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CompletedNCT07489846Updated Mar 24, 2026

Xpert® ERP on the GeneXpert® System

An observational study in Respiratory Tract Infections, sponsored by Cepheid. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Cepheid · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,200
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Respiratory Tract Infections
03

In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's enrollment of 3,200 is above the median of 300 across 295 observational studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Cepheid is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,200 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Nasopharyngeal Swab Specimens

    Nasopharyngeal Swab specimens from individuals with signs and symptoms of respiratory tract infection

    Diagnostic Test: Xpert ERP

Interventions

  • Diagnostic testXpert ERP

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

06

What researchers measure

Primary outcomes

  1. Xpert test compared to comparator(s) tests

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

    Time frame: Clinical Performance assessed on specimens collected at Baseline

07

Study locations

1 site
  • Quantigen
    Fishers, Indiana 46037, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07489846
Lead sponsor
Cepheid
Responsible party
Sponsor
First posted
Mar 24, 2026
Start date
May 13, 2025
Primary completion
Jan 28, 2026
Completion
Feb 2, 2026
Last update
Mar 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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