The investigational test evaluated in this study is the GYNI™ rapid point-of-care system, an automated in-vitro diagnostic system, intended to aid in the diagnosis of vaginitis in symptomatic women, by qualitatively detecting the following vaginitis conditions or pathogens at the point-of-care:
(1) Bacterial Vaginosis (2) Candida albicans (3) Candida non-albicans (4) T. vaginalis (5) vaginal atrophy (also referred to as atrophic vaginitis or genitourinary syndrome of menopause) (6) aerobic vaginitis/desquamative inflammatory vaginitis and (7) cytolytic vaginosis

Laboratory methods include cultures, a multiplex polymerase chain reaction (PCR) panel, and nucleic acid amplification testing (NAAT). Some rapid point-of-care tests are available, nevertheless, these tests are only for a subset of the related conditions, including BV and trichomoniasis. Each test can only diagnose a single cause, necessitating the conduction of multiple tests, thus increasing the turnover time and cost. Collectively, these findings suggest that current clinical practice is sub-optimal and indicate the need for a diagnostic modality that is efficient, cost-effective, allows for a wide range of diagnoses, and is usable during the clinic visit.

An insufficient in-clinic evaluation may result from the absence of suitable equipment (i.e., microscope), lack of proper training in the preparation and interpretation of a wet mount, time constraints, and lack of awareness that these measures allow improved detection of the causes of vaginitis1. As an alternative to microscope usage, providers can send vaginal samples for laboratory evaluation. Nevertheless, laboratory tests are aimed at detecting only infectious etiologies and cannot detect noninfectious conditions such as vaginal atrophy, desquamative inflammatory vaginitis (DIV, also termed aerobic vaginitis, AV), and cytolytic vaginosis. In addition, these methods are not available in many clinical settings, are expensive, time-consuming, and do not provide timely results, as many of these tests require a process that lasts from several hours15 to several days, thus not allowing a point-of-care diagnosis.