Overview
This clinical study aims to train the algorithm and assess the performance of the Ainos Flora Women's Vaginal Health Tester in identifying vaginal infections.
Description
Ainos Flora Women's Vaginal Health Tester is an in vitro diagnostic device implementing electronic nose technology to detect vaginal infections by examining metabolized gases of vaginal bacteria. The electronic nose system mainly comprises the Micro-Electro-Mechanical Systems (MEMS) gas sensor array and the Artificial Neural Network algorithm. The primary purpose of this study is to train the algorithm and assess the performance of the Ainos Flora in identifying vaginal infections. In addition, the primary outcome measures of this study, including sensitivity and specificity, will be used as a reference for the feasibility and sample size assessment of the next phase of pivotal clinical trials.
Eligibility
Inclusion Criteria:
- Female, Age ≥20 to ≤50.
- Have had sexual experience.
- Fully understand the subject's informed consent process and be willing to undergo all study-related assessments and procedures.
Exclusion Criteria:
Women who meet any of the following criteria by participant report will be excluded from
the study:
- During menstruation.
- Have performed vaginal washing within three days.
- Have been treated for vaginal infections within one week.