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Clinical Evaluation of the ID NOW™ CT/NG Test

NCT06395675 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7100

Last updated 2024-05-02

No results posted yet for this study

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.

Conditions

  • Chlamydia Trachomatis Infection
  • Neisseria Gonorrheae Infection
  • Asymptomatic Condition

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.

Sponsors & Collaborators

  • Abbott Rapid Dx

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-09
Primary Completion
2025-01-09
Completion
2025-01-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06395675 on ClinicalTrials.gov