V2.3.0 OM-UNN valid from 15
th
April 2015
28
-20% OD
cal
+20%
Fig.4-1 Doubt Range
4.1.1.3
Quality Control
The routine QC check involves processing of the QC material as a sample corresponding to the cartridge of
the same lot number in a run cycle, and its optical density is determined as follows:
OD
QC
= OD
450
– OD
630
It compares the OD
QC
with the QC materials pre-defined Upper and Lower limits OD
upper
and OD
lower
printed
on the QC barcode. If OD
QC
meets the following criteria as listed below, the QC is accepted, or it will be
rejected.
OD
lower
＜
OD
QC
＜
OD
upper
Note
The OD
upper
and OD
lower
printed on the QC barcode are affected by the K
cal
mentioned in Section
4.1.2
Quantitative Tests
4.1.2.1
Calibration
When Calibration is carried out for Quantitative Tests, make sure that the Calibration Curves used (which is
incorporated into the QC sample barcode) must be of the same lot as the cartridges. And the information of
the Calibration Curve represents the relationship between the OD and the concentration of the sample.
The following data are needed to create the Calibration Curve (See Fig.4-2):
Five or more groups of calibrator data, including OD and its corresponding concentration, (and this
information is stored in the Calibrator barcode;
One or two points calibrator will be used for processing the re-calibration;
Tolerance deviation of OD
cal0
;
