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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00300534

Enrollment

1000

Registered

2006-03-09

Start date

2002-08-31

Completion date

2009-07-31

Last updated

2012-09-07

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

Conditions

Syphilis

Keywords

Diagnosis

Brief 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.

Interventions

DEVICEAbbott Laboratories Determine test for syphilis

DEVICEInvestigational syphilis immunochromatographic strip test

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Consecutive patients

Exclusion criteria

* Less than age 18 years

Design outcomes

Primary

Measure	Time frame
Diagnosis of Treponema pallidum infection	7 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026