Clinical Evaluation of the ID NOW™ CT/NG Test

NCT06395675 | Not Yet Recruiting

• 1 other identifier: Abbott Diagnostics Scarborough
• Study Type: interventional
• Target: 7,100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  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.

  "up to 24 months"

Secondary Outcomes (1)

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

  "up to 24 months"

Study Arms (1)

Experimental: Female/Male collection

EXPERIMENTAL

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.

Diagnostic Test: ID NOW™

Interventions

ID NOW™ DIAGNOSTIC_TEST

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.

Experimental: Female/Male collection

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Reported using or having completed antimicrobial therapy within 14 days of enrollment in the study
• Urination within the previous one (1) hour
• Already participated in the study

Sponsors & Collaborators

• Abbott Rapid Dx: lead

Study Sites (1)

LSU Crescent Care Sexual Health Clinic

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Conditions

Gonorrhea; Asymptomatic Diseases

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Abinav Singh, PhD

CONTACT

0000000; Abinav.Singh@abbott.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each female participant will provide a 20-50 mL first-catch urine (FCU) sample, one (1) self-collected vaginal swab sample (SVS) and three (3) clinician-collected vaginal swabs (CVS). Each male participant will provide a 20-50 mL first-catch urine sample. Standard of care (SOC) samples should be collected first prior to clinical trial specimen collection If sites use urine as SOC, then SOC urine sample can be taken from the untreated sterile urine cup provided to collect first catch urine for this study. Samples will be collected, handled, stored, shipped, and tested according to the applicable package insert(s), as appropriate. The site will record the order of sample collection for each participant. The remaining urine will be aliquoted into applicable transport. tubes for each comparator method (3 tubes) and one (1) retained urine sample (5mL)

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: July 9, 2024
• Primary Completion: January 9, 2025
• Study Completion: January 9, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)