Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis

Schwebke, Jane R.; Gaydos, Charlotte A.; Nyirjesy, Paul; Paradis, Sonia; Kodsi, Salma; Cooper, Charles K.

doi:10.1128/jcm.00252-18

Cited by 71 publications

(66 citation statements)

References 28 publications

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“…Vaginitis is a common concern for many women, which has led to a growing body of literature on diagnostic methods (20,44,(46)(47)(48), epidemiology, and treatment of BV and other causes of vaginitis (7,49,50). Similarly to the present work, the evidence consistently supports the benefits of molecular methods to diagnose BV over traditional microscopic methods.…”

Section: Discussionsupporting

confidence: 75%

Molecular Diagnosis of Vaginitis: Comparing Quantitative PCR and Microbiome Profiling Approaches to Current Microscopy Scoring

et al. 2019

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Vaginitis is often diagnosed by microscopy and limited to testing for bacterial vaginosis (BV), vulvovaginal candidiasis, and trichomoniasis. Approximately 10% of vaginal swabs are negative but designated “altered flora” by BV Nugent score, leaving clinicians unsure how to treat patients. Accurate and comprehensive vaginitis diagnostics are needed to direct treatment and reduce risks of recurrent or more severe infections. Vaginal swabs were collected from 93 women (mean age, 23.53 years; range, 18 to 42 years) in a cross-sectional study. Microscopy results for BV and Candida were compared to those from two molecular approaches: (i) a comprehensive quantitative PCR (qPCR) assay, including testing for aerobic vaginitis (AV), Candida, sexually transmitted infections (STI), and BV (Applied Biosystems) with an accompanying BV interpretive algorithm (Coriell Life Sciences), and (ii) microbiome profiling of the 16S rRNA gene (Illumina). Microscopy plus BV Nugent score had 76% overall agreement with the qPCR plus BV interpretive algorithm method (24 positive, 47 negative). OF the nine samples designated altered flora by Nugent, five were categorized BV positive and four were BV negative by the qPCR method. Although BV negative, 3/4 of the latter samples had positive AV targets with one also was STI positive. Microscopic identification of Candida versus that by qPCR had 94% agreement (9 positive, 78 negative). The comprehensive qPCR assay revealed alternative etiologies summarized as 38% BV, 10% AV, 5% Candida, 2% STI, 10% mixed infection (positive targets in multiple panels), and 35% negative for all targets. 16S microbiome analysis confirmed the bacterial qPCR results and identified differentiating patterns between AV, BV, and Lactobacillus-dominated vaginal microbiomes.

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Section: Discussionsupporting

confidence: 75%

Molecular Diagnosis of Vaginitis: Comparing Quantitative PCR and Microbiome Profiling Approaches to Current Microscopy Scoring

et al. 2019

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“…Therefore, negative findings about incident herpes, chlamydiasis, gonorrhea and trichomoniasis should be interpreted with caution. Furthermore, the laboratory diagnosis of trichomoniasis and yeast infections relied on in-clinic wet mount, which allows immediate treatment and has high specificity, but lower sensitivity compared to newer molecular diagnostic tests [43][44][45]. Therefore, we cannot exclude the possibility that undiagnosed subclinical infections by these pathogens might have contributed to the prodromal state of cervical immunity.…”

Section: Limitations and Strengths Of The Studymentioning

confidence: 99%

Aberrant cervical innate immunity predicts onset of dysbiosis and sexually transmitted infections in women of reproductive age

et al. 2020

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Sexually transmitted infections (STIs) and vaginal dysbiosis (disturbed resident microbiota presenting with abnormal Nugent score or candidiasis) have been associated with mucosal inflammation and risk of HIV-1 infection, cancer and poor reproductive outcomes. To date, the temporal relationships between aberrant cervical innate immunity and the clinical onset of microbial disturbance have not been studied in a large population of reproductive age women. We examined data from a longitudinal cohort of 934 Ugandan and Zimbabwean women contributing 3,274 HIV-negative visits who had complete laboratory, clinical and demographic data. Among those, 207 women later acquired HIV, and 584 women were intermittently diagnosed with C. trachomatis (CT), N. gonorrhoeae (NG), genital herpes (HSV-2), T. vaginalis (TV), candidiasis, and abnormal intermediate (4-6) or high (7-10) Nugent score, i.e. bacterial vaginosis (BV). Immune biomarker concentrations in cervical swabs were analyzed by generalized linear and mixed effect models adjusting for site, age, hormonal contraceptive use (HC), pregnancy, breastfeeding, genital practices, unprotected sex and overlapping infections. High likelihood ratios (1.5-4.9) denoted the values of cervical immune biomarkers to predict onset of abnormal Nugent score and candidiasis at the next visits. When controlling for covariates, higher levels of β-defensin-2 were antecedent to BV, CT and HSV-2, lower anti-inflammatory ratio IL-1RA:IL-1β-to intermediate Nugent scores and candida, lower levels of the serine protease inhibitor SLPI-to candida, lower levels of the adhesion molecule ICAM-1-to TV, and lower levels of the oxidative stress mitigator and endothelial activation marker VEGF-to NG. Changes in innate immunity following onset of dysbiosis and infections were dependent on HC use when controlling for all other covariates. In conclusion, imminent female genital tract dysbiosis or infection can be predicted by distinct patterns of innate immunity. Future research should characterize biotic and abiotic determinants of this pre-existing innate immunity state.

