化学发光免疫法检测AFP的空白限-检出限和定量检测限的建立与评价-温冬梅

1001-764X201006-469-03··AFP、*528403AFPLoB、LoDLoQ。CLSIEP17-AAFPBayerCentaur240AFPLoB、LoDLoQAFPLLD、BLDFS。EP17-ALoB0．80ng/mlLoD2．60ng/mlLoQ3．30ng/mlLLD1．00ng/mlBLD2．20ng/mlFS2．20ng/ml。LoBLLDBayerCentaur240AFPLoBLoDLoQ。。R446A《》12。CLSI《》3AFPLoB、LoDLoQ4-5LLD、BLDFS。11．1BayerCentaur240、CD54L、CD54H98273019827302。1．2BayerAFP。1．3BayerAFPAFP5．50ng/mlAFPng/ml0、1．10、1．65、2．20、3．30、4．40、5．501～4。1．4－20℃1。1．54-5AFPLLD、BLDFS。1010dRLUs。1．6EP17-AEP17-A3AFPLoB、LoDLoQ。601125d。62＞2h5d。1．71．7．1LLD、BLDFS4-5。1．7．2LoBISOⅠⅡ5%α=β=5%LoB=μB+1．645σBμBσB。95PctBLoB=PctB100-αLoB=NBρ/100+0．5=0．95×NB+0．5。NBρ。1．7．3LoD·964·201011286ChinJClinLabSciNov．2010Vol．28No．6*2009A200976320091A038。1976。[e-mail]。SDsSDs=n1SD12+n2SD22+n3SD32+……+nmSDm2n1+n2+n3+……+n槡mn1n2……nm。LoD=LoB+CβSDSCβ95Cβ=1．645/1－1/4ffSDs。LoDLoD=LoB+DSβDSβ5。1．7．4LoQAFP20%=2CVCV≤1/2LoQ=LoD。22．1LLD10RLUs珔A1997．9s12699．7%RLUs3s3785．50ng/mlRLUs2088RLUs378LLD=378/2088×5．50=1．00ng/mlLLD1．00ng/ml。2．2BLD2．20ng/mlRLUs3sRLUs3843782．20ng/ml。1。1AFPng/mlRLUs1．101．652．203．304．405．50RLUs珔X±珔A588699909133217432088s205178175149134111CV%34．925．519．311．27．75．3珋x－3s－27165384885134217542．3FSCV20%FS2．20ng/mlCV19．3%20%FS2．20ng/ml。1。2．4LoBLoB95PctBLoB=NBρ/100+0．5=60×95/100+0．5=57．55758。60257580．8ng/mlLoB=0．8ng/ml。26010ng/ml510．5560．8520．6570．8530．6580．8540．6590．8550．8601．02．5LoD3。60LoDLoD=LoB+DSβDSβ5=3．205=60×0．05+0．5=3．5=1．40DSβ=3．20－1．40=1．80LoD=LoB+DSβ=0．80+1．80=2．60ng/ml。3AFPng/ml1．101．652．203．304．905．5011．601．802．703．504．206．2021．702．103．003．905．105．5031．301．602．504．104．805．5042．102．802．803．904．605．7052．301．803．204．404．905．9062．501．902．903．904．605．8071．402．902．503．204．305．2081．201．401．803．204．305．9092．602．202．503．705．205．90101．501．903．303．704．905．502．6LoQAFP20%TEa=2CVCV=1/2TEa。AFP3．30ng/mlCV9．56%10%LoQ=3．30ng/ml4。4AFPng/mlCV1．101．652．203．304．905．50珋xng/ml1．822．042．723．754．675．71sng/ml0．490．460．410．360．300．27CV%26．7822．4815．059．566．504．793Petersen、GregoriCasals、4-8·074·201011286ChinJClinLabSciNov．2010Vol．28No．6LLD、BLDFSAFPLLD、BLDFS4-5。EP17-ALoB0．8ng/ml1．3ng/mlLoD2．60ng/mlLoQ3．30ng/ml。AFP3．30ng/ml。AFPAFP0．8ng/ml“0．8ng/ml”AFP0．8ng/ml2．60ng/ml“2．60ng/ml”AFP3．30ng/ml。3．30ng/mlAFP。91AFPLLD、BLDFS1010。EP17-ALoD60LoD。2AFPLLD、BLD、FSRLUs。。EP17-AAFPLoB、LoDLoQ。3EP17-ALoB、LoD。495%99%EP17-ALoQ。5EP17-A。EP17-ALoDLoQAFP、。、。。41．Z．2006-02-07．2ISO/DIS15189．2-2007．———S．2007．3EP17-A．ProtocolsforDeterminationofLimitsofDetectionandLim-itsofQuantitationApprovedGuidelineS．NCCLS20041-39．4PetersenABGudmannPMilvang-GrnagerPetal．PerformanceevaluationofaspecificIgEassaydevelopedfortheADVIAcentaurimmunoassaysystemJ．ClinBiochem20043710882-892．5．J．200722552-54．6．AFP．J200730111293-1297．7．．J．200855269-270．8GregoriCasalsXavierFilellaJosepLluisBedini．EvaluationofanewultrasensitiveassayforcardiactroponinIJ．ClinBiochem200740181406-1413．9．M．2008161-191．2010-02-082010-06-06·174·201011286ChinJClinLabSciNov．2010Vol．28No．6