Description:
AssayKitFeatures&Benefits:
TheAmpliVueHSV1+2AssayisaninvitrodiagnostictestforthequalitativedetectionanddifferentiationofHerpessimplexvirustype1(HSV-1)andHerpessimplexvirustype2(HSV-2)nucleicacidsisolatedfromcutaneousandmucocutaneouslesionsofsymptomaticpatients.
Theassayconsistsofthreemajorsteps:(1)specimenpreparation(one-stepdilution),(2)isothermalHelicase-DependentAmplification(HDA)oftargetampliconsspecifictoHSV-1andHSV-2,and(3)detectionoftheamplifiedDNAbytarget-specifichybridizationprobesviaacolorimetricreactiononalateral-flowstripwhichisembeddedinaself-containeddisposablecassettetopreventampliconcontamination.
Specimenpreparationinvolvesasimpleonestepdilutioninwhichspecimensinviraltransportmediumareaddedtoadilutiontube. ThedilutedsampleistransferredintoReactionTubecontaininglyophilizedmixofHDAreagentsincludingprimersspecificfortheamplificationofHSV-1andHSV-2.CompetitiveamplificationoftheprocesscontrolDNAtakesplaceunlessamplificationinhibitorysubstancesarepresentorthesampleprocessingfails.
AftercompletionoftheHDAreaction,theReactionTubeistransferredtoaCassetteforrapiddetectionwiththetestresultdisplayedastestand/orcontrollinesinthewindowoftheCassette.Thedual-labeledprobe-ampliconhybridisthendetectedbythelateralflowstripwithintheCassette.TheHSV-1ampliconiscapturedattheT1-LineandHSV-2ampliconiscapturedattheT2-Line,whiletheprocesscontrolampliconiscapturedattheC-Line. TheBiotinintheamplicon-probecomplexescapturesthestreptavidin-conjugatedcolorparticlesforvisualizationandthemoleculartestresultisshownascoloredlinesthatarevisuallyread.
| Feature | Benefit |
|---|---|
Small,self-containedhand-heldcassette | Noisolationroomneeded Convenient,easy-to-use,disposabledevice |
HDAtechnology | Rapidmethodofnucleicacidamplificationthatdoesnotrequirethermalcycler |
LyophilizedMasterMixreagent | Easy-to-useformat,justrehydratewithdilutedsample. |
Smalleasy-to-useheatblocks | Eliminatesneedfordedicatedmolecularspaceandcostlycapitalequipment.Allowsfortestinginsmallerlabs. |
CLIAmoderatelycomplex | Requiresminimaltraining |
Refrigeratedstorage | Nofreezerneeded.2°Cto8°Cstorage. |
Longshelflife | 24monthsfromdateofmanufacture |
Roomtemperaturesetup | Noiceorcoolingblockrequired |
ProductSpecifications:
| ProductSpecName | ProductSpecData |
|---|---|
SampleType | Cutaneousandmucocutaneouslesionspecimensfromsymptomaticpatients |
Timetoresults | Approximately60minutes |
Reagentstorageconditions | 2°Cto8°CDilutionandReactionTubes;2°Cto30°CAmpliconCartridgeandDetectionCassette |
Controlsstorageconditions | 2°Cto8°C |
Samplepreparationstorageconditions | 20°Cto25°Cfor1hourpriortotesting;2°Cto8°Cfor8hours;and1monthat–20°Cto–70°C |
HSV-1Sensitivity* | CutaneousLesions–100%(95%CI88.6%to100%);MucocutaneousLesions–94.9%(95%CI90.3%to97.4%) |
HSV-1Specificity* | CutaneousLesions–97.1%(95%CI94.6%to98.5%);MucocutaneousLesions–96.5%(95%CI94.8%to97.7%) |
HSV-2Sensitivity* | CutaneousLesions-98.3%(95%CI91.0%to99.7%);MucocutaneousLesions-97.4%(93.4%to99.0%) |
HSV-2Specificity* | CutaneousLesions:95.6%(95%CI92.8%to97.3%);MucocutaneousLesions:95.8%(94.2%to97.0%) |
LOD* | HSV-1:1.1x105TCID50/mL;HSV-2:1.1x104TCID50/mL |
*RefertoPackageInsertforadditionalperformanceclaims.
