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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chlamydia Trachomatis Infection
- Sponsor
- NeuMoDx Molecular, Inc.
- Enrollment
- 4017
- Locations
- 12
- Primary Endpoint
- Clinical specificity and sensitivity
- Status
- Completed
- Last Updated
- 5 years ago
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.
Investigators
Eligibility Criteria
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.
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)