IMMUNOASSAYS IN AGRICULTURAL BIOTECHNOLOGY IMMUNOASSAYS IN AGRICULTURAL BIOTECHNOLOGY Edited by GUOMIN SHAN Copyright(cid:1)2011byJohnWiley&Sons,Inc.Allrightsreserved PublishedbyJohnWiley&Sons,Inc.,Hoboken,NewJersey PublishedsimultaneouslyinCanada Nopartofthispublicationmaybereproduced,storedinaretrievalsystem,ortransmittedinanyformorby anymeans,electronic,mechanical,photocopying,recording,scanning,orotherwise,exceptaspermitted underSection107or108ofthe1976UnitedStatesCopyrightAct,withouteitherthepriorwritten permissionofthePublisher,orauthorizationthroughpaymentoftheappropriateper-copyfeetothe CopyrightClearanceCenter,Inc.,222RosewoodDrive,Danvers,MA01923,(978)750-8400, fax(978)750-4470,oronthewebatwww.copyright.com.RequeststothePublisherforpermissionshould beaddressedtothePermissionsDepartment,JohnWiley&Sons,Inc.,111RiverStreet,Hoboken, NJ 07030, (201) 748-6011, fax (201) 748-6008, or online at http://www.wiley.com/go/permission. LimitofLiability/DisclaimerofWarranty:Whilethepublisherandauthorhaveusedtheirbestefforts inpreparingthisbook,theymakenorepresentationsorwarrantieswithrespecttotheaccuracyor completenessofthecontentsofthisbookandspecificallydisclaimanyimpliedwarrantiesof merchantabilityorfitnessforaparticularpurpose. Nowarrantymaybecreatedorextendedbysales representativesorwrittensalesmaterials.Theadviceandstrategiescontainedhereinmaynotbesuitablefor yoursituation. Youshouldconsultwithaprofessionalwhereappropriate. Neitherthepublishernorauthor shallbeliableforanylossofprofitoranyothercommercialdamages,includingbutnotlimitedtospecial, incidental,consequential,orotherdamages. Forgeneralinformationonourotherproductsandservicesorfortechnicalsupport,pleasecontactour CustomerCareDepartmentwithintheUnitedStatesat(800)762-2974,outsidetheUnitedStates at(317)572-3993orfax(317)572-4002. Wileyalsopublishesitsbooksinavarietyofelectronicformats.Somecontentthatappearsinprint maynotbeavailableinelectronicformats.FormoreinformationaboutWileyproducts,visitourwebsite at www.wiley.com. LibraryofCongressCataloging-in-PublicationDataisavailable. ISBN:978-0-470-28952-5 PrintedinSingapore oBook:978-0-470-90993-5 eBook:978-0-470-90992-8 ePub:978-0-470-92268-2 10 9 8 7 6 5 4 3 2 1 CONTENTS FOREWORD VII PREFACE IX CONTRIBUTORS XI CHAPTER1 INTRODUCTION 1 GuominShan CHAPTER2 PRINCIPLESOFIMMUNOASSAYS 5 ClaudiaSheedyandKerrmY.Yau CHAPTER3 ANTIBODYENGINEERINGINAGRICULTURALBIOTECHNOLOGY 23 PatrickDoyle,MehdiArbabi-Ghahroudi,ClaudiaSheedy, KerrmY.Yau,and J.ChristopherHall CHAPTER4 MICROTITERPLATEELISA 59 MichaelC.Brown CHAPTER5 LATERALFLOWDEVICES 91 MuraliBandla,RickThompson,andGuominShan CHAPTER6 IMMUNOASSAYMETHODVALIDATION 115 JeanSchmidtandClaraAlarcon CHAPTER7 REFERENCEMATERIALSANDCONSIDERATIONS 139 TandaceA.ScholdbergandG.RonaldJenkins CHAPTER8 AUTOMATIONOFIMMUNOASSAYS 175 MicheleYarnall CHAPTER9 DATAINTERPRETATIONANDSOURCESOFERROR 189 RodA.HermanandGuominShan v vi CONTENTS CHAPTER10 IMMUNOASSAYAPPLICATIONSINTRAITDISCOVERY, PRODUCTDEVELOPMENT,ANDREGISTRATION 219 BerylPacker,AndreSilvanovich,andG.DavidGrothaus CHAPTER11 IMMUNOASSAYAPPLICATIONSINGRAINPRODUCTS ANDFOODPROCESSING 241 GinaM.ClapperandLuluKurman CHAPTER12 IMMUNOASSAYAPPLICATIONSINSOILMONITORING 257 GuominShan CHAPTER13 IMMUNOASSAYAPPLICATIONSINPLANT-BASEDBIOPHARMA 271 ThomasPattersonandGregoryGilles CHAPTER14 IMMUNOASSAYSINVETERINARYPLANT-MADEVACCINES 289 GiorgioDeGuzman,RobertP.Shepherd,andAmandaM.Walmsley CHAPTER15 IMMUNOASSAYASAGMDETECTIONMETHODIN INTERNATIONALTRADE 309 RayShillitoandThomasCurrier CHAPTER16 FUTUREPERSPECTIVESANDCHALLENGES 325 ZiLucyLiu,Ai-GuoGao,LeslieA.Harrison,KerrmY.Yau,JohnLawry, andGuominShan INDEX 341 FOREWORD Thepowerfulanalyticaltechniqueofimmunoassayhasexperiencedever-expanding use in a variety of applications and settings since the pioneering work of Yallow and Berson a half century ago. The application of immunoassays to agricultural biotechnologyisexpandingandthuscreatesagreatneedforawidevarietyofusersto understand and implementimmunoassays andrelated technologies. Thisbookdescribestheapplicationofimmunoassaytechnologyinagricultural biotechnologyproductdiscovery,researchanddevelopment,manufacturing,quality control,andnationalandinternationalregulatorycompliance.Oneuniquefeatureof thisbookisitscontributors,whoareexperiencedpractitionersfrommajoragricultural biotechcompanies,immunoassayreagentmanufacturers,academicresearchinstitu- tions,andgovernment agencies.Coveringawidevarietyoftopics, the bookoffers practical guidance for assay/kit development, assay validation, data analysis and implementationaswellasdiscussionsofnewtechnologiesandperspectives.Itisan annotatedwindowintopreviousliteratureaswellasatextprovidingboththeoryand practicalinstructions.Thisbookwillfindwidespreadutilityamongallthoseinvolved in thisexciting newfield. BRUCE HAMMOCK Distinguished Professor ofEntomology & CancerResearch Center University ofCalifornia, Davis vii
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