The C-STFT under the leadership Prof. Linda Thienpont, Dr. Jim Faix, and Dr. Graham Beastall performed broad initiatives world-wide to create awareness about harmonization and standardization of TSH and fT4 assays among assay manufacturers, clinical laboratories, endocrinologists, physicians, and patients. The C-STFT collected information from these stakeholders from 2014-2016 on how changes in assay calibration are communicated to laboratories and physicians, on concerns by stakeholders about the changes in assay calibration and reference intervals (RIs), and on roles and work of stakeholders in the implementation of TSH and fT4 standardization and harmonization.
This document provides summaries of the different activities performed as part of this initiative, such as
• IFCC C-STFT Questionnaire for IVD manufacturers
• AACC Endocrinology Division Survey: Standardized Reference Intervals for thyroid testing
• Questions to IFCC member societies
• Questions to Endocrinologists in Belgium
• Outreach for comments from endocrinologists, physicians, and patient groups
It needs to be noted that the C-STFT under the leadership Prof. Linda Thienpont, Dr. Faix and Dr. Beastall performed additional activities customized to certain events or meetings with clinical and medical stakeholders as well as regulatory agencies. During the course of this initiative, the C-STFT received a lot of feedback, encouragement, opinions and suggestions from many individuals, which cannot be captured in this summary. This report or review (summary) only summarizes major activities where information was collected or requested in a consistent manner from stakeholders. All responses provided in this summary are anonymized.
- IFCC C-STFT Questionnaire for IVD manufacturers on manufacturer processes when communicating new reference intervals
- AACC Endocrinology Division Survey: Standardized Reference Intervals for thyroid testing
- IFCC C-STFT Questionnaire to IFCC Member Societies
- IFCC C-STFT Questionnaire to Endocrinologists in Belgium
- Collection of information from laboratory scientists, physicians, and patient organization