CLSI I/LA28 A2 : 2ED 2011
Current
The latest, up-to-date edition.
QUALITY ASSURANCE FOR DESIGN CONTROL AND IMPLEMENTATION OF IMMUNOHISTOCHEMISTRY ASSAYS
Hardcopy , PDF
English
31-01-2011
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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 |
| PD ISO/TS 17518:2015 | Medical laboratories. Reagents for staining biological material. Guidance for users |
| ISO/TS 17518:2015 | Medical laboratories — Reagents for staining biological material — Guidance for users |
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| CLSI MM6 A : 1ED 2003 | QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES |
| CLSI MM17 A : 1ED 2008 | VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS |
| CLSI EP21 A : 1ED 2003 | ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS |
| CLSI EP5 A2 : 2ED 2004 | EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS |
| CLSI GP28 A : 1ED 2005 | MICROWAVE DEVICE USE IN THE HISTOLOGY LABORATORY |
| CLSI EP12 A2 : 2ED 2008 | USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE |
| CLSI I/LA23 A : 1ED 2004 | ASSESSING THE QUALITY OF IMMUNOASSAY SYSTEMS: RADIOIMMUNOASSAYS AND ENZYME, FLUORESCENCE, AND LUMINESCENCE IMMUNOASSAYS |
| CLSI POCT13 A2 : 2ED 2005 | GLUCOSE MONITORING IN SETTINGS WITHOUT LABORATORY SUPPORT |
| CLSI M29 A3 : 3ED 2005 | ACQUIRED INFECTIONS; APPROVED GUIDELINE |
| CLSI I/LA18 A2 : 2ED 2001 | SPECIFICATIONS FOR IMMUNOLOGICAL TESTING FOR INFECTIOUS DISEASES |
| CLSI GP15 A3 : 3ED 2008 | CERVICOVAGINAL CYTOLOGY BASED ON THE PAPANICOLAOU TECHNIQUE |
| CLSI EP15 A2 : 2ED 2006 | USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
| CLSI I/LA2 A2 : 2ED 2006 | QUALITY ASSURANCE OF LABORATORY TESTS FOR AUTOANTIBODIES TO NUCLEAR ANTIGENS: (1) INDIRECT FLUORESCENCE ASSAY FOR MICROSCOPY AND (2) MICROTITER ENZYME IMMUNOASSAY METHODS |
| CLSI EP19 R : 1ED 2002 | A FRAMEWORK FOR NCCLS EVALUATION PROTOCOLS |
| CLSI I/LA21 A2 : 2ED 2008 | CLINICAL EVALUATION OF IMMUNOASSAYS |
| CLSI C24 A3 : 3ED 2006 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
| CLSI LA1 A2 : 2ED 94 | ASSESSING THE QUALITY OF RADIOIMMUNOASSAY SYSTEMS<br> |
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