associated bacteria versus practitioner-collected swabs. A cross-sectional study included 190 pregnant women enrolled before 20 weeks' gestation from September 2008 to November 2009. Self- and practitioner-collected swabs were taken during the same prenatal visit for each woman, qPCR assays performed for each, and the results compared. The quantification of the human albumin gene was used as an internal control to ensure sampling quality and accurate comparisons. The level of agreement of the qPCR assays for each microorganism was calculated with the Spearman product moment correlation coefficient and the kappa statistic. In all, 370 vaginal samples (185 self- and 185 practitioner-collected swabs) had a narrow range of values for the number of albumin gene copies and a significant correlation coefficient (Spearman's rho = 0.532; p < 0.001). The agreement between both sampling methods was excellent (Spearman's rho was 0.748 for Atopobium vaginae, 0.918 for Lactobacillus species, 0.940 for Gardnerella vaginalis; p < 0.001), especially for high concentrations of A. vaginae (≥10 copies/mL; kappa value = 0.973; p < 0.001) and G. vaginalis (≥10 copies/mL; kappa value = 0.903; p < 0.001). This study demonstrates the validity and reliability of self- versus practitioner-collected swabs for the molecular quantification of Lactobacillus species, G. vaginalis, and A. vaginae. [ABSTRACT FROM AUTHOR]

Randomized trials of bacterial vaginosis (BV) treatment among pregnant women to reduce preterm birth have had mixed results. Among non-pregnant women, BV recurs frequently after treatment. Randomized trials of early BV treatment for pregnant women in which recurrence was retreated have shown promise in reducing preterm birth. Syracuse's Healthy Start (SHS) program began in 1997; in 1998 prenatal care providers for pregnant women living in high infant mortality zip codes were encouraged to screen for abnormal vaginal flora at the first prenatal visit. Vaginal swabs were sent to a referral hospital laboratory for Gram staining and interpretation. SHS encouraged providers to treat and rescreen women with bacterial vaginosis or abnormal flora (BV). We abstracted prenatal and hospital charts of live births between January 2000 and March 2002 for maternal conditions and treatments. We merged abstracted data with local electronic data. We evaluated the effect of BV screening before 22 weeks gestation, treatment, and rescreening using a retrospective cohort study design. Among 838 women first screened before 22 weeks, 346 (41%) had normal flora and 492 (59%) women had BV at a mean of 13 weeks gestation; 202 (24%) did not have treatment documented and 290 (35%) received treatment at a mean of 15 weeks gestation; 267 (92%) of those treated were re-screened. Among pregnant women with early BV, 42 (21%) untreated women and 28 (10%) treated women delivered preterm (Odds Ratio [OR] 0.4, 95% confidence interval [CI] 0.2-0.7)). After adjustment for age, race, prior preterm birth and other possible confounders, treatment remained associated with a reduced risk of preterm birth compared to no treatment (aOR = 0.5, 95% CI 0.3-0.9); the aOR for women with normal flora was not significantly different. Conclusion: Screening, treatment, and rescreening for BV/abnormal flora between the first prenatal visit and 22 weeks gestation showed promise in reducing preterm births and deserves further study. [ABSTRACT FROM AUTHOR]

The purpose of this investigation was to determine the diagnostic accuracy of quantitative real-time polymerase chain reaction (PCR) assay in diagnosing bacterial vaginosis versus the standard methods, the Amsel criteria and the Nugent score. The Amsel criteria, the Nugent score, and results from the molecular tool were obtained independently from vaginal samples of 163 pregnant women who reported abnormal vaginal symptoms before 20 weeks gestation. To determine the performance of the molecular tool, we calculated the kappa value, sensitivity, specificity, and positive and negative predictive values. Either or both of the Amsel criteria (≥3 criteria) and the Nugent score (score ≥7) indicated that 25 women (15%) had bacterial vaginosis, and the remaining 138 women did not. DNA levels of Gardnerella vaginalis or Atopobium vaginae exceeded 10 copies/mL or 10 copies/mL, respectively, in 34 (21%) of the 163 samples. Complete agreement between both reference methods and high concentrations of G. vaginalis and A. vaginae was found in 94.5% of women (154/163 samples, kappa value = 0.81, 95% confidence interval 0.70-0.81). The nine samples with discordant results were categorized as intermediate flora by the Nugent score. The molecular tool predicted bacterial vaginosis with a sensitivity of 100%, a specificity of 93%, a positive predictive value of 73%, and a negative predictive value of 100%. The quantitative real-time PCR assay shows excellent agreement with the results of both reference methods for the diagnosis of bacterial vaginosis. [ABSTRACT FROM AUTHOR]

