Abstract:

Laboratory quality management and measurement result standardization are important foundations for the mutual accredit of clinical chemistry measurement result. Carrying out standardization work and establishing the standardization system of test items are the most effective means to realize the accuracy and comparability of test results and provide an accurate basis for regional and national laboratory quality. One of the important means to realize the comparability of test results is to establish and ensure the traceability of the results. At present,the metrological traceability of different items is achieved by establishing reference measurement procedures,reference materials and harmonization protocol in international organizations. The development of trueness verification plans and proficiency tests provides the foundations for the mutual accredit of clinical chemical test results. In this review,the current situation of clinical chemistry testing standardization is reviewed, so as to provide a reference for clinical laboratory quality management.

Key words: Clinical chemistry, Standardization, Metrological traceability, Reference system, Harmonization, Trueness verification, Result mutual accredit