Study of interlaboratory reliability and reproducibility of estrogen and progesterone receptor assays in Europe. Documentation of poor reliability and identification of insufficient microwave antigen retrieval time as a major contributory element of unreliable assays.
Balaton, Andre J
Barnes, Diana M
Bobrow, Lynda G
Miller, Keith D
AffiliationUnited Kingdom National External Quality Assessment Scheme for Immunocytochemistry and the Department of Histopathology, University College London Medical School, London, England.
MetadataShow full item record
AbstractImmunohistochemical assays for estrogen receptors (ERs) and progesterone receptors (PRs) have not been surveyed for technical validity. In the present study, the reliability of the immunohistochemical assay for ER and PR was evaluated using data from 105 laboratories participating in external quality assessment (EQA) during a 2-year period. Technical variables associated with reliable immunostaining were analyzed. The efficiency of the antigen retrieval step was identified as the single most important contributory factor influencing the overall reproducibility of the assays. Reliable assays were found in 24 (36%) of 66 laboratories participating in continual EQA, including the majority of centers known to have clinically validated results. Inadequate assay sensitivity, with subsequent weak staining, was the main cause of poor and variable results by laboratories using microwave antigen retrieval; too short a heating time was identified as the principal contributory factor. Extension of the heating time resulted in significant improvement regardless of all other variables in the immunohistochemical protocol. Continual participation in EQA is an effective means for identifying and ameliorating variables that influence the reliability of immunohistochemical assays for predictive markers, thereby assisting in technical validation and standardization.
CitationStudy of interlaboratory reliability and reproducibility of estrogen and progesterone receptor assays in Europe. Documentation of poor reliability and identification of insufficient microwave antigen retrieval time as a major contributory element of unreliable assays. 2001, 115 (1):44-58 Am. J. Clin. Pathol.
JournalAmerican Journal of Clinical Pathology
- Assessment of interlaboratory variation in the immunohistochemical determination of estrogen receptor status using a breast cancer tissue microarray.
- Authors: Parker RL, Huntsman DG, Lesack DW, Cupples JB, Grant DR, Akbari M, Gilks CB
- Issue date: 2002 May
- Tissue array technology for testing interlaboratory and interobserver reproducibility of immunohistochemical estrogen receptor analysis in a large multicenter trial.
- Authors: von Wasielewski R, Mengel M, Wiese B, Rüdiger T, Müller-Hermelink HK, Kreipe H
- Issue date: 2002 Nov
- Comparison of evaluations for hormone receptors in breast carcinoma using two manual and three automated immunohistochemical assays.
- Authors: Arihiro K, Umemura S, Kurosumi M, Moriya T, Oyama T, Yamashita H, Umekita Y, Komoike Y, Shimizu C, Fukushima H, Kajiwara H, Akiyama F
- Issue date: 2007 Mar
- [Evaluation of interlaboratory results of immunohistochemical techniques].
- Authors: Losi L, Ragazzini T
- Issue date: 1997 Jun
- Estrogen receptor-negative, progesterone receptor-positive breast carcinoma: poor clinical outcome.
- Authors: Keshgegian AA, Cnaan A
- Issue date: 1996 Oct