Principles of analytic validation of immunohistochemical assays: Guideline from the College of American Pathologists Pathology and Laboratory Quality Center.
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Linda A Bradley | Jeffrey D Goldsmith | Patrick L Fitzgibbons | Lisa A Fatheree | Paul E Swanson | L. Bradley | R. Alsabeh | P. Swanson | P. Fitzgibbons | S. Shen | L. Fatheree | Randa Alsabeh | Regan S Fulton | J. Goldsmith | R. Fulton | Thomas S Haas | R. Karabakhtsian | Patti A Loykasek | Monna Marolt | Anthony T Smith | Rouzan G Karabakhtsian | Steven S Shen | Monna J Marolt
[1] T. Grogan,et al. A New Rabbit Monoclonal Antibody (4B5) for the Immunohistochemical (IHC) Determination of the HER2 Status in Breast Cancer: Comparison With CB11, Fluorescence In Situ Hybridization (FISH), and Interlaboratory Reproducibility , 2007, Applied immunohistochemistry & molecular morphology : AIMM.
[2] Rhona J. Souers,et al. Laboratory compliance with the American Society of Clinical Oncology/college of American Pathologists guidelines for human epidermal growth factor receptor 2 testing: a College of American Pathologists survey of 757 laboratories. , 2010, Archives of pathology & laboratory medicine.
[3] Eileen Erinoff,et al. Addressing Challenges in Genetic Test Evaluation: Evaluation Frameworks and Assessment of Analytic Validity , 2011 .
[4] S. Temin,et al. Systematic Review on Hormone Receptor Testing in Breast Cancer , 2012, Applied immunohistochemistry & molecular morphology : AIMM.
[5] S. Boccia,et al. Human Genome Epidemiology: A Scientific Foundation for Using Genetic Information to Improve Health and Prevent Disease , 2005, Preventing Chronic Disease.
[6] G. Fountzilas,et al. Evaluation of current prognostic and predictive markers in breast cancer: a validation study of tissue microarrays. , 2013, Anticancer research.
[7] J. Bart,et al. Validation of the 4B5 rabbit monoclonal antibody in determining Her2/neu status in breast cancer , 2009, Modern Pathology.
[8] C. di Loreto,et al. Hormone receptor and human epidermal growth factor receptor 2 status evaluation on ThinPrep specimens from breast carcinoma , 2012, Cancer cytopathology.
[9] Xin He,et al. Validation of Methods for Oropharyngeal Cancer HPV Status Determination in US Cooperative Group Trials , 2012, The American journal of surgical pathology.
[10] C. Goodman,et al. Food and Drug Administration Center for Devices and Radiological Health , 1988 .
[11] E. Hsi. A practical approach for evaluating new antibodies in the clinical immunohistochemistry laboratory. , 2001, Archives of pathology & laboratory medicine.
[12] Clive R Taylor,et al. Recommendations for Improved Standardization of Immunohistochemistry , 2007, Applied immunohistochemistry & molecular morphology : AIMM.
[13] Hugo M. Lourenço,et al. HER2/Neu Detection by Immunohistochemistry: Optimization of In-house Protocols , 2009, Applied immunohistochemistry & molecular morphology : AIMM.
[14] B. Rasmussen,et al. Semi-quantitative scoring of potentially predictive markers for endocrine treatment of breast cancer: a comparison between whole sections and tissue microarrays , 2006, Journal of Clinical Pathology.
[15] Dylan Reilly,et al. Standardization of HER2 immunohistochemistry in breast cancer by automated quantitative analysis. , 2009, Archives of pathology & laboratory medicine.
[16] M. J. van de Vijver,et al. Assessment of a HER2 scoring system for gastric cancer: results from a validation study , 2008, Histopathology.
[17] M. Ehinger,et al. Tissue microarray is inappropriate for analysis of BCL6 expression in diffuse large B‐cell lymphoma , 2007, European journal of haematology.
[18] M. Prasad,et al. Comparative evaluation of high-throughput small-core (0.6-mm) and large-core (2-mm) thyroid tissue microarray: is larger better? , 2012, Archives of pathology & laboratory medicine.
[19] G. Lauer,et al. Immunohistochemical comparison of differentiation markers on paraffin and plastic embedded human bone samples. , 2009, Journal of physiology and pharmacology : an official journal of the Polish Physiological Society.
[20] M. Espié,et al. Immunohistochemical and molecular analyses of HER2 status in breast cancers are highly concordant and complementary approaches , 2011, British Journal of Cancer.
[21] D. Faratian,et al. Tissue microarray technology in the routine assessment of HER‐2 status in invasive breast cancer: a prospective study of the use of immunohistochemistry and fluorescence in situ hybridization , 2008, Histopathology.
