Clinical Evaluation of the ID NOW™ CT/NG Test

This study is evaluating the ID NOW™ CT/NG test, a rapid test designed to detect Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections. Researchers want to see how well this test works in urine samples and self-collected vaginal swabs from people with and without symptoms. The study will compare the ID NOW™ CT/NG test results to other established tests. You might be able to join if you are 14 years or older (18+ outside the US), have been sexually active in the last six months, and are either getting screened for STIs or have symptoms like lower abdominal pain. The study aims to enroll about 7,100 participants.

Study design: This is an interventional study planning to enroll approximately 7,100 participants to evaluate the ID NOW™ CT/NG test.
What's involved: You would provide urine samples and, for females, self-collected and clinician-collected vaginal swabs. These samples will be used for the ID NOW™ CT/NG test and other comparison tests.
Compensation: Not stated in the trial record.
Follow-up: The study will measure the agreement of test results for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Clinical Evaluation of the ID NOW™ CT/NG Test

UNKNOWN

NAAges 14+InterventionalDiagnostic

Abbott Rapid Dx

~7,100 participants

Updated 2024-05-02 on ClinicalTrials.gov

What's tested:ID NOW™

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA)

Measured over "up to 24 months"

Conditions

Chlamydia Trachomatis Infection

Neisseria Gonorrheae Infection

Asymptomatic Condition

Where it's being run

1 sites across 1 states

Louisiana1

Who to contact

Abinav Singh, PhD

[email protected]

0000000

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Eligibility criteria

Inclusion

Aged 14 years or older in US or 18 years or older in OUS

Sexual activity within the past six (6) months

Asymptomatic and presenting for STI screening, OR Symptomatic with suspected sexually transmitted infection and one or more of the following symptoms:

lower abdominal, pelvic, or adnexal pain

abnormal vaginal discharge

pain or discomfort with sexual intercourse

bleeding between menstrual cycles and/or after sex

pain, discomfort, frequency, or urgency with urination

Able and willing to provide approximately 20-50 mL first-catch urine sample, one (1) self-collected vaginal swab, and three (3) Clinician-collected vaginal swabs.

The participant and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented assent and consent of their parent or legal guardian, unless the site has an IRB/EC (Institutional Review Board/Ethics Committee) approved waiver for parental consent for minors)

Aged 14 years or older in US or 18 years or older in OUS

Sexual activity within the past six (6) months

Asymptomatic and presenting for STI screening, OR

Symptomatic with suspected sexually transmitted infection and one or more of the following symptoms:

discharge from penis

burning sensation during urination

pain or swelling in one or both testicles

Able and willing to provide approximately 20-50 mL first-catch urine sample

Already participated in the study

Exclusion

Reported using or having completed antimicrobial therapy within 14 days of enrollment in the study

Urination within the previous one (1) hour

What this trial measures

Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA)"up to 24 months"
The primary objective of this study is to demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA) of the ID NOW™ CT/NG test using first catch urine tested directly, and self-collected vaginal swabs (SVS) placed in Sample Elution buffer immediately after collection. 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.

Trialytics