Vaginal Infection, Vaginitis
Conditions
Keywords
E-Nose
Brief summary
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.
Detailed 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.
Interventions
DEVICEVaginal swab for RT-PCR
Screening for Bacterial vaginosis (BV) / Trichomonas / Chlamydia trachomatis / Candida albicans
DEVICEVaginal swab for culture
Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli
DEVICEMetabolic gas signatures detected by Ainos Flora (operated by participant)
The participant operates the Ainos Flora to collect signatures of metabolic gases in the vagina by herself.
DEVICEMetabolic gas signatures detected by Ainos Flora (operated by medical staff)
The medical staff operates the Ainos Flora to collect signatures of metabolic gases in the participant's vagina.
Sponsors
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Taiwan Carbon Nano Technology Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This clinical study is a prospective study to evaluate the sensitivity and specificity of the Ainos Flora Female Vaginal Health Tester in identifying vaginal infections. Potential subjects will be patients in the gynecological clinic. The study will evaluate the performance of the Ainos Flora Female Vaginal Health Tester by comparing it to the conventional real-time polymerase chain reaction (RT-PCR) and culture methods for the diagnosis of vaginitis to calculate both sensitivity and specificity.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the sensitivity and specificity of Ainos Flora in subjects compared to RT-PCR and culture groups in identifying the types of vaginitis. | Up to 6 months. | * Bacterial infection : Bacterial vaginosis (BV) / Escherichia coli / Trichomonas / Group B streptococcus / Chlamydia trachomatis / Neisseria gonorrhea * Fungal infection: Candida albicans * Mixed infection: Bacterial and fungal infections coexist * No infection: Healthy participant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the change in sensitivity as the number of subjects is changed. | Up to 6 months. | When the number of subjects reaches 30,60,90,120, input the collected gas data into the algorithm and calculate the sensitivity. We can then assess the change in sensitivity when the number of subjects changes from 30 to 60, 90, and 120. |
| Assess the change in specificity as the number of subjects is changed. | Up to 6 months. | When the number of subjects reaches 30,60,90,120, input the collected gas data into the algorithm and calculate the specificity. We can then assess the change in specificity when the number of subjects changes from 30 to 60, 90, and 120. |
Countries
Taiwan
Contacts
Primary ContactDr. Fung-Wei Chang
Outcome results
None listed