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Quidel/Solana Influenza A+B Assay/M122/20 reactions

价格
面议
货号:M122
浏览量:127
品牌:Quidel
服务
全国联保
正品保证
正规发票
签订合同
商品描述

Description:

SolanaInfluenzaA+BControlSet

Features&Benefits:

TheSolanaInfluenzaA+BAssayisarapidqualitativeinvitrodiagnostictestforthedetectionanddifferentiationofinfluenzaAandinfluenzaBviralRNAinnasalandnasopharyngealswabsfrompatientswithsignsandsymptomsofrespiratoryinfection.

TheSolanaInfluenzaA+BAssayamplifiesanddetectsviralRNApresentintransportmediacontainingnasopharyngealornasalswabspecimensobtainedfromsymptomaticpatients.

Theassayconsistsoftwomajorsteps:(1)specimenpreparation,and(2)amplificationanddetectionoftargetsequencesspecifictoinfluenzaAand/orinfluenzaBusingisothermalReverseTranscriptase—Helicase-DependentAmplification(RT-HDA)inthepresenceoftarget-specificfluorescenceprobeswhichisperformedintheSolanainstrument.

Resultsaredisplayedonthetouchscreen,canbesavedtotheinstrument,printed,andarecapableofbeingsenttotheLISandexportedthroughoneofSolana’sfiveUSBports.SolanaInfluenzaA+BisalsosupportedbythepowerofVirena®.


FeatureBenefit
RT-HDAtechnology

Rapidmethodofisothermalnucleicacidamplificationthatdoesnotrequirethermalcycler

LyophilizedMasterMixreagent

Easy-to-useformat,justaddprocessedsampletorehydrate

Small,easy-to-useinstrument

Eliminatestheneedfordedicatedmolecularspaceandcostlycapitalequipment,allowingfortestinginsmallerlabs

CLIAmoderatelycomplex

Requiresminimaltraining

Refrigeratedstorage

Nofreezerneeded,2˚Cto8˚Cstorage

Longshelflife

Currently12monthsfromdateofmanufacture

Roomtemperaturesetup

Noiceorcoolingblockrequired

ProductSpecifications:

ProductSpecNameProductSpecData
Sampletype
Nasalswabsandnasopharyngealswabsintransportmedia*obtainedfrompatientssymptomaticofrespiratoryinfection

*BD/CopanVTM,RemelM4,RemelM4RT,RemelM5,RemelM6,orCopeneSwab
Timetoresults

Approximately45minutes

Reagentstorageconditions

LysisandReactionTubes;2˚Cto8˚C

Controlsstorageconditions

2°Cto8°C

Samplepreparationstorageconditions

Specimensshouldbecollected,transported,stored,andprocessedaccordingtoCLSIM41-A.Specimensshouldbestoredat2°Cto8°Cuntiltested.SpecimenscollectedinBDUTM,RemelM4,M4RT,M5,andM6(3mL)arestableat2°Cto8°Cforupto9days

Note:SpecimenscollectedinCopaneSwabtransportmediaarestableat2°Cto8°Cforupto48hours

ClinicalSensitivity(culture)
InfluenzaA:98.6%(95%CI96.8%to99.4%)
InfluenzaB:100%(95%CI95.7%to100%)
ClinicalSpecificity(culture)
InfluenzaA:95.1%(95%CI93.7%to96.3%)
InfluenzaB:99.3%(95%CI98.7%to99.6%)
ClinicalSensitivity(PCR)
InfluenzaA:97.2%(95%CI95.0%to98.4%)
InfluenzaB:100.0%(95%CI95.4%to100%)
ClinicalSpecificity(PCR)
InfluenzaA:96.7%(95%CI95.4%to97.7%)
InfluenzaB:98.9%(95%CI98.2%to99.4%)
LOD(InfluenzaA)
A/Taiwan/42/06:7.5x102TCID50/mL
A/California/07/2009:4.7x102TCID50/mL
A/Texas/50/2012:6.3x100TCID50/mL
LOD(InfluenzaB)
B/Brisbane/60/08:8.5x101TCID50/mL
B/Massachusetts/2/2012:3.3x101TCID50/mL
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