Clinical Validation of a Test for the Diagnosis of Vaginitis.

ABSTRACT:

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 col

SUBMITTER: Gaydos CA 

PROVIDER: S-EPMC5635603 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature