Calibration Example
Calibration is a required Quality practice for all other types of clinical testing laboratories.
- Calibration: a process of testing and adjusting an IHC assay to establish a desired correlation between stain intensity and biomarker concentration.
- Calibration verification: the assaying of IHC reference materials with known biomarker concentrations to substantiate that the IHC assay has sufficient analytic sensitivity.
- IHC Reference Material: also known as “calibrators”, these are test materials with known biomarker concentrations, traceable to a primary reference standard.
