Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine - Part 2: Immunohistochemistry Test Performance Characteristics.

All laboratory tests have test performance characteristics (TPCs), whether or not they are explicitly known to the laboratorian or the pathologist. TPCs are thus also an integral characteristic of immunohistochemistry (IHC) tests and other in situ, cell-based molecular assays such as DNA or RNA in situ hybridization or aptamer-based testing. Because of their descriptive, in situ, cell-based nature, IHC tests have a limited repertoire of appropriate TPCs. Although only a few TPCs are relevant to IHC, proper selection of informative TPCs is nonetheless essential for the development of and adherence to appropriate quality assurance measures in the IHC laboratory. This paper describes the TPCs that are relevant to IHC testing and emphasizes the role of TPCs in the validation of IHC tests. This is part 2 of the 4-part series "Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine."

[1]  Valsamo Anagnostou,et al.  Antibody validation. , 2010, BioTechniques.

[2]  William J. Howat,et al.  Antibody validation of immunohistochemistry for biomarker discovery: Recommendations of a consortium of academic and pharmaceutical based histopathology researchers , 2014, Methods.

[3]  Massimo Gion,et al.  Considerations on development, validation, application, and quality control of immuno(metric) biomarker assays in clinical cancer research: an EORTC-NCI working group report. , 2003, International journal of oncology.

[4]  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.

[5]  N. Nagelkerke,et al.  Analysing collaborative trials for qualitative microbiological methods: accordance and concordance. , 2002, International journal of food microbiology.

[6]  M. Hammond,et al.  Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays. , 2010, Archives of pathology & laboratory medicine.

[7]  M. Dowsett,et al.  Revisiting the technical validation of tumour biomarker assays: how to open a Pandora's box , 2011, BMC medicine.

[8]  MYC and BCL2 overexpression is associated with a higher class of Memorial Sloan-Kettering Cancer Center prognostic model and poor clinical outcome in primary diffuse large B-cell lymphoma of the central nervous system , 2016, BMC Cancer.

[9]  James H. Doroshow,et al.  AACR-FDA-NCI Cancer Biomarkers Collaborative Consensus Report: Advancing the Use of Biomarkers in Cancer Drug Development , 2010, Clinical Cancer Research.

[10]  W. McGuire,et al.  How to integrate steroid hormone receptor, flow cytometric, and other prognostic information in regard to primary breast cancer , 1993, Cancer.

[11]  H. Najmabadi,et al.  Detection of HER2 status in breast cancer: comparison of current methods with MLPA and real-time RT-PCR. , 2013, Asian Pacific journal of cancer prevention : APJCP.

[12]  Liang Han,et al.  LTBP2 is a prognostic marker in head and neck squamous cell carcinoma , 2016, Oncotarget.

[13]  Clive R. Taylor,et al.  Standardization of Positive Controls in Diagnostic Immunohistochemistry: Recommendations From the International Ad Hoc Expert Committee , 2015, Applied immunohistochemistry & molecular morphology : AIMM.

[14]  R. Golouh,et al.  Prognostic significance of PU.1 in follicular lymphoma , 2006, The Journal of pathology.

[15]  D. Altman,et al.  Statistics Notes: Diagnostic tests 1: sensitivity and specificity , 1994, BMJ.

[16]  Tom Long,et al.  Verifying performance characteristics of quantitative analytical systems: calibration verification, linearity, and analytical measurement range. , 2014, Archives of pathology & laboratory medicine.

[17]  Expression of bcl-6 and CD10 protein is associated with longer overall survival and time to treatment failure in follicular lymphoma. , 2004, American journal of clinical pathology.

[18]  M. Dolled-Filhart,et al.  Development of a Companion Diagnostic PD-L1 Immunohistochemistry Assay for Pembrolizumab Therapy in Non–Small-cell Lung Cancer , 2016, Applied immunohistochemistry & molecular morphology : AIMM.

[19]  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 (unabridged version). , 2010, Archives of pathology & laboratory medicine.

[20]  J Cummings,et al.  Biomarker method validation in anticancer drug development , 2008, British journal of pharmacology.

[21]  Viswanath Devanarayan,et al.  Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement , 2006, Pharmaceutical Research.

