scope:

This standard is aimed at manufacturers and users. In the following, procedures for the assessment of comparison measurements are described that consider the specific situation of simultaneous application of POCT procedures and methods in the central laboratory.

This standard specifies measures for the analytical and clinical assessment of a measurand when using different diagnostic methods (both POCT and non-POCT) in medical diagnostic testing. The measures shall ensure that results that are determined in various sample materials are concordant. Samples within the meaning of this standard are native blood or anti-coagulated blood, urine and other body fluids of patients treated in the facility. POCT is used in the context of medical treatment, but also outside of medical science. This standard only applies for POCT within the context of medical science but not for POCT in self-testing.