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Analytical performance and clinical utility of a bioassay for thyroid-stimulating immunoglobulins.
MedLine Citation:
PMID:  23355204     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
The analytical performance and the clinical utility of a thyrotropin receptor (TSHR)-stimulating immunoglobulin (TSI) bioassay were compared with those of a TSHR-binding inhibitory immunoglobulin (TBII) assay. Limits of detection (LoD) and quantitation (LoQ), assay cutoff, and the half-maximal effective concentration (EC(50)) were measured. Dilution analysis was performed in sera of hyperthyroid patients with Graves disease (GD) during antithyroid treatment (ATD). Titer was defined as the first dilution step at which measurement of TSI or TBII fell below the assay cutoff. The LoD, LoQ, cutoff, and EC(50) of the bioassay were 251-, 298-, 814-, and 827-fold lower than for the TBII assay. There were 22%, 42%, 23%, and 14% more positive samples in the TSI bioassay at dilutions of 1:3, 1:9, 1:27, and 1:81 (P < .0001), respectively. Responders to ATD demonstrated marked differences in titers compared with nonresponders. The bioassay detected lower levels of TSHR autoantibodies, and the dilution analysis provided similar predictive values of both assays in GD.
Authors:
Johannes J Leschik; Tanja Diana; Paul D Olivo; Jochem König; Ulrike Krahn; Yunsheng Li; Michael Kanitz; George J Kahaly
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  American journal of clinical pathology     Volume:  139     ISSN:  1943-7722     ISO Abbreviation:  Am. J. Clin. Pathol.     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-01-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370470     Medline TA:  Am J Clin Pathol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  192-200     Citation Subset:  AIM; IM    
Affiliation:
Dept of Medicine I, Gutenberg University Medical Center, Mainz 55101, Germany; Kahaly@ukmainz.de.
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