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Clinical Evaluation of the ID NOW™ CT/NG Test
Sponsor: Abbott Rapid Dx
Summary
The objective of this study is to determine the performance of the ID NOW™ CT/NG test in male urine, female urine, and self-collected vaginal swabs when tested by intended users (i.e., untrained operators). ID NOW™ CT/NG test results will be compared to results from up to three (3) FDA cleared CT/NG nucleic acid amplification tests (NAATs) for each sample type.
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
7100
Start Date
2024-07-09
Completion Date
2025-01-09
Last Updated
2024-05-02
Healthy Volunteers
Yes
Interventions
ID NOW™
The ID NOW™ CT/NG is an in vitro qualitative molecular assay for the rapid differential. detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in urine, and self-collected vaginal swabs (SVS) in symptomatic and asymptomatic individuals.
Locations (1)
LSU Crescent Care Sexual Health Clinic
New Orleans, Louisiana, United States