The roadmap of harmonization of clinical laboratory measurement techniques

W. G. Miller, G. L. Myers, M. L. Gantzer, S. E. Kahn, E. R. Schonbunner, L. M. Thienpont, D. M. Bank, R. H. Christenson, J. H. Eckfeldt, S. E. Lo, C. M. Nubling, C. M. Sturgeon

Research output: Contribution to journalArticlepeer-review

Abstract

The results of implementation of different clinical laboratory techniques are to be equal in clinically significant limits to be optimally applied in diagnostics of diseases and treatment of patients. When the results of laboratory tests are not standardized and harmonized for the very same clinical assay the results can be expressed by unmatched numbers. Unfortunately, in some handbooks the values are presented based on the results of application of specific laboratory techniques without considering possibility or likelihood of differences between various techniques. When this is a case, accumulation of data of different clinical research studies and working out of clinical handbooks on this basis will be inconsistent. Inadequate understanding of issue that the results of laboratory tests are not standardized and harmonized can lead to incorrect clinical, financial, managerial or technical decisions. The standardization of clinical laboratory techniques was applied to many measurands related to primary referent techniques (standard specimen of pure substance) or/and developed referent measurement techniques. However, harmonization of clinical laboratory techniques for those measurands which are not related any developed measurement techniques is quite problematic due to inadequate determination of measurand, its inadequate analytical specificity, insufficient attention to commutability of referent materials and poor systematic approach to harmonization. To overcome these issues an infrastructure is to be developed to support systematic approach to identification and prioritization of measurands which are to be harmonized on the basis of clinical importance and technical applicability. The management of technical implementation harmonization process for specific measurands.

Original languageEnglish (US)
Pages (from-to)54-61
Number of pages8
JournalKlinichescheskaya Laboratornaya Diagnostika
Issue number2
StatePublished - Dec 11 2013

Keywords

  • Clinical laboratory measurement techniques
  • Commutability of referent materials
  • Harmonization
  • Infrastructure of systemic identification and prioritization of measurands
  • Management of implementation of harmonization of measurands
  • Referent measurement techniques

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