ID NOW™ Test for Chlamydia and Gonorrhea

N/A

Waitlist Available

Research Sponsored by Abbott Rapid Dx

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be asymptomatic and presenting for STI screening, or symptomatic with suspected sexually transmitted infection and experiencing specific symptoms

Participants providing vaginal samples and urine must be aged 14 years or older in the US or 18 years or older in other countries

Timeline

Screening 3 weeks

Treatment Varies

Follow Up "up to 24 months"

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the accuracy of the ID NOW™ CT/NG test in detecting Chlamydia and Gonorrhea in male urine, female urine, and self-collected vaginal swabs

Who is the study for?

This trial is for individuals who may have gonorrhea or chlamydia but show no symptoms. Participants will provide samples of male urine, female urine, or self-collected vaginal swabs to be tested.

What is being tested?

The study aims to evaluate the ID NOW™ CT/NG test's accuracy in detecting gonorrhea and chlamydia using different types of samples. It compares this new test with up to three established tests.

What are the potential side effects?

There are generally no side effects associated with providing a sample for the ID NOW™ CT/NG test. The procedure involves collecting urine or a vaginal swab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am showing symptoms of an STI or I am here for an STI check-up without symptoms.

Select...

I am at least 14 years old in the US or 18 in other countries and can provide vaginal samples and urine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ "up to 24 months"

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~"up to 24 months"

This trial's timeline: 3 weeks for screening, Varies for treatment, and "up to 24 months" for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Demonstrate the accuracy of the ID NOW™ CT/NG test in the hands of untrained users by a usability questionnaire.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: Female/Male collectionExperimental Treatment1 Intervention

Each female participant will provide a 20-50 mL first-catch urine sample, and one (1) self-collected vaginal swab sample and three (3) clinician-collected vaginal swabs. Each male participant will provide a 20-50 mL first-catch urine sample. Each urine sample will be collected in an untreated sterile urine cup. The site staff will test 1.5 ml of urine directly from the specimen cup with ID NOW within two (2) hours of collection. The remaining urine will be aliquoted into applicable transport tubes for each comparator. One (1) self-collected vaginal swab will be collected by the participant in a clinical setting and tested on the device within 2 hours. Three (3) vaginal swabs will be collected by the clinician according to institutional procedures and manufacturer's instructions, one for each of the three (3) NAATs for comparator testing. For comparator tests, the order of CVS sample collection will be randomized.

0 / 2Eligibility criteria met