实验诊断学(英文版)第一章

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.Medicallabora