Detection of Chlamydia (CT) and Gonorrhea (NG)

Meridian Bioscience

Status: Completed

Conditions: Gonorrhea; Chlamydia

Treatments: Device: illumigene CT and NG assays, illumipro-10

Study type: Observational

Funder types: Industry

Identifiers

NCT02055742

MBI-01-CTNG

Meridian Bioscience, Inc. (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 14 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

700 participants in 1 patient group

Specimen Collection

Treatment:

Device: illumigene CT and NG assays, illumipro-10