The assay signal for each calibrator concentration, along with linearity and correlation information, must be used to quantitate all subsequent unknown samples, including patient samples and QC. The calibration information can be evaluated in an automated or manual fashion.
Many automated analyzers record, evaluate, and store calibration information without laboratory personnel intervention.
- Pass criteria are usually programmed into the manufacturer software which controls the instrument.
- This strategy has advantages in terms of reducing errors and increasing efficiencies.
- The strategy has limitations, including decreased ability to make calibration modifications such as changing set points or adding additional passing criteria.
Some assays allow for calibration information to be manually entered and manipulated. Manual calibration settings allow for calibration curve performance to be determined by the laboratory.
- This strategy is more common with highly complex assays that are usually termed 'laboratory-developed tests' (LDTs). A common example of such testing is mass spectrometry-based assays.
