Xpert® Hemorrhagic Fever on the GeneXpert® Edge X System

Cepheid408 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

408

Conditions

Hemorrhagic Fever

Interventions

Xpert Hemorrhagic Fever testDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

USAMRIID

Frederick, Maryland, United States

Outcomes

Primary Outcomes

Clinical performance comparing Xpert Hemorrhagic Fever to known status of specimens

Xpert test compared to expected status

Time frame: Clinical Performance assessed in specimens collected at Baseline

Data from ClinicalTrials.gov

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