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TheAmpliVueC.difficileAssayisaninvitrodiagnostictestforthedirect,qualitativedetectionoftheClostridiumdifficileToxinAgene(tcdA)inunformedstoolspecimensofpatientssUSPectedofhavingClostridiumdifficile-associateddisease(CDAD).
The assayutilizeshelicase-dependentamplification(HDA)fortheamplificationofahighlyconservedfragmentoftheToxinAgenesequenceandaself-containeddisposableamplificationdetectiondevicethatallowsforvisualevaluationofassayresults.
Adilutedsampleislysedbysimpleheattreatment,aliquotedandaddedtoaReactionTubecontaininglyophilizedmixofHDAreagentsincludingprimersspecificfortheamplificationofafragmentfromtheconservedregionoftheC.difficileDNA.CompetitiveamplificationoftheprocesscontrolDNAtakesplaceunlessamplificationinhibitorysubstancesarepresentorthesampleprocessingfails.
AftercompletionoftheHDAreaction,theReactionTubeistransferredtoaCassetteforrapiddetectionwiththetestresultdisplayedastestand/orcontrollinesinthewindowoftheCassette.Thedual-labeledprobe-ampliconhybridisthendetectedbythelateralflowstripwithintheCassette.Thebottomlinecapturesthetestampliconandthetoplinecapturesthecontrolamplicon.Thebiotinlabelbindsthestreptavidin-conjugatedcolorparticlesforvisualizationandthemoleculartestresultisshownascoloredlinesvisIBLetothenakedeye.c-diffcdiff
| Feature | Benefit |
|---|---|
Small,self-containedhand-heldcassette | Convenient,easy-to-use,disposabledevice |
HDAtechnology | Rapidmethodofnucleicacidamplificationthatdoesnotrequirethermalcycler |
Lyophilizedreagents | Easy-to-useformat,justrehydrateandaddsample.Reagentsarestableathighertemperaturesthanliquidreagents |
Smalleasy-to-useheatblocks | Eliminatesneedfordedicatedmolecularspaceandcostlycapitalequipment.Allowsfortestinginsmallerlabs |
CLIAmoderatelycomplex | Requiresminimaltraining |
Refrigeratedstorage | Nofreezerneeded.2°Cto8°Cstorage |
Longshelflife | 2yearsfromdateofmanufacture |
Roomtemperaturesetup | Noiceorcoolingblockrequired |
| ProductSpecName | ProductSpecData |
|---|---|
Volume/vial | 2.0mL |
SpecimenType | WholeAntisera |
Preservative | ≤0.1%SodiumAzide |
Storage | 2°Cto8°C |
Sensitivity* | 93.6% |
Specificity* | 94.1% |
LOD | 4.2CFU/assay |
Shelflife | 24months |
*RefertoPackageInsertforadditionalperformanceclaims.
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