Description:
AssayKitFeatures&Benefits:
TheAmpliVueBordetellaAssayisaninvitrodiagnostictestforthequalitativedetectionofBordetellapertussisnucleicacidsisolatedfromnasopharyngealswabspecimensobtainedfrompatientssUSPectedofhavingrespiratorytractinfectionattributabletoBordetellapertussis.
Theassayutilizeshelicase-dependentamplification(HDA)oftheinsertionsequenceIS481andaself-containeddisposableamplificationdetectiondevicethatallowsforvisualevaluationofassayresults.
Abufferedsampleislysedbysimpleheattreatment,aliquotedandaddedtoaReactionTubecontaininglyophilizedmixofHDAreagentsincludingprimersspecificfortheamplificationoftheinsertionsequenceIS481.CompetitiveamplificationoftheprocesscontrolDNAtakesplaceunlessamplificationinhibitorysubstancesarepresentorthesampleprocessingfails.
AftercompletionoftheHDAreaction,theReactionTubeistransferredtoaCassetteforrapiddetectionwiththetestresultdisplayedastestand/orcontrollinesinthewindowoftheCassette.Thedual-labeledprobe-ampliconhybridisthendetectedbythelateralflowstripwithintheCassette.Thebottomlinecapturesthetestampliconandthetoplinecapturesthecontrolamplicon.Thebiotinlabelbindsthestreptavidin-conjugatedcolorparticlesforvisualizationandthemoleculartestresultisshownascoloredlinesvisIBLetothenakedeye.
| 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 |
ProductSpecifications:
| ProductSpecName | ProductSpecData |
|---|---|
SampleType | Nasopharyngealswabs |
Timetoresults | Approximately80minutes |
Reagentstorageconditions | 2ºCto8ºCProcessBufferandReactionTubes;2ºCto30ºCAmpliconCartridgeandDetectionCassette |
Controlsstorageconditions | 2ºCto8ºC |
Samplepreparationstorageconditions | 25ºC±2ºCfor2daysandthenat2ºCto8ºCforupto8moredaysbeforetestingorat<–15ºCor<–70ºCforupto32daysbeforetesting |
PositivePercentAgreement* | 97.0%(95%CI89.5%to99.2%) |
NegativePercentAgreement* | 98.1%(95%CI96.8%to98.8%) |
LOD* | 2,358CFU/mL(3.93CFU/assay) |
