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MDx-Chex for BCID2 is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast, Gram positive and Gram negative bacteria, as vell as snciated antimicrobial resistance genes, by the BioFire FilmArray Blood Culture Identification 2 (BCID2) Panel on FilmArray systems. Control 1 - GN: Gram negative bacteria: Acinetobacter colcacer in complex, Baceronides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella oxytoca, Klebsiella pneumats Jray, Proteus spp., Salmonella spp., Serratia marcescens, Heisseria vivoca, Neisseria meningitides, Poeudnonas aeruginosa, Stenotrophomonas matophilia; antimicrobial resistance genes: KPC, CTX-M, IMP, NDM, OXA-Ike, VIM, mcr- 1. Control 2 - GPY: Gram positive bacteria: Enterococcus face: 11, 27712-10, nr., iUDM, U.Steria monocytogenes, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdumsis, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes; yeast: Candida dhicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Cryptococcus neoformans/gatit; animicrobial resistance genes mecA/C and MREJ, vanA/B. This product is not intended to replace manufacturer controls provided with the device.

MDx-Chex for BCID2 Control 1 - GN is positive for certain pathogens and antimicrobial resistance genes in the FilmArray BCID 2 panel and negative for those contained in MDx-Chex for BCID2 Control 2 - GPY. MDx-Chex for BCID2 Control 2 - GPY is positive for the remaining pathogen and antimicrobial resistance genes and negative for those present in MDx-Chex for BCID2 Control 1 - GN (see Table 1 below). Each control mix also contains and controls for blood and blood culture media components that have been identified as PCR inhibitors namely hemoglobin, leukocyte DNA, and anticoagulants. MDx-Chex for BCID2 is a quality control containing stabilized blood components, blood culture media components, and inactivated microorganisms resulting in a full-process, cellular-based control for the BioFire BCID2 Panel. Use of full-process cellular controls are necessary to evaluate the entire analytical process, including sample lysis, nucleic acid isolation and purification, amplification, detection, and analysis, as well as the impact of PCR inhibitors and preanalytical variables. Routine use of full process quality controls can help identify variations in the test system that can lead to incorrect results.

Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection, and transport of venous whole blood samples for use in conjunction with cell-free DNA next-generation sequencing liquid biopsy assays that have been cleared or approved for use with samples collected in the Cell-Free DNA BCT device.

Cell-Free DNA BCT is a sterile, single use, direct-draw blood collection tube comprised of 3 components (i.e. glass tube with rubber stopper, anticoagulant, and cell preservatives). The blood collection tube manufactured with USP Type III glass containing cerium oxide (to prevent color change associated with gamma irradiation). Each tube includes 200 uL ± 10% of liquid reagent composition includes an anticoagulant K3EDTAand a preservative. The device is intended to be placed inside a tube holder or an adaptor that contains a needle designed to pierce the tube closure and allow blood to flow into the tube. Once the vein has been penetrated blood collection needle or a blood collection set), the tube is pushed into the holder, and the blood enters the tube. Once a tube has drawn the appropriate amount of blood (10 mL), it is disengaged from the holder and inverted 10 times to mix the blood. The specimen is then transported to the lab for plasma isolation and extraction of cfDNA.