Roche Diagnostics
Operatorโs Manual ยท Version 3.4 A-31
Cedex Bio analyzer 2 Introduction to the analyzer
Daily operation
Precalibration At any given time, there is only one accepted calibration result for each test. You can,
however, install and precalibrate a reserve reagent set. This is done, for example, to
ensure continuous sample processing.
Quality control (QC)
QC is performed at regular intervals to check the integrity of the whole measuring
system. For each test, up to three controls are defined. The results are compared
against predefined ranges or values and then interpreted accordingly.
Control A control is a sample that has been measured using all tests it is associated with, in
order to define the ranges and values that determine the correct functioning of the
analyzer.
When QC is due With regards to when it needs to be performed, QC is divided in the following types:
o QC After Cal
The QC measurement is due after calibration of the test.
o Interval QC
QC is due whenever its interval has expired. QC measurements of this type are
performed in a batch, typically once or twice a day.
o Default QC
QC is performed at certain times during routine operation. This is done to fit in
with laboratory processes and procedures.
Ways of performing QC With regards to how QC is performed, the following methods are provided:
o Default QC
Default QC is an automated process for performing multiple QC measurements
at the time when you define the QC orders. This is the ideal method if you want to
perform QC at certain times and days.
This method only applies to tests whose controls are defined to be performed as
part of Default QC. Therefore, if you intend to work with the Default QC
function, you need to configure the tests accordingly.
Default QC follows a streamlined procedure where the necessary QC orders are
automatically defined as soon as you identify a control. An order is defined for
each test for which this control is defined, provided the test is currently active on
the system. A wizard helps you select the controls, and a placement list supports
you in preparing and loading the controls.
o Interval QC
This method applies to tests whose controls have an interval defined.
Interval QC is a process that is suitable both for performing a single QC
measurement and for performing all QC measurements that are due. You can
select all tests that require QC simply by pressing a button. (This selection also
reflects QC of the type QC After Cal.) A wizard helps you select the controls, and
a placement list supports you in preparing and loading them.