To study the prevalence of bacterial vaginosis (BV) in pregnant women and to evaluate the accuracy of clinical criteria for the diagnosis of BV. In this observational study 502 asymptomatic pregnant women were screened for bacterial vaginosis in a rural health care facility by Gram stain. Accuracy of clinical diagnosis using individual and two of Amsel’s criteria was evaluated. The frequency of BV was 8.6% by Nugent’s method. For Amsel’s criteria, sensitivity and specificity was 51.2 and 98%, with 71% PPV and 95.5% NPV. The most sensitive individual criterion was vaginal pH, but with lowest specificity. The criterion with highest specificity was clue cells. The combination of the two criteria, vaginal pH and positive amine test, had best positive and negative predictive values 60.5 and 97.8%, respectively. The diagnosis of BV according to Amsel’s criteria may be simplified using a combination of the two criteria, vaginal pH and amine test, in settings where microscopy or Gram staining is not available. [ABSTRACT FROM AUTHOR]

Objective This study measures the relative performance of three methods for diagnosing bacterial vaginosis (BV) during pregnancy and assesses the implications of measurement for clinical practice and surveillance. Methods A sample ( n = 1,780) of English or Spanish speaking women, with a singleton intrauterine pregnancy and receiving prenatal care at a consortium of public health centers in Philadelphia were consecutively enrolled. Gram stain, clinician’s diagnosis, and a commercial test were the three diagnostic methods used to assess BV. Sensitivity, specificity, and the positive and negative predictive values of clinical diagnosis and the commercial test were assessed using the gram stain/Nugent score as a gold standard. Results The prevalence of BV, measured on the same population, differed considerably depending on the diagnostic test used. The measured prevalences were 55% (Gram stain), 28.5% (clinician’s diagnosis), and 12.6% (commercial test). The prevalence of BV (diagnosed by gram stain) was twice as high among African American women compared to White women. Only 69% BV-positive high-risk women were treated for BV. Conclusions Inaccurate diagnosis of BV leads to missed cases. The identification of true cases is critical for assigning treatment and for assessing treatment effectiveness. Clinician’s routine diagnosis fell short of recommended procedures and performed poorly compared to gold standard in case ascertainment. This inability to ascertain cases may have an impact on our ability to prevent preterm birth. [ABSTRACT FROM AUTHOR]

In a population of 956 women, attending for contraceptive advice, 131 (13.7%) were found to have BV acording to Amsel's criteria. Clue cells were detected in 200 (20.9%) women, a positive amine ('sniff') test in 191 (20.0%), a vaginal pH > or = 4.7 in 243 (25.4%) and a "characteristic" vaginal discharge in 104 (10.9%) women. Sensitivity, specificity, positive and negative predictive values in relation to BV were calculated for each of these four criteria. The detection of clue cells, an increased pH and a positive sniff test showed excellent sensitivity (86-100%) values, but had a less satisfactory positive predictive value (52-68%). Vaginal discharge was found to be a poor predictor of BV. The vaginal flora in women with clue cells, increased vaginal pH or a positive sniff test was very similar to that of the women with BV, every after excluding concomitant cases of BV and the three respective criteria. Thus, a positive amine test, which is easily performed, strongly suggests BV and a vaginal flora predominated by Gardnerella vaginalis, Mycoplasma hominis, Mobiluncus species and anaerobic species on one hand, and lack of lactobacilli on the other. When there is a clinical suspicion of BV, the sniff test is positive and differential diagnoses are excluded, one can safely treat a woman for bacterial vaginosis. [ABSTRACT FROM AUTHOR]