Hemorrhagic Fever
Conditions
Brief summary
A multi-site observation study that was conducted a geographically diverse sites across the United States
Detailed description
Capillary and venous whole blood specimens were prospectively collected from consented individuals symptomatic or asymptomatic of fever
Interventions
DIAGNOSTIC_TESTXpert Hemorrhagic Fever test
Detection and identification of RNA from multiple viruses from whole blood specimens
Sponsors
Cepheid
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance comparing Xpert Hemorrhagic Fever to known status of specimens | Clinical Performance assessed in specimens collected at Baseline | Xpert test compared to expected status |
Countries
United States
Outcome results
None listed