Multipoint Calibration

The system includes the following distinct data checks for multipoint calibration methods:

Precision of replicates

The Precision of replicates check is based on the following factors:

·   minimum number of replicates

·   number of replicates

·   maximum deviation as a percent of mean rate or delta (d) (The value of d is a fixed decimal number)

Absorbance change of curve, high level - low level (min ABS delta)

This check is used to verify the difference in the reaction rate or ABS change exceeds a minimum value that is based on the following parameters:

·   mean rate or delta of the highest calibration level

·   mean rate or delta of the lowest calibration level

·   minimum rate or delta difference

Curve Type

This check verifies that the calibration curve is increasing or decreasing, method dependent, at each calibrator level. The check is based on a comparison calculation using the mean rate or delta of each calibrator level.

Calibrator fit check

This check is used to evaluate if the calibrator value that is calculated from the new calibration curve (fitted value) is within a specific limit of the original calibrator standard values. The check is based on the following parameters:

·   FV (assigned value) of each calibrator level

·   fitted concentration value of each level from new curve

·   maximum concentration deviation at each calibrator level

RMS check

This check is the comparison of a calculated root mean square (RMS) value against a predetermined maximum RMS value which is based on the following parameters:

·   root mean square of concentration deviations from calibration curve fit (RMS)

·   maximum value of root mean square (MAXRMS)