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Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis
Journal article   Open access   Peer reviewed

Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis

Jane R Schwebke, Charlotte A Gaydos, Paul Nyirjesy, Sonia Paradis, Salma Kodsi and Charles K Cooper
Journal of clinical microbiology, v 56(6)
Jun 2018
DOI: https://doi.org/10.1128/JCM.00252-18
PMID: 29643195
Featured in Collection :   UN Sustainable Development Goals @ Drexel
url
https://doi.org/10.1128/jcm.00252-18View
Published, Version of Record (VoR) Open
url
https://doi.org/10.1128/JCM.00252-18View
Published, Version of Record (VoR) Open

Abstract

Ambulatory Care Facilities Candida - genetics Candidiasis, Vulvovaginal - diagnosis Clinical Laboratory Techniques - methods Cross-Sectional Studies Female Gardnerella vaginalis - genetics Humans Logistic Models Microscopy Reagent Kits, Diagnostic Sensitivity and Specificity Trichomonas vaginalis - genetics Trichomonas Vaginitis - diagnosis Vagina - microbiology Vagina - parasitology Vaginosis, Bacterial - diagnosis
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, spp., and 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, spp., and 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 gene , and culture). The investigational test, clinician diagnosis, and in-clinic testing were compared to reference methods for bacterial vaginosis, spp., and 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.

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72 citations in Web of Science
83 citations in Scopus

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UN Sustainable Development Goals (SDGs)

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#3 Good Health and Well-Being

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Collaboration types
Industry collaboration
Domestic collaboration
International collaboration
Web of Science research areas
Microbiology
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