![]() BIOFIRE ® FILMARRAY ® Pneumonia plus PanelĢThe stated performance is the aggregate of the prospective data from the clinical study.BIOFIRE ® FILMARRAY ® Gastrointestinal Panel.BIOFIRE ® FILMARRAY ® Respiratory Panels.BIOFIRE ® FILMARRAY ® Meningitis/Encephalitis Panel.Taken together, the BIOFIRE ® FILMARRAY ® panels comprise the largest infectious disease pathogen menu commercially available. ![]() Accurate: The average positive agreement rate (or sensitivity) across all pathogens on the BCID2 panel is 99%, and the negative agreement rate (or specificity) is 99.8% 2.īIOFIRE ® BCID2 is one of five FDA-cleared and CE-marked panels for use on the BIOFIRE ® systems.BCID2 detects 10 antimicrobial resistance genes and emerging pathogens like C.auris and S.maltophilia Comprehensive: Simultaneously tests forĤ3 targets and identifies pathogens in more thanĩ out of 10 positive blood cultures.The BIOFIRE ® BCID2 Panel is designed for the BIOFIRE ® systems, an FDA, CE-IVD, and TGA certified multiplex PCR system that integrates sample preparation, amplification, detection and analysis. With just one test you can identify pathogens more than 9 out of 10 positive blood cultures in about 1 hour with only 2 minutes of hands-on time. The BIOFIRE ® Blood Culture Identification 2 (BCID2) Panel tests for a comprehensive list of 33 pathogens and 10 antibiotic resistance genes associated with bloodstream infections. The EUA for the FilmArray BioThreat-E Test enables CLIA moderate and high complexity laboratories to conduct a PCR test for Ebola in-house, providing results in approximately one hour.Simple, comprehensive pathogen ID from blood cultures § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C.This test has been authorized only for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) and not for any other viruses or pathogens and.This test has been authorized by FDA under an Emergency Use Authorization for use by CLIA Moderate and High Complexity Laboratories.This test has not been FDA cleared or approved.A multiplex FilmArray panel could aid in rapid and actionable AFI diagnosis. c Preliminary off-panel exclusivity studies assessing specificity with closely related organisms or organisms that may be found in whole blood show no significant cross-reactivity. For example, estimated LoD levels for the following organisms: dengue virus New Guinea C at 360 copies/mL, Marburgvirus Musoke at 50 copies/mL, Zika virus at 130 copies/mL, Leishmania donovani at 10 copies/mL, Plasmodium at 10 copies/mL, Bacillus anthracis at 64 copies/mL, and Yersinia pestis at 15 copies/mL. Estimated LoD studies demonstrate clinically relevant detection levels and exclusivity testing shows high specificity. in venous blood specimens from individuals with signs and/or symptoms of AFI or recent AFI and with known or suspected exposure to target pathogens. The FilmArray GF Panel detects and identifies nucleic acid from 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, and Plasmodium spp. The FilmArray System is an in vitro diagnostic test platform that combines nucleic acid purification and nested multiplex PCR for the simultaneous identification of many infectious agents in under an hour using a closed, sample-to-answer system. BioFire Defense is developing the Global Fever (GF) Panel to be used on the FilmArray System in collaboration with the Department of Defense a and NIAID b. Helm, Corike Toxopeus, Pascal Belgique, Lex Border, Olivia Davidson, Alex Kelley, Micah Mortenson, Cynthia PhillipsĪBSTRACT: Acute Febrile Illness (AFI) can be caused by a large number of pathogens that include bacteria, viruses and parasites. Analytical Performance of the FilmArray Global Fever Panel
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