Xpert® Hemorrhagic Fever on the GeneXpert® Edge X System

Cepheid

Status: Completed

Conditions: Hemorrhagic Fever

Treatments: Diagnostic Test: Xpert Hemorrhagic Fever test

Study type: Observational

Funder types: Industry

Identifiers

NCT07370454

P259C

Details and patient eligibility

About

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

Full description

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

Enrollment: 408 patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

408 participants in 1 patient group

Capillary and venous whole blood specimens

Description:

whole blood specimens from individuals asymptomatic or symptomatic of fever

Treatment:

Diagnostic Test: Xpert Hemorrhagic Fever test