罗氏准确度评估方案

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1、Blood-glucoseMonitoringSystemEvaluationProtocolAccuracyStudyProtocolforGlucoseMeterEvaluations4PurposeThisprotocolisaguidancetoolforperformingaccuracystudiesandisrecommendedforusewiththeRocheACCU-CHEKandAccuDataglucosemonitoringsystems.1Ifyouwishtoincludeothermanufacturers’systemsinyourstudiesyoush

2、ouldcontacteachvendortoobtaintheirrecommendedevaluationprotocols.IntroductionAccuracy,alsoknownas“trueness,”istheclosenessofagreementbetweenatestresultandanacceptedreferencevalue.AccuracystudiesonACCU-CHEKandAccuDataglucosemonitoringsystemsareconductedbyperformingwholebloodtestsonthemetersystemandt

3、hentestingplasmaorserumfromthesame(orconcurrentlycollected)samplesusingyourreferencechemistryanalyzer.Avarietyofstatisticalindicatorscanbeemployedtoassesstheoutcomeofastudy,butthemostcommonindicatorsofaccuracyarethecorrelationcoefficient(r),slope,yintercept,standarderror,andbiasanalysis.FactorstoCo

4、nsider1.Anappropriatereferencemethodforyouraccuracystudyistheprimarysystemusedinyourlaboratorytoperformroutineandstatglucosetesting.Theaccuracyofthereferencemethodshouldbedemonstrablethroughcomparativestudieswithadefinitivemethodorthroughtraceabilityofstandardreferencematerials.2.Aminimumof20sample

5、s–optimally40samples–shouldbeanalyzedinyourstudy.7,8Everyindividualsamplehasauniquematrixcausingittoexhibitaparticularcorrelationtoyourreferenceanalyzer.Itisimportanttoincludesamplesfromabalancedvarietyofsubjectsthatrepresentyourtypicalpatientpopulationinyourstudyinordertopreventmatrix-basedbiasesf

6、romskewingyourstudyoutcome.Healthystaffvolunteersmaybeusedasasupplementalsourceofsamples,buttheyarenotrepresentativeofyourpatientpopulationandshouldnotbeusedasamajoritysourceofsamples.3.Glucosevaluesthatarewelldistributedthroughouttheanalyticalmeasurementrange(AMR)ofthesystemshouldbeincludedinthest

7、udy.Approximately50%oftheglucosevaluesshouldbeoutsideofthenormalrange.ThevalidityofstatisticalanalysisofyourstudydataisdependentuponagooddistributionofdatapointsthroughouttheAMR.TheRoche“GlucoseSpikingProto