NeuMoDx PrEDiCTiNG Study Evaluation Plan
- Conditions
- Neisseria Gonorrheae InfectionChlamydia Trachomatis Infection
- Interventions
- Diagnostic Test: NeuMoDx CT/NG AssayDiagnostic Test: FDA-cleared NAATs
- Registration Number
- NCT03970850
- Lead Sponsor
- NeuMoDx Molecular, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4017
- 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.
- Female subject reports that she had a hysterectomy.
- Subject self-reports use of antibiotics within 28 days of study enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multi-arm - Symptomatic and Asymptomatic Males NeuMoDx CT/NG Assay Arm 1 - Urine from males subjects Multi-arm - FDA cleared NAATs (Comparator) FDA-cleared NAATs Arm 3 - Comparator (for females - vaginal and urine NAATs and for males - 3 urine NAATs) Multi-arm - Symptomatic and Asymptomatic Females NeuMoDx CT/NG Assay Arm 2 - Endocervical, self-collected (in the clinical setting) and physician-collected vaginal swabs and urine from female subjects
- Primary Outcome Measures
Name Time Method Clinical specificity and sensitivity 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 Outcome Measures
Name Time Method Valid results rate Through study completion, an average of 1 year Evaluate indeterminate and unresolved rates
Trial Locations
- Locations (12)
Planned Parenthood - Southwest and Central Florida
🇺🇸Tampa, Florida, United States
Healthcare Clinical Date, Inc. (Segal Trials)
🇺🇸North Miami, Florida, United States
TriCore Reference Labs
🇺🇸Albuquerque, New Mexico, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
LSU Health Science
🇺🇸New Orleans, Louisiana, United States
Indiana University (IU)
🇺🇸Indianapolis, Indiana, United States
NeuMoDx Molecular, Inc.
🇺🇸Ann Arbor, Michigan, United States
Planned Parenthood - Northern, Central and Southern New Jersey
🇺🇸Newton, New Jersey, United States
Henry Ford Health System (HFHS)
🇺🇸Detroit, Michigan, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Planned Parenthood - Gulf Coast
🇺🇸Houston, Texas, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States