title: Antibody validation of immunohistochemistry for biomarker discovery: recommendations of a consortium of academic and pharmaceutical based histopathology researchers.
abstract: As biomarker discovery takes centre-stage, the role of immunohistochemistry within that process is increasing. At the same time, the number of antibodies being produced for "research use" continues to rise and it is important that antibodies to be used as biomarkers are validated for specificity and sensitivity before use. This guideline seeks to provide a stepwise approach for the validation of an antibody for immunohistochemical assays, reflecting the views of a consortium of academic and pharmaceutical based histopathology researchers. We propose that antibodies are placed into a tier system, level 1-3, based on evidence of their usage in immunohistochemistry, and that the degree of validation required is proportionate to their place on that tier.
authors: Cancer Research UK Cambridge Institute, University of Cambridge, Li Ka Shing Centre, Cambridge CB2 0RE, UK. Electronic address: will.howat@cruk.cam.ac.uk.
authors: William J
authors: WJ
authors: Howat
authors: MedImmune, Granta Park, Cambridge, UK.
authors: Arthur
authors: A
authors: Lewis
authors: UCL Advanced Diagnostics, 21 University Street, London WC1E 6JJ, UK.
authors: Phillipa
authors: P
authors: Jones
authors: Department of Immunology, Genetics and Pathology, Rudbeck Laboratory, Uppsala University, Uppsala, Sweden.
authors: Caroline
authors: C
authors: Kampf
authors: Department of Immunology, Genetics and Pathology, Rudbeck Laboratory, Uppsala University, Uppsala, Sweden.
authors: Fredrik
authors: F
authors: Pontén
authors: Department of Pathology, Academic Medical Center, Amsterdam, The Netherlands.
authors: Chris M
authors: CM
authors: van der Loos
authors: AstraZeneca Oncology Innovative Medicines, Macclesfield, UK.
authors: Neil
authors: N
authors: Gray
authors: AstraZeneca Oncology Innovative Medicines, Macclesfield, UK.
authors: Chris
authors: C
authors: Womack
authors: University of Westminster, London, UK.
authors: Anthony
authors: A
authors: Warford
mesh_terms: D000818:Animals; D000906:Antibodies / Q000737:chemistry*; D015415:Biomarkers / Q000737:chemistry / Q000378:metabolism*; D014408:Biomarkers, Tumor / Q000378:metabolism; D035843:Biomedical Research / Q000379:methods; D002460:Cell Line; D002626:Chemistry, Pharmaceutical / Q000379:methods; D000939:Epitopes / Q000737:chemistry; D015972:Gene Expression Regulation, Neoplastic; D006801:Humans; D007150:Immunohistochemistry / Q000379:methods*; D009369:Neoplasms / Q000276:immunology / Q000378:metabolism; D010641:Phenotype; D011506:Proteins / Q000737:chemistry*; D012333:RNA, Messenger / Q000378:metabolism; D015203:Reproducibility of Results
chemical_list: D000906:Antibodies; D015415:Biomarkers; D014408:Biomarkers, Tumor; D000939:Epitopes; D011506:Proteins; D012333:RNA, Messenger
keywords: Antibody validation; Biomarker; Guidelines; Histopathology; Immunohistochemistry