Xpert® Hemorrhagic Fever on the GeneXpert® Edge X System

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

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

USAMRIID

Frederick, Maryland, 21702, United States

About this study

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

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 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

Treatment and study plan

Xpert Hemorrhagic Fever test

Diagnostic Test

Detection and identification of RNA from multiple viruses from whole blood specimens

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Cepheid

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jan 27, 2026
Registry last updated: Jan 27, 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.

Published trials that share one or more normalized conditions with this study.

Completed