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1、CardioChekLipidPanelEvaluationProtocolPage11252010PolymerTechnologySystemsInc.CardioChekPAComparisonStudyEvaluationProtocolBiasStudyPrecisionLinearRegressionFapplicationwithcomparisonstotheReferenceLabatyStardCardioChekL
2、ipidPanelEvaluationProtocolPage31252010Aminimumof20patientsshouldbeusedsothatthedataisstatisticallyrelevant.TheassayrangesfthepatientsedshouldencompassthedynamicrangeoftheCardioChekLipidPanelassaysbedistributedtotheexten
3、tpossibleasindicatedinthetablebelow.Notethatitisoftendifficulttofillthehigherrangeintheseinstanceswherethedesirednumberofpatientscannotbeobtainedinanybracketadditionaldonsshouldbeaddedtotherangetofulfillthe20donminimum.T
4、hemedonsthatcanbeusedthegreatertheconfidenceintheanalysisofthecomparisonthus20isaminimum30to40donsispreferred.SampleDistributionTableTESTMEASURINGRANGEBIN1RANGE%SamplesBIN2RANGE%SamplesBIN3RANGE%SamplesBIN4RANGE%SamplesB
5、IN5RANGE%SamplesTotalCholesterol100400mgdL100160mgdL15%161199mgdL25%200239mgdL25%240280mgdL25%280mgdL10%HDLCholesterol15100mgdL1535mgdL15%3645mgdL25%4655mgdL25%5670mgdL25%70mgdL10%Triglycerides50500mgdL50100mgdL15%101150
6、mgdL25%151200mgdL25%201300mgdL25%300mgdL10%SampleCollectionHlingSampleCollectionftheCardioChekTesting.UndernmaloperatingsituationsbloodwhichisusedfCardioChektestingiseithernonanticoagulatedcollectedinacapillarypipettecon
7、tainingtheanticoagulantsodiumheparin.Fthiscomparisonstudyananticoagulatedspecimenisnecessarytoallowthebloodtobeusedfseveralminuteswhilethetestingiscompleted.Thusvenousbloodisobtainedusingbloodcollectiontubescontainingthe
8、anticoagulantlithiumheparin(greentop).Alwayscollectfreshwholebloodusinganaseptictechniqueavoidingexcessivebloodcelltraumacausinglysingofthecells.Itwillnotbepossibletoobservelysinginthewholebloodspecimenshouldhemolysisbeo
9、bservedinthecentrifugedbloodwhichissenttothelabatyftestingthatdonmustbeeliminatedfromthestudyanalysis.FtheCardiochekstudyitisnotpossibletousebloodcollectiontubeswithoutanticoagulant(clottubeswhichincluderedtopSST)Testthe
10、sampleswithinonehouraftercollection.Mixthesampleswellbygentlyinverting(toavoidhemolysis)thecollectiontube78timesaftercollection.AlltestingontheCardioChekshouldbeperfmedusingasinglebloodcollectiontube.Ifmethanonetubeiscol
11、lectedfromasingledonthesamplesshouldbepooledinaseparateplasticconicaltube.Thisshouldbenotedonthedatacollectionfminthelineitemlabeled“Specimen”seepage7.SampleCollectionftheReferenceLabatyTest.Themajityoflabatiesprefertoru
12、nlipidanalysisusingaserumspecimen.Thusatthetimeofbloodcollectiontubeswithoutanticoagulant(clottubesredtopSST)shouldbecollected.Thissampleisallowedtoclotthencentrifugedtheserumsenttothereferencelab.Alternativelyifaheparin
13、specimenisacceptableinthereferencelabaseparateheparinbloodcollectiontube(greentop)shouldbecollectedcentrifugedtheplasmasenttothereferencelabatyfanalysisoftheCholesterolHDLTriglycerideconcentrationinthesample.Alwayschecki
14、nadvancewiththereferencelabatytoconfirmwhichspecimenisrequired.IMPTANT:TheCardioChekisawholebloodanalyzer.SerumplasmaarenotappropriatesamplesftheCardioChek.TestingProcedureDataCollectionfBiasStudyFeachofthepatientsusethe
15、followingprocedure:1.TurnontheCardioChekPA.theMEMoChipfthelotofLipidPanelstripsbeingused.aLipidPanelTestStripintotheanalyzer.2.ThedisplayshouldreadAPPLYSAMPLE.IftheCardioChekdisplaysRUNTESTpresstheEnterbuttontogettoAPPLY
16、SAMPLEdisplay3.Gentlymixthevenousbloodsamplethroughinversion.RemovethestopperaCardioChek40μLcapillaryintothetubetocollecta40μLbloodsampleftheLipidPanel.Whencompletereplacethestopper.4.MakesureAPPLYSAMPLEisdisplayed.Dispe
17、nsethebloodsampleontothebloodapplicationwindowoftheteststrip.(TheCardioChekPAwillautomaticallybegintestingthesample.)5.AlternativelyaprecisionpipettecanbeusedtotransferthebloodspecimensfromthecollectiontubeottheCardioChe
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