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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,000
Los Angeles Department of Health Services
Los Angeles, California, United States
Fulton County Department of Health
Atlanta, Georgia, United States
Chicago Department of Public Health
Chicago, Illinois, United States
Bell Flower Clinic
Indianapolis, Indiana, United States
Diagnosis of Treponema pallidum infection
Time frame: 7 days
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New York City Department of Health
New York, New York, United States