Xpert® ERP on the GeneXpert® System

A multi-site observational all-comers study that will be conducted at geographically diverse sites within the United States

Completed

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Key information

Conditions

Respiratory Tract Infections Infections Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Quantigen

Fishers, Indiana, 46037, United States

About this study

Prospectively collected Nasopharyngeal swab specimens will be collected from consented individuals with signs and symptoms of respiratory tract infection at a single timepoint

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

NPS specimen from participant who presents with signs and symptoms of RTI
NPS specimen collected in commercially available UTM/VTM only

Exclusion criteria

NPS specimen collected from a participant previously enrolled in this study
Principal Investigator feels the participant is not suitable to participate in the study

Treatment and study plan

Xpert ERP

Diagnostic Test

Detection and Identification of DNA and RNA from multiple bacteria and viruses from nasopharyngeal swabs

Primary outcomes

Xpert test compared to comparator(s) tests

Time frame: Clinical Performance assessed on specimens collected at Baseline

Evaluating the clinical performance (PPA and NPA) of Xpert ERP relative to comparator(s)

Sponsors and collaborators

Lead sponsor

Cepheid

Industry

Registry information

Official study title

Clinical Evaluation of the Xpert® Expanded Respiratory Panel on the GeneXpert® System Using Nasopharyngeal Swab Specimens

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 24, 2026
Registry last updated: Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed