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OpenTrials
Completed

NCT Number: NCT07591740

Xpert Hemorrhagic Fever on Edge X in Trained and Untrained Users

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

Completed

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Key information

Conditions

Hemorrhagic Fever Hemorrhagic Fevers, Viral Infections RNA Virus Infections Virus Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

No-Resistance Consulting Group

Birmingham, Alabama, 35242, United States

About this study

Capillary and Venous whole blood collected from consented healthy individuals contrived with pseudoviral constructs from multiple viruses and non-contrived were tested by untrained users in a CW environment and trained users in a laboratory setting on the Edge X instrument.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Clinical Performance assessed at Baseline

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

Sponsors and collaborators

Lead sponsor

Cepheid

Industry

Registry information

Official study title

Comparison Study of the Xpert Hemorrhagic Fever Test Between Trained and Untrained Users on the GeneXpert Edge X System

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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