Logo image
Back
Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study
Journal article   Open access   Peer reviewed

Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study

Jane R Schwebke, Stephanie N Taylor, Ronald Ackerman, Robert Schlaberg, Neil B Quigley, Charlotte A Gaydos, Steven E Chavoustie, Paul Nyirjesy, Carmelle V Remillard, Philip Estes, …
Journal of clinical microbiology, v 58(2)
28 Jan 2020
DOI: https://doi.org/10.1128/JCM.01643-19
PMID: 31748322
Featured in Collection :   UN Sustainable Development Goals @ Drexel
url
https://europepmc.org/articles/pmc3576693View
Accepted (AM)Open Access (License Unspecified),  Open
url
https://doi.org/10.1128/JCM.01643-19View
Published, Version of Record (VoR) Open

Abstract

Adolescent Adult Aged Bacteria - genetics Candida - genetics Candidiasis, Vulvovaginal - diagnosis Candidiasis, Vulvovaginal - microbiology Cross-Sectional Studies Female Humans Middle Aged Nucleic Acid Amplification Techniques - methods Nucleic Acid Amplification Techniques - standards Prospective Studies Reagent Kits, Diagnostic - standards Sensitivity and Specificity Trichomonas vaginalis - genetics Trichomonas Vaginitis - diagnosis United States United States Food and Drug Administration Vagina - microbiology Vaginosis, Bacterial - diagnosis Vaginosis, Bacterial - microbiology Young Adult
Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and 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 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 vaginitis (CV/TV) assays. The results were compared to Nugent (plus Amsel for intermediate Nugent) scores for BV, cultures and DNA sequencing for VVC, and a composite of NAAT and culture for The prevalences of infection were similar for clinician- and patient-collected samples: 49% for BV, 29% for VVC due to the species group, 4% for VVC due to , and 10% for 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 species group; 84.7% and 99.1% for ; and 96.5% and 95.1% for 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 diagnostic NAATs that can detect the main causes of vaginitis.

Metrics

24 Record Views
42 citations in Web of Science
50 citations in Scopus

Details

UN Sustainable Development Goals (SDGs)

This publication has contributed to the advancement of the following goals:

#3 Good Health and Well-Being

InCites Highlights

Data related to this publication, from InCites Benchmarking & Analytics tool:

Collaboration types
Industry collaboration
Domestic collaboration
Web of Science research areas
Microbiology
Logo image