BioFire® JI Control Panel M420
The BioFire® JI Control Panel M420 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of gram-positive and gram-negative bacteria, antimicrobial resistance gene, and yeast pathogens included in the BioFire® Joint Infection (JI) Panel on the BioFire® systems.
BioFire JI Control Panel M420 is comprised of 2 controls, BioFire® JI Positive Control and BioFire® JI Negative Control. BioFire JI Positive Control contains surrogate control material composed of synthetic nucleic acid corresponding to genome segments of the pathogens and antimicrobial resistance markers listed in the assay. BioFire JI Negative Control contains no nucleic acid. BioFire JI Control Panel M420 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire JI Panel assay. This product is not intended to replace manufacturer controls provided with the device.