title: Tissue array technology for testing interlaboratory and interobserver reproducibility of immunohistochemical estrogen receptor analysis in a large multicenter trial.
abstract: Semiquantitative immunohistochemical assessment of estrogen receptor (ER) is used to predict the likelihood of response to antiestrogen therapy in breast carcinoma. If semiquantitative immunohistochemical analysis leads to therapeutic decisions, the importance of standardization and quality control increases. ER assessment reproducibility was studied among 172 laboratories using tissue microarray slides with 20 tissue spots negative and 10 tissue spots expressing ER at low, medium, or high levels. More than 80% of the laboratories demonstrated ER positivity in the medium- and high-expressing tissue spots, but only about 43% succeeded with tissue spots with low expression. Poor interlaboratory agreement was based on insufficient retrieval efficacy as shown by additional tests using autoclave pretreatment. The immunohistochemical scores used to quantify therapeutic target molecules remain inconclusive as long as progress toward standardized immunohistochemical procedures and evaluation is not achieved. Tissue microarray technology has proved its suitability for large-scale immunohistochemical trials, giving rise to new dimensions in control assessment.
authors.affiliation: Institute of Pathology, Hannover Medical School, Germany.
authors.forename: Reinhard
authors.initials: R
authors.lastname: von Wasielewski
authors.forename: Michael
authors.initials: M
authors.lastname: Mengel
authors.forename: Birgitt
authors.initials: B
authors.lastname: Wiese
authors.forename: Thomas
authors.initials: T
authors.lastname: Rüdiger
authors.forename: Hans Konrad
authors.initials: HK
authors.lastname: Müller-Hermelink
authors.forename: Hans
authors.initials: H
authors.lastname: Kreipe
mesh_terms: D005260:Female; D005858:Germany; D006801:Humans; D007150:Immunohistochemistry / Q000379:methods* / Q000592:standards; D007755:Laboratories, Hospital; D015588:Observer Variation; D016612:Paraffin Embedding / Q000379:methods* / Q000592:standards; D011960:Receptors, Estrogen / Q000032:analysis*; D015203:Reproducibility of Results; D016707:Tissue Fixation / Q000379:methods / Q000592:standards
chemical_list: D011960:Receptors, Estrogen