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ABSTRACT Bacterial vaginosis (BV) is the most common cause of abnormal vaginal discharge. BV represents a dysbiosis with the acquisition of a diverse community of anaerobic bacteria and a reduction in lactobacilli burden. Our objective was to evaluate the Aptima BV assay kit for the diagnosis of BV. From May to August 2019, we enrolled outpatients and inpatients, including nonpregnant women above 18 with vaginosis symptoms, consulting at Nantes University hospital. The Aptima BV assay measures the loads of Gardnerella vaginalis, Atopobium vaginae, and Lactobacillus species in relation to overall bacterial load. The Aptima BV assay was compared to Nugent scoring (NS). A total of 456 women were enrolled, and 347 patients met the inclusion criteria with data available for the analysis. NS was used to classify the samples and 144 (41.5%) samples were classified as normal (NS = 0–3), 45 (13%) as BV (NS = 7–10), 38 (11%) presented an intermediate vaginal microbiota (3

Abstract Background The most common pathological cause of abnormal vaginal discharge in reproductive-aged women is bacterial vaginosis (BV). Amsel’s criteria and Nugent scoring systems are commonly employed approaches for the diagnosis of BV. Despite the Nugent scoring system being the gold standard method for diagnosing BV, Amsel’s criteria are generally preferred in clinical setup owing to the fact Nugent scoring requires considerable time and expert microscopist. This study was conducted to determine the diagnostic value of Amsel’s criteria by comparing it with the Nugent scoring system. Methods This was a descriptive cross-sectional study conducted at Tribhuvan University Teaching Hospital, Nepal from October 2016 to September 2017. Vaginal specimens were collected from a total of 141 women presenting with abnormal vaginal discharge. The sensitivity, specificity, positive predictive value, and negative predictive value of Amsel’s criteria were calculated, and each component of Amsel’s criteria was compared to the Nugent scoring system. Results The sensitivity, specificity, positive predictive value, and negative predictive value of Amsel’s criteria were 50%, 98.2%, 87.5%, and 88.8% respectively. The clue cells showed 100% specificity and vaginal discharge with pH > 4.5 had 89.3% sensitivity while compared with Nugent’s scoring system. Conclusions Amsel’s criteria can be used as an adjunct method to Nugent scoring for the diagnosis of BV in the hands of skilled manpower in resources limited countries. The presence of clue cell and positive whiff test of Amsel’s criteria shows good match with Nugent’s score.

Background: The most common pathological cause of abnormal vaginal discharge in reproductive-aged women is bacterial vaginosis (BV). Amsel's criteria and Nugent scoring systems are commonly employed approaches for the diagnosis of BV. Despite the Nugent scoring system being the gold standard method for diagnosing BV, Amsel's criteria are generally preferred in clinical setup owing to the fact Nugent scoring requires considerable time and expert microscopist. This study was conducted to determine the diagnostic value of Amsel's criteria by comparing it with the Nugent scoring system.Methods: This was a descriptive cross-sectional study conducted at Tribhuvan University Teaching Hospital, Nepal from October 2016 to September 2017. Vaginal specimens were collected from a total of 141 women presenting with abnormal vaginal discharge. The sensitivity, specificity, positive predictive value, and negative predictive value of Amsel's criteria were calculated, and each component of Amsel's criteria was compared to the Nugent scoring system.Results: The sensitivity, specificity, positive predictive value, and negative predictive value of Amsel's criteria were 50%, 98.2%, 87.5%, and 88.8% respectively. The clue cells showed 100% specificity and vaginal discharge with pH > 4.5 had 89.3% sensitivity while compared with Nugent's scoring system.Conclusions: Amsel's criteria can be used as an adjunct method to Nugent scoring for the diagnosis of BV in the hands of skilled manpower in resources limited countries. The presence of clue cell and positive whiff test of Amsel's criteria shows good match with Nugent's score. [ABSTRACT FROM AUTHOR]

Preterm birth (PTB) is the most common cause of neonatal morbidity and mortality worldwide. Approximately half of PTBs is linked with microbial etiologies, including pathologic changes to the vaginal microbiota, which vary according to ethnicity. Globally more than 50% of PTBs occur in Asia, but studies of the vaginal microbiome and its association with pregnancy outcomes in Asian women are lacking. This study aimed to longitudinally analyzed the vaginal microbiome and cytokine environment of 18 Karen and Burman pregnant women who delivered preterm and 36 matched controls delivering at full term. Using 16S ribosomal RNA gene sequencing we identified a predictive vaginal microbiota signature for PTB that was detectable as early as the first trimester of pregnancy, characterized by higher levels of Prevotella buccalis, and lower levels of Lactobacillus crispatus and Finegoldia, accompanied by decreased levels of cytokines including IFNγ, IL-4, and TNFα. Differences in the vaginal microbial diversity and local vaginal immune environment were associated with greater risk of preterm birth. Our findings highlight new opportunities to predict PTB in Asian women in low-resource settings who are at highest risk of adverse outcomes from unexpected PTB, as well as in Burman/Karen ethnic minority groups in high-resource regions.

Preterm birth (PTB) is the most common cause of neonatal morbidity and mortality worldwide. Approximately half of PTBs is linked with microbial etiologies, including pathologic changes to the vaginal microbiota, which vary according to ethnicity. Globally more than 50% of PTBs occur in Asia, but studies of the vaginal microbiome and its association with pregnancy outcomes in Asian women are lacking. This study aimed to longitudinally analyzed the vaginal microbiome and cytokine environment of 18 Karen and Burman pregnant women who delivered preterm and 36 matched controls delivering at full term. Using 16S ribosomal RNA gene sequencing we identified a predictive vaginal microbiota signature for PTB that was detectable as early as the first trimester of pregnancy, characterized by higher levels of Prevotella buccalis , and lower levels of Lactobacillus crispatus and Finegoldia , accompanied by decreased levels of cytokines including IFNγ, IL-4, and TNFα. Differences in the vaginal microbial diversity and local vaginal immune environment were associated with greater risk of preterm birth. Our findings highlight new opportunities to predict PTB in Asian women in low-resource settings who are at highest risk of adverse outcomes from unexpected PTB, as well as in Burman/Karen ethnic minority groups in high-resource regions. [ABSTRACT FROM AUTHOR]

Introduction: The vaginal flora of healthy adult women of reproductive age group constitutes predominantly Lactobacilli which inhibits the growth of other microorganisms (by maintaining acidic pH). The vaginal microflora is altered in favour of anaerobes in women using Intra Uterine Contraceptive Device (IUCD). Also, it can cause morphologic changes in both squamous and endocervical columnar cells. Similarly, the prevalence of vaginal lactobacilli is reduced among women using diaphragm-spermicide or spermicide alone. Aim: To study the effects of different contraceptive methods on cervical cytology and vaginal flora. Materials and Methods: Two years prospective study included 120 women of reproductive age group using barrier, tubal ligation, IUCDs, Oral Contraceptive Pills (OCPs) and injectable methods of contraception and a control group including 60 women not using any contraceptive. Cervical and vaginal smears were obtained. Cervical smears were reported using the Bethesda system and Gram stained vaginal smears were scored using Nugent scoring. SPSS (Statistical Package for the Social Sciences) software for Windows Version 19.0 and test of significance applied was Chi-square test. Results: The most common contraception used was barrier (68.3%) followed by tubal ligation (14.2%), IUCD (9.2%), OCPs (6.6%) and injectable (1.7%). The presenting complaints were pain lower abdomen (46.7%) followed by menstrual complaints (22.5%). Epithelium showed reactive changes (45%) followed by metaplasia (25%), koilocytotic change (5%), cytolytic effect (5%) and satellitosis (4.2%). Women showed normal flora in 51.7%, altered in 30% and bacterial vaginosis in 18.3%. Conclusion: Cervico-vaginal changes were more frequent in contraceptive users as compared to the control group.

Bacterial vaginosis (BV) is a dysbiosis of vaginal microbiota characterized by a shift from Lactobacillus species predomination to a heterogeneous mixture of anaerobes. We compared the performance characteristics of the Allplex ™ BV molecular assay with the reference test, Nugent score microscopy, for vaginal swab specimens from symptomatic South African women. A total of 213 patients were enrolled, of whom 99 (46.5%) and 132 (62.0%) were diagnosed with BV by Nugent and Allplex™, respectively. The Allplex™ BV assay displayed a sensitivity of 94.9% (95% CI, 88.7%−97.8%) and a specificity of 66.7% (95% CI, 57.6%−74.6%), with an agreement of 79.8% (95% CI, 73.9%−84.7%) (κ = 0.60). Assay design may be enhanced for improved specificity by accounting for differences in healthy and BV-associated vaginal microbiomes among women of different ethnicities. [ABSTRACT FROM AUTHOR]

