Development and clinical validation of a self-/point-of-care test for the diagnosis of bacterial vaginosis and vulvovaginal candidiasis

Vaginitis is the presence of vaginal symptoms such as discharge, itching and odor, and one of the main reasons women visit primary care. Bacterial vaginosis (BV), a disturbance of the healthy vaginal microbiome, and vulvovaginal candidiasis (VVC), a yeast infection, are by far the two most common causes. The number of misdiagnoses of these conditions by clinicians is extremely high due to overlapping symptoms and the lack of performant point-of-care tests. Many women practice self-diagnosis and self-treatment using over-the-counter products, but also here, misdiagnoses are extremely frequent. Mistreatment too often leads to worsening of symptoms. Here, I aim to develop and validate a self-/point-of-care test for the diagnosis of both BV and VVC. I will continue my research on promising biomarkers for BV and VVC (i.e. sialidase, amylase and mannan). Next, I will translate the obtained results into the development a lateral flow test. I will optimize sampling procedures, the test buffer, and the specificity of the assay. Lastly, the diagnostic performance of the test will be assessed in a clinical study. My project responds to the clear need for a self/point-of-care test to aid women and clinicians in the management of vaginitis.