title: Evaluation of a manual ELISA kit for determination of HER2/neu in serum of breast cancer patients.
abstract: BACKGROUND
  Our aim was to conduct an analytical validation in a routine laboratory setting of the cerb-B2/c-neu ELISA assay kit from Calbiochem used to measure the extracellular domain (ECD) of HER2/neu in the serum of breast cancer patients.
  
  
  METHODS
  The evaluation was based on three different production lots used in a routine laboratory setting. The reference value was based on a population of 217 patients with breast cancer not overexpressing HER2.
  
  
  RESULTS
  The detection limit, below that given by the manufacturer, was 0.34 ng ml(-1) and the quantification limit was 0.90 ng ml(-1). Reproducibility and repeatability were at least 95%, precision coefficients of variation varied between 6 and 8.5% and trueness measured by dilution tests and the standard additions method varied between 97 and 107%. The threshold was estimated at 5 ng ml(-1).
  
  
  CONCLUSIONS
  This technique presents satisfactory levels of accuracy for routine laboratory use.
authors.affiliation: Pôle de Biologie, CHU de Grenoble, Grenoble, France. ASGauchez@chugrenoble.fr
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Gauchez
authors.forename: Nadia
authors.initials: N
authors.lastname: Ravanel
authors.forename: Danièle
authors.initials: D
authors.lastname: Villemain
authors.forename: François-Xavier
authors.initials: FX
authors.lastname: Brand
authors.forename: Dominique
authors.initials: D
authors.lastname: Pasquier
authors.forename: Raoul
authors.initials: R
authors.lastname: Payan
authors.forename: Mireille
authors.initials: M
authors.lastname: Mousseau
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000737:chemistry / Q000276:immunology; D001943:Breast Neoplasms / Q000201:enzymology*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods* / Q000592:standards; D005260:Female; D006461:Hemolysis; D006801:Humans; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000097:blood* / Q000276:immunology; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000911:Antibodies, Monoclonal; D011933:Reagent Kits, Diagnostic; D018719:Erb-b2 Receptor Tyrosine Kinases