[22]  Manfred Dietel,et al.  HER2 diagnostics in gastric cancer—guideline validation and development of standardized immunohistochemical testing , 2010, Virchows Archiv.

[23]  Linda A Bradley,et al.  Principles of analytic validation of immunohistochemical assays: Guideline from the College of American Pathologists Pathology and Laboratory Quality Center. , 2014, Archives of pathology & laboratory medicine.

[24]  L. Goldstein,et al.  High concordance between immunohistochemistry and fluorescence in situ hybridization testing for HER2 status in breast cancer requires a normalized IHC scoring system , 2008, Modern Pathology.

[25]  J. Luck,et al.  Clinical and prognostic significance of the expression of the c-erbB-2 and c-erbB-3 oncoproteins in primary and metastatic malignant melanomas and breast carcinomas. , 1997, Anticancer research.

[26]  D. Armbruster,et al.  Limit of blank, limit of detection and limit of quantitation. , 2008, The Clinical biochemist. Reviews.

[27]  C. Corless,et al.  Monoclonal Antibody DOG1.1 Shows Higher Sensitivity Than KIT in the Diagnosis of Gastrointestinal Stromal Tumors, Including Unusual Subtypes , 2009, The American journal of surgical pathology.

[28]  Benjamin Geiger,et al.  The catalog of human cytokeratins: Patterns of expression in normal epithelia, tumors and cultured cells , 1982, Cell.

[29]  W. L. McGuire,et al.  Breast cancer prognostic factors: evaluation guidelines. , 1991, Journal of the National Cancer Institute.

[30]  Clive R. Taylor,et al.  Standardization of Negative Controls in Diagnostic Immunohistochemistry: Recommendations From the International Ad Hoc Expert Panel , 2014, Applied immunohistochemistry & molecular morphology : AIMM.

[31]  J. Lasota,et al.  DOG1 Antibody in the Differential Diagnosis of Gastrointestinal Stromal Tumors: A Study of 1840 Cases , 2009, The American journal of surgical pathology.

[32]  G. Kominami.  Sensitivity of immunoenzymometric assay and detection method of enzyme. , 1994, Journal of immunoassay.

[33]  H. Soares,et al.  Method Validation and Measurement of Biomarkers in Nonclinical and Clinical Samples in Drug Development: A Conference Report , 2005, Pharmaceutical Research.

[34]  Gene A Pennello,et al.  Analytical and clinical evaluation of biomarkers assays: When are biomarkers ready for prime time? , 2013, Clinical trials.

[35]  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.

[36]  C. Cheung,et al.  An Audit of Failed Immunohistochemical Slides in a Clinical Laboratory: The Role of On-Slide Controls , 2017, Applied immunohistochemistry & molecular morphology : AIMM.

[37]  D. Allred,et al.  Progesterone receptor by immunohistochemistry and clinical outcome in breast cancer: a validation study , 2004, Modern Pathology.

[38]  I. Broadbent,et al.  High-Sensitivity Monoclonal Antibodies Specific for Homoserine Lactones Protect Mice from Lethal Pseudomonas aeruginosa Infections , 2013, Applied and Environmental Microbiology.

[39]  J. Floege,et al.  Nanoparticle-based test measures overall propensity for calcification in serum. , 2012, Journal of the American Society of Nephrology : JASN.

[40]  Clive R Taylor,et al.  Predictive Biomarkers and Companion Diagnostics. The Future of Immunohistochemistry: “In Situ Proteomics,” or Just a “Stain”? , 2014, Applied immunohistochemistry & molecular morphology : AIMM.

[41]  Eileen M. Burd,et al.  Validation of Laboratory-Developed Molecular Assays for Infectious Diseases , 2010, Clinical Microbiology Reviews.

[42]  A. Saah,et al.  Sensitivity and Specificity Reconsidered: The Meaning of These Terms in Analytical and Diagnostic Settings , 1997, Annals of Internal Medicine.

[43]  Kevin S. Smith,et al.  A Novel Monoclonal Antibody Against DOG1 is a Sensitive and Specific Marker for Gastrointestinal Stromal Tumors , 2008, The American journal of surgical pathology.