Document Detail

Immunohistochemistry Validation Procedures and Practices: A College of American Pathologists Survey of 727 Laboratories.
MedLine Citation:
PMID:  23276171     Owner:  NLM     Status:  Publisher    
Context.-The immunohistochemistry (IHC) laboratory represents a dynamic area of surgical pathology with limited practice guidelines. Studies have shown significant interlaboratory variability in results. Objective.-To establish baseline parameters for IHC validation procedures and practice, and to assess their feasibility of implementation. Design.-In September 2010, a questionnaire was distributed by the College of American Pathologists. It was composed of 32 questions relating to nonpredictive assays as well as non-US Food and Drug Administration (non-FDA)-approved, predictive IHC assays other than human epidermal growth factor 2 (HER2/neu). Results.-For non-FDA approved, nonpredictive IHC assays, 68% of laboratories had a written validation procedure. Eighty-six percent of laboratories validated the most recently introduced nonpredictive antibody. Seventy-five percent used 21 or fewer total cases for the validation and 40% used weakly or focally positive cases. Forty-six percent of respondents had a written procedure for validation procedures for non-FDA approved, predictive marker IHC assays other than HER2/neu. Seventy-five percent of laboratories validated the most recently introduced predictive antibody other than HER2/neu. Fewer than half used 25 or more cases for the validation, and 47% used weakly or focally positive cases. Conclusion.-Some laboratories have written validation procedures that appear to build upon HER2/neu testing guidelines. Some laboratories also manage to validate new antibodies according to those standards; however, many do not. There appears to be a need for further validation guideline development for nonpredictive and non-FDA approved predictive antibody IHC assays.
Lindsay B Hardy; Patrick L Fitzgibbons; Jeffery D Goldsmith; Richard N Eisen; Mary Beth Beasley; Rhona J Souers; Raouf E Nakhleh
Publication Detail:
Journal Detail:
Title:  Archives of pathology & laboratory medicine     Volume:  137     ISSN:  1543-2165     ISO Abbreviation:  Arch. Pathol. Lab. Med.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-1     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7607091     Medline TA:  Arch Pathol Lab Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  19-25     Citation Subset:  -    
From the Department of Pathology, Beth Israel Deaconess Medical Center, Boston, Massachusetts (Drs Hardy and Goldsmith); the Department of Pathology, St Jude Medical Center, Fullerton, California (Dr Fitzgibbons); the Department of Pathology, Greenwich Hospital, Greenwich, Connecticut (Dr Eisen); the Department of Pathology, Mt Sinai Medical Center, New York, New York (Dr Beasley); Statistics/Biostatistics, College of American Pathologists, Northfield, Illinois (Ms Souers); and the Department of Pathology, Mayo Clinic Florida, Jacksonville (Dr Nakhleh).
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