Quality Control Samples

  • Quality control samples should be prepared at a minimum of four concentration levels (QC_LLOQ, QC_Low, QC_Mid, and QC_High).
  • An additional QC level QC_Dil must be included in at least one of the runs to test for dilution integrity.
  • Six replicates of each QC concentration levels should be analyzed in each validation run.
  • Acceptance criteria for QC: The individual back-calculated concentration of each QC sample for the three in-range QC levels must be within accepted deviations from nominal.