Laboratory Guidebook实验室指南 变更通知书.pdf

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1、UnitedStatesFoodSafetyOfficeofLaboratoryQAStaffDepartmentofandInspectionPublicHealth950CollegeStationRoadAgricultureServiceScienceAthens,GA30605_______________________________________________________________________________________________LaboratoryGuidebookNoticeofChangeChapternew,

2、revised,orarchived:MLGAppendix2.05Title:MostProbableNumberProcedureandTablesEffectiveDate:06/29/14Descriptionandpurposeofchange(s):TheconfirmationprocedureforinconclusivescreentestsforMPNtubeswasadded.ThemethodsdescribedinthisguidebookareforusebytheFSISlaboratories.FSISdoesnotspecif

3、icallyendorseanyofthementionedtestproductsandacknowledgesthatequivalentproductsmaybeavailableforlaboratoryuse.Methodvalidationisnecessarytodemonstratetheequivalenceofalternativetestsasdetailedinthedocumenttitled“FSISGuidanceforEvaluatingTestKitPerformance”availableontheFSISwebsite._

4、______________________________________________________________________________________QD-F-Micro-0004.07IssuingAuthority:Director,LaboratoryQualityAssuranceStaff(LQAS)Page1of1Effective:09/30/13UnitedStatesDepartmentofAgricultureFoodSafetyAndInspectionService,OfficeofPublicHealthScie

5、nceMLGAppendix2.05Page1of8Title:MostProbableNumberProcedureandTablesRevision:05Replaces:04Effective:06/29/14APP2ProcedureAPP2.1IntroductionAPP2.1.1FortheconvenienceofanalystsusingtheproceduresinthisGuidebook,tablesofMostProbableNumbers(MPN)areprovidedinthisappendix.APP2.1.2MPNisapro

6、ceduretoestimatethepopulationdensityofviablemicroorganismsinatestsample.Itisbasedupontheapplicationofthetheoryofprobabilitytothenumbersofobservedpositivegrowthresponsestoastandarddilutionseriesofsampleinoculumplacedintoasetnumberofculturemediatubes.Positivegrowthresponseafterincubat

7、ionmaybeindicatedbysuchobservationsasgasproductioninfermentationtubesorvisibleturbidityinbrothtubes,dependinguponthetypeofmediaemployed.Thesampleshouldbedilutedinsuchamannerthathigherdilutionsofthesamplewillresultinfewerpositiveculturetubesintheseries.Thenumberofsampledilutionstobep

8、reparedisgenerallyb