CLSI I/LA28

Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays, 2nd Edition

This document provides guidelines for the development of validated diagnostic, prognostic, and predictive immunohistochemical assays.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2016. The document’s next scheduled review is generally five years after the reaffirmation date.

This document is available in electronic format only.

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Chairholder: Stephen M. Hewitt, MD, PhD and Max Robinowitz, MD

Date of Publication: January 31, 2011

Order Code PDF: CLSI ILA28A2E
ISBN Number: 1-56238-745-6

Order Code Print: print not available

Edition: Second

Pages: 152

CLSI I/LA28 Additional Details

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This document was formerly sold under the code MM04.

CLSI I/LA28 Abstract

Immunohistochemistry is an analytical technique that applies an antibody reagent to detect and visualize an antigen in cytological and surgical pathology microscopy specimens in the context of histomorphology and cytomorphology. The clinical-pathological interpretation of the presence and patterns of the antibody-antigen reactions is performed in a manner similar to other molecular pathology assays. Immunohistochemistry is used in diagnostic pathology for diagnosis, determination of prognosis, and predictive assays for response to therapy. Accurate and reproducible results require quality assurance of the total test system including the design control of the reagents and the preexamination (preanalytical), examination (analytical), and postexamination (postanalytical) interpretation steps (processes) of the assay to ensure its clinical applicability. This guideline focuses on validation of immunohistochemistry assays on formalin-fixed, paraffin-embedded pathology material. The audience for this guideline includes the assay developer, the reagent supplier, laboratory histotechnologist who performs the assay, and the laboratory director/pathologist who implements and interprets the assay.