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Candida/Vaginal Trichomonas/Gardnerella Antigen Test Kit (Colloidal Gold Method) Clinical Trial

Candida/Vaginal Trichomonas/Gardnerella Antigen Test Kit (Colloidal Gold Method) Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097660
Enrollment
Unknown
Registered
2025-02-24
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candida/Trichomonas vaginalis/Gardnerella infection

Interventions

Gardnerella positive group:NA
Trichomonas vaginalis positive group:NA
Negative group:NA
Candida positive group:NA

Sponsors

Changsha City Maternal and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Those who meet one or more of the following conditions: a. Clinically diagnosed with candidal vaginitis/trichomonas vaginitis/bacterial vaginosis/mixed vaginitis;b. Patients with one or more symptoms such as increased vaginal discharge, abnormal leukorrhea odor, external genital itching, and burning;c. People without the above symptoms. ? No age limit; 2.Participants in the self-assessment test study are aged 16 to 70 years (including 16 and 70 years); 3.Gender: Female; 4.Willing to participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Those who have not signed the informed consent form or are missing key information of the study participants; 2.Those who cannot understand the requirements of participating in the trial; 3.Patients who have had sexual intercourse, taken a tub bath, douching, or local medication within 24 hours; 4.Participants who are menstruating or have vaginal bleeding; 5. Study participants who meet any of the following conditions cannot participate in the self-testing evaluation trial: 1) Have a medical or laboratory testing related professional background;2) Have experience operating similar test kits; 6.Other circumstances where the investigator deems it inappropriate for inclusion.

Design outcomes

Primary

MeasureTime frame
Positive agreement rate;95% confidence interval;Kappa value;Negative agreement rate;Overall agreement rate;

Countries

China

Contacts

Public ContactYang Weiping

Changsha City Maternal and Child Health Care Hospital

zxg3270@163.con+86 731 84196689

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026