CLSI I/LA28-A2 (R2018) PDF

Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline-Second Edition, ILA28A2E

CLSI I/LA28-A2 (R2018) – Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline-Second Edition, ILA28A2E

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