Chapter 2
Measuring Principle
2.5 Calibration
Data reduction is performed using a master curve with
2-point
recalibration
.
The starting point of data reduction is the
master curve
, stored in
RFID Tag of the reagent kit..
To compensate differences between reagent lots, different
analyzers and environmental conditions,
assay calibration
must
be run and validated according to the indications reported in the
assay Instructions for Use (indications may vary per assays).
The measuring signals of the calibrators allow the shift of all
master curve points to a
working curve
, corresponding with the
actual conditions during measurement.
Brief description:
·
The stored
master curve
is generally defined with 10 master
curve base points.
·
Two
calibrators
with defined concentration values are measured.
These measured signals (RLU) are compared with the master
curve signal of the corresponding calibrator concentrations.
·
The
relative difference
between the measured RLU and the
master RLU of the calibrators is calculated and a linear
extrapolation is performed between the recalculated RLU (Y-
axis)and the logarithmic (Log) concentrations (X-axis).
·
Based on appropriate compensation factors, a
re-adjustment
of the master curve points is made in order to achieve, by a
“cubic spline function”, the
working curve
.
Page 2-6
Operating instructions