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CLSI I/LA28 A2 : 2ED 2011

Current

Current

The latest, up-to-date edition.

QUALITY ASSURANCE FOR DESIGN CONTROL AND IMPLEMENTATION OF IMMUNOHISTOCHEMISTRY ASSAYS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-31-2011

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
Part 1 - The Scientific Theory and Principles of the Design
         and Development of Immunohistochemistry Assays
5 Design Control Process for Immunohistochemistry Assay
   Discovery, Development, and Clinical Implementation
6 Specimen Requirements for Immunohistochemistry Assays
7 Analyte (Antigen)
8 Primary Antibody
9 Detection Methodologies and Chemistries
10 Design Principles for Processing and Immunostaining Steps
11 Design Principles for Interpretation of Immunohistochemistry
   Assays
Part 2 - The Implementation of Immunohistochemistry Assays
         by Pathologists and Technologists
12 Assay Verification and Validation in the End-User
   Laboratory
13 Selection of Immunohistochemistry Assay by Surgical
   Pathologist

Gives guidelines for the development of validated diagnostic, prognostic, and predictive immunohistochemical assays.

DevelopmentNote
Supersedes NCCLS MM4 A. (03/2011)
DocumentType
Miscellaneous Product
ISBN
1-56238-745-6
Pages
152
PublisherName
Clinical Laboratory Standards Institute
Status
Current
Supersedes

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