Reproducibility of Elecsys^® Anti-TSHR Test Results in a Lot-to-Lot Comparison

Abstract

Most recently, a new rapid and fully-automated TSH receptor autoantibody (TRAb) assay has been established. This assay system uses the M22 human monoclonal antibody for competing against the patient's TSH receptor autoantibodies (TRAb) to be detected. The aim of our present study was to compare the reproducibility of TRAb values based on measurements with different TSH receptor preparations in a lot-to-lot comparison. For TRAb values > 2 IU/l the relative differences ranged from −9.0 to +10.0%. The mean difference was 0.28 ± 8%. For TRAb values around the cutoff for positivity (1.75 IU/l) a higher range of relative differences from −20 up to +15% was obtained. The overall mean of differences was −0.8±14%. The data clearly demonstrate that the automated TRAb assay has a high stability in regard to TSH receptor preparations.

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