|
|
The aim of this report is to examine what - if any - effects the introduction of the European Directive 98/79/EC has had on the performance of in-vitro diagnostic devices (kits) used in determining hormones and related measurands in medical diagnostic laboratories.
The observations covered the period from 1993-2008, results being taken from EQA surveys at three year intervals.
The measurands chosen were: cortisol, progesterone,testosterone,17β oestradiol (E2), free triiodothyronine (fT3), total triiodothyronine (TT3), free thyroxine (fT4), total thyroxine (TT4), thyrotropin (TSH), luteotropin (LH), follitropin (FSH), prolactin (PRL), parathyrin (PTH), thyroglobulin (Tg), anti-thyroid microsomes (MAb), anti-thyroid peroxidase (Anti-TPO), anti-thyroglobulin (Anti-Tg) and anti-TSH-receptor (TRAb).
The results showed the following trends and tendencies:
a. The precision has improved over the observation period, mainly due to automation made possible by the use of non-radioisotopic labelling.
b. The accuracy – in terms of comparison with reference method values – has not been influenced by the Directive 98/79/EC
c. Introduction of international standards and reference preparations does not itself result in better comparison of results between kits from different manufacturers
d. Harmonisation in methodology has led to improved comparison between different manufacturers – an example being the assay of thyroid-receptor antibodies, where components are often only available from one producer
DOI: Clin. Lab. 2009;55:86-105
|
