Immunodiagnostics and Patient Safety - Toc - Beck-Shop

Patient Safety 3
Immunodiagnostics and Patient Safety
Bearbeitet von
Krystyna Sztefko
1. Auflage 2011. Taschenbuch. X, 172 S. Paperback
ISBN 978 3 11 024947 7
Format (B x L): 17 x 24 cm
Gewicht: 315 g
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Contents
Preface ................................................................................................................
Abbreviations ......................................................................................................
ix
xi
Part I – Immunoassay: Theory, practice, and patient safety .................................
1
1
Immunochemical methods – Basic principles and definitions .......................
1.1 Antibody as immunoassay reagent .........................................................
1.2 Antigen as immunoassay reagent ...........................................................
1.3 The course of the immunochemical reaction .........................................
1.4 Immunoassay formats ............................................................................
1.5 Labels in immunochemical reactions ....................................................
1.6 Separation of bound and unbound fractions ..........................................
1.7 Other technologies based on the antigen-antibody reaction ..................
1.8 Basic theory of immunoassay and patient safety ....................................
3
3
7
7
9
14
14
15
16
2
Immunoassay standardization .......................................................................
2.1 Reference materials for small molecules ................................................
2.2 Reference materials for proteins ............................................................
2.3 Reference methods ................................................................................
2.4 Reference methods for heterogeneous proteins......................................
2.5 Traceability ............................................................................................
2.6 The uncertainty of measurement ............................................................
2.7 Epitope as a solution for better standardization......................................
2.8 Harmonization of immunoassays ..........................................................
2.9 Immunoassay standardization and the patient’s safety ...........................
17
17
18
19
20
20
21
23
24
24
3
Immunoassay calibration and calibration curve fitting ..................................
3.1 Calibration process................................................................................
3.2 Commutability problem ........................................................................
3.3 Matrix effect ..........................................................................................
3.4 Calibration and patient safety ................................................................
27
27
28
28
29
4
Reference intervals and immunoassay ...........................................................
4.1 General problems with reference intervals for analytes
measured by immunoassay....................................................................
4.2 Limitation of different approaches to reference intervals ........................
4.3 Reference intervals and patient safety ....................................................
31
31
32
33
Laboratory preanalytical and analytical phase of immunoassay ....................
5.1 Laboratory preanalytical factors and immunoassay ................................
5.2 Blood collection devices .......................................................................
5.3 Anticoagulants ......................................................................................
35
35
36
37
5
vi Contents
5.4
5.5
5.6
6
7
Hemolysis, lipemia, hyperbilirubinemia, paraproteinemia,
and immunoassay................................................................................
Analyte stability in fresh and frozen serum samples .............................
Analytical phase in immunoassay measurement ..................................
Human natural antibodies and immunoassay ................................................
6.1 The human immune system .................................................................
6.2 Chemical structure of immunoglobulins ..............................................
6.3 Antigen-combining site and complementarity-determining regions ......
6.4
Genes for immunoglobulin variable regions ........................................
6.5
Diversification of immunoglobulins in vivo .........................................
6.6
Natural antibody against exogenous (nonself ) and
endogenous (self ) antigens ..................................................................
6.7
Natural antibodies and patient safety ...................................................
37
38
40
43
43
44
45
46
47
48
51
Immunoassay interference – How to recognize, eliminate,
or reduce it....................................................................................................
7.1
Definition and prevalence of interference in immunoassay ..................
7.2
Cross-reactivity versus interference in immunoassay ............................
7.3 Analyte specific and nonspecific binding proteins
as a source of interference in immunoassay .........................................
7.4 Autoantibodies as a source of interference ...........................................
7.5
Nonimmune IgG complexes as a source of interference ......................
7.6
Interference from heterophilic antibodies ............................................
7.7
Detection of heterophilic antibodies in the patient’s sample ................
7.8
Methods used for removal or inactivation of interfering
heterophilic antibodies ........................................................................
7.9
High-dose effect (hook effect, prozone effect) ......................................
7.10 Low-dose hook effect ..........................................................................
7.11 Interference from heterophilic antibodies and patient safety ................
7.12 Interpretation of immunoassay results is an art ....................................
89
92
95
96
97
Immunoassay and patient safety ....................................................................
8.1
Fallibility of immunoassays ..................................................................
8.2
Know your immunoassay.....................................................................
8.3
Basic knowledge on critical points in immunoassay for physicians ......
8.4
Immunoassay in research.....................................................................
8.5 Who is responsible for the patient’s safety? ..........................................
103
103
105
110
113
113
Part II – Immunochemistry measurements in practice:
Examples of problems in some current immunoassays...........................
115
8
Example 1
Example 2
Parathyroid hormone (PTH) – Heterogeneity as a major
problem in PTH measurement by immunochemistry........................
Human chorionic gonadotropin (hCG) – Problems
of heterogeneity and lack of standardization ....................................
53
53
54
59
63
66
69
78
117
123
Contents
vii
Example 3 Troponin measurement by immunoassay –
Problem of low assay sensitivity and interference
from heterophilic antibodies ............................................................
Example 4 Aldosterone and proteolytic renin activity (PRA) –
Are they useful together? ..................................................................
Example 5 Thyroglobulin measurement – Autoantibody problem ......................
Example 6 Prolactin measurement by immunoassay – Heterogeneity
and macroform problems.................................................................
Example 7 Thyroid function tests – Most frequently measured
and most difficult to interpret: Reference interval
for thyroid-stimulating hormone (TSH) and problems
of free thyroid hormone fraction measurement .................................
149
Index ...................................................................................................................
161
129
137
141
145