Xpert® ERP on the GeneXpert® System

Cepheid3,200 enrolled

Overview

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

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

3,200

Conditions

Respiratory Tract Infections

Interventions

Xpert ERPDIAGNOSTIC_TEST

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Quantigen

Fishers, Indiana, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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