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Establishment and evaluation of a new rapid saliva-based moleculer detection method used for screening of syphilis

Establishment and evaluation of a new rapid saliva-based moleculer detection method used for screening of syphilis

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046329
Enrollment
Unknown
Registered
2021-05-14
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Syphilis

Interventions

Gold Standard:Serological detection of syphilis: TPPA+ and TRUST/RPR+
Index test:DNA target sequence

Sponsors

Shanghai Skin Disease Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Reach the diagnostic criteria of syphilis; 2. Without treatment or regular treatment of syphilis; 3. Male or female; 4. Aged 18 to 70 years; 5. Willing to cooperate with the researcher; 6. Willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Antibiotics were used within 2 weeks; 2. Use antibacterial mouthwash within one week; 3. Fail to collect saliva sample; 4. Considered unsuitable by the researchers.

Design outcomes

Primary

MeasureTime frame
DNA sequence;SEN, SPE, ACC, AUC of ROC;—

Countries

China

Contacts

Public ContactYe Meiping

Shanghai Skin Disease Hospital

yemeiping1988@163.com+86 15002187079

Outcome results

None listed

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