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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN272201600002C | Other Grant/Funding Number | NIAID | |
| W911QY-13-D-0080 | Other Grant/Funding Number | U.S. Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study will evaluate the clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel.
The FilmArray Global Fever (GF) Panel, developed by BioFire Defense in collaboration with the U.S. Department of Defense and NIAID, uses an automated, multiplex PCR system to evaluate whole blood samples for 19 pathogens simultaneously in under an hour. Targets of the GF Panel are Chikungunya virus, CCHF virus, dengue virus (serotypes 1-4), Ebolavirus, Lassa virus, Marburgvirus, West Nile virus, Yellow fever virus, Zika virus, Bacillus anthracis, Francisella tularensis, Leptospira spp., Salmonella enterica serovar Typhi and Paratyphi A, Yersinia pestis, Leishmania donovani complex, Plasmodium spp., P. falciparum, and P. ovale/vivax. BioFire Defense is conducting a prospective clinical study to evaluate the sensitivity and specificity of the GF Panel when used to test blood collected from subjects with fever or who have recently had fever. This multi-center study is being conducted at locations around the world.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects/Specimens | Subjects/Specimens that meet the eligibility criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study | Other | Observational study |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel | Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay | 18 months |
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Inclusion Criteria:
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Subjects with fever will be prospectively enrolled, and whole blood will be collected.
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Phillips, Ph. D. | BioFire Defense LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States | ||
| Washington University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35716700 | Derived | Manabe YC, Betz J, Jackson O, Asoala V, Bazan I, Blair PW, Chang A, Chusri S, Crump JA, Edgel KA, Faix DJ, Fernandez S, Fox AT, Garcia JA, Grogl M, Hansen EA, Heang V, House SL, Jongsakul K, Kaburise MB, Klungthong C, Lamorde M, Letizia AG, Lorenzana I, Luy M, Maro VP, Mores CN, Myers CA, Oduro AR, Parham L, Porzucek AJ, Prouty M, Rabiger DS, Rubach MP, Siles C, Silva M, Ukachu C, Waitumbi JN, Phillips CL, Jones BW. Clinical evaluation of the BioFire Global Fever Panel for the identification of malaria, leptospirosis, chikungunya, and dengue from whole blood: a prospective, multicentre, cross-sectional diagnostic accuracy study. Lancet Infect Dis. 2022 Sep;22(9):1356-1364. doi: 10.1016/S1473-3099(22)00290-0. Epub 2022 Jun 15. |
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IPD will not be shared with other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 22, 2020 | Aug 13, 2021 | ICF_000.pdf |
| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Whole blood specimen may be retained at the participating clinical sites for future use. Specimen nucleic acid may be retained at BioFire and participating clinical sites for future performance evaluations of the FilmArray.
| St Louis |
| Missouri |
| 63110 |
| United States |
| Naval Medical Research Unit Two | Phnom Penh | Cambodia |
| United States Army Medical Research Directorate Georgia | Tbilisi | Georgia |
| Naval Medical Research Unit Three | Navrongo | Ghana |
| Universidad Nacional Autonoma de Honduras | Tegucigalpa | Central District | Honduras |
| United States Army Medical Research Directorate Kenya | Kisumu | Kenya |
| Naval Medical Research Unit Six | Iquitos | Peru |
| Kilimanjaro Christian Medical Centre | Moshi | Tanzania |
| Armed Forces Research Institute of Medical Sciences | Bangkok | Thailand |
| Infectious Diseases Institute | Kampala | Uganda |