Calibration Curves: Acceptance Criteria

  • The back-calculated concentrations of the individual standards must be within accepted deviation from the nominal value.
  • Deletion of calibrators should be done one at a time in a sequential manner beginning with the most deviant calibrator.
  • At least 3/4th of the original calibration standards are mandatory to meet the accuracy requirements.
  • The quantitation range of the study samples should not be affected by these changes. At least one standard calibrator at the LLOQ and ULQ must be within specification.
  • If the quantitation range is modified, three quality control levels within the adjusted calibration range should fulfill the accuracy requirements.