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Validation of clinical performance of reproductive tract pathogen detection technology based on microfluidic chip

Validation of clinical performance of reproductive tract pathogen detection technology based on microfluidic chip - Verification of the performance of microfluidic detection methods for 5 reproductive tract pathogens

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084114
Enrollment
Unknown
Registered
2024-05-10
Start date
2024-05-13
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Genital tract pathogen infection

Interventions

Gold Standard:The gold standard for the diagnosis of these five common reproductive tract pathogens is fluorescent quantitative PCR
Index test:PCR combined with microfluidic chip

Sponsors

Huashan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Inclusion criteria of positive group: A. Age =18 years old, male or female; B. A history of non-marital sexual intercourse or a history of sexual partner infection; C. Clinically diagnosed gonorrhea, urethritis, vaginitis, etc., and identified any infection of five reproductive tract pathogens (NG, UU, MG, MH, CT) by routine examination method or PCR; D. Fully understand the research content, able to participate in the follow-up research behavior, I am willing to cooperate and participate in the whole process. And cooperate to sign informed consent. For patients without civil capacity, their client needs to agree and sign a consent form, and can cooperate with the full follow-up. (2) Inclusion criteria of control group: A. Age between 18 and 85 years old, male or female; B. Five kinds of reproductive tract pathogens (NG, UU, MG, MH, CT) were excluded by routine examination or PCR; C. Fully understand the research content and can participate in the follow-up research behavior, and I am willing to cooperate and participate in the whole process. And cooperate to sign informed consent.

Exclusion criteria

Exclusion criteria: A. Patients in the medication period, after sexual life or menstruating period at the time of initial sampling; B. Patients with other major systemic diseases (such as myocardial infarction, cerebrovascular disease, epilepsy, malignant tumor, etc.) or mental abnormalities that affect their follow-up and cooperation with the examination; C. Pregnant patients; D. Patients enrolled in other trials.

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of nucleic acid detection of Neisseria gonorrhoeae;Sensitivity and specificity of nucleic acid detection of Ureaplasma urealyticum ;Sensitivity and specificity of nucleic acid detection of Mycoplasma genitalium;Sensitivity and specificity of nucleic acid detection of Mycoplasma hominis;Sensitivity and specificity of nucleic acid detection of Chlamydia trachomatis;

Countries

China

Contacts

Public ContactLu Xiaonian

Huashan Hospital affiliated to Fudan University

13816830396@139.com+86 138 1683 0396

Outcome results

None listed

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