实验诊断学(英文版)第一章.ppt

实验诊断学(英文版)第一章.ppt

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Chapter1GeneralofClinicalLaboratory,LIPing,Generalofclinicallaboratory,PrinciplestoclinicallaboratoryTheinterpretationoflaboratorytestsTheethicalpractice,Principletoclinicallaboratory,ResponsibilitiesCollectionofInformationCollectionofSpecimens（Informedconsent、Adequateprivacy）PerformanceofTestReportingofResultStorageandRetentionofMedicalRecordsAccesstoMedicalRecords,Responsibilities,Thepatient-assurancethequalityandintegralityoftheserviceColleagueandprofessional-maintainprofessionalreputation,aimtocontributetheadvancementofprofessionSociety-contributetothegeneralwell-beingofsociety;complywithrelevantlawsandregulationsofprofessionalactivities.,Collectionofinformation,IdentifyadequatelypatientsandspecimensEnablethetesttobecorrectlyinterpretedOtherlegitimatepurposes,Performanceofthetest,Accreditationprogram,Patientsinterests,Processstandard,Workswithhighskillandcompetence,Goodperformanceoftests,ReportingofResult,Testresultsareconfidentialunlessdisclosureisauthorized.ReporttheresultscorrectlyandtimelyProvidetheconsultationabouttheselectionandinterpretationoftestsproperly,AccesstoMedicalRecords,clinicianrequestingthetest;thepatient;laboratoryandhospitalstaffifrequiredforthemanagementofthepatient;otherauthorizedindividuals.Whenarequestismadeforaccesstotestresultsbyanauthorizedperson,thelaboratorymustfirstsatisfyitselfastotheidentityofthepersonmakingtherequest.,Who?

INTERPRETLABORATORYTEST,Selecttest,Patientsprepareforsampling,Collectspecimen,Pre-processofspecimen,Analyzespecimen,Check、reportresult,Makeclinicaldecision,Biologicalvariability,improperorinconsistentpreparation,ImproperorinconsistantCollection,Improperprovision,suboptimumselection,Analyticalvariabilty,InadequateRVs,MinimizevariabilityNoconfusionandmisunderstandingabouttestresults,TestingCycle,Biologicvariatinon,Endogenousbiorhythmsforphysiologicparameters,Differentconstitutionalfactorsandlifestyleamongsubjects,within-subjectvariation,subject-tosubjectvariation,Biologicalvariation,WidthofthetestsReferencinterval（RI）,thediagnosticefficiencyofalaboratorytest,BiologicalrhythmsConstitutionalfactorsExtrinsicfactors,ThreetypesofBiologicalrhythms,Biologicvariation,endogenousbiorhythmsforphysiologicparameters,Differentconstitutionalfactorsandlifestyleamongsubjects,within-subjectvariation,subject-tosubjectvariation,Biologicalvariation,WidthofthetestsReferencinterval（RI）,thediagnosticefficiencyofalaboratorytest,BiologicalrhythmsConstitutionalfactorsExtrinsicfactors,BiologicvariabiltyConstitutionalfactor,infants,children,adults,elderly,rapidphysiologicchanges、hemolysis、bilirubin,Plasmaproteinenzymesexhormones,constantuntilmenopauseinwomenandmiddleageinmen,age-relateddifferencesinnutrition、intercurrentdisease,Agespecificreferencelimits,age,Age,BiologicvariabiltyConstitutionalfactor,Geneticheterogeneity,phenotypicdifferences,Differentconcentrationofanalyte,Differentreactivitytowardsnucleicacidprobesandantibodies,false-negative,Misleading,Geneticheterogeneity,Biologicvariabilty-ExtrinsicFactors,vascularinterstitialspace,supine,stand,H2OSmallanalyte,plasmavolume,Concentrationofnondiffusiblanalyte,homeostasisofvasculartone,renninaldosteronecatecholamines,Posture,BiologicvariabiltyExtrinsicFactors,shiftsinplasmawaterglomerularfiltrationrateurineproductionreleaseofmacromoleculesfromcellsandtissues,Exercise,Biologicvariabilty-ExtrinsicFactors,mealrelatedfastingrelatedRecommendation:

durationoffastingbeforespecimencollectionistypically12hours,TGTCBUNGLU.,LacAcetoneGlucagons.,Diet,BiologicvariabiltyExtrinsicFactors,TypesofInterferenceAnalyticalinterferencePhysiologicinterferenceRecommendationRecognizedrugspotentialforoccurrence,withdrawmedicationsbeforesamplingwheneverpossible,Evaluatanysuspiciousresultsinlightofasubjectsmedicationhistory.,Drug,Biologicvariabilty-ExtrinsicFactors,plasmavolume,erythrocytemass,plasmaproteinsynthesis,altereddistributionofcardiacoutput,endocrinologicchanges,hyperventilation,Pregnancy,Biologicvariation-summary,BiologicalrhythmsCircadian,Ultradian,InfradianrhythmsConstitutinalfactorsGender,age,geneExtrinsicfactorsPosture,Exercise,Diet,Drugs,Pregnancy,Caffeine,Alcoholuse,OralContraceptives,IntercurrentIllness,EstablishandvalidateRVs,Establishclinicalperformancecharacteristics,Why?

