Detection of Chlamydia (CT) and Gonorrhea (NG)
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 14 - 89 |
| Updated: | 12/9/2017 |
| Start Date: | March 1, 2014 |
| End Date: | September 9, 2014 |
Clinical Study Protocol for the Illumigene® Chlamydia and Illumigene® Gonorrhea DNA Amplification Assays
To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the illumipro-10,
with male urine, female urine, physician-collected (medical professional) endocervical swabs
and self-collected vaginal swabs taken from symptomatic and asymptomatic patient populations.
with male urine, female urine, physician-collected (medical professional) endocervical swabs
and self-collected vaginal swabs taken from symptomatic and asymptomatic patient populations.
Inclusion Criteria:
1. Male or female
2. Any ethnicity or race
3. Subject >14 and <89 years of age
4. Subject who voluntarily gives written informed consent; not applicable for leftover
specimens
5. Symptomatic or asymptomatic subject who is able and willing to provide the required
urine and swab samples for testing for CT and NG
6. Leftover urine specimens
Exclusion Criteria:
1. Subjects < 14 or >90 years of age
2. Subjects who are unwilling to sign the written informed consent; not applicable for
leftover specimens
3. Subject who is unwilling or unable to provide the required urine and swab samples for
testing; not applicable for leftover specimens
4. Individuals who have been on antibiotic medications within 10 days.
5. Multiple sets of specimens from the same subject at different office visits
6. Samples collected or processed in manner other than specified in the study protocol
and Investigational Use Only package insert.
7. Frozen archived specimens
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