MDx-Chex™ for BC-GP is intended for use as an external positive and negative assayed control to monitor theperformance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistancegenes, by the Luminex VERIGENE® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on LuminexVERIGENE® systems. The MDx-Chex™ for BC-GP Positive and Negative Controls are composed of a bufferedsolution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components.Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcuslugdunensis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis,Enterococcus faecium, Streptococcus anginosus group; Species: Staphylococcus spp., Streptococcus spp., Listeria spp.;antimicrobial resistance genes: mecA, vanA and vanB. Negative Control: buffered solution only. This productis 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.