| Publications by Biophoenix' Principals |
| Immunoassays in Clinical Endocrinology | |
|---|---|
 |
 |
| Publisher: | PJB Publications Ltd |
| Year of publication: | 1991 |
| Type of publication: | Market report |
| Publisher's reference (if any): | CBS 167 |
| Author(s): | Sreten Bogdanovic |
| Approximate page count: | 130 |
| Price when published: | £300 |
Remarks:
| |
IMMUNOASSAYS IN CLINICAL ENDOCRINOLOGY
a report for
Clinica World Medical Device & Diagnostic News
TABLE OF CONTENTS
CHAPTER 1
INTRODUCTION
1.1 Scope of this Report 1
1.2 An Overview of Endocrinology 2
1.2.1 Introduction to Hormones 3
1.2.2 Development of Modern Endocrinology 3
1.2.3 Chemical Diversity of Hormones 4
1.2.4 Effects of Hormones 4
1.2.5 Mode of Action of Hormones 5
1.2.6 Factors Affecting the Biological Activity
of Hormones 5
1.2.6.1 Tissue Conversion 5
1.2.6.2 Receptor Concentration 5
1.2.6.3 Serum Protein Binding 6
1.3 Measurement of Hormone Levels 6
1.3.1 Introduction 6
1.3.2 Chromatography 6
1.3.3 Mass Spectrometry 7
1.3.4 Bioassay 7
1.3.5 Tissue Morphology 8
1.3.6 Immunoassay Methodologies 8
1.3.6.1 General Characteristics of Immunoassays 8
1.3.6.2 Antigens and Antibodies 8
1.3.6.3 Labelling 9
1.3.6.4 Bound-Free Separation 9
1.3.6.5 Competitive Immunoassays 9
1.3.6.6 Non-immunological Competitive Binding
Assays 10
1.3.6.7 Immunometric Immunoassays 10
1.3.6.8 Homogeneous Immunoassays 11
1.3.6.9 Commercial Immunoassay Configurations 12
1.3.6.9.1 Kits and Associated Instrumentation 12
1.3.6.9.2 Self-Contained Cartridge Systems 12
1.3.6.10 Antibodies 13
1.3.6.10.1 Polyclonal Antibodies 13
1.3.6.10.2 Monoclonal Antibodies and their
Production 13
1.3.6.11 Accuracy and Standardisation in
Endocrine Immunoassays 14
1.3.6.11.1 Small Molecule Analytes 14
1.3.6.11.2 Polypeptides and Proteins 14
1.3.6.11.3 Matrix Effects 15
1.3.6.11.4 Analytical Sensitivities
and Detection Limits 15
1.4 Laboratory Investigations in Endocrinology 16
1.4.1 Assay of Basal Hormone Levels 16
1.4.2 Histochemistry 17
1.4.3 Stimulation and Suppression Tests 17
1.4.3.1 Feedback Control of Hormone Secretion 17
1.4.3.2 Receptor-Mediated Control of Hormone
Sensitivity 18
1.4.3.3 Use of Stimulation and Suppression Tests 18
1.5 End-Users of Endocrine Tests 18
1.6 US Dollar Exchange Rates Used for this Report 19
CHAPTER 2
THYROID FUNCTION TESTING I
2.1 Introduction 20
2.2 Composition of the Thyroid Gland 20
2.3 Hormones Produced by the Thyroid 20
2.4 Thyroid-Stimulating Hormone (TSH) 21
2.5 Measurement of Thyroid-related Hormones 21
2.5.1 Introduction 21
2.5.2 Thyroid Hormone Binding Proteins 21
2.5.3 Relationship of Binding Protein and
Thyroid Hormone Levels 22
