NeuMoDx PrEDiCTiNG Study Evaluation Plan

NeuMoDx Molecular, Inc.4,017 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

4,017

Conditions

Chlamydia Trachomatis Infection Neisseria Gonorrheae Infection

Interventions

NeuMoDx CT/NG AssayDIAGNOSTIC_TEST

NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System

FDA-cleared NAATsDIAGNOSTIC_TEST

Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs

Eligibility

Sex: ALLMin age: 14 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (15)

University of Alabama

Birmingham, Alabama, United States

Healthcare Clinical Date, Inc. (Segal Trials)

North Miami, Florida, United States

Outcomes

Primary Outcomes

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)

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

Valid results rate

Evaluate indeterminate and unresolved rates

Time frame: Through study completion, an average of 1 year

Data from ClinicalTrials.gov

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