NeuMoDx PrEDiCTiNG Study Evaluation Plan

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection

Intervention / Treatment
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* Diagnostic Test: NeuMoDx CT/NG Assay
* Diagnostic Test: FDA-cleared NAATs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multi-arm - Symptomatic and Asymptomatic Males<br>Arm 1 - Urine from males subjects | Diagnostic Test: NeuMoDx CT/NG Assay<br>* NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System<br>|
| Active Comparator: Multi-arm - Symptomatic and Asymptomatic Females<br>Arm 2 - Endocervical, self-collected (in the clinical setting) and physician-collected vaginal swabs and urine from female subjects | Diagnostic Test: NeuMoDx CT/NG Assay<br>* NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System<br>|
| Active Comparator: Multi-arm - FDA cleared NAATs (Comparator)<br>Arm 3 - Comparator (for females - vaginal and urine NAATs and for males - 3 urine NAATs) | Diagnostic Test: FDA-cleared NAATs<br>* Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical specificity and sensitivity | Clinical specificity and sensitivity of NeuMoDx CT/NG Assay for both CT and NG relative to an individual's patient infected status (PIS) | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valid results rate | Evaluate indeterminate and unresolved rates | Through study completion, an average of 1 year |