Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection
Conditions
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.
Interventions
DIAGNOSTIC_TESTNeuMoDx CT/NG Assay
NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System
DIAGNOSTIC_TESTFDA-cleared NAATs
Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs
Sponsors
NAMSA
NeuMoDx Molecular, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female subjects of at least 14 years of age or older. 2. 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. 3. 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. 4. Subject is willing to provide all required specimens.
Exclusion criteria
1. Female subject reports that she had a hysterectomy. 2. Subject self-reports use of antibiotics within 28 days of study enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Valid results rate | Through study completion, an average of 1 year | Evaluate indeterminate and unresolved rates |
Countries
United States
Outcome results
None listed