Immunoassays : development, applications and future trends

470 Pages·2017·14.12 MB·English

by  Richard O'Kennedy

Immunoassays

Pan Stanford Series on Renewable Energy — Volume 2
Immunoassays
Development, Applications and Future Trends
edited by
editors
Richard 0’Kennedy
Preben Maegaard
Anna Krenz Caroline Murphy
Wolfgang Palz
The Rise of Modern Wind Energy
Wind Power
for the World
April21,2017 8:57 PSPBook-9inx6in 00-O’Kennedy-Prelims
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Immunoassays:Development,ApplicationsandFutureTrends
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ISBN978-981-4669-97-9(Hardcover)
ISBN978-1-315-20654-7(eBook)
PrintedintheUSA
April21,2017 8:57 PSPBook-9inx6in 00-O’Kennedy-Prelims
Contents
Preface xv
Glossary xvii
1 AnOverviewofImmunoassays 1
CarolineMurphy,SarahGilgunn,andRichardO’Kennedy
1.1 IntroductiontoAntibodiesandImmunoassays 1
1.1.1 PolyclonalAntibodyProduction 3
1.1.2 ProductionofMonoclonalAntibodies 4
1.1.3 RecombinantAntibodyFragments 5
1.1.3.1 Productionofrecombinantantibodies
byphagedisplaytechnology 6
1.2 TypesofImmunoassays 7
1.3 ChoosingaSuitableImmmunoassayTechnique 9
1.3.1 DetectionofTargetAnalyte:AnImmunometric
Approach 9
1.3.1.1 Directimmunoassay 9
1.3.1.2 Indirectimmunoassay 10
1.3.1.3 Sandwichimmunoassay 11
1.3.2 DetectionofSmallMoleculesUsinga
CompetitiveApproach 12
1.4 SignalGenerationinImmunoassays 14
1.4.1 SignalGeneration 14
1.4.1.1 Colourimetryasamethodof
immuno-detection 14
1.4.1.2 Luminescenceasamethodof
immuno-detection 18
1.4.2 Nanomaterials,forSignalGenerationand
Immobilisation 21
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vi Contents
1.5 NextGenerationSignalTransductionSystems 23
1.5.1 ElectrochemicalTransducersforImmunoassay
Applications 24
1.5.2 NanomechanicalSensors/PiezoelectricMass
Sensors 24
1.5.3 OpticalSignalTransduction 27
1.6 ConclusionsandKeyIssues 27
2 RecombinantAntibodiesforDiagnosticApplications:Design
ConsiderationsandStructuralCorrelates 37
StephenHeartyandRichardO’Kennedy
2.1 DiagnosticAntibodies:Co-optingNaturalImmunity 38
2.2 HarnessingNaturalDiversity 38
2.3 Affinity 41
2.4 ExploitingSyntheticDiversityinvitro 43
2.4.1 IntroducingDiversity 44
2.4.2 IntroducingDiversity:AffinityMaturation 46
2.5 ParadigmsChallenged 47
2.6 Single-DomainAntibodies 49
2.7 Conclusion 53
3 SurfacesandImmobilisationStrategiesforUsein
ImmunoassayDevelopment 59
ChandraK.DixitandPaulConroy
3.1 Introduction 60
3.2 TailoringImmunoassaySurfaces 63
3.2.1 SurfaceDesigning/Modulationand
CustomisationforAntibodyImmobilisation
andImmunoassayDevelopment 64
3.2.1.1 Precursormodulationand
post-manufacturetreatmentsfor
controllingthesurfaceproperties 64
3.2.1.2 Graftingfunctionalgroupsbyphysical
andchemicalmethods 69
3.3 AntibodyImmobilisation 71
3.4 AntibodyConjugationtoQuantumDots 75
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Contents vii
3.5 AspectsandCaseStudiesofAntibodyImmobilisation 76
3.6 ConclusionsandFuturePerspectives 80
4 ImmunoassayValidation 89
PaulLeonard
4.1 WhyIsValidationNecessary? 90
4.2 AssayValidationOverview 90
4.2.1 Planning‘ItTakesTimetoSaveTime’ 91
4.3 AssayDevelopment 92
4.3.1 ImmunogenforAntibodyProductionand
Screening 95
4.3.2 AntibodyProduction 96
4.3.3 AssayFormat 96
4.4 Pre-validation 97
