ABBOTT ARCHITECT AFP雅培说明书

1systemenAFP7K6748-8962/R3B7K6S0ReadHighlightedChangesRevisedNovember,2009AFPCustomerService:Contactyourlocalrepresentativeorfindcountryspecificcontactinformationon°CCautionSerialNumberManufacturerControlNumberReagentLotReactionVesselsSeptumSampleCupsReplacementCapsConsultinstructionsforuseSeeREAGENTSsectionforafullexplanationofsymbolsusedinreagentcomponentnaming.2WARNING:TheconcentrationofAFPinagivenspecimen,determinedwithassaysfromdifferentmanufacturers,canvaryduetodifferencesinassaymethodsandreagentspecificity.TheresultsreportedbythelaboratorytothephysicianmustincludetheidentityoftheAFPassayused.Valuesobtainedwithdifferentassaymethodscannotbeusedinterchangeably.If,inthecourseofmonitoringapatient,theassaymethodusedfordeterminingAFPlevelsseriallyischanged,additionalsequentialtestingshouldbecarriedout.Priortochangingassays,thelaboratoryMUST:ForCancerManagement-Confirmbaselinevaluesforpatientsbeing1.seriallymonitored.ForPrenatalTesting-Establisharangeofnormalvaluesforthenew2.assaybasedonnormalserum,plasma,andamnioticfluidsfrompregnantwomenwithconfirmedgestationalage.NAMEARCHITECTAFP(alpha-fetoprotein)INTENDEDUSETheARCHITECTAFPassayisaChemiluminescentMicroparticleImmunoassay(CMIA)forthequantitativedeterminationofalpha-fetoprotein(AFP)in:Humanserumorplasmatoaidinthemanagementofpatientswith1.nonseminomatoustesticularcancer.Humanserum,plasma,andamnioticfluidat15to21weeksgestation2.toaidinthedetectionoffetalopenneuraltubedefects(NTD).TestresultswhenusedinconjunctionwithultrasonographyoramniographyareasafeandeffectiveaidinthedetectionoffetalopenNTD.SUMMARYANDEXPLANATIONOFTESTThediscoveryofalpha-fetoprotein(AFP)infetalserumwasfirstrecordedbyBergstrandandCzarin1956.1Alpha-fetoproteinisasinglepolypeptidechainglycoproteinwithamolecularweightofapproximately70,000daltons.Thephysicochemicalpropertiesandaminoacidcompositionaresimilartothoseofalbumin.2,3SynthesisofAFPoccursprimarilyintheliverandyolksacofthefetus.Itissecretedintofetalserum,reachingapeakatabout13weeksgestationandgraduallydecliningthereafter.ElevatedserumAFPlevelssubsequentlyreappearduringpregnancyandinconjunctionwithseveralmalignantdiseases.CancerManagementAlpha-fetoprotein(AFP)wasfirstdescribedasahumantumor-associatedproteinin1964byTatarinov.4SincethenithasbeenshownthatelevationofserumAFPabovevaluestypicallyfoundinhealthyindividualsoccursinseveralmalignantdiseases,5-8mostnotablynonseminomatoustesticularcancerandprimaryhepatocellularcarcinoma.Inthecaseofnonseminomatoustesticularcancer,adirectrelationshiphasbeenobservedbetweentheincidenceofelevatedAFPlevelsandthestageofdisease.9,10ElevatedAFPlevelshavealsobeenobservedinpatientsdiagnosedashavingseminomawithnonseminomatouselementsbuthavenotbeenobservedinpatientswithpureseminoma.7,9,11,12Humanchorionicgonadotropin(hCG)andAFParealsoimportantprognosticindicatorsofsurvivalrateamongpatientswithadvancednonseminomatousgermcelltesticulartumors.13TheusefulnessofAFPmeasurementsinthemanagementofpatientswithnonseminomatoustesticularcancershasbeenwelldocumented.7,11,14Forpatientsinclinicalremissionfollowingtreatment,AFPlevelsgenerallydecrease.11Post-operativeAFPvalueswhichfailtoreturntonormalstronglysuggestthepresenceofresidualtumor.6,7,11TumorrecurrenceisoftenaccompaniedbyariseinAFPbeforeprogressivediseaseisclinicallyevident.7,9Greaterthan70%ofpatientswithprimaryhepatocellularcarcinomahavebeenreportedtohaveelevatedlevelsofserumAFP.5,6,15ElevatedAFPlevelshaveoccasionallybeenfoundinassociationwithgastrointestinaltractcancerswithandwithoutlivermetastases16andonlyrarelyinothermalignancies.5,6SerumAFPhasbeenfoundtobeelevatedduringpregnancy,indiseasessuchasataxiatelangiectasia,hereditarytyrosinemia,teratocarcinomaandinbenignhepaticconditions,suchasacuteviralhepatitis,chronicactivehepatitisandcirrhosis.6,15,17ElevationofserumAFPinbenignhepaticdiseasesisusuallytransient.5AFPtestingisnotrecommendedasascreeningproceduretodetectcancerinthegeneralpopulation.PrenataltestingManystudieshaveconfirmedtheutilityofAFPintheearlydetectionoffetalopenneuraltubedefects(NTD).18-20IntheUS,NTD,primarilyanencephalyandspinabifida,occurattherateofbetween1and2per1000livebirthsandareamongthemostcommonmajorcongenitalmalformations.21TheincidenceofNTDvariesgeographicallyandacrossracialgroups.22-26Anencephalyisincompatiblewithlifeandaccountsforone-thirdtoone-halfofallNTD.Openspinabifidacanvarywidelyinseverity.ReportsfromthescientificliteraturesuggestadditionalfactorstobeconsideredwhenassessingtheriskofanNTDbeingpresent.22-28Oneistheeffectofmaternalweight.Maternalbloodvolume,asreflectedbymaternalweight,hasbeenreportedtoaffectmaternalserumAFP(MSAFP)concentrationinmaternalcirculation;thehigherthematernalweight,thelowertheMSAFPconcentration.26,29Anotherfactortoconsiderismaternaldiabetes.Insulindepen