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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abbott Laboratories Determine test for syphilis | No Intervention | Abbott Laboratories Determine rapid test for syphilis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abbott Laboratories Determine test for syphilis | Device |
| ||
| Investigational syphilis immunochromatographic strip test |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of Treponema pallidum infection | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert E. Johnson, MD, MPH | Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Department of Health Services | Los Angeles | California | United States | |||
| Fulton County Department of Health |
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| ID | Term |
|---|---|
| D013587 | Syphilis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
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| Device |
|
| Atlanta |
| Georgia |
| United States |
| Chicago Department of Public Health | Chicago | Illinois | 60616 | United States |
| Bell Flower Clinic | Indianapolis | Indiana | 46202 | United States |
| New York City Department of Health | New York | New York | United States |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |