Authors:	Lehmann, Markus
Title:	Multicentric Standardization of a Bioassay for Thyroid Receptor Stimulating Antibodies Multizentrische Standardisierung eines Bioassays zum Nachweis von Schilddrüsen-stimulierenden Antikörpern
Online publication date:	24-Jun-2020
Year of first publication:	2020
Language:	english
Abstract:	In this doctoral thesis, the standardization process across several international laboratories for a bioassay detecting thyroid stimulating antibodies (TSAbs) is presented. This process consisted of using the 2nd IS for TSAbs to create a dose-response curve, where the linear range was identified. This linear range comprised 2nd IS concentrations between 5 mIU/L and 80 mIU/L. The linear range was then used to convert several previously selected patient serum samples from SRR% to mIU/L. The results of this process showed a high variability, especially when comparing the results of the two conducting laboratories, which was amplified by higher levels of TSAb respectively 2nd IS. A reason for the high variability could be identified in a differing behavior of the 2nd IS in comparison to the TSAb positive patient serum samples during measurement. This doctoral thesis shows the feasibility of standardizing a TSAb bioassay but at the same time demonstrates that the 2nd IS increases the variability of the bioassay’s results considerably. Conclusively, the 2nd IS might not be the best choice as a reference for the standardization process. This means that a different reference for standardization should be considered.
DDC:	610 Medizin 610 Medical sciences
Institution:	Johannes Gutenberg-Universität Mainz
Department:	FB 04 Medizin
Place:	Mainz
ROR:	https://ror.org/023b0x485
DOI:	http://doi.org/10.25358/openscience-4998
URN:	urn:nbn:de:hebis:77-diss-1000036024
Version:	Original work
Publication type:	Dissertation
License:	In Copyright
Information on rights of use:	https://rightsstatements.org/vocab/InC/1.0/
Extent:	79 Blätter
Appears in collections:	JGU-Publikationen