Description:
SolanaInfluenzaA+BControlSetFeatures&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®.
| Feature | Benefit |
|---|---|
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:
| ProductSpecName | ProductSpecData |
|---|---|
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 |
