Description:
AssayKitFeatures&Benefits:
TheSolanaGASAssayisarapidinvitrodiagnostictestforthequalitativedetectionofGroupAβ-hemolyticStreptococcus(Streptococcuspyogenes)nucleicacidsisolatedfromthroatswabspecimensobtainedfrompatientswithsignsandsymptomsofpharyngitis,suchassorethroat.
TheSolanaGASAssay,whenperformedontheSolanainstrument,allowsfortherapid,accuratedetectionofGroupAStrepwithouttheneedforcultureconfirmation.
Theassayutilizeshelicase-dependentamplification(HDA)oftheDNaseB(sdaB)sequenceandfluorescentprobe-baseddetectionintheSolanainstrumenttodetermineassayresults.
Athroatswabsampleoranaliquotofliquidtransportmediaislysedbysimpleheattreatment,diluted,andaddedtoaReactionTubecontainingthelyophilizedHDAreagentsincludingprimersspecificfortheamplificationoftheDNAaseB(sdaB)sequenceaswellassequencespecificprobes.Competitiveprocesscontrol(PRC)isincludedintheLysisTubetomonitorsampleprocessing,inhibitorysubstancesinclinicalsamples,reagentfailureorinstrumentfailure.
Resultsaredisplayedonthetouchscreen,canbesavedtotheinstrument,printed,andarecapableofbeingsenttotheLISandexportedthroughoneofSolana’sfourUSBports.SolanaGASissupportedbythepowerofVirena®.
Feature | Benefit |
---|---|
HDAtechnology | Rapidmethodofnucleicacidamplificationthatdoesnotrequirethermalcycler |
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 | Throatswabspecimensobtainedfrompatientssymptomaticofacutepharyngitis |
Timetoresults | Approximately35minutes |
Reagentstorageconditions | Lysis,DilutionandReactionTubes;2˚Cto8˚C |
Controlsstorageconditions | 2˚Cto8˚C |
Samplepreparationstorageconditions(culturedenrichedbroth) | 25˚Cto2˚Cforupto2daysandthenat2˚Cto8˚Cforupto6moredaysbeforetestingorat≤–15˚Cor≤–70˚Cforupto34daysbeforetesting |
ClinicalSensitivity | 98.2%(95%CI95.5%to99.3%) |
ClinicalSpecificity | 97.2%(95%CI95.9%to98.1%) |
LOD | 6.81x104CFU/mL |