title: Should functional sensitivity of a new thyroid stimulating hormone immunoassay be monitored routinely? The ADVIA Centaur TSH3-UL assay experience.
abstract: OBJECTIVE
  We emphasize the importance of routine follow-up of subnormal TSH concentrations with QC materials.
  
  
  METHODS
  The functional sensitivity (FS) of the ADVIA Centaur system TSH assay was assessed. We report the values yielded for QC materials in two clinical laboratories.
  
  
  RESULTS
  The FS was <0.02 mIU/L. The low-TSH QC (a serum pool) showed unacceptable between-lot imprecision (mean 0.0252 mIU/L, CV 22%).
  
  
  CONCLUSIONS
  We do encourage healthcare laboratories to constitute low-TSH serum pools to ensure that the results they report meet 3rd-generation criteria.
authors.affiliation: Laboratoire d'Explorations Fonctionnelles par les Isotopes, Hôpitaux Universitaires de Strasbourg, 1 place de l'Hôpital, 67091 Strasbourg Cedex, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Reix
authors.forename: Catherine
authors.initials: C
authors.lastname: Massart
authors.forename: Françoise
authors.initials: F
authors.lastname: Gasser
authors.forename: Béatrice
authors.initials: B
authors.lastname: Heurtault
authors.forename: Arnaud
authors.initials: A
authors.lastname: Agin
mesh_terms: D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards; D006801:Humans; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013972:Thyrotropin / Q000097:blood*
chemical_list: D011933:Reagent Kits, Diagnostic; D013972:Thyrotropin