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| Name | Class |
|---|---|
| NAMSA | OTHER |
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This investigational study will be conducted to evaluate the performance of the NeuMoDxâ„¢ CT/NG Assay on the NeuMoDxâ„¢ 288 Molecular System and NeuMoDxâ„¢ 96 Molecular System (collectively referred to as NeuMoDxâ„¢ CT/NG Assay test system).
Clinical performance characteristics of the NeuMoDx CT/NG Assay on NeuMoDxâ„¢ 288 Molecular System and NeuMoDxâ„¢ 96 Molecular System will be evaluated in a multi-center, prospective, sampling study by comparing the diagnoses made by the NeuMoDxâ„¢ CT/NG Assay to Patient Infected Status (PIS) as the reference standard.
Prospectively collected urine and swab specimens from individual subjects will be tested using the NeuMoDxâ„¢ CT/NG Assay at one of the three NeuMoDx testing sites. Subjects' PIS for CT and PIS for NG will be determined by a central laboratory using FDA-cleared, legally marketed CT/NG combo assays on pre-specified sample matrices according to the PIS determination algorithms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-arm - Symptomatic and Asymptomatic Males | Active Comparator | Arm 1 - Urine from males subjects |
|
| Multi-arm - Symptomatic and Asymptomatic Females | Active Comparator | Arm 2 - Endocervical, self-collected (in the clinical setting) and physician-collected vaginal swabs and urine from female subjects |
|
| Multi-arm - FDA cleared NAATs (Comparator) | Active Comparator | Arm 3 - Comparator (for females - vaginal and urine NAATs and for males - 3 urine NAATs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuMoDx CT/NG Assay | Diagnostic Test | NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical specificity and sensitivity | Clinical specificity and sensitivity of NeuMoDx CT/NG Assay for both CT and NG relative to an individual's patient infected status (PIS) | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Valid results rate | Evaluate indeterminate and unresolved rates | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Subjects eligible for CT/NG screening (make sure it matches the protocol)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Healthcare Clinical Date, Inc. (Segal Trials) |
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| FDA-cleared NAATs | Diagnostic Test | Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs |
|
| North Miami |
| Florida |
| 33161 |
| United States |
| Planned Parenthood - Southwest and Central Florida | Orlando | Florida | 32817 | United States |
| Planned Parenthood - Southwest and Central Florida | Tampa | Florida | 33617 | United States |
| Indiana University (IU) | Indianapolis | Indiana | 46202 | United States |
| LSU Health Science | New Orleans | Louisiana | 70112 | United States |
| NeuMoDx Molecular, Inc. | Ann Arbor | Michigan | 48108 | United States |
| Henry Ford Health System (HFHS) | Detroit | Michigan | 48202 | United States |
| Planned Parenthood - Northern, Central and Southern New Jersey | Elizabeth | New Jersey | 07201 | United States |
| Planned Parenthood - Northern, Central and Southern New Jersey | Newton | New Jersey | 07860 | United States |
| Planned Parenthood - Northern, Central and Southern New Jersey | Riverside Park | New Jersey | 08075 | United States |
| TriCore Reference Labs | Albuquerque | New Mexico | 87505 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Planned Parenthood - Gulf Coast | Houston | Texas | 77023 | United States |
| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae 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 |
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