Xpert® ERP on the GeneXpert® System

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07489846

Enrollment

3200

Registered

2026-03-24

Start date

2025-05-13

Completion date

2026-02-02

Last updated

2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Tract Infections

Brief summary

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

Detailed description

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

Interventions

DIAGNOSTIC_TESTXpert ERP

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Xpert test compared to comparator(s) tests	Clinical Performance assessed on specimens collected at Baseline	Evaluating the clinical performance (PPA and NPA) of Xpert ERP relative to comparator(s)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026