Description:
AssayKitFeatures&Benefits:
TheAmpliVueGBSAssayisaninvitrodiagnostictestforthedirect,qualitativedetectionofGroupBStreptococcusfromvaginal/rectalswabsfollowing18to24hoursincubationinLimbroth.
The assayutilizeshelicase-dependentamplification(HDA)fortheamplificationofahighlyconservedfragmentoftheThiolase(atoB)genesequenceandaself-containeddisposableamplificationdetectiondevicethatallowsforvisualevaluationofassayresults.
AnovernightLimBrothcultureenrichedfromaswabislysedbysimpleheattreatment,aliquotedandaddedtoaReactionTubecontaininglyophilizedmixofHDAreagentsincludingprimersspecificfortheamplificationofafragmentfromtheconservedregionoftheThiolase(atoB)DNA.CompetitiveamplificationoftheprocesscontrolDNAtakesplaceunlessamplificationinhibitorysubstancesarepresentorthesampleprocessingfails.
AftercompletionoftheHDAreaction,theReactionTubeistransferredtoaCassetteforrapiddetectionwiththetestresultdisplayedastestand/orcontrollinesinthewindowoftheCassette.Thedual-labeledprobe-ampliconhybridisthendetectedbythelateralflowstripwithintheCassette.Thebottomlinecapturesthetestampliconandthetoplinecapturesthecontrolamplicon.Thebiotinlabelbindsthestreptavidin-conjugatedcolorparticlesforvisualizationandthemolecular testresultisshownascoloredlinesvisIBLetothenakedeye.
| Feature | Benefit |
|---|---|
Small,self-containedhand-heldCassette | Noisolationroomneeded Convenient,easy-to-use,disposabledevice |
HDAtechnology | Rapidmethodofnucleicacidamplificationthatdoesnotrequirethermalcycler |
LyophilizedMasterMixreagent | Easy-to-useformat,justrehydrateandaddsample. |
Smalleasy-to-useheatblocks | Eliminatesneedfordedicatedmolecularspaceandcostlycapitalequipment.Allowsfortestinginsmallerlabs |
CLIAmoderatelycomplex | Requiresminimaltraining |
Refrigeratedstorage | Nofreezerneeded.2˚Cto8˚Cstorage |
Longshelflife | 24 monthsfromdateofmanufacture |
Roomtemperaturesetup | Noiceorcoolingblockrequired |
ProductSpecifications:
| ProductSpecName | ProductSpecData |
|---|---|
Sampletype | Vaginal/rectalswabspecimens |
Timetoresults | Approximately80minutes |
Reagentstorageconditions | 2˚Cto8˚CLysis,DilutionandReactionTubes;2˚Cto30˚CAmpliconCartridgeandDetectionCassette |
Controlsstorageconditions | 2˚Cto8˚C |
Samplepreparationstorageconditions(culturedenrichedbroth) | 20⁰Cto25⁰Cor2⁰Cto8⁰Cforupto25hourspriortotesting |
Sensitivity* | 99.5% |
Specificity* | 92.7% |
LOD* | 1.39x106CFU/mL |
*RefertoPackageInsertforadditionalperformanceclaims.
