Description:
SolanaRSV+hMPVAssayKitFeatures&Benefits:
TheSolanaRSV+hMPVAssayisarapidqualitativeinvitrodiagnostictestforthedetectionanddifferentiationofRespiratorySyncytialVirus(RSV)andHumanMetapneumovirus(hMPV)viralRNAinnasalandnasopharyngealswabsfrompatientswithsignsandsymptomsofrespiratoryinfection.
TheSolanaRSV+hMPVAssayamplifiesanddetectsviralRNApresentintransportmediacontainingnasopharyngealornasalswabspecimensobtainedfromsymptomaticpatients.
Theassayconsistsoftwomajorsteps:(1)specimenpreparation,and(2)amplificationanddetectionoftargetsequencesspecifictoRSVand/orhMPVusingisothermalReverseTranscriptase—Helicase-DependentAmplification(RT-HDA)inthepresenceoftarget-specificfluorescenceprobeswhichisperformedintheSolanainstrument.
Resultsaredisplayedonthetouchscreen,canbesavedtotheinstrument,printed,andarecapableofbeingsenttotheLISandexportedthroughoneofSolana’sfiveUSBports.SolanaRSV+hMPVisalsosupportedbythepowerofVirena®.
| 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 |
Controlstorageconditions | 2˚Cto8˚C |
Samplepreparationstorageconditions | Specimensshouldbecollected,transported,stored,andprocessedaccordingtoCLSIM41-Aandstoredat2°Cto8°Cuntiltested.SpecimenscollectedinBDUTM,RemelM4,M4RT,M5,andM6(3mL),andCopaneSwabarestableat2°Cto8°Cforupto9days |
PPA(PCR) | RSV:95.5%(95%CI91.0%to97.8%) hMPV:95.6%(95%CI89.1%to98.3%) |
NPA(PCR) | RSV:99.9%(95%CI91.0%to97.8%) hMPV:99.8%(95%CI99.6%to99.9%) |
LOD(RSV) | RSVA,A2(VR-1540):7.9x103TCID50/mL RSVB,Wash/18537/62(VR-1580):3.9x102TCID50/mL |
LOD(hMPV) | hMPV16TypeA1,IA10-2003:3.7x10²TCID50/mL hMPV20TypeA2IA14-2003Ggene:1.2x104TCID50/mL hMPV5TypeB1,Peru3-2003:3.8x10³TCID50/mL hMPV4TypeB2,Peru1-2002:2.3x10³TCID50/mL |
