EP12-A

EP12-AVol.22No.14ReplacesEP12-PVol.20No.15UserProtocolforEvaluationofQualitativeTestPerformance;ApprovedGuidelineThisdocumentprovidesaprotocoldesignedtooptimizetheexperimentaldesignfortheevaluationofqualitativetests;tobettermeasureperformance;andtoprovideastructureddataanalysis.AguidelineforglobalapplicationdevelopedthroughtheNCCLSconsensusprocess.NCCLS...ServingtheWorld’sMedicalScienceCommunityThroughVoluntaryConsensusNCCLSisaninternational,interdisciplinary,nonprofit,standards-developing,andeducationalorganizationthatpromotesthedevelopmentanduseofvoluntaryconsensusstandardsandguidelineswithinthehealthcarecommunity.Itisrecognizedworldwidefortheapplicationofitsuniqueconsensusprocessinthedevelopmentofstandardsandguidelinesforpatienttestingandrelatedhealthcareissues.NCCLSisbasedontheprinciplethatconsensusisaneffectiveandcost-effectivewaytoimprovepatienttestingandhealthcareservices.Inadditiontodevelopingandpromotingtheuseofvoluntaryconsensusstandardsandguidelines,NCCLSprovidesanopenandunbiasedforumtoaddresscriticalissuesaffectingthequalityofpatienttestingandhealthcare.PUBLICATIONSAnNCCLSdocumentispublishedasastandard,guideline,orcommitteereport.StandardAdocumentdevelopedthroughtheconsensusprocessthatclearlyidentifiesspecific,essentialrequirementsformaterials,methods,orpracticesforuseinanunmodifiedform.Astandardmay,inaddition,containdiscretionaryelements,whichareclearlyidentified.GuidelineAdocumentdevelopedthroughtheconsensusprocessdescribingcriteriaforageneraloperatingpractice,procedure,ormaterialforvoluntaryuse.Aguidelinemaybeusedaswrittenormodifiedbytheusertofitspecificneeds.ReportAdocumentthathasnotbeensubjectedtoconsensusreviewandisreleasedbytheBoardofDirectors.CONSENSUSPROCESSTheNCCLSvoluntaryconsensusprocessisaprotocolestablishingformalcriteriafor:•theauthorizationofaproject•thedevelopmentandopenreviewofdocuments•therevisionofdocumentsinresponsetocommentsbyusers•theacceptanceofadocumentasaconsensusstandardorguideline.MostNCCLSdocumentsaresubjecttotwolevelsofconsensus—“proposed”and“approved.”Dependingontheneedforfieldevaluationordatacollection,documentsmayalsobemadeavailableforreviewatanintermediate(i.e.,“tentative”)consensuslevel.ProposedAnNCCLSconsensusdocumentundergoesthefirststageofreviewbythehealthcarecommunityasaproposedstandardorguideline.Thedocumentshouldreceiveawideandthoroughtechnicalreview,includinganoverallreviewofitsscope,approach,andutility,andaline-by-linereviewofitstechnicalandeditorialcontent.TentativeAtentativestandardorguidelineismadeavailableforreviewandcommentonlywhenarecommendedmethodhasawell-definedneedforafieldevaluationorwhenarecommendedprotocolrequiresthatspecificdatabecollected.Itshouldbereviewedtoensureitsutility.ApprovedAnapprovedstandardorguidelinehasachievedconsensuswithinthehealthcarecommunity.Itshouldbereviewedtoassesstheutilityofthefinaldocument,toensureattainmentofconsensus(i.e.,thatcommentsonearlierversionshavebeensatisfactorilyaddressed),andtoidentifytheneedforadditionalconsensusdocuments.NCCLSstandardsandguidelinesrepresentaconsensusopinionongoodpracticesandreflectthesubstantialagreementbymateriallyaffected,competent,andinterestedpartiesobtainedbyfollowingNCCLS’sestablishedconsensusprocedures.ProvisionsinNCCLSstandardsandguidelinesmaybemoreorlessstringentthanapplicableregulations.Consequently,conformancetothisvoluntaryconsensusdocumentdoesnotrelievetheuserofresponsibilityforcompliancewithapplicableregulations.COMMENTSThecommentsofusersareessentialtotheconsensusprocess.Anyonemaysubmitacomment,andallcommentsareaddressed,accordingtotheconsensusprocess,bytheNCCLScommitteethatwrotethedocument.Allcomments,includingthosethatresultinachangetothedocumentwhenpublishedatthenextconsensuslevelandthosethatdonotresultinachange,arerespondedtobythecommitteeinanappendixtothedocument.ReadersarestronglyencouragedtocommentinanyformandatanytimeonanyNCCLSdocument.AddresscommentstotheNCCLSExecutiveOffices,940WestValleyRoad,Suite1400,Wayne,PA19087,USA.VOLUNTEERPARTICIPATIONHealthcareprofessionalsinallspecialtiesareurgedtovolunteerforparticipationinNCCLSprojects.PleasecontacttheNCCLSExecutiveOfficesforadditionalinformationoncommitteeparticipation.Volume22EP12-AiUserProtocolforEvaluationofQualitativeTestPerformance;ApprovedGuidelineAbstractNCCLSdocumentEP12-A—UserProtocolforEvaluationofQualitativeTestPerformance;ApprovedGuidelineprovidestheuserwithaconsistentapproachforprotocoldesignanddataanalysiswhenevaluatingqualitativediagnostictests.Guidanceisprovidedforbothreproducibilityandmethod-comparisonstudies.NCCLS.UserProtocolforEvaluationofQualitativeTestPerformance;ApprovedGuideline.NCCLSdocumentEP12-A(ISBN1-56238-468-6).NCCLS,940WestValleyRoad,Suite1400,Wayne,Pennsylvania19087-1898USA,2002.THENCCLSconsensusprocess,whichisthemechanismformovingadocumentthroughtwoormorelevelsofreviewbythehealthcarecommunity,isanongoingprocess.Usersshouldexpectrevisededitionsofanygivendocument.Becauserapidchangesintechnologymayaffecttheprocedures,methods,andprotocolsinastandardorguideline,usersshouldreplaceoutdatede