Harmonization: its time has come07/05/2017
The July 2017 issue of Clinical Chemistry includes two important articles. A benchmark study on the global harmonization of assays for serum thyroid stimulating hormone (TSH) prompted an editorial that should be read by all laboratory medicine specialists.
The primary study is: “Harmonization of serum thyroid stimulating hormone measurements paves the way for the adoption of a more uniform reference internal”. The study was conducted by the IFCC Committee for the Standardization of Thyroid Function Tests (C-TFT) under the inspirational leadership of Linda Thienpont. A large number of co-authors include representatives from the many TSH method manufacturers who supported the study. As the title suggests harmonization greatly reduces the between-method variability of TSH assays meaning that the adoption of a global reference interval is a realistic target. This article may be found at: Clin Chem 2017; 63: 1248-1260.
The editorial by Greg Miller has as its title “Harmonization: its time has come”. The editorial explains the difference in metrological terms between method standardization and method harmonization. For the large majority of analytes measured in the clinical laboratory there is no suitable pure certified reference material (CRM), reference measurement procedure (RMP) or commutable matrix-based CRM. Nonetheless, as the TSH study demonstrates, it is still possible to achieve method harmonization, which should lead to better clinical outcomes. Using the approach and protocols from the TSH study the way is now clear for reducing the between-method variability f large numbers of clinically important biomarkers. Greg Miller concludes with the information that a new ISO standard on method harmonization is in preparation to assist this process.
The full reference for the editorial is Clin Chem 2017; 63: 1184-1186 and a pdf of the article is available here.