Linearity Testing • 7837 Linearity Testing7.1 Information regarding linearity testsObserve the applicable regulations and directives of theresponsible regulatory agencies when performing glu-cose control tests. See also safety message “Allergy orinjury caused by reagents and other working solutions”on page 16. For information about sources for productsrequired during linearity testing, contact your local Rocherepresentative.Linearity tests can help you to check the function andaccuracy of the entire system over the full range of spec-ified values. Linearity samples should be treated inexactly the same manner as previously described for con-trol solutions used in glucose control testing.The term “Linearity” describes the ability of the system tomaintain a constant accuracy over the full range of spec-ified values. If test results were plotted against referencevalues as a curve over the full range of these values, theideal (high linearity) would be a straight line. Linearity isthe range of values from the lowest to the highest forwhich an instrument is proven capable of giving accurateresults.Linearity testing intervals The linearity of the system should be checked before it isused the first time for patient testing. The intervals forsubsequent linearity tests are determined by the facilitythat operates the system. Linearity testing can also be runwhen you want to check the overall performance of thesystem.When using a data management system for configu-ration, it is possible to partially or fully disable thefunctions described in this chapter. In this case, therespective buttons in Main Menu 2 do not appear. Seealso Appendix A.
