Xpert Hemorrhagic Fever on Edge X in Trained and Untrained Users

NCT07591740 | Completed FDA Device

• 1 other identifier: P259C3
• Study Type: observational
• Target: 725
• Locations: 1 country
• Sites: 1

Brief Summary

A multi-site observation study that was conducted in the United States at 3 CLIA Waived sites with Untrained Users testing on Xpert Hemorrhagic fever tests on Edge X instruments

Conditions

Hemorrhagic Fever

Outcome Measures

Primary Outcomes (1)

• Clinical Performance [PPA and NPA] of Xpert on Edge X in Untrained and Trained Users

  Evaluating the PPA and NPA of Xpert compared to expected status of specimens

  Clinical Performance assessed at Baseline

Study Arms (1)

CWB and VWB specimens from consented blood donors

Non-Contrived and Contrived CWB and VWB specimens with pseudoviral constructs from multiple viruses

Diagnostic Test: Xpert Hemorrhagic Fever test

Interventions

Xpert Hemorrhagic Fever test DIAGNOSTIC_TEST

Detection and identification of RNA from multiple viruses in CWB and VWB from individuals with signs and symptoms of the suspected infections and/or individuals who are at risk for exposure or may have been exposed to these viruses.

CWB and VWB specimens from consented blood donors

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Whole blood specimens collected from individuals asymptomatic of fever

You may qualify if:

• \- Capillary and venous whole blood specimens from individuals asymptomatic for fever
• Whole blood specimens collected in EDTA specimens collection devices only- Whole Blood specimens collected in EDTA specimen collection devices only

You may not qualify if:

• Participants vaccinated with a Hemorrhagic Fever live virus vaccine within the past 28 days.
• Participant was previously enrolled into this protocol. • VWB and CWB specimens were not collected according to the manufacturer's instructions.

Sponsors & Collaborators

• Cepheid: lead

Study Sites (1)

No-Resistance Consulting Group

Birmingham, Alabama, 35242, United States

Location

MeSH Terms

Conditions

Hemorrhagic Fevers, Viral

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: October 21, 2024
• Primary Completion: March 14, 2025
• Study Completion: March 13, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)