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Diesse Chorus - Kinetics Acceptance; Initial Value Check; Check of the Trend; Calibration in the Qualitative Tests

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CHORUS
Rev. 0 del 06/2012 93
In case the test requires an analytical calibration, the corresponding data must be stored in the
memory beforehand since the mathematical algorithm processes them as described below.
The aim of this paragraph is to indicate the main elements of the different steps of the analytical
evaluation routine which is carried out by the mathematical algorithms.
5.3.1 K
INETICS ACCEPTANCE
At the end of the test concerning either a sample, a calibrator or a QC, the kinetics is analyzed to
check the congruence with the following checks:
5.3.1.1 Initial value check
In case of increasing kinetics, if it turns out that:
OD1, OD2, OD3 take a negative value,
error SeeManual0 is generated
OD1 400,
error SeeManual1 is generated
In case of decreasing kinetics, the result must be:
OD1, OD2, OD3 take a negative value,
error SeeManual0 is generated
OD1 700
Error SeeManual4 is generated
5.3.1.2 Check of the trend
In case of increasing kinetics with
OD2 – OD3 > 300 (parabola type kinetics)
error SeeManual2 is generated
In case of increasing kinetics with
OD2 – OD1 > 100
OD3 – OD2 > 5* (OD2 – OD1 ) ( exponential kinetics )
error SeeManuel3 is generated
5.3.2 C
ALIBRATION IN THE QUALITATIVE TESTS
During the qualitative tests the optical density of the calibrator for each batch of the test is determined
by the following formula:
OD
cal
= ( OD3 – OD1 ) * coeff
where:
OD1 and OD3 are the optical densities determined after processing the calibrator with the
instrument.
Coeff is the adjustment coefficient that is supplied by the calibrator and which is reported on its
label.

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