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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CWB and VWB specimens from consented blood donors | Non-Contrived and Contrived CWB and VWB specimens with pseudoviral constructs from multiple viruses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xpert Hemorrhagic Fever test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Performance [PPA and NPA] of Xpert on Edge X in Untrained and Trained Users | Evaluating the PPA and NPA of Xpert compared to expected status of specimens | Clinical Performance assessed at Baseline |
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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:
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Whole blood specimens collected from individuals asymptomatic of fever
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No-Resistance Consulting Group | Birmingham | Alabama | 35242 | United States |
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| ID | Term |
|---|---|
| D006482 | Hemorrhagic Fevers, Viral |
| ID | Term |
|---|---|
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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