CLSI ILA28
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays
This CLSI document provides guidelines for developing validated immunohistochemistry assays for diagnostic, prognostic, and predictive applications. It supports laboratories in ensuring the accuracy, reliability, and clinical relevance of these assays.
This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2016.
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{{FormatPrice(nonMemberPrice)}} List PriceImmunohistochemistry 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.
The purpose of this document is to provide guidance to all of the stakeholders involved with design and implementation of immunohistochemistry (IHC) assays. It is intended for use by all clinical and reference laboratories performing immunocytochemical assays on cytological preparations or immunohistochemical assays on surgical pathology specimens, for the manufacturers of commercial reagents and test kits, and for individuals and organizations involved in the development and implementation of laboratory quality assurance (QA) programs for these assays. This guideline presents information on the total product life cycle of the discovery, design, development, verification, and analytical and clinical validation of IHC and immunocytochemistry (ICC) reagents, kits, and systems. Its emphasis is that accurate and reliable IHC and ICC results require attention to the total test system of the assay.
This document is available in electronic format only.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
CLSI ILA28QG
Free
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.
The purpose of this document is to provide guidance to all of the stakeholders involved with design and implementation of immunohistochemistry (IHC) assays. It is intended for use by all clinical and reference laboratories performing immunocytochemical assays on cytological preparations or immunohistochemical assays on surgical pathology specimens, for the manufacturers of commercial reagents and test kits, and for individuals and organizations involved in the development and implementation of laboratory quality assurance (QA) programs for these assays. This guideline presents information on the total product life cycle of the discovery, design, development, verification, and analytical and clinical validation of IHC and immunocytochemistry (ICC) reagents, kits, and systems. Its emphasis is that accurate and reliable IHC and ICC results require attention to the total test system of the assay.
This document is available in electronic format only.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.