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5. Analytical Quality Assurance (AQA)
The
certificate for the test kit, available for each lot
produced, documents the quality of the reagents
contained in the test kit.
Calibration function:
The calculated function must agree, within specified tolerances,
with the function electronically stored in the photometer.
Confidence interval:
Maximum deviation from the desired value over the entire mea-
suring range; every measurement value can be affected by this
deviation; this parameter is a measure for the accuracy.
Standard deviation for the procedure:
Measurement for the dispersion of the measurement values over
the entire measuring range, expressed in ± mg/l.
Coefficient of variation for the procedure:
Measurement for the dispersion of the measurement values over
the entire measuring range, expressed in %. The smaller the stan-
dard deviation/coefficient of variation for the procedure, the more
pronounced the linearity of the calibration curve.
5.2 Quality Control for the User
A complete check comprises the entire system, i.e.
the working equipment and the mode of operation.
The photometer offers an optimum degree of support
in this regard, in the form of the different quality
mode. The instrument, or the whole system (includ-
ing reagents and all accessories) will be checked,
depending on which quality mode selected. All of
Checking the
working
equipment
Pipette Test kit
Checking the
handling operations
Influence of the sample
XII
checking operations can thus be supported by the
photometer and the check values accordingly docu-
mented as per GLP (Good Laboratory Practice)
recommendations (see Function description, "Analy-
tical Quality Assurance").
The following diagram provides an overview
regarding internal quality-assurance aspects:
Photometer
Suspend the bottom
Carefully pipette 3 ml of
Heat the reaction cell in
Remove the reaction
sediment in the cell by
the sample into a reaction
eactor at
cell fr
cell, close tightly with the
148 °C for 2 hours.
swirling.
r
screw cap and mix
cell rack to cool.
vigorously. Caution, the
cell becomes very hot!
Test for recovery
Thermoreactor
Swirl the cell after
-
10 minutes.
= Test for the
overall system
Release 05/04
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