title: Technical evaluation of the first fully automated assay for the detection of TSH receptor autoantibodies.
abstract: BACKGROUND
  Graves' 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.
  
  
  METHODS
  The Elecsys Anti-TSHR immunoassay utilizes a porcine TSH receptor (TSHR) and the human thyroid stimulating monoclonal TSHR autoantibody M22.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Central Institute for Clinical Chemistry and Laboratory Medicine, University Hospital Duesseldorf, Germany. hermsen@med.uni-duesseldorf.de
authors.forename: Derik
authors.initials: D
authors.lastname: Hermsen
authors.forename: Martina
authors.initials: M
authors.lastname: Broecker-Preuss
authors.forename: Marco
authors.initials: M
authors.lastname: Casati
authors.forename: Jordi Camara
authors.initials: JC
authors.lastname: Mas
authors.forename: Anja
authors.initials: A
authors.lastname: Eckstein
authors.forename: Dieter
authors.initials: D
authors.lastname: Gassner
authors.forename: Josef
authors.initials: J
authors.lastname: van Helden
authors.forename: Keiko
authors.initials: K
authors.lastname: Inomata
authors.forename: Jochen
authors.initials: J
authors.lastname: Jarausch
authors.forename: Jürgen
authors.initials: J
authors.lastname: Kratzsch
authors.forename: Klaus
authors.initials: K
authors.lastname: Mann
authors.forename: Naoko
authors.initials: N
authors.lastname: Miyazaki
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Navarro Moreno
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Murakami
authors.forename: Heinz-Jürgen
authors.initials: HJ
authors.lastname: Roth
authors.forename: Jaeduk Yoshimura
authors.initials: JY
authors.lastname: Noh
authors.forename: Werner A
authors.initials: WA
authors.lastname: Scherbaum
authors.forename: Matthias
authors.initials: M
authors.lastname: Schott
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000276:immunology; D001323:Autoantibodies / Q000097:blood*; D006111:Graves Disease / Q000175:diagnosis* / Q000276:immunology; D006801:Humans; D007118:Immunoassay; D008163:Luminescent Measurements; D051379:Mice; D011989:Receptors, Thyrotropin / Q000276:immunology*; D012680:Sensitivity and Specificity; D013552:Swine
chemical_list: D000911:Antibodies, Monoclonal; D001323:Autoantibodies; D011989:Receptors, Thyrotropin