title: Clinical value of the first automated TSH receptor autoantibody assay for the diagnosis of Graves' disease (GD): an international multicentre trial.
abstract: BACKGROUND
  Most recently, a new rapid and fully automated electrochemiluminescence immunoassay for the determination of TSH receptor autoantibodies (TRAb) based on the ability of TRAb to inhibit the binding of a human thyroid-stimulating monoclonal antibody (M22) has been established.
  
  
  OBJECTIVE
  To evaluate this assay system in clinical routine based on an international multicentre trial and to compare the results with other established TRAb assays.
  
  
  METHODS
  Totally 508 Graves' disease (GD), 142 autoimmune thyroiditis, 107 subacute thyroiditis, 109 nonautoimmune nodular goitre, 23 thyroid cancer patients and 446 normal controls were retrospectively evaluated.
  
  
  RESULTS
  ROC plot analysis revealed an area under curve of 0.99 (95% CI: 0.99-1.0) indicating a high assay sensitivity and specificity. The highest sensitivity (99%) and specificity (99%) was seen at a cut-off level of 1.75 IU/l. Here, the calculated positive predictive value was 95%, whereas the negative predictive value was 100%. Applying the ROC plot-derived cut-off of 1.75 IU/l we found a sensitivity for TRAb positivity within the group of newly diagnosed GD patients of 97% which is in accordance to the sum of different nonautomated porcine TSH receptor-based assays with a sensitivity of 94% indicating an excellent analytical performance of the new assay format. Detailed comparison of the automated and the sum of manual assays revealed a near identical specificity.
  
  
  CONCLUSIONS
  Our results demonstrate that this new assay system has a high sensitivity for detecting GD and specificity for discriminating from other thyroid diseases. This assay may represent the future technology for rapid fully automated TRAb detection.
authors.affiliation: Department of Endocrinology, Diabetes and Rheumatology, University Hospital Duesseldorf, Moorenstrasse 5, Duesseldorf, Germany. matthias.schott@med.uni-duesseldorf.de
authors.forename: Matthias
authors.initials: M
authors.lastname: Schott
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: Ruth
authors.initials: R
authors.lastname: Golla
authors.forename: Claudia
authors.initials: C
authors.lastname: Graeber
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: Naoko
authors.initials: N
authors.lastname: Miyazaki
authors.forename: Miguel Angel Navarro
authors.initials: MA
authors.lastname: Moreno
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Murakami
authors.forename: Heinz Jürgen
authors.initials: HJ
authors.lastname: Roth
authors.forename: Werner
authors.initials: W
authors.lastname: Stock
authors.forename: Jaeduk Yoshimura
authors.initials: JY
authors.lastname: Noh
authors.forename: Werner A
authors.initials: WA
authors.lastname: Scherbaum
authors.forename: Klaus
authors.initials: K
authors.lastname: Mann
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001322:Autoanalysis; D001323:Autoantibodies / Q000032:analysis*; D002648:Child; D005260:Female; D006111:Graves Disease / Q000175:diagnosis* / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011989:Receptors, Thyrotropin / Q000032:analysis / Q000276:immunology; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D013959:Thyroid Diseases / Q000175:diagnosis / Q000276:immunology; D013964:Thyroid Neoplasms / Q000175:diagnosis; D013967:Thyroiditis, Autoimmune / Q000175:diagnosis
chemical_list: D001323:Autoantibodies; D011989:Receptors, Thyrotropin