MDx-Chex™ for BC-GN is intended for use as an external positive and negative assayed control to monitorthe performance of the qualitative detection of Gram-Negative bacteria and associated antimicrobialresistance genes, by the Luminex VERIGENE® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) onLuminex VERIGENE® systems. The MDx-Chex™ for BC-GN Positive and Negative Controls are composedof a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture mediacomponents. Positive Control: Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Klebsiellaoxytoca, Pseudomonas aeruginosa, Species: Acinetobacter spp., Citrobacter spp., Enterobacter spp., Proteusspp.; antimicrobial resistance genes: CTX-M, IMP, KPC, NDM, OXA and VIM. Negative Control: bufferedsolution only. This product is not intended to replace manufacturer controls provided with the device.
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorganisms associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate.