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| ID | Type | Description | Link |
|---|---|---|---|
| AC2PS-US12-001 | Other Identifier | Gen-ProbeAC2PS-US12-001Eval of COMBO2 Assay On PANTHER System in Male Urine is testing protocol for AGCPS-US11-002 |
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The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs and male first-catch urine and urethral swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® System
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specimen Collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APTIMA Assays; PANTHER System | Device | APTIMA Assays; PANTHER System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease | approximately one year |
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Inclusion Criteria:
In addition, the subject must meet at least one of the following criteria:
Exclusion Criteria:
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Symptomatic and asymptomatic subjects at least 16 years of age.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Reid, PhD | Gen-Probe, Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Anthony Mills MD Inc. |
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urine
| Los Angeles |
| California |
| 90069 |
| United States |
| Benchmark Research | San Francisco | California | 94102 | United States |
| Planned Parenthood Southern New England | New Haven | Connecticut | 06511 | United States |
| AGA Clinical Trials | Hialeah | Florida | 33012 | United States |
| Wishard Health Services | Indianapolis | Indiana | 46202 | United States |
| Louisiana State University Health Sciences | New Orleans | Louisiana | 70112 | United States |
| John Hopkins University | Baltimore | Maryland | 21205 | United States |
| New England Center for Clinical Research - New Bedford Clinic | New Bedford | Massachusetts | 02744 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Laboratory Corporation of America | Burlington | North Carolina | 27215 | United States |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27599-7030 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Molecular Pathology Laboratory Network, Inc. | Maryville | Tennessee | 37804 | United States |
| Planned Parenthood Houston and Southeast Texas | Houston | Texas | 77023 | United States |
| Tidewater Clinical Research, Inc. -Tidewater Physicians for Women | Norfolk | Virginia | 23502 | United States |
| ID | Term |
|---|---|
| D002690 | Chlamydia Infections |
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| 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 |
| D016870 | Neisseriaceae Infections |
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