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“…Accurate diagnosis and management of vaginitis is challenging due to the nonspecific nature of patient-reported symptoms, which may overlap with multiple etiologic agents that do not consistently predict the underlying cause(s) [7]. Inclinic diagnostic methods lack sensitivity and specificity for the detection and differentiation of causative agents of vaginitis [8]. Recurrent infections are common, requiring multiple clinic visits, which may be attributed to initial misdiagnosis of these syndromes [9].…”

Section: Introductionmentioning

confidence: 99%

“…BD MAX™ Vaginal Panel (MAX VP; Becton, Dickinson and Company, Quebec, Canada) uses real-time PCR for the amplification of specific DNA targets to differentially detect (a) bacterial vaginosis through algorithmic analysis of lactobacilli (L. crispatus and L. jensenii) and bacteria involved in BV (G. vaginalis, A. vaginae, Megasphaera-1, and BVAB-2); (b) Candida group (C. albicans, C. tropicalis, C. parapsilosis, and C. dubliniensis), C. glabrata, and C. krusei; and (c) Trichomonas vaginalis. Previous studies have described the performance of MAX VP compared to clinical diagnosis and nonamplification methods [8,16]. In this study, we performed a clinical evaluation of the performance of MAX VP compared to Affirm, the standard of care, for the detection of putative vaginal pathogens in symptomatic women.…”

Section: Introductionmentioning

confidence: 99%

Diagnostic performance of two molecular assays for the detection of vaginitis in symptomatic women

Thompson

Timm

Borders

et al. 2019

Eur J Clin Microbiol Infect Dis

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The three main causes of vaginitis are bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis (TV). Two multiplex assays are commercially available for detection of DNA from organisms associated with vaginitis: BD Affirm™ VPIII Microbial Identification Test (Affirm) and BD MAX™ Vaginal Panel (MAX VP). Here, the performance of MAX VP was compared to that of Affirm, which was considered the standard of care. Four vaginal swabs were collected from each subject with the following: BD Affirm™ VPIII Ambient Temperature Transport System (ATTS), BD MAX™ UVE Specimen Collection Kit, Hologic Aptima® Vaginal Swab Specimen Collection Kit, and BD ESwab™ collection and transport system (ESwab). Candida culture, Gram stain followed by Nugent scoring, and the Hologic Aptima® Trichomonas vaginalis assay were used for discordant analysis. Results were considered true positive if there were at least two tests positive for any vaginitis target. A total of 200 symptomatic women were evaluated in the study. The sensitivity and specificity of MAX VP for BV was 96.2% and 96.1%, respectively, compared to 96.2% and 81.6% for Affirm. The sensitivity and specificity of MAX VP for Candida spp. was 98.4% and 95.4%, respectively, compared to 69.4% and 100% for Affirm. MAX VP and Affirm showed 100% concordance for detection of TV. These results demonstrate improved accuracy of MAX VP compared to Affirm for the detection of BV and Candida spp. and no difference for detection of TV between the two tests.

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Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis

Cited by 71 publications

References 28 publications

Molecular Diagnosis of Vaginitis: Comparing Quantitative PCR and Microbiome Profiling Approaches to Current Microscopy Scoring

Molecular Diagnosis of Vaginitis: Comparing Quantitative PCR and Microbiome Profiling Approaches to Current Microscopy Scoring

Aberrant cervical innate immunity predicts onset of dysbiosis and sexually transmitted infections in women of reproductive age

Diagnostic performance of two molecular assays for the detection of vaginitis in symptomatic women

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