[22] Y. Rustum,et al. Double Immunohistochemical Staining Method for HIF-1α and its Regulators PHD2 and PHD3 in Formalin-fixed Paraffin-embedded Tissues , 2010, Applied immunohistochemistry & molecular morphology : AIMM.
[23] Mark Leys,et al. Health care policy: qualitative evidence and health technology assessment. , 2003, Health policy.
[24] Maria J Grant,et al. A typology of reviews: an analysis of 14 review types and associated methodologies. , 2009, Health information and libraries journal.
[25] Anthony Rhodes,et al. 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, American journal of clinical pathology.
[26] M. Vyberg,et al. Demonstration of CDX2 is Highly Antibody Dependant , 2012, Applied immunohistochemistry & molecular morphology : AIMM.
[27] A. Fassina,et al. Morphological quality and nucleic acid preservation in cytopathology , 2008, Journal of Clinical Pathology.
[28] G. Birdsong,et al. Immunohistochemical detection of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 expression in breast carcinomas , 2009, Cancer.
[29] A. Rajwanshi,et al. Immunochemistry for oestrogen receptor, progesterone receptor and HER2 on cell blocks in primary breast carcinoma , 2012, Cytopathology : official journal of the British Society for Clinical Cytology.
[30] P. Drev,et al. Tissue Microarrays for Routine Diagnostic Assessment of HER2 Status in Breast Carcinoma , 2008, Applied immunohistochemistry & molecular morphology : AIMM.
[31] F. Schmitt,et al. HER2 evaluation using the novel rabbit monoclonal antibody SP3 and CISH in tissue microarrays of invasive breast carcinomas , 2006, Journal of Clinical Pathology.
[32] M. Bui,et al. The CD117 immunohistochemistry tissue microarray survey for quality assurance and interlaboratory comparison: a College of American Pathologists Cell Markers Committee Study. , 2006, Archives of pathology & laboratory medicine.
[33] P. Adegboyega,et al. Effect of Decalcification on the Immunohistochemical Expression of ABH Blood Group Isoantigens , 2003, Applied immunohistochemistry & molecular morphology : AIMM.
[34] H. Wiker,et al. Rapid and Specific Diagnosis of Tuberculous Pleuritis With Immunohistochemistry by Detecting Mycobacterium Tuberculosis Complex Specific Antigen MPT64 in Patients From a HIV Endemic Area , 2008, Applied immunohistochemistry & molecular morphology : AIMM.
[35] S. Teutsch,et al. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative: methods of the EGAPP Working Group , 2009, Genetics in Medicine.
[36] M. Dowsett,et al. Revisiting the technical validation of tumour biomarker assays: how to open a Pandora's box , 2011, BMC medicine.
[37] C. Forster,et al. Concordance Between Tissue Microarray and Whole-section Estrogen Receptor Expression and Intratumoral Heterogeneity , 2012, Applied immunohistochemistry & molecular morphology : AIMM.
[38] Glenn A. Bowen. Document Analysis as a Qualitative Research Method , 2009 .
[39] John M S Bartlett,et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. , 2014, Archives of pathology & laboratory medicine.
[40] G. Tate,et al. Comparison of immunocytochemical sensitivity between formalin-fixed and alcohol-fixed specimens reveals the diagnostic value of alcohol-fixed cytocentrifuged preparations in malignant effusion cytology. , 2011, American journal of clinical pathology.
[41] D. Arber. Effect of Prolonged Formalin Fixation on the Immunohistochemical Reactivity of Breast Markers , 2002, Applied immunohistochemistry & molecular morphology : AIMM.
[42] T. Thomson,et al. Tissue microarray for routine analysis of breast biomarkers in the clinical laboratory. , 2009, American journal of clinical pathology.
[43] D. Mayr,et al. Comprehensive immunohistochemical analysis of Her-2/neu oncoprotein overexpression in breast cancer: HercepTest™ (Dako) for manual testing and Her-2/neuTest 4B5 (Ventana) for Ventana BenchMark automatic staining system with correlation to results of fluorescence in situ hybridization (FISH) , 2009, Virchows Archiv.
[44] Anthony Rhodes,et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. , 2006, Archives of pathology & laboratory medicine.
[45] H. Körner,et al. Androgen Receptor Determination in Breast Cancer: A Comparison of the Dextran-coated Charcoal Method and Quantitative Immunohistochemical Analysis , 2008, Applied immunohistochemistry & molecular morphology : AIMM.
[46] A. Chan,et al. The contribution of bifunctional SkipDewax pretreatment solution, rabbit monoclonal antibodies, and polymer detection systems in immunohistochemistry. , 2007, Archives of pathology & laboratory medicine.
[47] G. Stenman,et al. HER2-testing in 538 consecutive breast cancer cases using FISH and immunohistochemistry. , 2010, Pathology, research and practice.
