Multiple bloodstream bacteria nucleic acid IVD, control
Definition
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 both multiple gram negative and gram positive bacterial species associated with bloodstream infection [e.g., Klebsiella pneumoniae, Escherichia coli (E. coli), Pseudomonas aeruginosa, Enterococcus faecium and Staphylococcus aureus) in a clinical specimen and/or culture isolate.