Chlamydia, Gonorrhea
Conditions
Brief summary
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.
Interventions
DEVICEillumigene CT and NG assays, illumipro-10
Sponsors
Meridian Bioscience, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease | Up to 60 days | Testing of each set of subject samples is completed within 60 days of sample collection |
Countries
United States
Outcome results
None listed