2.5.4 Thyroid Hormone Binding Capacity 23
2.5.5 Direct Assay of Free Thyroid Hormones 24
2.5.5.1 Equilibrium Dialysis 24
2.5.5.2 Labelled Analogue Immunoassays 24
2.5.5.3 Back-Titration (Two-Step) Immunoassays 24
2.5.5.4 Solid Phase Antigen Immunoassays 25
2.5.5.5 Commercial Development of Free
Thyroid Hormone Assays 25
2.5.5.6 Analytical Problems with Free
Thyroid Hormone Assays 25
2.5.6 Measurement of TSH in Adults 27
2.5.7 Measurement of TSH in Neonates 27
2.6 The TRH Test 27
2.7 The TSH Stimulation Test 28
2.8 In vivo Radioisotope Tests 28
2.8.1 Thyroidal Isotope Uptake 28
2.8.2 Perchlorate Discharge Test 29
2.9 Role of Ultrasound and X-ray Scanning 29
2.10 Antithyroid Antibodies 30
2.10.1 Antithyroglobulin Antibodies 30
2.10.2 Thyroid Microsomal Antibodies 30
2.10.3 Thyroid-Stimulating Antibodies 31
CHAPTER 3
THYROID FUNCTION TESTING II
3.1 Introduction 32
3.2 Overview of Hypothyoidism and Hyperthyroidism 32
3.3 Goitres 32
3.3.1 Introduction 32
3.3.2 Endemic Goitres 33
3.3.3 Dyshormonogenetic Goitres 33
3.3.4 Non-Toxic Goitres 33
3.3.5 Treatment of Goitres 34
3.3.6 Autoimmune Thyroiditis 34
3.3.7 Prevalence of Goitres and Thyroiditis 34
3.4 Hypothyroidism 35
3.4.1 Overview of Hypothyroid Conditions 35
3.4.2 Therapy for Hypothyroidism 35
3.4.3 Neonatal Hypothyroidism 35
3.5 Hyperthyroidism 36
3.5.1 Overview of Hyperthyroid Conditions 36
3.5.2 Graves' Disease 36
3.5.2.1 Aetiology 36
3.5.2.2 Clinical Features and Specific
Treatments 37
3.5.3 Toxic Goitres 38
3.5.4 Therapy for Hyperthyroidism 38
3.6 Thyroid Cancer 38
3.7 Biochemical Thyroid Screening Strategies 38
3.8 Market Data for Tests of Thyroid Function 40
3.8.1 Supplying Companies and Market Shares 40
TSH 40
Total T4 41
FT4 41
Total T3 42
FT3 42
T3 Uptake 43
T4 Uptake 43
TBG 44
3.8.2 Sales forecasts to 1995 45
TSH 45
Total T4 45
Free T4 46
Total T3 46
Free T3 47
Other thyroid, e.g. Tg 47
3.8.3 Summary of Forecast Growth Rates 48
CHAPTER 4
REPRODUCTIVE ENDOCRINOLOGY
4.1 Introduction 49
4.2 Reproductive Function in Females 49
4.2.1 Ovarian Hormones 49
4.2.2 Gonadotrophins 49
4.2.3 Ovaries and Eggs 50
4.2.4 Ovarian Steroid Production 51
4.2.5 Inhibin 52
4.2.6 The Menstrual Cycle 52
4.2.6.1 Follicular Phase 52
4.2.6.2 Luteal Phase 52
4.2.6.3 Summary of Cyclic Hormone Changes 54
4.3 Role of Immunoassays in the Investigation of
Female Reproductive Disorders 54
4.4 Menstrual Irregularity and Failure 55
4.4.1 Causes of Menstrual Irregularity and
Failure 55
4.4.1.1 Defects of Ovarian Function 55
4.4.1.2 Defective Pituitary or Hypothalamic
Function 56
4.4.1.3 Effects of other Endocrine Disorders 57
4.4.2 Diagnostic Investigation of Menstrual
Failure 57
4.4.3 Treatment of Menstrual Failure 58
