title: Clinical utility of serum HER-2/neu testing on the Bayer Immuno 1 automated system in breast cancer.
abstract: The clinical utility of automated serum HER-2/neu measurements in breast cancer run on the Bayer random analyzer Immuno 1 was analyzed in several steps: [a] The reference interval was determined for 242 normal healthy pre- and postmenopausal females. [b] The clinical specificity of serum HER-2/neu to separate healthy controls from 210 patients with non-malignant breast--and non-breast diseases was calculated. [c] The clinical sensitivity of cross-sectional serum HER-2/neu values for 204 patients (pts) with stage I-IV breast cancer was established. [d] Specimens from 103 stage IV breast cancer pts were tested for their parallel between serial serum HER-2/neu results and disease course.
  
  
  RESULTS
  [a] The value of 13.03 ng/ml exceeded 95% of the results from the healthy female population. Based on the mean +2 standard deviations value of 14.7 ng/dl, the upper limit of normal was established at 15 ng/ml. [b] The specificity for benign breast diseases and other benign non-breast diseases was 98.0% and 94.6%, respectively. [c] The correlation of increased serum HER-2/neu levels and stage of breast cancer revealed the best sensitivity of 40% for stage IV disease. [4] Thirty-eight (36.9%) of 103 stage IV patients had initial HER-2/neu values > 15 ng/ml, 33 of whom showed longitudinal HER-2/neu concentrations which paralleled the clinical course of the disease giving a sensitivity of 86.8%.
authors.affiliation: Bayer Corporation, Diagnostics Division, 511 Benedict Avenue, Tarrytown, NY 10591-5097, USA.
authors.forename: G B
authors.initials: GB
authors.lastname: Cook
authors.forename: I E
authors.initials: IE
authors.lastname: Neaman
authors.forename: J L
authors.initials: JL
authors.lastname: Goldblatt
authors.forename: D R
authors.initials: DR
authors.lastname: Cambetas
authors.forename: M
authors.initials: M
authors.lastname: Hussain
authors.forename: D
authors.initials: D
authors.lastname: Lüftner
authors.forename: K K
authors.initials: KK
authors.lastname: Yeung
authors.forename: D W
authors.initials: DW
authors.lastname: Chan
authors.forename: M K
authors.initials: MK
authors.lastname: Schwartz
authors.forename: W J
authors.initials: WJ
authors.lastname: Allard
mesh_terms: D001331:Automation; D001943:Breast Neoplasms / Q000097:blood*; D005260:Female; D006801:Humans; D009362:Neoplasm Metastasis; D011933:Reagent Kits, Diagnostic; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000097:blood*; D012680:Sensitivity and Specificity
chemical_list: D011933:Reagent Kits, Diagnostic; D018719:Erb-b2 Receptor Tyrosine Kinases