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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.
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Ages Eligible for Study:
14 Years to 89 Years (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Symptomatic and asymptomatic subjects at least 14 years of age
Male or female
Any ethnicity or race
Subject >14 and <89 years of age
Subject who voluntarily gives written informed consent; not applicable for leftover specimens
Symptomatic or asymptomatic subject who is able and willing to provide the required urine and swab samples for testing for CT and NG
Leftover urine specimens
Subjects < 14 or >90 years of age
Subjects who are unwilling to sign the written informed consent; not applicable for leftover specimens
Subject who is unwilling or unable to provide the required urine and swab samples for testing; not applicable for leftover specimens
Individuals who have been on antibiotic medications within 10 days.
Multiple sets of specimens from the same subject at different office visits
Samples collected or processed in manner other than specified in the study protocol and Investigational Use Only package insert.