Possible protocol for determining reportable range, analytical sensitivity, and precision in combined experiments based on current CLSI guidelines

Performance characteristicAnalyte concentration testedaComment(s)
Reportable range (for quantitative assays)×××××××××××7-11 concentrations across anticipated measuring range; 2-4 replicates on same day
Analytical sensitivity (LOD)×××××8-12 replicates of 4-5 samples at the low concentration end over 5 days
    Qualitative assay×××Use concentrations at LOD, 20% above LOD, and 20% below LOD; test in duplicate over 15 days (include data from analytical sensitivity runs to provide data over 20 days)
    Quantitative assay×××Use high, low, and LOD concentrations; test in duplicate over 19 days (include data from reportable range study as day 1 to provide data over 20 days)
  • a ×, the concentration is tested. The reportable range is from concentration 2 to concentration 10; the LOD, LLOQ, and upper limit of linearity are at concentrations 2, 4, and 10, respectively.