Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining

Study Overview
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Brief Summary
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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
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This study consists of two sub-studies: 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. 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.

Official Title
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Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining

Conditions
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Vaginal Infection

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hospital name + infection type + number<br>There is no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The score for smear | This score consists of uniformity, impurities, cell degeneration, and clarity for evaluating a smear. | December 2023 | 
| Diagnosis of vaginitis type | 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. | March 2024 | 
| Relative Abundance | Relative Abundance is from 16S rRNA gene sequencing and metagenomic sequencing for patients without clearly diagnosis. | May 2024 | 
| Intensity | The intensity is tested by liquid chromatography-tandem mass spectrometry for targeted metabolites for patients without clearly diagnosis. | May 2024 |