Description:1.IntendedUse TheGenWayCytomegalyIgGAntibodyELISATestKithasbeendesignedforthedetectionand thequantitativedeterminationofspecificIgGantibodiesagainstCytomegalovirusinserumand plasma. Thisassayisintendedforresearchuseonly. 2.GeneralInformation Cytomegalyiscausedbyaviralinfection,whichshowsaninapparentprogression,howeverleads toserioussymptomswithimmune-compromisedadultsandnewborns. Thecytomegalyvirus(CMV)withaparticlediameterof100nm(inclusiveenvelopethevirion measures200nm)belongstothefamilyofherpesviridaelikeHerpes1andHerpes2.The transmissioniseffectedviasalivaandbylong-termintimatecontacts.Theincubationtimeis2-10 daysforprimaryinfections. CytomegalyappearsoftenduringthegrAvidity,andperyearupto5%ofthepregnantwomenshow clinicalsignsofthedisease.Intheearlyphasetheillnessfrequentlyremainsundetected,andthe affectedwomenthemselvesshownosymptoms.Whenhowevernewbornsareinfected(1%ofthe births),theseshowin10%ofthecasesdiseasesymptomswithlatedamageslikeretinitis,ulceraof themucousmembrane,viralpneumonia,meningitis,microencephaly,hydrocephalusandskin ulcerations.Theincidenceofwomencapableofchildbearingisestimatedtobe65%,sothatan assessmentoftheimmunestatusbeforepregnancyismandatory.Afteranegativeresult,acontrol checkisrecommendedinthe20th weekofgestation. Besidesthesymptomatictreatmentaspecifictherapywithphosphonoformateandgancicloviris possIBLe.Avaccinationdoesnotexist,sothatinthecaseofaninfectiononlypassiveCMV immunoglobulinsareadmiNISTered. Togetherwiththedifferentialassessmentoftheabovementionedsymptoms,thediagnosisis performedclinicallyintissuesamplesviatheso-called“owleyes”.Thefollowinglaboratory methodsareavailable:CFandELISA,determinationofvirusnucleicacid(PCR)aswellasvirus isolation(cellculture).SEROlogically,IgGandIgMantibodiescanbedetectedandquantitatedby theELISAtechnique.AlsothemeasurementoftheavidityoftheIgGmoleculesisappropriate. 3.PrincipleoftheTest TheGenWayCytomegalyIgGantibodytestkitisbasedontheprincipleoftheenzyme immunoassay(EIA).Cytomegalovirusantigenisboundonthesurfaceofthemicrotiterstrips. Dilutedsampleserumorready-to-usecalibratorsarePipettedintothewellsofthemicrotiterplate. AbindingbetweentheIgGantibodiesoftheserumandtheimmobilizedCytomegalovirusantigen takesplace.Afteraonehourincubationatroomtemperature,theplateisrinsedwithdilutedwash solution,inordertoremoveunboundmaterial.Thenready-to-useanti-human-IgGperoxidase conjugateisaddedandincubatedfor30minutes.Afterafurtherwashingstep,thesubstrate(TMB) solutionispipettedandincubatedfor20minutes,inducingthedevelopmentofabluedyeinthe wells.Thecolordevelopmentisterminatedbytheadditionofastopsolution,whichchangesthe colorfrombluetoyellow.Theresultingdyeismeasuredspectrophotometricallyatthewavelength of450nm.TheconcentrationoftheIgGantibodiesisdirectlyproportionaltotheintensityofthe color.AdditionalInformation:NameCytomegalyIgGELISARelatedProductNamesCytomegalyIgGELISAApplicationsEnzymeimmunoassaybasedonmicrotiterplateforthedetectionandquantitativedeterminationofhumanIgGantibodiesagainstCytomegalovirusinserumandplasmaIntendedUseResearchUseOnly