Calibration 2.000 Workgroup

In 1998 the Calibration 2000 plan was introduced. Its aim was the development of commutable calibration- and trueness verifier-materials, to be used in calibration of the medical laboratories by way of the calibrators and verification using the trueness verifiers from the achieved effect and from IVD compatibility of methods. A large number of disciplines worked together on the project.

A general system, the Twin study concept, was developed for the demonstration of commutability. In various publications from the Calibration 2000 project the importance of commutable material for external quality control was demonstrated. The developed materials are still used as national calibrators. For lipids and enzymes calibration materials have been developed and are being used extensively.

The IVD-guidelines should eventually lead to identical calibration of laboratories. The materials will also be used as trueness verifiers and for the testing of IVD compatibility. Due to Calibration 2000 an international pilot study for enzymes has been carried out for trueness verification of the most-used methods.

For proteins a commutable material has been developed for which target values have already been awarded. In endocrinology promising results have been achieved for TSH. A national harmonization/calibration material has been developed for human growth hormone that is being used extensively. In the field of coagulation, effects have been achieved for Factor VIII. In the area of flow cytometry varying results have been found with stabilization buffers. Further standardization appears to be unnecessary for hemocytometry. A commutable reference material has been developed.

In November 2013 the name of the study group was changed in Study group Calibration 2.000

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