4.5 Hirsutism and Virilism 58
4.5.1 Introduction 58
4.5.2 Aetiology of Hirsutism 58
4.5.2.1 Introduction to the Endocrinology
of Hair Growth 58
4.5.2.2 Steroid Metabolism 59
4.5.2.3 Polycystic Ovary Syndrome 59
4.5.2.4 Congenital Adrenal Hyperplasia 60
4.5.2.5 Other Causes of Hirsutism 60
4.5.3 Virilism 60
4.5.4 Diagnostic Investigation of Hirsutism and
Virilism 61
4.5.5 Treatment of Hirsutism and Virilism 61
4.6 Infertility 62
4.6.1 Introduction 62
4.6.2 Possible Causes of Infertility 62
4.6.3 Medical Management of Infertility 62
4.6.4 Ovulation Tests 63
4.6.4.1 Introduction 63
4.6.4.2 Boots-Celltech OVEIA 63
4.7 Pregnancy 65
4.7.1 Endocrinology of Pregnancy 65
4.7.2 Sheehan's Syndrome 66
4.7.3 Monitoring Foetal Well-Being 66
4.7.4 Pregnancy-associated Hormones 66
4.7.4.1 Human Chorionic Gonadotrophin (hCG) 66
4.7.4.2 Human Placental Lactogen (hPL) 67
4.7.4.3 Human Chorionic Thyrotrophin (hCT) 67
4.7.4.4 Relaxin 67
4.7.4.5 Prostaglandins 68
4.7.4.6 Prolactin 68
4.7.4.7 Other Pregnancy-associated Proteins 68
4.8 Male Sexual Function 69
4.8.1 The Testes and its Accessory Glands 69
4.8.2 Fertility in Males 69
4.8.3 Sexual Maturation in Males 69
4.8.4 Testosterone and Dihydrotestosterone 70
4.8.5 Overview of Disordered Male Sexual Function 71
4.8.5.1 Introduction 71
4.8.5.2 Impotence 71
4.8.5.3 Failure of Ejaculation 71
4.8.5.4 Delayed Puberty 72
4.8.5.5 Primary Testicular Failure 72
4.8.5.5.1 Maldevelopment 72
4.8.5.5.2 Orchitis and Torsion 72
4.8.5.5.3 Idiopathic Oligospermia 73
4.8.5.5.4 Absent or Deficient Steroid
Synthesis 73
4.8.5.5.5 Peripheral Androgen Resistance 73
4.8.5.5.6 Testicular Tumours 73
4.8.5.6 Diagnostic Investigation of Male Sexual
Dysfunction 74
4.9 Market Data for Reproductive Hormones 75
4.9.1 Supplying Companies and Market Shares 75
FSH 75
LH 76
Prolactin 77
hCG (quantitative) 77
hPL 78
Oestradiol 78
Free Oestriol 78
Total Oestriol 79
Progesterone 79
17à-hydroxyprogesterone 79
Testosterone 80
DHEA-Sulphate 80
Ovulation Test Kits 81
Pregnancy Test Kits 81
4.9.2 Sales Forecasts to 1995 82
LH 82
FSH 82
Prolactin 83
Quantitative hCG 83
hPL 84
Oestradiol 84
Free and Total Oestriol 85
Progesterone 85
Testosterone 86
Other Reproductive Hormones 86
Pregnancy and ovulation test kits 87
4.9.3 Summary of Forecast Growth Rates 87
CHAPTER 5
ENDOCRINOLOGY AND METABOLIC FUNCTION
5.1 Introduction 88
5.2 Disorders of Calcium Metabolism 88
5.2.1 Calcium and Phosphate Metabolism 88
5.2.2 Hormones Regulating Calcium Metabolism 89
5.2.2.1 Introduction 89
5.2.2.2 Parathyroid Hormone 89
5.2.2.3 1,25-dihydroxyvitamin D3 89
5.2.2.4 Calcitonin 90
5.2.3 Osteoblasts and Osteoclasts 90
5.2.4 Endocrine Aspects of Disordered Calcium
