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This is a multi-site, observational, cross-sectional clinical study that includes geographically diverse sites within and outside the United States.
Capillary and venous whole blood specimens will be prospectively collected from consented individuals who present with acute febrile illness and clinical suspicion of infection with fever-causing agents
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capillary and venous WB specimens | WB specimens collected from individuals who present with AFI and have clinical suspicion of infection caused by at least one fever-causing agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xpert Tropical Fever test | Diagnostic Test | Detection and identification of nucleic acids from multiple fever-causing pathogens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance [PPA and NPA] of Xpert Tropical Fever | Evaluating the PPA and NPA of Xpert Tropical Fever relative to the comparator(s) | Clinical performance on specimens collected at Baseline (Day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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Whole blood specimens collected from individuals with AFI and infection caused by fever-causing pathogens
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Health Research Center | San Diego | California | 92134 | United States |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| D000071243 | Zika Virus Infection |
| D003715 | Dengue |
| D007922 | Leptospirosis |
| D065632 | Chikungunya Fever |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| D000079426 |
| Vector Borne Diseases |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D018354 | Alphavirus Infections |
| D014036 | Togaviridae Infections |