Detection of Chlamydia (CT) and Gonorrhea (NG)
This trial is active, not recruiting.
|Treatment||illumigene ct and ng assays, illumipro-10|
|Sponsor||Meridian Bioscience, Inc.|
|Start date||March 2014|
|End date||December 2016|
|Trial size||700 participants|
|Trial identifier||NCT02055742, MBI-01-CTNG, Meridian Bioscience, Inc.|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Aurora, CO||Planned Parenthood of the Rocky Mountains||no longer recruiting|
|Fall River, MA||New England Center for Clinical Research||no longer recruiting|
|Philadelphia, PA||Planned Parenthood Southeastern PA||no longer recruiting|
Qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease
time frame: Up to 60 days
Male or female participants from 14 years up to 89 years old.
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
|Official title||Clinical Study Protocol for the Illumigene® Chlamydia and Illumigene® Gonorrhea DNA Amplification Assays|
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