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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, 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 ied 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 ied 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 rst 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

conguration, 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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Roche ACCU-CHEK Inform II Manual do Operador Página 81