[48] H. Cramer,et al. ER, PR, and Her2 immunocytochemistry on cell‐transferred cytologic smears of primary and metastatic breast carcinomas: A Comparison Study With Formalin‐Fixed Cell Blocks and Surgical Biopsies , 2013, Diagnostic cytopathology.
[49] Rhona J. Souers,et al. Immunohistochemistry validation procedures and practices: a College of American Pathologists survey of 727 laboratories. , 2013, Archives of pathology & laboratory medicine.
[50] B. Gilks,et al. Canadian Association of Pathologists-Association canadienne des pathologistes National Standards Committee/Immunohistochemistry: best practice recommendations for standardization of immunohistochemistry tests. , 2010, American journal of clinical pathology.
[51] M. Gulley,et al. Recommended principles and practices for validating clinical molecular pathology tests. , 2009, Archives of pathology & laboratory medicine.
[52] J. Brock,et al. A comparison of equivocal immunohistochemical results with anti-HER2/neu antibodies A0485 and SP3 with corresponding FISH results in routine clinical practice. , 2011, American journal of clinical pathology.
[53] Comparison of tissue microarray and full section in immunohistochemistry of gastrointestinal stromal tumors , 2009, Pathology international.
[54] Jianfeng Xu,et al. PTEN Protein Loss by Immunostaining: Analytic Validation and Prognostic Indicator for a High Risk Surgical Cohort of Prostate Cancer Patients , 2011, Clinical Cancer Research.
[55] S. Tripp,et al. A comparison of immunohistochemical stain quality in conventional and rapid microwave processed tissues. , 2006, American journal of clinical pathology.
[56] E. Provenzano,et al. An Immunohistochemical and Fluorescence In Situ Hybridization-based Comparison Between the Oracle HER2 Bond Immunohistochemical System, Dako HercepTest, and Vysis PathVysion HER2 FISH Using Both Commercially Validated and Modified ASCO/CAP and United Kingdom HER2 IHC Scoring Guidelines , 2010, Applied immunohistochemistry & molecular morphology : AIMM.
[57] B. Rerkamnuaychoke,et al. Human epidermal growth-factor receptor 2 overexpression in gastric carcinoma in Thai patients. , 2012, Journal of the Medical Association of Thailand = Chotmaihet thangphaet.
[58] Donald A Berry,et al. NCCN Task Force Report: Estrogen Receptor and Progesterone Receptor Testing in Breast Cancer by Immunohistochemistry. , 2009, Journal of the National Comprehensive Cancer Network : JNCCN.
[59] J. Kim,et al. Stimulation of large-conductance Ca2+-activated K+ channels by the Na+/Ca2+ exchanger inhibitor dichlorobenzamil in cultured human umbilical vein endothelial cells and mouse aortic smooth muscle cells. , 2009, Journal of physiology and pharmacology : an official journal of the Polish Physiological Society.
[60] D. Allred,et al. Development of Standard Estrogen and Progesterone Receptor Immunohistochemical Assays for Selection of Patients for Antihormonal Therapy , 2007, Applied immunohistochemistry & molecular morphology : AIMM.
[61] E. Murphy,et al. Qualitative research methods in health technology assessment: a review of the literature. , 1998, Health technology assessment.
[62] A. Tzankov,et al. Modern techniques for the diagnostic evaluation of the trephine bone marrow biopsy: methodological aspects and applications. , 2008, Progress in histochemistry and cytochemistry.
[63] N. Sneige,et al. Optimal fixation conditions for immunocytochemical analysis of estrogen receptor in cytologic specimens of breast carcinoma , 2003, Cancer.
[64] J. Lanchbury,et al. A Robust Immunohistochemical Assay for Detecting PTEN Expression in Human Tumors , 2011, Applied immunohistochemistry & molecular morphology : AIMM.
[65] V. Livolsi,et al. TTF-1 Expression in Ovarian and Uterine Epithelial Neoplasia and its Potential Significance, an Immunohistochemical Assessment With Multiple Monoclonal Antibodies and Different Secondary Detection Systems , 2009, International journal of gynecological pathology : official journal of the International Society of Gynecological Pathologists.
[66] K. Jirström,et al. Quality aspects of the tissue microarray technique in a population‐based cohort with ductal carcinoma in situ of the breast , 2008, Histopathology.
[67] A. Mulligan,et al. The Effect of Prolonged Fixation on the Immunohistochemical Evaluation of Estrogen Receptor, Progesterone Receptor, and HER2 Expression in Invasive Breast Cancer: A Prospective Study , 2011, The American journal of surgical pathology.
[68] M. Vyberg,et al. Thyroid Transcription Factor-1 in Primary CNS Tumors , 2011, Applied immunohistochemistry & molecular morphology : AIMM.
