Clinical Evaluation of a Self-Testing Kit for Vaginal Infection Diagnosis

Abstract

Vaginitis is a common disorder among women of varying ages that arises from a change in the normal pH balance of vaginal bacteria or an infection. Characteristic symptoms of itching, irritation, and odor cause considerable discomfort and increase the risk of contracting other sexually transmitted infections. Because of the sensitive and personal nature of the condition, some women may be reluctant to seek treatment. This behavior not only fails to solve the problem but may also delay medical treatment and result in additional medical complications. The pH changes associated with vaginitis and vaginosis, which are characterized by the presence or absence of inflammation, respectively, are well known but can vary. For example, bacterial vaginosis and trichomoniasis infection will raise vaginal pH above 4.5, while vulvovaginal candidiasis does not result in any measurable change to pH. Nonetheless, diagnostic tools relying on pH measurement are a valuable approach from which additional testing and treatment may be launched. Here, we focused on the use of a vaginal self-test tool and tested 50 patients, including pregnant women. When used according to the instructions, the Hygeia Touch Self-Testing Kit for Vaginal Infection demonstrated over 88% accuracy compared to a clinical diagnostic workup, with a sensitivity of 87% and a specificity of 89% in the patients where the swab was correctly interpreted. This study demonstrated an effective self-test method with high acceptability among women that provided them with greater autonomy regarding health management.