To determine and compare the efficacy of Kakrasingi (Pistacia integerrima J.L. Stewart ex Brandis) with metronidazole in bacterial vaginosis (BV). A randomized (1:1) standard controlled, single-center study was conducted in diagnosed patients (n = 62) of BV. The intervention group (n = 31) and standard group (n = 31) received orally, the gall of P. integerrima powder (1 g) and metronidazole (400 mg) respectively twice a day for 7 days. The primary efficacy endpoint included clinical cure as assessed by Amsel's criteria evaluated at the test of cure visit (day 14–18). The secondary efficacy endpoints were a microbiologic cure (considered as a Nugent score of 0–3), therapeutic cure (includes both clinical and microbiologic cure) evaluated at the test of cure visit (day 14–18), and vaginal symptoms scale (VSS) at day 14–18, 21–24, and 30–34 and safety profile. The data were statistically inferred by the parametric and non-parametric tests with a 5 % level of significance and a 95% confidence interval. The clinical, microbiological, and therapeutic cure rates were 54.83 %, 51.61 %, and 51.61 % for the intervention and 51.61 %, 45.16 %, and 45.16 % for the control group. The comparison showed no significant difference in clinical (p = 0.88), microbiological (p = 0.93), and therapeutic cure rates (p = 0.93). The VSS mean score on days 14–18 was 3.67 ± 2.90 and 4.22 ± 2.61 in the intervention and control groups respectively, moderately statistically more significant (p = 0.03) in the intervention than in the control group. P. integerrima showed a similar effect as metronidazole in treating BV with no adverse effects. • Tclinical, microbiological, and therapeutic cure rates for bacterial vaginosis (BV) were 54.83%, 51.61%, and 51.61% for the P. integerrima gall powder (1g) and 51.61%, 45.16%, and 45.16% for metronidazole twice a day for 7 days on days 14-18 with no statistical difference (p >0.05). • The VSS at post-intervention was 3.67±2.90 and 4.22±2.61 in the intervention and control groups respectively (p =0.03). • No adverse effects were reported in both groups. • P. integerrima possesses a versatile pharmacological activities such as antimicrobial, anti-inflammatory, analgesic and antioxidant activities. [ABSTRACT FROM AUTHOR]

Bacterial vaginosis (BV) is the most common cause of abnormal vaginal discharge. BV represents a dysbiosis with the acquisition of a diverse community of anaerobic bacteria and a reduction in lactobacilli burden. Our objective was to evaluate the Aptima BV assay kit for the diagnosis of BV. From May to August 2019, we enrolled outpatients and inpatients, including nonpregnant women above 18 with vaginosis symptoms, consulting at Nantes University hospital. The Aptima BV assay measures the loads of Gardnerella vaginalis, Atopobium vaginae, and Lactobacillus species in relation to overall bacterial load. The Aptima BV assay was compared to Nugent scoring (NS). A total of 456 women were enrolled, and 347 patients met the inclusion criteria with data available for the analysis. NS was used to classify the samples and 144 (41.5%) samples were classified as normal (NS = 0-3), 45 (13%) as BV (NS = 7-10), 38 (11%) presented an intermediate vaginal microbiota (3 < NS < 7), 79 (22.7%) had various bacteria (excluding vaginal flora), 29 (8.3%) had insufficient bacterial density, and 12 (3.5%) had a predominance of yeasts. The Aptima BV kit displayed a sensitivity of 91.1% and specificity of 94.4% with a positive predictive value (PPV) of 83.7% and a negative predictive (NPV) value of 97.1%. The results of this monocentric retrospective study show that Aptima BV kit has a good diagnostic correlation compared to standard of care for dysbiotic diagnosis cases. IMPORTANCE The possibility exists of the involvement of a new molecular test in the routine algorithm of bacterial vaginosis diagnosis in microbiology laboratories. This manuscript reports on our experience, and we propose an organization combining Nugent scoring and molecular testing, especially for intermediate Nugent scores.

Introduction: Bacterial vaginosis (BV) is the commonest cause of abnormal vaginal discharge in women of child-bearing age and is associated with increased susceptibility to HIV-AIDS and sexually transmitted diseases. In obstetrics, BV has been implicated in causing various complications. In clinical practice, BV is diagnosed using Amsel criteria and Nugent scoring. Using modified Amsel criteria, we determined that the fulfilling of any two instead of three criteria can be diagnostic of BV. Methodology: This prospective cross-sectional study involved pregnant females complaining of excessive vaginal discharge admitted in a tertiary health centre in central India. Four vaginal swabs were collected for the diagnosis of BV by Amsel criteria, modified Amsel criteria, and Nugent scoring on Gram stain. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy of each individual criterion and combinations of criteria were calculated by using Nugent scoring as the gold standard and by chi square test. Results: In the present study overall prevalence of BV was 12%. The sensitivity of individual or a combination of two criteria was almost same or higher than that of Amsel criteria. Specificity of each combination of criteria was comparable to that of Amsel criteria. However, a combination of high pH and amine odor test had the highest sensitivity (88%) and highest PPV (62%). Diagnostic accuracy of all combinations in our study was equal to or slightly higher than that of Amsel criteria. Conclusion: Diagnostic accuracy of new modified Amsel criteria is as reliable as that of Amsel criteria. [ABSTRACT FROM AUTHOR]

