IDS IDS-iSYS, User Manual

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The general tab shows whether a calibration has passed or not, type of
curve fit used, analyte it refers to and date of calibration. It also displays
data for the controls including target values, mean obtained values, CV%
and status (i.e. pass/fail).
Displays the calibration curve and each calibrator:
•
Raw data obtained.
•
Target value.
•
Value calculated using the mathematic model of the calibration.
•
Calibrator lot.
Displays value of coe ffi cient of determination (r2).
Allows calculation of multiple-point calibrations after removing a calibrator.
Displays the RLU values for Immunoassays using the chemiluminescence
method or absorbancy values for methods using enzymatic detection.
For Biochemistry, reaction kinetics for each of the calibrators and controls
are displayed.
Displays traceability data for the modules and ancillary reagents used for
each replicate of the calibrators and controls.
Criteria For Validating a Calibration
•
Calculated percentage of translation is lower than the programmed limit (Immunoassay).
•
Percentage of the deviation on calibrator signal (RLU) is within acceptable limits provided by IDS
(Immunoassay).
•
CV calculated with the RLU of each calibrator is lower than the acceptable limit defined for each calibrator;
when a limit is set at 0 or when the relevant option is selected (Calibration tab of the analytical configuration),
the CV is not verified (Immunoassay).
•
Di ff erence between the calculated and the target value (in %) is within the acceptable limit of curve fitting
defined for each calibrator. This criteria is not applied to calibrations with a master curve (Immunoassay).
•
ODs of the blank and the reaction are within the programmed limits (Biochemistry).
•
Sensitivity is higher than the programmed limit (Biochemistry).
•
Coe ffi cient of determination of the function calculated is higher than the programmed limit.
•
Function corresponds to configured rules.
•
Control(s) is (are) within acceptable limits.
Use
3-10- Results (continued)
IDS-iSYS User Manual - Revision M1
Use 3-10
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Software version V 14