OBJECTIVE-Vaginitis may be diagnosed as bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis, or coinfection. A new molecular test assays the vaginal microbiome and organisms that cause three common infections. The objective of the trial was to evaluate the clinical accuracy of the investigational test for vaginal swabs collected by patients (self) or clinicians. The primary and secondary outcomes were to compare the investigational test with reference methods for the three most common causes of vaginitis and compare clinician-collected with self-collected swabs.METHODS-We conducted a cross-sectional study in which women with symptoms of vaginitis were recruited at ten clinical centers and consented to the investigation between May and September 2015. The woman collected a vaginal swab, sheathed, and then handed it to the clinician. These swabs were to evaluate how self-collected swabs compared with cliniciancollected swabs. The clinician collected an investigational test swab and reference test swabs. From 1,740 symptomatic patients, clinician-collected and self-collected vaginal swabs were Each author has indicated that he or she has met the journal's requirements for authorship.
Financial DisclosureDr. Gaydos' and Dr. Schwebke's institutions received grant money to perform this study. Dr. Nyirjesy has been a consultant for Symbiomix Therapeutics, Novadigm Therapeutics, Viamet Pharmaceuticals, Cidara Therapeutics, and Perrigo. He has received research grants to his institution from Becton Dickinson, Alfa Wasserman SpA, Novadigm Therapeutics, Viamet Pharmaceuticals, Symbiomix Therapeutics, and Curatek Pharmaceuticals. Ms. Paradis and Dr. Cooper are employed by Becton Dickinson, the study sponsor. The other authors did not report any potential conflicts of interest. In bacterial vaginosis, lactobacilli are decreased, with increases in microorganisms such as Atopobium vaginae, Gardnerella vaginalis, Mobiluncus mulieris, Prevotella species, BVAB-2, and Megasphaera species. 7-9 Candida albicans is responsible for 65-90% of vaginal Candida species infections, and non-albicans Candida species are responsible for up to 30%. [10][11][12] Trichomoniasis is the most common curable sexually transmitted infection in the world. 1992;40:554A.). 16,17 A single molecular test with high sensitivity and specificity might provide a clinical benefit. 18 The study objectives were to compare the investigational molecular test with three reference methods for the diagnosis of vaginitis and compare clinician-collected swabs with self-collected swabs. Comparisons for self-collection were made to demonstrate accuracy could be maintained if self-collection was used for busy clinicians to save time.
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MATERIALS AND METHODSThe study design was a diagnostic accuracy cross-sectional study ( Fig. 1). At ten clinical centers, all eligible patients were recruited consecutively from clinics identified as sexually transmitted diseases, human immunodeficiency virus, family planning, and gynecology if they reporte...