Multi-site Study of Rapid Diagnostic Syphilis Assays

Centers for Disease Control and Prevention (CDC)

Status: Completed

Conditions: Syphilis

Treatments: Device: Investigational syphilis immunochromatographic strip test; Device: Abbott Laboratories Determine test for syphilis

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00300534

CDC-NCHSTP-2875

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Consecutive patients

Exclusion criteria

• Less than age 18 years

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

Abbott Laboratories Determine test for syphilis

No Intervention group

Description:

Abbott Laboratories Determine rapid test for syphilis

Treatment:

Device: Investigational syphilis immunochromatographic strip test

Device: Abbott Laboratories Determine test for syphilis