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蚂蚁淘在线 / 品牌中心 / Quidel / Quidel/AmpliVue HSV 1+2/M109/1 mL

Quidel/AmpliVue HSV 1+2/M109/1 mL

价格
面议
货号：M109
浏览量：127
品牌：Quidel
服务
全国联保
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商品描述

Description:

QuidelMolecularHSV1+2ControlSet

Features&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.


FeatureBenefit
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:

ProductSpecNameProductSpecData
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.

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