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    Evaluation of HER-2/neu immunohistochemical assay sensitivity and scoring on formalin-fixed and paraffin-processed cell lines and breast tumors: a comparative study involving results from laboratories in 21 countries.

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    Authors
    Rhodes, Anthony
    Jasani, Bharat
    Anderson, Elizabeth
    Dodson, Andrew R
    Balaton, André J
    Affiliation
    UK NEQAS-ICC, The Department of Histopathology, University College London Medical School, England.
    Issue Date
    2002-09
    
    Metadata
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    Abstract
    Variation in assay sensitivity was studied in more than 90 laboratories that assayed 4formalin-fixed, paraffin-processed breast and ovarian carcinoma cell lines with graded levels of HER-2/neu protein overexpression and known levels of HER-2/neu gene amplification, in addition to breast carcinomas fixed and processed in the laboratories. Main methods were the HercepTest (DAKO, Ely, England) and individualized protocols using a polyclonal antibody and the CB11 clone. While the proportion of laboratories achieving appropriate results with the HercepTest was significantly higher than for participants using other assays, laboratories using other assays showed significant improvement in the second assessment run. The level of agreement in evaluations by 26 laboratories using the HercepTest was excellent on cell lines and tumors and was significantly greater than that achieved by the remaining 41 laboratories using other immunohistochemical methods. While laboratories using the DAKO HercepTest had the highest level of reproducibility in assay sensitivity and evaluation, the significant improvement in results by laboratories using other antibodies in the second assessment run suggests that stringent quality control and an ongoing quality assurance program using a standard reference material have the potential to improve the reliability of immunohistochemical assays for HER-2/neu, regardless of the antibody used.
    Citation
    Evaluation of HER-2/neu immunohistochemical assay sensitivity and scoring on formalin-fixed and paraffin-processed cell lines and breast tumors: a comparative study involving results from laboratories in 21 countries. 2002, 118 (3):408-17 Am. J. Clin. Pathol.
    Journal
    American Journal of Clinical Pathology
    URI
    http://hdl.handle.net/10541/83542
    DOI
    10.1309/97WN-W6UX-XJWT-02H2
    PubMed ID
    12219783
    Type
    Article
    Language
    en
    ISSN
    0002-9173
    ae974a485f413a2113503eed53cd6c53
    10.1309/97WN-W6UX-XJWT-02H2
    Scopus Count
    Collections
    All Paterson Institute for Cancer Research

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