faid50实验方法

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1、SAM316.04 Page1of12UnitedStatesDepartmentofAgriculture CenterforVeterinaryBiologics TestingProtocolSAM316SupplementalAssayMethodfortheTitrationofCanineParvovirusinCell CultureDate:June30,2011Number:SAM316.04Supersedes:SAM316.03,August6,2007StandardRequirement:9CFR,Part113.317Co

2、ntact:AletheaM.Fry,(515)337-7460Approvals:/s/DonnaM.GatewoodDate:14Jul11DonnaM.Gatewood,SectionLeader Virology/s/ByronE.RippkeDate:16Jul11 ByronE.Rippke,DirectorPolicy,Evaluation,andLicensingCenterforVeterinaryBiologics/s/RebeccaL.W.HydeDate:22Jul11 RebeccaL.W.Hyde,SectionLeade

3、rQualityManagementCenterforVeterinaryBiologicsUnitedStatesDepartmentofAgriculture AnimalandPlantHealthInspectionService P.O.Box844Ames,IA50010MentionoftrademarkorproprietaryproductdoesnotconstituteaguaranteeorwarrantyoftheproductbyUSDA anddoesnotimplyitsapprovaltotheexclusionof

4、otherproductsthatmaybesuitable.UNCONTROLLEDCOPYCenterforVeterinaryBiologicsSAM316.04 TestingProtocolPage2of12SupplementalAssayMethodfortheTitrationofCanineParvovirusinCellCultureTableofContents1.Introduction2.Materials2.1Equipment/instrumentation2.2Reagents/supplies3.Preparatio

5、nfortheTest3.1Personnelqualifications/training3.2Preparationofequipment/instrumentation3.3Preparationofreagents/controlprocedures3.4Preparationofthesample4.PerformanceoftheTest5.InterpretationoftheTestResults6.ReportofTestResults7.References8.SummaryofRevisionsUNCONTROLLEDCOPYC

6、enterforVeterinaryBiologicsSAM316.04 TestingProtocolPage3of12SupplementalAssayMethodfortheTitrationofCanineParvovirusinCellCulture1.IntroductionThisSupplementalAssayMethod(SAM)describesaninvitrotestmethodforassaying modified-livecanineparvovirus(CPV)vaccinesforviralcontent.Them

7、ethodusestheCrandell felinekidney(CRFK)celllineasthetestsystem.CPVendpointisdeterminedbystaining inoculatedcellculturesbyanindirectfluorescentantibody(IFA)stainingmethod.2.Materials2.1Equipment/instrumentationEquivalentequipmentorinstrumentationmaybesubstitutedforanybrandnameli

8、sted below.2.1.1Incubator,36°±2°C,highhumidity,5%±1%CO