Xpert® Hemorrhagic Fever on the GeneXpert® Edge X System

January 22, 2026 updated by: Cepheid

Clinical Evaluation of the Xpert Hemorrhagic Fever Test Using Clinical Specimens and Contrived Samples on the GeneXpert Edge X System

A multi-site observation study that was conducted a geographically diverse sites across the United States

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Capillary and venous whole blood specimens were prospectively collected from consented individuals symptomatic or asymptomatic of fever

Study Type

Observational

Enrollment (Actual)

408

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
    • Maryland
      • Frederick, Maryland, United States, 21702
        • USAMRIID

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

Yes

Sampling Method

Probability Sample

Study Population

Whole blood specimens collected from blood donors symptomatic or asymptomatic of fever

Description

Inclusion Criteria:

  • Capillary and venous whole blood specimens from blood donors who symptomatic for fever lasting ≤ 10 days OR asymptomatic for fever
  • Whole blood specimens collected in EDTA specimens collection devices only

Exclusion Criteria:

  • Any whole blood specimens from blood donors vaccinated with a Hemorrhagic Fever live virus vaccine within the past 28 days
  • Any whole blood specimen that were previously enrolled
  • Any whole blood specimens not collected according to the manufacturer's instructions

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
Capillary and venous whole blood specimens
whole blood specimens from individuals asymptomatic or symptomatic of fever
Diagnostic test: Xpert Hemorrhagic Fever test
Detection and identification of RNA from multiple viruses from whole blood specimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance comparing Xpert Hemorrhagic Fever to known status of specimens
Time Frame: Clinical Performance assessed in specimens collected at Baseline
Xpert test compared to expected status
Clinical Performance assessed in 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)

January 13, 2025

Primary Completion (Actual)

April 29, 2025

Study Completion (Actual)

October 3, 2025

Study Registration Dates

First Submitted

October 17, 2025

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P259C

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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