Xpert® Hemorrhagic Fever on the GeneXpert® Edge X System

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

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

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