Xpert® ERP on the GeneXpert® System

March 18, 2026 updated by: Cepheid

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

3200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Fishers, Indiana, United States, 46037
        • Quantigen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Specimens collected from individuals with signs and symptoms of respiratory tract infection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nasopharyngeal Swab Specimens
Nasopharyngeal Swab specimens from individuals with signs and symptoms of respiratory tract infection
Diagnostic test: Xpert ERP
Detection and Identification of DNA and RNA from multiple bacteria and viruses from nasopharyngeal swabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Clinical Performance assessed on specimens collected at Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cepheid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2025

Primary Completion (Actual)

January 28, 2026

Study Completion (Actual)

February 2, 2026

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P286C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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