Clinical Evaluation of the ID NOWâ„¢ CT/NG Test (NCT06395675) | Clinical Trial Compass
UnknownNot Applicable
Clinical Evaluation of the ID NOWâ„¢ CT/NG Test
United States7,100 participantsStarted 2024-07-09
Plain-language summary
The objective of this study is to determine the performance of the ID NOWâ„¢ CT/NG test in male urine, female urine, and self-collected vaginal swabs when tested by intended users (i.e., untrained operators). ID NOWâ„¢ 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.
Who can participate
Age range14 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: Participants providing vaginal samples and urine
* 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)
Inclusion Criteria -Participants providing urine only
* 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
* …
What they're measuring
1
Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA)