BioFire Global Fever Panel – IVD

• The BioFire Global Fever Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with BioFire^® FilmArray^® 2.0 and BioFire^® FilmArray^® Torch Systems. The BioFire Global Fever Panel detects and identifies selected bacterial, viral, and protozoan nucleic acids directly from EDTA whole blood collected from individuals with signs and/or symptoms of acute febrile illness or recent acute febrile illness and known or suspected exposure to the following target pathogens:
  • chikungunya virus,
  • dengue virus (serotypes 1, 2, 3 and 4),
  • Leptospira spp.,
  • Plasmodium spp. (including species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale).

• Evaluation for more common causes of acute febrile illness (e.g., infections of the upper and lower respiratory tract or gastroenteritis, as well as non-infectious causes) should be considered prior to evaluation with this panel. Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities.

Software

• Installing the BioFire Global Fever Panel Pouch Module on BioFire FilmArray Systems Technical Note

• BioFire Global Fever Panel v2.1 Electronic Report Module (ERM) Technical Note

Technical Notes

SDS

• Interim Guidelines for Laboratory Verification of Performance of the BioFire Global Fever Panel (PDF 219 KB)

BIOFIRE SHIELD Global Fever Panel – IVD External Control Kit NHPS

Reporting