4.4.1 SelectAssayReagents 97
4.4.2 EvaluateAssayConditions 97
4.4.3 DefineCalibrationModel 98
4.4.4 EvaluateSelectivityandSpecificity 99
4.4.5 PreliminaryEstimatesforLLOQandULOQ 100
4.4.6 PreliminaryEstimatesofPrecisionand
Accuracy 101
4.4.7 EstimationoftheAssayLimitofDetection
(LOD) 104
4.4.8 ReferenceMethod 107
4.4.9 ValidationSamplesandMethodDefinition 108
4.4.10 EvaluateExtractionEfficiency/Effects 108
4.5 Pre-studyValidation 110
4.5.1 Stability 110
4.5.2 EvaluateDilutionalLinearity 111
4.5.3 EvaluateAssayRobustnessandRuggedness 112
4.5.4 AssayValidationReportandDocumentation 112
4.6 Summary 113
5 Lab-on-a-ChipImmunoassaySystems 117
BarryByrneandLouiseM.Barrett
5.1 Introduction 118
5.2 SubstratesUsedforMicrofluidicChipDesign 119
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viii Contents
5.3 MicrofluidicChannelDesignandFabrication 122
5.4 AnalyteDelivery,MixingandWashing 125
5.5 AntibodyIntegration 128
5.6 Lab-on-a-Chip–BasedImmunodetection:Applications 132
5.6.1 BacterialPathogensandToxins 132
5.6.2 MarineandFungalToxins 140
5.7 DiseaseMarkersandTheirDetectionUsing
Microfluidics-BasedDevices 145
5.8 Conclusions 148
6 ClinicalApplicationsofImmunoassays 161
KarenLawlerandGregorKijanka
6.1 ClinicalSpecimenAnalysis 162
6.2 CardiovascularDisease 165
6.2.1 IschemicHeartDiseaseandCardiacEnzymes 165
6.2.2 HeartFailureandBrainNatriureticPeptide 166
6.2.3 SerumLipidsandLipoproteins 167
6.3 RespiratoryDisease 168
6.3.1 BacterialRespiratoryInfections 168
6.3.1.1 Streptococcuspneumonia 168
6.3.1.2 Legionellaspecies 169
6.3.1.3 Mycoplasmapneumonia 169
6.3.1.4 Haemophilusinfluenzae 170
6.3.1.5 Chlamydiapneumonia 170
6.3.2 FungalRespiratoryInfections 170
6.3.2.1 Aspergillus 170
6.3.3 ViralRespiratoryInfections 171
6.3.3.1 InfluenzaAandB 171
6.3.4 CysticFibrosis 171
6.3.5 PulmonaryEmbolismandD-Dimers 172
6.4 Endocrinology 173
6.4.1 Type1DiabetesMellitus 173
6.4.2 ThyroidDisease 173
6.4.3 AdrenalHormoneandCushing’sSyndrome 174
6.5 Rheumatology 175
6.5.1 RheumatoidArthritis 175
6.5.2 SystemicLupusErythematosus 176
6.5.3 SystemicSclerosis 177
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Contents ix
6.5.4 Sjo¨gren’sSyndrome 177
6.5.5 Vasculitis 178
6.5.6 DermatomyositisandPolymyositis 178
6.6 Oncology 179
6.6.1 Alpha-Fetoprotein 179
6.6.2 Prostate-SpecificAntigen 180
6.6.3 CarbohydrateAntigens 181
6.6.3.1 CA125 181
6.6.3.2 CA15-3andCA27-29 181
6.6.3.3 CA19-9 181
6.6.4 CarcinoembryonicAntigen 181
6.6.5 Beta-HumanChorionicGonadotrophin 182
6.6.6 Antibody-AssociatedParaneoplasticDisease 182
6.7 Conclusion 183
7 Immunoassay-BasedDetectionofInfectiousandParasitic
Diseases 191
PaulJ.Conroy
7.1 Introduction 192
7.2 CurrentTechnologiesfortheDetectionofInfectious
DiseasesinHumans 193
7.2.1 AppropriateTechnologies 196
7.2.2 HumanImmunodeficiencyVirus(HIV) 197
7.2.3 Tuberculosis 198
7.2.4 Malaria 199
7.2.5 RapidlySpreadingInfectiousAgents 200
7.3 ChallengesinDetectingInfectiousandParasitic
Diseases 202
7.3.1 CurrentResearchintoNewPlatform
Development 202
7.3.2 CurrentAntibodiesforInfectiousDisease
Agents 205
7.4 FutureTrends 207
7.4.1 RapidAssayDevelopment:Antibodies 207
7.4.2 RapidAssayDevelopment:Microfluidicsand
NanotechnologyandTheirRelevanceto
InfectiousDiseaseDetection 209
7.5 Conclusion 212