TABLE 2.

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

Performance characteristicAnalyte concentration testedaComment(s)
LowMediumHigh
1234567891011
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
Precision
    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.