Clinical Information

This test is intended to aid in the diagnosis of vulvovaginal candidiasis from vaginal samples collected from symptomatic individuals. Vaginitis is characterized by a spectrum of signs and symptoms, including vaginal/vulvar irritation, odor, discharge, and pruritus. Vaginitis may develop as a result of mechanical and/or chemical irritants (eg, feminine hygiene products, contraceptive materials), or due to a dysbiosis of the microbiota in the vaginal tract. Up to 90% of vaginitis cases are infectious due to Bacterial vaginosis (BV), vulvovaginal candidiasis (Candida vaginitis, CV) and/or trichomoniasis (Trichomonas vaginalis, TV). BV, CV and TV individually account for 22% to 50%, 17% to 39%, and 4% to 35% of vaginitis cases, respectively.

CV, commonly known as a yeast infection, is the second most frequent cause of vaginitis. CV is characterized by an overgrowth of Candida species in the vaginal tract and is associated with development of inflammation, abnormal vaginal discharge, vaginal soreness, pruritus, dyspareunia, and external dysuria. Up to 89% of CV cases are caused by C albicans, while non-albicans species may be responsible for 11%. C glabrata, which is responsible for the majority of non-albicans CV in the U.S., has decreased susceptibility to standard antifungal regiments for CV as compared to C albicans, which is why C glabrata is specifically reported by this assay.