CLSI I/LA28-A2:2011 (R2018)

CLSI I/LA28-A2:2011 (R2018)

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

193,00 €


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.

Información adicional

Autor Clinical and Laboratory Standards Institute (CLSI)
Publicado por CLSI
Tipo de Documento Norma
Tema /subgroups/17906
Fecha de confirmación 2018-01-01
EAN ISBN 1562387456
Número de páginas 156
Reemplaza CLSI MM04-A
Palabra clave CLSI I/LA28-A2 (R2018)