Hemorrhagic Fever
Conditions
Brief summary
A multi-site observation study that was conducted in the United States at 3 CLIA Waived sites with Untrained Users testing on Xpert Hemorrhagic fever tests on Edge X instruments
Detailed description
Capillary and Venous whole blood collected from consented healthy individuals contrived with pseudoviral constructs from multiple viruses and non-contrived were tested by untrained users in a CW environment and trained users in a laboratory setting on the Edge X instrument.
Interventions
DIAGNOSTIC_TESTXpert Hemorrhagic Fever test
Detection and identification of RNA from multiple viruses in CWB and VWB from individuals with signs and symptoms of the suspected infections and/or individuals who are at risk for exposure or may have been exposed to these viruses.
Sponsors
Cepheid
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Capillary and venous whole blood specimens from individuals asymptomatic for fever • Whole blood specimens collected in EDTA specimens collection devices only- Whole Blood specimens collected in EDTA specimen collection devices only
Exclusion criteria
* Participants vaccinated with a Hemorrhagic Fever live virus vaccine within the past 28 days. * Participant was previously enrolled into this protocol. • VWB and CWB specimens were not collected according to the manufacturer's instructions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance [PPA and NPA] of Xpert on Edge X in Untrained and Trained Users | Clinical Performance assessed at Baseline | Evaluating the PPA and NPA of Xpert compared to expected status of specimens |
Countries
United States
Outcome results
None listed