NeuMoDx PrEDiCTiNG Study Evaluation Plan

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03970850
Study type	Interventional
Source	NeuMoDx Molecular, Inc.
Contact
Status	Completed
Phase	N/A
Start date	July 22, 2019
Completion date	February 25, 2020

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