HelpcliniciantoselectthemosteffectivetestsandtestingstrategiesHelpcliniciantotranslatelaboratoryresultsintoaprobabilitystatementHelpthelaboratorydirectortofocustheresourcesofthelaboratoryontestswiththehighestclinicalrelevance,How?

Collectdata,phaseIIandphaseIIIclinicaltrials,EstablishandvalidateRVs,Howtoassurethevalidityoftheparametersderivedfromclinicaltrials?

UsegoldstandardtodefineeverysubjectsstatusAbroadspectrumofhealthyanddiseasedsubjects,includepatientswithawiderangeofclinicalpresentations.CIsshouldbecalculatedforalltheparametersthatareestimated.Whennewtestcompareswiththeoldtest,assuresampleofpatientslargeenoughanddataexactly.,?

SensitivityandSpecificity,SensitivityandSpecificity,ExpresstheprobabilitythatadiseasedsubjectwillhaveanabnormalresultExpresstheprobabilitythatanondiseasedpatientwillhavearesultwithintheRI,Sensitivity（Se）=TP/（TP+FN）,Specificity（Sp）=TN/（TN+FP）,PredictiveValue,TheprobabilitythatasubjectwithapositivetestresulttrulyhasthediseaseTheprobabilitythatasubjectwithanegativetestresulttrulyishealthy.PVsareonlyaccuratewhenthetestisappliedtopopulationswithadiseaseprevalencethatissimilartothatofthestudysample.,PV+=TP/（TP+FP）,PV-=TN/（TN+FN）,Note,ROCCurves,WhatisROCcurveusedfor?

Determinethemostefficientdecisionthresholdorcutoffvalueforalaboratorytest.Comparetherelativeclinicalaccuraciesofdifferentlaboratorytestsinaparticularclinicalsetting,?

ROCCurves,LikelihoodRatios,LHRexpresstheprobabilitythataparticularwilloccurinadiseasedsubjectdividedbytheprobabilitythatthesameoutcomewilloccurinanondiseasedsubject.Forcontinousvariabletest,LHRscanbeestablishedfordifferentrangesoftestresults,sothemagnitudeofatestresultprovidesadditionaldiscriminatorypower,LHR+=Se/（1-Sp）=TPrate/FPrate,LHR-=（1-Se）/Sp=FNrate/TNrate,LikelihoodRatios,TPraterepresentbenefitofthetest,FPraterepresentsthecostsassociatedwithtesting,soLHR+representsacost-benefitratio.ItissimilartoLHR-.TheLHR+andLHR-allowthedirectestimationoftheposttestprobabilityofdiseaseinviewofthenewinformationcontributedbythetestresult.,LHR+=TPrate/FPrate,LikelihoodRatios,LHRallowtheinformationfromdifferentmodalitiestobecombinedinserialdiagnosticschemesor“criticalpathways”forwhichoverallpredictivevaluescanbecalculated.,EstimatingLHRfromROCCurves,LHRsforaparticulartestcanalsobeobtaineddirectlyformaROCcurvebyevaluatingtheslopesofthecurveindifferentregionscontinuousvariabletestpositive/negativetesttestthatclassifiedintomorethantwointervals,ETHICALPRACTICE,Ethicalpracticecanberegardedasappropriatetechnicalpracticeaccompaniedbyintegrityinattitudesandbehavior.Medicallaboratoryservicesareanintegralpartofmedicalservices,Thesamestandardsandethicalprinciplesthatgovernthedeliveryofclinicalserviceswillalsoapplytothedeliveryoflaboratoryservices.,Definitions,WhyDoWeNeedEthics?

ETHICALPRACTICE,TechnicallycompetentserviceConsultation（selectandinterpretthetests）ProtectthepatientsinterestsConfidentialityMedicalethicsexistfortheprotectionofpatients,andthisprotectionmustnotbecompromised.,Doctor-PatientRelationship,CommonRequirementsOfMedicalLaboratoryEthics,SpecialRequirementsOfMedicalLaboratoryEthics,PrinciplesOfEthics,Autonomy、Beneficence、Nonmaleficence、JusticeTheethicalstandardsofthoseworkinginmedicallaboratoriesarederivedfrommedicalethicsandincorporatethesameprinciples.,MedicalEthics,EthicsInMedicalLaboratories,Thanks!