HumanAntiScl-70IgGELISAkit试剂盒说明书

第第页HumanAntiScl—70IgGELISAkit试剂盒说明书HumanAntiScl70IgGELISAKITCat3300140SCGIntendedUse:ADIsAntiScl70isanindirectsolidphaseenzymeimmunoassay（ELISA）forthequantitativemeasurementofIgGclassautoantibodiesagainstScl70inhumanserumorplasma.Thekitisintendedforinvitroresearchuseonly（RUO）asanaidinthediagnosisofscleroderma.INTRODUCTIONRheumatoidautoimmunediseasesareoftenassociatedwiththeoccurrenceofautoantibodiesagainstseveralnuclearorcytoplasmicantigens.TodaythebestinvestigatedimmunoreactiveantigensaredoublestrandedDNA（dsDNA）,singlestrandedDNA（ssDNA）,Sm（Smith）,snRNP（smallnuclearribonucleoproteinparticles）,thecomplexRNP/SmwhichisstabilizedbyribonuleicacidaswellasSSA（Ro）andSSB（La）.TheantigenScl70,a70kDmolecularweightprotein,alsoknownasDNAtopoisomerase1,isassociatedwithscleroderma.AntiScl70antibodies（alsocalledantitopoisomeraseI）isatypeofantinuclearautoantibodyseenmainlyindiffusesystemicscleroderma,butisalsoseenthemorelimitedformofsystemicsclerodermacalledCRESTsyndrome.AntiScl70antibodiesareassociatedwithmoreseveresclerodermadisease.TodaythebestinvestigatedimmunoreactiveantigensaredoublestrandedDNA（dsDNA）,singlestrandedDNA（ssDNA）,Sm（Smith）,snRNP（smallnuclearribonucleoproteinparticles）,thecomplexRNP/SmwhichisstabilizedbyribonuleicacidaswellasSSA（Ro）andSSB（La）.TheantigenScl70,a70kDmolecularweightprotein,alsoknownasDNAtopoisomerase1,isassociatedwithscleroderma.Inrheumatoidautoimmunediseasesvariousprofilesofautoantibodiestotheseantigenscanbedetected.InahighincidencetheyarerelatedtoactiveandinactivesystemicLupuserythrematodes,mixedconnectivetissuediseases（SharpSyndrome）,rheumatoidarthritis,SjögrenSyndrome,Scleroderma,photosensitvedermatitisanddruginducedlupus.InLupuspatientstypicallyantidsDNAantibodiescanbedetected.PatientswithouttheseantibodiesveryoftenshowantissDNAantibodiesandantiSSAandantiSSBarepresent.Astrongcorrelationbetweenantibodyconcentrationandseveretyofthediseasehasbeenobservedwithhigherantibodyconcentrationsinactivephasesofthedisease.Thusquantitationismoreinformativecomparedtosimpletiteringbyimmunoflourescence.Mostoftheseparametersarenotspecificforjustonediseasebuttheyoccurinvariouscombinations.Thepatternofdifferentantibodycombinationsandtheirconcentrationtogetherwiththewholeclinicalpictureofthepatientarehelpfuldiagnostictoolsintheassessmentofrheumatoidautoimmunediseases.AntiScl70isfoundin～75%patientswiththediffuseprogressiveformofscleroderma.ThepresenceofantiScl70seemstoexcludethepresenceofanticentromereantibody,whichisamarkerforasubsetofpatientswithsclerodermaknownasCREST（calcinosis,sclerodactyly,andtelangiectasia）syndrome.SPECIFICITY:ThemicroplateiscoatedwithScl70antigenhighlypurifiedbyaffinitychromatography.TheAntiScl70testkitisspecificonlyforautoantibodiesdirectedtoScl70.NocrossreactivitytotheotherENAantigenshavebeenobserved.Sensitivity:ThelowerdetectionlimitforAntiScl70hasbeendeterminedat1.0U/ml.SpeciesReactivity:Thiskitisdesignedtotesthumansamples.Itdetec