Enzyme Immunoassays: From Concept to Product Development

Pirmais vāks
Springer Science & Business Media, 1996. gada 30. jūn. - 464 lappuses
This unique reference provides a pragmatic approach to the development of successful commercial immunodiagnostic products based on enzyme immunoessay technology. Presenting both the basic and applied principles, Enzyme Immunoassays gathers information on all aspects of this process, from the initial conceptualization to the introduction of the product to the market.

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Atlasītās lappuses

Saturs

Introduction
3
A Historical Perspective
8
Diagnostic Markets and Economics
12
Scope of the Book
19
References
21
Antibodies Biochemistry Structure and Function
24
Antibody Classification
32
Antibody Structure
36
References
224
Product Development
229
Immunoassay Classification and Commercial Technologies
231
Classification
232
Heterogeneous Enzyme Immunoassays
240
Homogeneous Enzyme Immunoassays
244
Commercial Technologies
258
References
269

Antibody Functions
40
Auxiliary Binding Systems
41
References
48
AntigenAntibody Reactions
52
AntigenAntibody Binding
53
Antibody Affinity and Avidity
57
antibody Specificity and CrossReactivity
59
Quantitation of AntigenAntibody Reactions
60
References
70
Conjugation Techniques
72
Functional Groups on Proteins
73
Chemical Modification of Protein Functional Groups
76
CrossLinking Reagents for Protein Conjugation
78
Practical Aspects
104
References
110
Antibody Production
117
Nature and Preparation of Immunogen
119
Immunization
133
Antibody Screening
138
Monoclonal Antibodies
140
Purification
144
Stabilization and Storage
149
References
151
Enzymes and Signal Amplification Systems
155
Enzymes
162
Signal Amplification Systems
182
References
187
Separation and SolidPhase Systems
193
SolidPhase Systems
206
Immobilization of Immunoreagents
216
Assay Development Evaluation and Validation
275
Selection of Assay Format
277
Preparation of the Solid Phase
283
Blocking
302
Enzyme Labels
304
Sample and Standard Preparation
305
Assay Conditions
307
Assay Evaluation
313
Quality AssuranceQuality Control QAQC
341
Assay Validation
343
References
353
Reagent Formulations and Shelf Life Evaluation
360
Liquid Formulations
361
Solid Formulations
366
Preparation of Reference Standards and Calibrators
381
Shelf Life Evaluation
386
References
397
Data Analysis
401
Standard or Calibration Curves
402
CurveFitting Techniques
409
Statistical Descriptors
415
References
423
Documentation Registration and Diagnostic StartUps
426
Documentation Systems
427
ISO 9000 Certification
435
ISO 9000 Series Standards
437
Diagnostics StartUps
445
References
450
Index
453
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