Vaginal Infection
Conditions
Brief summary
The goal of this observational study is to explore a standardized sample process for improving the accuracy of vaginal microbiota evaluation and to explore a more complete and comprehensive method for vaginal microbiota evaluation based on gram staining.
Detailed description
This study consists of two sub-studies: 1. Sub-study on Standardized method of Microscopic Slide Preparation: this sub-study aims to compare different slide preparation methods and dilution levels based on various aspects, including uniformity, impurities, clarity and so on, and then explore the optimal method and dilution level. Additionally, it will summarize the conversion method for white blood cells between wet mount and gram staining, and for white blood cells between high-power microscopy and oil immersion microscopy. 2. Sub-study on Vaginal Microbiota Evaluation on Gram Staining: For patients with diagnosed vaginal infection type, it will calculate the consistency of results between different laboratories. And it will evaluate the effectiveness combined artificial intelligence technology and other technological platforms. Besides, for patients without diagnosed vaginal infection type, different methods such as 16S rRNA gene sequencing and metagenomic sequencing are used for analysis and profiling to guide treatment.
Interventions
None listed
Sponsors
Jiangsu Bioperfectus Technologies Co., Ltd
Tianjin Medical University General Hospital
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Non-pregnant women who visit our research settings and conduct vaginal discharge examination based on Gram-stained smear. * No sexual intercourse, vaginal douching, or vaginal medication within the last 72 hours. * Not during menstruation (menstrual period ended ≥3 days ago).
Exclusion criteria
* Receiving systemic or vaginal antifungal or antibiotic treatment within the past week.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The score for smear | December 2023 | This score consists of uniformity, impurities, cell degeneration, and clarity for evaluating a smear. |
| Diagnosis of vaginitis type | March 2024 | The Diagnosis of vaginitis type based on Gram-stained smear and antigen testing, including aerobic vaginitis(AV), bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), and normal. |
| Relative Abundance | May 2024 | Relative Abundance is from 16S rRNA gene sequencing and metagenomic sequencing for patients without clearly diagnosis. |
| Intensity | May 2024 | The intensity is tested by liquid chromatography-tandem mass spectrometry for targeted metabolites for patients without clearly diagnosis. |
Contacts
Primary ContactFengxia Xue, PhD
Outcome results
None listed