NCT03970850

NeuMoDx PrEDiCTiNG Study Evaluation Plan

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,017 (actual)
• Sponsor: NeuMoDx Molecular, Inc. · Industry
• Sex: All
• Age: 14 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chlamydia Trachomatis Infection
• Neisseria Gonorrheae Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	NeuMoDx CT/NG Assay	NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System
DIAGNOSTIC_TEST	FDA-cleared NAATs	Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs

Timeline

• Start date: 2019-07-22
• Primary completion: 2020-02-25
• Completion: 2020-02-25
• First posted: 2019-06-03
• Last updated: 2020-06-12

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study