Metabolism 91
5.2.4.1 Overview 91
5.2.4.2 Hyperparathyroidism and Hypercalcaemia 91
5.2.4.2.1 Primary Hyperparathyroidism 91
5.2.4.2.2 Secondary and Tertiary
Hyperparathyroidism 91
5.2.4.2.3 Hypoparathyroidism and
Hypocalcaemia 92
5.2.4.2.4 Pseudohypoparathyroidism 92
5.2.4.3 Disorders of Bone Mineralisation 92
5.2.4.3.1 Rickets and Osteomalacia 92
5.2.4.3.2 Osteoporosis 93
5.3 Growth Hormone and Growth Disorders 93
5.3.1 Overview of Growth Hormone and its Secretion 93
5.3.2 Somatomedin C 94
5.3.3 Aberrant Growth Hormone Secretion 94
5.3.3.1 Introduction 94
5.3.3.2 Acromegaly and Gigantism 95
5.3.3.2.1 Aetiology and Clinical Features 95
5.3.3.2.2 Diagnostic Investigations 95
5.3.3.3 Treatment 96
5.3.3.4 Pituitary Dwarfism 96
5.3.3.4.1 Aetiology and Clinical Features 96
5.3.3.4.2 Diagnostic Investigations 96
5.3.3.4.3 Treatment 97
5.4 Hormones and Digestive Function 97
5.4.1 Diabetes and Insulin 97
5.4.1.1 Overview of Diabetes 97
5.4.1.2 Insulin Synthesis 97
5.4.1.3 Insulin Secretion 98
5.4.1.4 Types of Diabetes 98
5.4.1.5 Screening For Diabetes 98
5.4.1.5.1 Measurement of Basal Glucose
Concentration 98
5.4.1.5.2 Oral Glucose Tolerance Test 99
5.4.1.6 Clinical Features of IDDM 99
5.4.1.7 Clinical Features of NIDDM 100
5.4.1.8 In vitro Tests in the Management
of Diabetes 100
5.4.1.8.1 Insulin Replacement Therapy 100
5.4.1.8.2 Oral Hypoglycaemic Therapy 100
5.4.1.8.3 Measurement of Blood or Urinary
Glucose Concentration 101
5.4.1.8.4 Measurement of Glycosylated
Proteins 101
5.4.2 Nondiabetic Hypoglycaemia 101
5.4.2.1 Aetiology and Clinical Features 101
5.4.2.2 Insulinomas 102
5.4.2.2.1 Clinical Features 102
5.4.2.2.2 Diagnostic Investigations 103
5.4.2.2.3 Management of Insulinomas 103
5.4.2.3 Management of Other Types of
Hypoglycaemia 104
5.4.2.4 Neonatal Hypoglycaemia 104
5.4.3 Disturbances of other Digestion-related
Hormones 105
5.4.3.1 Glucagon or Somatostatin Oversecretion 105
5.4.3.2 Gastrin Oversecretion 105
5.5 Hormones Affecting Blood Pressure and
Electrolyte Balance 106
5.5.1 The Adrenal Cortex 106
5.5.2 Adrenocorticotrophic Hormone (ACTH) 106
5.5.3 Adrenal Cortical Steroid Production 106
5.5.4 Measurement of Adrenal Steroids 107
5.5.5 Cortisol 108
5.5.6 Cushing's Syndrome 108
5.5.6.1 Aetiology and Clinical Features 108
5.5.6.2 Diagnostic Investigations 109
5.5.6.2.1 Urinary Free Cortisol 109
5.5.6.2.2 Dexamethasone Suppression Tests 109
5.5.6.2.3 Insulin Tolerance Test 109
5.5.6.2.4 Basal and Stimulated Serum ACTH 110
5.5.6.3 Treatment of Cushing's Syndrome 110
5.5.7 Addison's Disease 110
5.5.7.1 Aetiology and Clinical Features 110
5.5.7.2 Diagnostic Procedures
and Investigations 111
