Multi-Center Clinical Performance Evaluation of the NeuMoDx™ Chlamydia Trachomatis (CT) / Neisseria Gonorrhoeae (NG) [CT/NG] Assay on the NeuMoDx™ 288 Molecular System and the NeuMoDx™96 Molecular System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NeuMoDx Molecular, Inc.
- Enrollment
- 4,017
- Locations
- 15
- Primary Endpoint
- Clinical specificity and sensitivity
Study Overview
Brief Summary
This investigational study will be conducted to evaluate the performance of the NeuMoDx™ CT/NG Assay on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System (collectively referred to as NeuMoDx™ CT/NG Assay test system).
Detailed Description
Clinical performance characteristics of the NeuMoDx CT/NG Assay on NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System will be evaluated in a multi-center, prospective, sampling study by comparing the diagnoses made by the NeuMoDx™ CT/NG Assay to Patient Infected Status (PIS) as the reference standard.
Prospectively collected urine and swab specimens from individual subjects will be tested using the NeuMoDx™ CT/NG Assay at one of the three NeuMoDx testing sites. Subjects' PIS for CT and PIS for NG will be determined by a central laboratory using FDA-cleared, legally marketed CT/NG combo assays on pre-specified sample matrices according to the PIS determination algorithms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male and female subjects of at least 14 years of age or older.
- •Subject must be able and willing to provide informed consent. The use of a 'surrogate' or 'Legally Authorized Representative' is allowed and shall follow the site's standard procedures, under which the clinical investigation will be conducted.
- •Subjects undergoing a routine pelvic examination, subjects eligible for screening evaluations for possible STDs and/or subjects known to be partners with a person with a confirmed or suspected STD.
- •Subject is willing to provide all required specimens.
Exclusion Criteria
- •Female subject reports that she had a hysterectomy.
- •Subject self-reports use of antibiotics within 28 days of study enrollment.
Arms & Interventions
Multi-arm - Symptomatic and Asymptomatic Males
Arm 1 - Urine from males subjects
Intervention: NeuMoDx CT/NG Assay (Diagnostic Test)
Multi-arm - Symptomatic and Asymptomatic Females
Arm 2 - Endocervical, self-collected (in the clinical setting) and physician-collected vaginal swabs and urine from female subjects
Intervention: NeuMoDx CT/NG Assay (Diagnostic Test)
Multi-arm - FDA cleared NAATs (Comparator)
Arm 3 - Comparator (for females - vaginal and urine NAATs and for males - 3 urine NAATs)
Intervention: FDA-cleared NAATs (Diagnostic Test)
Outcomes
Primary Outcomes
Clinical specificity and sensitivity
Time Frame: Through study completion, an average of 1 year
Clinical specificity and sensitivity of NeuMoDx CT/NG Assay for both CT and NG relative to an individual's patient infected status (PIS)
Secondary Outcomes
- Valid results rate(Through study completion, an average of 1 year)