[69] T. Molina,et al. Variable sensitivity and specificity of TTF-1 antibodies in lung metastatic adenocarcinoma of colorectal origin , 2005, Modern Pathology.
[70] J. E. Boers,et al. HER2 status in gastro-oesophageal adenocarcinomas assessed by two rabbit monoclonal antibodies (SP3 and 4B5) and two in situ hybridization methods (FISH and SISH) , 2011, Histopathology.
[71] Manfred Dietel,et al. HER2 diagnostics in gastric cancer—guideline validation and development of standardized immunohistochemical testing , 2010, Virchows Archiv.
[72] Jack Cuzick,et al. Assessment of Ki67 in breast cancer: recommendations from the International Ki67 in Breast Cancer working group. , 2011, Journal of the National Cancer Institute.
[73] O. Nielsen,et al. Optimization of Antibodies for Detection of the Mismatch Repair Proteins MLH1, MSH2, MSH6, and PMS2 Using a Biotin-Free Visualization System , 2006, Applied immunohistochemistry & molecular morphology : AIMM.
[74] H. Kataoka,et al. Optimization of tissue processing for immunohistochemistry for the detection of human glypican-3. , 2010, Acta histochemica.
[75] Helen M. Moore,et al. Effects of preanalytical variables on the detection of proteins by immunohistochemistry in formalin-fixed, paraffin-embedded tissue. , 2011, Archives of pathology & laboratory medicine.
[76] G. Bussolati,et al. Technical pitfalls potentially affecting diagnoses in immunohistochemistry , 2008, Journal of Clinical Pathology.
[77] Johannes B Reitsma,et al. Evaluation of QUADAS, a tool for the quality assessment of diagnostic accuracy studies , 2006, BMC medical research methodology.
[78] M. Hammond,et al. Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays. , 2010, Archives of pathology & laboratory medicine.
[79] P. V. van Diest,et al. Validation of a Fully Automated HER2 Staining Kit in Breast Cancer , 2010, Cellular oncology : the official journal of the International Society for Cellular Oncology.
[80] Christopher Otis,et al. Quality assurance for design control and implementation of immunohistochemistry assays; Approved guidelinesecond edition , 2011 .
[81] Ping Tang,et al. Tissue microarray-based immunohistochemical study can significantly underestimate the expression of HER2 and progesterone receptor in ductal carcinoma in situ of the breast , 2011, Biotechnic & histochemistry : official publication of the Biological Stain Commission.
[82] J. D. van der Walt,et al. Call for a European programme in external quality assurance for bone marrow immunohistochemistry; report of a European Bone Marrow Working Group pilot study , 2009, Journal of Clinical Pathology.
[83] M. Dowsett,et al. Standardization of HER2 testing: results of an international proficiency-testing ring study , 2007, Modern Pathology.
[84] G. Mills,et al. Clinical Assessment of PTEN Loss in Endometrial Carcinoma: Immunohistochemistry Out-Performs Gene Sequencing , 2011, Modern Pathology.
[85] G. Sauter,et al. HER-2/neu analysis in breast cancer bone metastases , 2009, Journal of Clinical Pathology.
[86] D. Murphy,et al. Interlaboratory comparison of immunohistochemical testing for HER2: results of the 2004 and 2005 College of American Pathologists HER2 Immunohistochemistry Tissue Microarray Survey. , 2009, Archives of pathology & laboratory medicine.
[87] M. Peterson,et al. Reliability of Her2/neu, estrogen receptor, and progesterone receptor testing by immunohistochemistry on cell block of FNA and serous effusions from patients with primary and metastatic breast carcinoma , 2011, Diagnostic cytopathology.
[88] F. O'Malley,et al. Updated recommendations from the Canadian National Consensus Meeting on HER2/neu testing in breast cancer , 2007, Current oncology.
[89] K. Aogi,et al. Usefulness of liquid-based cytology in hormone receptor analysis of breast cancer specimens , 2011, Virchows Archiv.
[90] K. Allison,et al. Achieving 95% cross-methodological concordance in HER2 testing: causes and implications of discordant cases. , 2010, American journal of clinical pathology.
[91] J. van der Velden,et al. Validation of tissue microarray technology in endometrioid cancer of the endometrium , 2006, Journal of Clinical Pathology.
[92] L. Rogers,et al. Fixation time does not affect expression of HER2/neu: a pilot study. , 2010, American journal of clinical pathology.
[93] Anthony Rhodes,et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. , 2010, Archives of pathology & laboratory medicine.
[94] M. J. van de Vijver,et al. Microarray-Based Determination of Estrogen Receptor, Progesterone Receptor, and HER2 Receptor Status in Breast Cancer , 2009, Clinical Cancer Research.