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- W2619154328 abstract "At the time this thesis was started, the Committee for Standardization of Thyroid Function Tests (C-STFT) Phase I-III method comparisons had been performed and it was demonstrated that harmonization of thyroid stimulating hormone (TSH) and standardization of free thyroxine (FT4) immunoassays was necessary, but also that it was feasible. Within the time frame of my thesis, a final method comparison was performed (Phase IV). The native samples used for the Phase IV method comparison, covered the complete measurement range of the TSH and FT4 assays. The manufacturers included their master calibrators for measurement in parallel with the samples and according to the same protocol. This allowed them to perform a technical recalibration based on the target values provided to them by the C-STFT. After the successful harmonization and standardization efforts, the next step was to test the hypothesis that common reference intervals (RIs) could be used. This would also serve as proof-of-concept. The RI studies proved that the harmonization of TSH and standardization of FT4 assays were successful and that common RIs could be established, be it for FT4 within a margin of 12.5%. Also the first actions towards carefully preparing implementation of the harmonized and standardized assays were undertaken.The use of two applications, previously developed for monitoring instability in clinical chemistry analytes, was investigated for monitoring TSH and FT4 assays in the pre- harmonization/standardization phase. The first observations demonstrated that a higher variability was seen for TSH and FT4 than for clinical chemistry analytes. Nevertheless, the tools were able to document whether or not laboratories perform nicely within the stability limits and in concordance with the peer group moving median. This looks promising for the utility of mainly the Percentiler in the post-harmonization and -standardization phase to monitor the sustainability of the achieved recalibration status." @default.
- W2619154328 created "2017-06-05" @default.
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- W2619154328 date "2017-01-01" @default.
- W2619154328 modified "2023-09-24" @default.
- W2619154328 title "Improving quality, stability, and comparability of in vitro diagnostic medical devices for thyroid function tests" @default.
- W2619154328 hasPublicationYear "2017" @default.
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