Forsum U, Hallén A, Larsson PG. Bacterial vaginosis– a laboratory and clinical diagnostics enigma. Review. APMIS 2005;113:153–61.Diagnosing bacterial vaginosis (BV) has long been based on the clinical criteria of Amsel et al., whereby three of four defined criteria must be satisfied. Though there are other criteria and scoring methods which function well in comparison (i.e. Nugent scoring), it is not certain that they will always identify the same category of patients. Point-of-care methods based on various combinations of microbial products, presence of RNA, or more complex laboratory instrumentations such as sensor arrays, have also been introduced for the diagnosis of BV. No method for diagnosing BV can at present be regarded as the best. It could be that– based partly on tacit knowledge on the part of the clinical investigators scoring in the clinic– various scoring systems have been chosen to fit a particular BV-related problem in a particular population. In this review we critically examine these pertinent issues influencing clinical scoring and laboratory diagnostics of BV. [ABSTRACT FROM AUTHOR]

Forsum U, Holst E, Larsson PG, Vasquez A, Jakobsson T, Mattsby-Baltzer I. Bacterial vaginosis– a microbiological and immunological enigma. Minireview. APMIS 2005;113:81–90.The development of bacterial vaginosis (BV) among women of childbearing age and the resulting quantitative and qualitative shift from normally occurring lactobacilli in the vagina to a mixture of mainly anaerobic bacteria is a microbiological and immunological enigma that so far has precluded the formulation of a unifying generally accepted theory on the aetiology and clinical course of BV. This critical review highlights some of the more important aspects of BV research that could help in formulating new basic ideas respecting the biology of BV, not least the importance of the interleukin mediators of local inflammatory responses and the bacterial shift from the normally occurring lactobacilli species:L. crispatus, L. gasseri, L. jensenii,andL. inersto a mixed flora dominated by anaerobic bacteria. [ABSTRACT FROM AUTHOR]

The etiological cause of bacterial vaginosis (BV) is the change of the vaginal ecosystem characterized by a decrease of lactobacilli and an increase of other germs, such as Gardnerella vaginalis and Atopobium vaginae. Molecular tools have revolutionized the diagnosis of these conditions. The aim of this paper was to compare results obtained from 158 vaginal swabs collected from women aged between 18 and 59 years old and subjected to microscopic evaluation (Nugent Score), culture and to the multiparametric molecular assay Vaginitis and Vaginosis Multiplex-Tandem (MT) PCR (AU27117) - Nuclear Laser Medicine. In 50 samples we also used matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) for bacterial microbiome identification. Our results showed a moderate concordance between traditional and molecular methods for diagnosis of candidiasis and a lower concordance for BV and normal flora. MALDI TOF MS allowed us to discriminate more than 10 species of lactobacilli with a greater abundance of Lactobacillus gasseri, Lactobacillus paracasei spp. paracasei, Lactobacillus pentosus and Lactobacillus crispatus in BV and altered flora. This work underlined how the integration of different assays and metagenomics studies can greatly expand our current understanding of vaginal microbial diversity, providing more reliable diagnostic criteria for BV and its intermediate condition diagnosis.

Introduction: The vaginal flora of healthy adult women of reproductive age group constitutes predominantly Lactobacilli which inhibits the growth of other microorganisms (by maintaining acidic pH). The vaginal microflora is altered in favour of anaerobes in women using Intra Uterine Contraceptive Device (IUCD). Also, it can cause morphologic changes in both squamous and endocervical columnar cells. Similarly, the prevalence of vaginal lactobacilli is reduced among women using diaphragm-spermicide or spermicide alone., Aim: To study the effects of different contraceptive methods on cervical cytology and vaginal flora., Materials and Methods: Two years prospective study included 120 women of reproductive age group using barrier, tubal ligation, IUCDs, Oral Contraceptive Pills (OCPs) and injectable methods of contraception and a control group including 60 women not using any contraceptive. Cervical and vaginal smears were obtained. Cervical smears were reported using the Bethesda system and Gram stained vaginal smears were scored using Nugent scoring. SPSS (Statistical Package for the Social Sciences) software for Windows Version 19.0 and test of significance applied was Chi-square test., Results: The most common contraception used was barrier (68.3%) followed by tubal ligation (14.2%), IUCD (9.2%), OCPs (6.6%) and injectable (1.7%). The presenting complaints were pain lower abdomen (46.7%) followed by menstrual complaints (22.5%). Epithelium showed reactive changes (45%) followed by metaplasia (25%), koilocytotic change (5%), cytolytic effect (5%) and satellitosis (4.2%). Women showed normal flora in 51.7%, altered in 30% and bacterial vaginosis in 18.3%., Conclusion: Cervico-vaginal changes were more frequent in contraceptive users as compared to the control group.