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Linearity Testing

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, contact your local Roche

representative.

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.

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Roche ACCU-CHEK Inform II Betreibershandbuch Seite 77