The conventional RMP for standardization of FT4 measurements
The C-STFT developed and validated an ED ID-LC/tandem MS cRMP for FT4. It was accepted as IFCC endorsed reference method (18) and listed in the JCTLM Database (4). Currently establishing a network of competent reference laboratories.
The APTM for harmonization of TSH measurements
The C-STFT applied PCA to existing data from a split-sample method comparison study, confirming the validity of the statistical approach. The APTM approach was elaborated and validated for TSH (23).
The Phase I, II and III method comparison studies
The cRMP and surrogate RMP were used in Phase I-III studies to demonstrate feasibility. Phase I assessed quality, Phase II was proof-of-concept, Phase III investigated performance over the complete measuring range.
The Phase IV study - Technical recalibration
FT4
91 clinically relevant samples, covered entire concentration range. Main outcome in Figures 3-4 (ref 26).
TSH
101 samples harmonization panel, value assigned by robust factor analysis. Main outcome in Figures 5-6 (ref 27).
IVD manufacturers who recently joined
Sanyo Chemical Industries and Wako Pure Chemical Industries with Accuraseed FT4 and TSH assays.