NCT00300534

Multi-site Study of Rapid Diagnostic Syphilis Assays

Multi-site Study of Rapid Diagnostic Syphilis Assays of Persons Attending STD Clinics in High Syphilis Morbidity Areas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The performance of an investigational immunochromatographic strip (ICS) test for the diagnosis of syphilis is compared with the Abbott Laboratories Determine ICS test. The study population consists of patients with and without syphilis presenting to sexually transmitted disease clinics in five cities in the United States. Specimens include finger-stick whole blood (investigational test only) and whole blood, plasma, and serum by venipuncture.

Conditions

• Syphilis

Interventions

Type	Name	Description
DEVICE	Abbott Laboratories Determine test for syphilis
DEVICE	Investigational syphilis immunochromatographic strip test

Timeline

• Start date: 2002-08-01
• Primary completion: 2005-12-01
• Completion: 2009-07-01
• First posted: 2006-03-09
• Last updated: 2012-09-07

Locations

5 sites across 1 country: United States