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.

2.50
Hdl Handle:
http://hdl.handle.net/10541/83542
Title:
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.
Authors:
Rhodes, Anthony; Jasani, Bharat; Anderson, Elizabeth; Dodson, Andrew R; Balaton, André J
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.
Affiliation:
UK NEQAS-ICC, The Department of Histopathology, University College London Medical School, England.
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
Issue Date:
Sep-2002
URI:
http://hdl.handle.net/10541/83542
DOI:
10.1309/97WN-W6UX-XJWT-02H2
PubMed ID:
12219783
Type:
Article
Language:
en
ISSN:
0002-9173
Appears in Collections:
All Paterson Institute for Cancer Research

Full metadata record

DC FieldValue Language
dc.contributor.authorRhodes, Anthony-
dc.contributor.authorJasani, Bharat-
dc.contributor.authorAnderson, Elizabeth-
dc.contributor.authorDodson, Andrew R-
dc.contributor.authorBalaton, André J-
dc.date.accessioned2009-10-05T14:24:05Z-
dc.date.available2009-10-05T14:24:05Z-
dc.date.issued2002-09-
dc.identifier.citationEvaluation 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.en
dc.identifier.issn0002-9173-
dc.identifier.pmid12219783-
dc.identifier.doi10.1309/97WN-W6UX-XJWT-02H2-
dc.identifier.urihttp://hdl.handle.net/10541/83542-
dc.description.abstractVariation 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.en
dc.language.isoenen
dc.subjectBreast Canceren
dc.subjectCultured Tumour Cellsen
dc.subject.meshBreast Neoplasms-
dc.subject.meshCarcinoma-
dc.subject.meshFemale-
dc.subject.meshFixatives-
dc.subject.meshFormaldehyde-
dc.subject.meshHumans-
dc.subject.meshImmunohistochemistry-
dc.subject.meshLaboratories-
dc.subject.meshParaffin Embedding-
dc.subject.meshPathology, Clinical-
dc.subject.meshQuality Control-
dc.subject.meshReceptor, erbB-2-
dc.subject.meshReproducibility of Results-
dc.subject.meshSensitivity and Specificity-
dc.subject.meshTissue Fixation-
dc.subject.meshTumor Cells, Cultured-
dc.titleEvaluation 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.en
dc.typeArticleen
dc.contributor.departmentUK NEQAS-ICC, The Department of Histopathology, University College London Medical School, England.en
dc.identifier.journalAmerican Journal of Clinical Pathologyen
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