ep15-a.准确度精密度评价.pdf

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1、EP15-AReplacesEP15-PVol.21No.25Vol.18No.22UserDemonstrationofPerformanceforPrecisionandAccuracy;ApprovedGuidelineThisdocumentdescribesthedemonstrationofmethodprecisionandaccuracyforlaboratoryanalytedeterminationsutilizingaprotocoldesignedtobecompletedwithinfiveworkingday

2、sorless.AguidelineforglobalapplicationdevelopedthroughtheNCCLSconsensusprocess.NCCLS...ServingtheWorld’sMedicalScienceCommunityThroughVoluntaryConsensusNCCLSisaninternational,interdisciplinary,nonprofit,theneedforfieldevaluationordatacollection,documentsstandards-develop

3、ing,andeducationalorganizationthatmayalsobemadeavailableforreviewatanintermediatepromotesthedevelopmentanduseofvoluntary(i.e.,“tentative”)consensuslevel.consensusstandardsandguidelineswithinthehealthcareProposedAnNCCLSconsensusdocumentundergoesthecommunity.Itisrecognized

4、worldwideforthefirststageofreviewbythehealthcarecommunityasaapplicationofitsuniqueconsensusprocessintheproposedstandardorguideline.Thedocumentshoulddevelopmentofstandardsandguidelinesforpatientreceiveawideandthoroughtechnicalreview,includingantestingandrelatedhealthcarei

5、ssues.NCCLSisbasedonoverallreviewofitsscope,approach,andutility,andaline-theprinciplethatconsensusisaneffectiveandcost-by-linereviewofitstechnicalandeditorialcontent.effectivewaytoimprovepatienttestingandhealthcareservices.TentativeAtentativestandardorguidelineismadeavai

6、lableforreviewandcommentonlywhenaInadditiontodevelopingandpromotingtheuseofrecommendedmethodhasawell-definedneedforafieldvoluntaryconsensusstandardsandguidelines,NCCLSevaluationorwhenarecommendedprotocolrequiresthatprovidesanopenandunbiasedforumtoaddresscriticalspecificd

7、atabecollected.Itshouldbereviewedtoensureitsissuesaffectingthequalityofpatienttestingandhealthutility.care.ApprovedAnapprovedstandardorguidelinehasachievedPUBLICATIONSconsensuswithinthehealthcarecommunity.ItshouldbeAnNCCLSdocumentispublishedasastandard,reviewedtoassessth

8、eutilityofthefinaldocument,toguideline,orcommitteereport.ensureattainmentofconsensus(i.e.,thatcommentso