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Linearity Testing
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7 Linearity Testing
Information regarding linearity tests
Observe the applicable regulations and directives of the
responsible regulatory agencies when performing
linear ity tests. For information about sources for products
required during linearity testing, call your local Roche
representative or for technical assistance contact
ACCU-CHEK Customer Care.
Linearity tests can help you to check the function and
accuracy of the entire system over the full range of
spec ified values. Linearity samples should be treated in
exactly the same manner as previously described for
con trol solutions used in glucose control testing.
The term “Linearity” describes the ability of the system to
maintain a constant accuracy over the full range of
spec ified values. If test results were plotted against
reference values as a curve over the full range of these
values, the ideal (high linearity) would be a straight line.
Linearity is the range of values from the lowest to the
highest for which an instrument is proven capable of
giving accurate results.
Linearity testing intervals
The linearity of the system should be checked before it is
used the first time for patient testing. The intervals for
subsequent linearity tests are determined by the facility
that operates the system. Linearity testing can also be run
when you want to check the overall performance of the
system.
Note: When using a data management system for
configuration, it is possible to partially or fully disable
the functions described in this chapter. In this case,
the respective buttons in
Main Menu 2
do not appear.
(See also Appendix A).
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