The BIOFIRE BioThreat Panel v2.5 demonstrates comparable sensitivity on the FILMARRAY 2.0 and SPOTFIRE systems

Rapid and sensitive detection of biothreat agents represents a critical capability for first responders, federal agencies, and militaries around the world. For nearly a decade, the BIOFIRE BioThreat Panel v2.5 has been an easy-to use, automated, “lab in a pouch” detection tool utilizing qualitative, multiplexed polymerase chain reaction (PCR) with the BIOFIRE FILMARRAY 2.0 instrument to detect biothreat agents directly from environmental samples in approximately one hour. The BIOFIRE BioThreat Panel v2.5 detects Bacillus anthracis , Brucella melitensis , Burkholderia mallei/pseudomallei , Coxiella burnetii , Francisella tularensis , Rickettsia prowazekii , Yersinia pestis , Eastern equine encephalitis virus, Orthomarburgvirus marburgense , Orthopoxvirus spp., variola virus, Venezuelan equine encephalitis virus, Western equine encephalitis virus, Orthoebolavirus zairense , and toxin-encoding genes from Clostridium botulinum (botulinum toxin) and Ricinus communis (Ricin toxin). Sensitivity of the BioThreat Panel v2.5 was evaluated on the FILMARRAY 2.0 and SPOTFIRE instruments through side-by-side testing with both platforms. The limit of detection (LoD) for each of the 16 biothreat targets on the panel, including seven bacterial pathogens, seven viral pathogens, and two toxin-encoding genes was determined. The BioThreat Panel v2.5 exhibited equivalent or better sensitivity on SPOTFIRE compared to FILMARRAY 2.0 for all targets, except for Yersinia pestis , which displayed reduced sensitivity due to a modified calling scheme on SPOTFIRE. This study demonstrates that the BioThreat Panel v2.5 can provide sensitive biothreat detection across both BIOFIRE FILMARRAY 2.0 and SPOTFIRE automated PCR instruments.