TABLE 2

Variables to be detailed in Materials and Methods for the cAST under evaluation

ParameteraTesting considerationsData to be documented in study publication (if applicable)
Regulatory status of cASTcASTs that have not undergone regulatory approval may not be optimizedRegulatory status of cAST (RUO, IUO, or IVD)
Version/edition of cAST hardware/softwareNewer approved versions/editions are often designed to enhance performanceVersion/edition of hardware/software
Range of antimicrobial agent concentrations testedSome concentration ranges may differ from those in BMD panelsRange of concentrations tested and description of how MICs are evaluated if concentrations in cAST panel differ from those in BMD panel
Lot numbersPerformance variability among lot numbers of cAST panels or gradient diffusion strips may be encounteredNumber of lot numbers evaluated
Inoculum suspension preparation and panel inoculationSingle inoculum for reference BMD and cAST?Indication of whether same inoculum was used for both BMD and cAST
QCAcceptable ranges for CLSI QC strains for cASTs may be slightly different from those published in M100Manufacturer's QC instructions followed precisely
  • a cAST, commercial antimicrobial susceptibility test; RUO, research use only; IUO, investigational use only; IVD, in vitro diagnostic; QC, quality control.