A Formalin-Fixed, Paraffin-Processed Cell Line Standard for Quality Control of Immunohistochemical Assay of HER-2/neu Expression in Breast Cancer

Rhodes, Anthony; Jasani, Bharat; Couturier, Jérôme; McKinley, MJ; Morgan, John; Dodson, Andrew; Navabi, H.; Miller, Keith; Balaton, A.

doi:10.1309/4ncm-qj9w-qm0j-6qje

Cited by 83 publications

(58 citation statements)

References 29 publications

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“…Species-specific tumor cell lines are being used for IHC controls (e.g., IHC for HER-2/neu). 55,57 This approach provides an identical tissue control among different laboratories and is an excellent way to compare results among them.…”

Section: Controls Positive Tissue Controlmentioning

confidence: 99%

Suggested Guidelines for Immunohistochemical Techniques in Veterinary Diagnostic Laboratories

et al. 2008

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Abstract. This document is the consensus of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) Subcommittee on Standardization of Immunohistochemistry on a set of guidelines for immunohistochemistry (IHC) testing in veterinary laboratories. Immunohistochemistry is a powerful ancillary methodology frequently used in many veterinary laboratories for both diagnostic and research purposes. However, neither standardization nor validation of IHC tests has been completely achieved in veterinary medicine. This document addresses both issues. Topics covered include antibody selection, fixation, antigen retrieval, antibody incubation, antibody dilutions, tissue and reagent controls, buffers, and detection systems. The validation of an IHC test is addressed for both infectious diseases and neoplastic processes. In addition, storage and handling of IHC reagents, interpretation, quality control and assurance, and troubleshooting are also discussed. Proper standardization and validation of IHC will improve the quality of diagnostics in veterinary laboratories.

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Section: Controls Positive Tissue Controlmentioning

confidence: 99%

Suggested Guidelines for Immunohistochemical Techniques in Veterinary Diagnostic Laboratories

et al. 2008

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“…However, cell lines and tissue arrays are mostly of unknown analyte concentrations. [10][11][12] Laboratories do not measure analytic response curves as part of any proficiency test. Moreover, PT data collection in the United States typically evaluates laboratory performance from the interpretive (postanalytic) result, not review of the actual stain.…”

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confidence: 99%

Quantitative Assessment of Immunohistochemistry Laboratory Performance by Measuring Analytic Response Curves and Limits of Detection

Sompuram¹,

Vani²,

Schaedle³

et al. 2018

Archives of Pathology &Amp; Laboratory Medicine

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Context.-Numerous studies highlight interlaboratory performance variability in diagnostic immunohistochemistry (IHC) testing. Despite substantial improvements over the years, the inability to quantitatively and objectively assess immunostain sensitivity complicates interlaboratory standardization.Objective.-To quantitatively and objectively assess the sensitivity of the immunohistochemical stains for human epidermal growth factor receptor type 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) across IHC laboratories in a proficiency testing format. We measure sensitivity with parameters that are new to the field of diagnostic IHC: analytic response curves and limits of detection.Design.-Thirty-nine diagnostic IHC laboratories stained a set of 3 slides, one each for HER2, ER, and PR. Each slide incorporated a positive tissue section and IHControls at 5 different concentrations. The IHControls comprise cell-sized clear microbeads coated with defined concentrations of analyte (HER2, ER, and/or PR). The laboratories identified the limits of detection and then mailed the slides for quantitative assessment.Results.-Each commercial immunostain demonstrated a characteristic analytic response curve, reflecting strong reproducibility among IHC laboratories using the same automation and reagents prepared per current Good Manufacturing Practices. However, when comparing different commercial vendors (using different reagents), the data reveal up to 100-fold differences in analytic sensitivity. For proficiency testing purposes, quantitative assessment using analytic response curves was superior to subjective interpretation of limits of detection.Conclusions.-Assessment of IHC laboratory performance by quantitative measurement of analytic response curves is a powerful, objective tool for identifying outlier IHC laboratories. It uniquely evaluates immunostain performance across a range of defined analyte concentrations.

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“…Utilizaram-se os mesmos critérios de avaliação dos resultados nos cortes histológicos e esfregaços, baseados no sistema de graduação do HercepTest, e considerando positivos apenas os casos 3+. Trabalhos recentes demonstram que esta positividade imunohistoquímica 3+ apresenta elevada correlação com a amplificação do gene HER-2 pela técnica de FISH 15,23,24 . A avaliação da imunoexpressão do HER-2, utilizando diferentes anticorpos e a graduação do HercepTest, revelou alta amplificação do gene nos casos fortemente positivos (3+), independentemente do anticorpo 14 .…”

Section: Discussionunclassified

Imunoexpressão da proteína Her-2 em punção aspirativa com agulha fina de carcinoma de mama: correlação com os achados da peça cirúrgica

Oliveira¹,

Santos²,

Kanamura³

et al. 2003

Rev. Bras. Ginecol. Obstet.

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portamento da célula tumoral e das etapas críti-cas do processo de desenvolvimento e progressão do câncer, com identificação de marcadores moleculares, acrescentando assim novos parâme-tros utilizados como fatores prognósticos e preditivos do carcinoma de mama.A procura por novos marcadores que possam ser preditivos é de importância crítica no desenvolvimento de terapias antineoplásicas. A família dos receptores de fator de crescimento epidérmico (c-erbB ou HER) é um dos grupos mais investigados atualmente.O papel do HER-2 tem despertado grande interesse como indicador de resistência as várias formas de tratamento sistêmico para o câncer de Introdução O aprimoramento do conhecimento da biologia molecular tem permitido a obtenção de dados científicos mais pormenorizados sobre o com-

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A Formalin-Fixed, Paraffin-Processed Cell Line Standard for Quality Control of Immunohistochemical Assay of HER-2/neu Expression in Breast Cancer

Cited by 83 publications

References 29 publications

Suggested Guidelines for Immunohistochemical Techniques in Veterinary Diagnostic Laboratories

Suggested Guidelines for Immunohistochemical Techniques in Veterinary Diagnostic Laboratories

Quantitative Assessment of Immunohistochemistry Laboratory Performance by Measuring Analytic Response Curves and Limits of Detection

Imunoexpressão da proteína Her-2 em punção aspirativa com agulha fina de carcinoma de mama: correlação com os achados da peça cirúrgica

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