Technical evaluation of the first fully automated assay for the detection of TSH receptor autoantibodies
2008; Elsevier BV; Volume: 401; Issue: 1-2 Linguagem: Inglês
10.1016/j.cca.2008.11.025
ISSN1873-3492
AutoresDerik Hermsen, Martina Broecker-Preuß, Marco Casati, Jordi Càmara, Anja Eckstein, Dieter Gassner, Josef van Helden, Keiko Inomata, Jochen Jarausch, Jürgen Kratzsch, Klaus Mann, Naoko Miyazaki, Miguel Ángel Navarro Moreno, Tsukasa Murakami, Heinz-Jürgen Roth, Jaeduk Yoshimura Noh, Werner A. Scherbaum, M. Schott,
Tópico(s)Hypothalamic control of reproductive hormones
ResumoGraves' disease (GD) is mediated by autoantibodies which bind to the TSH receptor (TRAb). The aim of the present study was to evaluate the technical performance of the first fully automated immunoassay for TRAb detection. The Elecsys® Anti-TSHR immunoassay utilizes a porcine TSH receptor (TSHR) and the human thyroid stimulating monoclonal TSHR autoantibody M22. Intraassay and total imprecision CV were determined between 1.4%–14.9%, and 2.4%–28.8%, respectively. Using the 20% CV criteria the functional sensitivity was found at 0.73 IU/L. The median CV at the cut-off (1.75 IU/L) was found to be 11%. Comparison studies with five TRAb immunoassays yielded slopes and intercepts between 1.02–1.48, and − 0.74–0.56, respectively. Correlation coefficients were determined between 0.895 and 0.978. ROC plot analysis of patients with GD, patients with other thyroid disorders and healthy controls revealed an AUC of 0.99 resulting in a sensitivity of 97% and a specificity of 99% at a TRAb level of 1.75 IU/L. The evaluation of the TRAb immunoassay generated homogeneous performance data and demonstrated a high degree of comparability to established TRAb assays. The automated TRAb assay represents a major improvement of thyroid testing in clinical practice.
Referência(s)