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NOT YET RECRUITING
NCT06395675
NA

Clinical Evaluation of the ID NOW™ CT/NG Test

Sponsor: Abbott Rapid Dx

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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