Clinical Evaluation of the FilmArray® Global Fever (GF) Panel

Conditions

Fever

Brief summary

This study will evaluate the clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel.

Detailed description

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.

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.

2022-06-1523 citations

10.1016/s1473-3099(22)00290-0

Interventions

OTHERObservational study

Observational study

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Whole blood in EDTA (prospectively collected via informed consent) * Subject has a recorded or self-reported fever within the past two days. * Subject has not participated in the study within the last 30 days.

Design outcomes

Primary

Measure	Time frame	Description
Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel	18 months	Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay

Countries

Cambodia, Georgia, Ghana, Honduras, Kenya, Peru, Tanzania, Thailand, Uganda, United States

Outcome results

None listed