5.5.7.2.1 Screening for Addison's Disease 111
5.5.7.2.2 Treatment of Addison's Disease 111
5.5.7.2.3 Withdrawal of Temporary
Steroid Therapy 111
5.5.8 Aldosterone 112
5.5.8.1 Function of Aldosterone 112
5.5.8.2 Renin-Angiotensin System 112
5.5.8.3 Primary Aldosteronism 112
5.5.8.3.1 Aetiology and Clinical Features 112
5.5.8.3.2 Laboratory Investigations 113
5.5.8.4 Secondary Aldosteronism and
Aldosterone Deficiency 114
5.6 Market Data for Digestive/Metabolic Hormones 114
5.6.1 Supplying Companies and Market Shares 114
Aldosterone 114
Angiotensin I (Renin Activity) 114
Cortisol 115
Gastrin 115
hGH 115
Insulin 116
Parathyroid Hormone 116
Glucose Test Strips and Readers 117
For Blood 117
For Urine 117
5.6.2 Sales Forecasts to 1995 117
Calcitonin 117
Cortisol 118
hGH 118
Insulin 119
Parathyroid hormone 119
Other metabolic hormones 120
Glucose Test Strips and Readers 120
Blood glucose test strips and readers 120
Urinalysis test strips and readers 120
5.6.3 Summary of Forecast Growth Rates 121
CHAPTER 6
ENDOCRINOLOGY AND CANCER
6.1 Introduction 122
6.2 Assessment of Tumour Differentiation 122
6.3 Biochemical Grading and Staging of Tumours 122
6.4 General Features of Endocrine Tumours 123
6.4.1 Tumours of Peripheral Endocrine Organs 123
6.4.2 Pituitary Tumours 124
6.4.3 Pancreatic Tumours 124
6.4.4 Prevalence of Endocrine Activity in Tumours 124
6.5 Survey of Specific Endocrine Tumours 125
6.5.1 The Carcinoid Syndrome and Carcinoid
Tumours 125
6.5.2 Multiple Endocrine Neoplasia 126
6.5.3 VIPomas 127
6.5.4 PP-omas 127
6.5.5 Vasopressinomas 128
6.5.6 hCG-secreting Tumours 128
6.6 Hormone Receptor Assays 129
6.6.1 Introduction 129
6.6.2 Radioreceptor Assays 130
6.6.3 Immunoassays and Immunohistochemistry 130
6.6.4 Receptor Assays in the Management of
Breast Cancer 130
6.6.5 Potential Value of Corticosteroid
Receptor Assays 131
6.7 Market Data for Cancer-related
Endocrinology Products 131
6.7.1 Supplier Information 132
6.7.2 Sales Forecasts to 1995 132
6.7.3 Summary of Forecast Growth Rates 132
CHAPTER 7
COMPANY PROFILES
7.1 Introduction 133
7.2 Abbott 133
7.3 Amersham International 133
7.4 Ares-Serono Group 134
7.5 Baxter 135
7.6 Becton Dickinson 135
7.7 Behring 136
7.8 bioMerieux 136
7.9 Boehringer Mannheim 137
7.10 Ciba-Corning Diagnostics 137
7.11 CIS Bioindustries 138
7.12 Diagnostic Products Corporation 138
7.13 Novo-Nordisk 139
7.14 Pharmacia-LKB 140
7.15 Sanofi-Diagnostics Pasteur 140
7.16 Sorin Biomedica 141
7.17 Endocrinology Market Summary 142
7.17.1 Market by Geographical Area
and Product Group 142
7.17.2 Breakdown of the Total Geographical Market 142
7.17.3 Leading Diagnostics Companies 143
APPENDIX 1
CORPORATE DIRECTORY 144
| |
