Description:
SolanaStrepCompleteAssayKitFeatures&Benefits:
TheSolanaStrepCompleteAssayisarapidinvitrodiagnostictestforthequalitativedetectionofGroupAβ-hemolyticStreptococcus(Streptococcuspyogenes),andpyogenicGroupC/G(streptococcusdysgalactiae)nucleicacidsisolatedfromthroatswabspecimensobtainedfrompatientswithsignsandsymptomsofpharyngitis,suchassorethroat.
TheSolanaStrepCompleteAssay,whenperformedontheSolanainstrument,allowsfortherapid,accuratedetectionofGroupAandpyogenicGroupC/GStrepwithouttheneedforcultureconfirmation.
Athroatswabsampleoranaliquotofliquidtransportmediaislysedbysimpleheattreatment,diluted,andaddedtotwoReactionTubes,onecontainingprimersandprobesspecificforGroupAStrep,theothercontainingprimersandprobesforstrepdysgalactiaeHDAreagentsincludingprimersspecificfortheamplificationoftheDNAaseB(sdaB)sequenceaswellassequencespecificprobes.Competitiveprocesscontrol(PRC)isincludedintheLysisTubetomonitorsampleprocessing,inhibitorysubstancesinclinicalsamples,reagentfailureorinstrumentfailure.
Resultsaredisplayedonthetouchscreen,canbesavedtotheinstrument,printed,andarecapableofbeingsenttotheLISandexportedthroughoneofSolana’sfourUSBports.SolanaStrepCompleteissupportedbythepowerofVirena®.
| Feature | Benefit |
|---|---|
HDAtechnology | Rapidmethodofnucleicacidamplificationthatdoesnotrequirethermalcycler |
LyophilizedMasterMixreagent | Easy-to-useformat,justaddprocessedsampletorehydrate |
Small,easy-to-useinstrument | Eliminatestheneedfordedicatedmolecularspaceandcostlycapitalequipment,allowingfortestinginsmallerlabs |
CLIAmoderatelycomplex | Requiresminimaltraining |
Refrigeratedstorage | Nofreezerneeded,2˚Cto8˚Cstorage |
Longshelflife | Currently12monthsfromdateofmanufacture |
Roomtemperatureatsetup | Noiceorcoolingblockrequired |
ProductSpecifications:
| ProductSpecName | ProductSpecData |
|---|---|
Sampletype | Throatswabspecimensobtainedfrompatientssymptomaticofacutepharyngitis |
Timetoresults | Approximately35minutes |
Reagentstorageconditions | Lysis,DilutionandReactionTubes;2˚Cto8˚C |
Controlstorageconditions | 2˚Cto8˚C |
Samplepreparationstorageconditions(culturedenrichedbroth) | 25˚Cto2˚Cforupto2daysandthenat2˚Cto8˚Cforupto6moredaysbeforetestingorat≤–15˚Cor≤–70˚Cforupto34daysbeforetesting |
ClinicalSensitivityStreptococcuspyogenes | 98.8%(95%CI97.3%to99.4%) |
ClinicalSpecificityStreptococcuspyogenes | 98.9%(95%CI98.3%to99.2%) |
ClinicalSensitivityStreptococcusdysgalactiae | 100%(95%CI95.3%to100%) |
ClinicalSpecificityStreptococcusdysgalactiae | 99.5%(95%CI99.1%to99.7%) |
LODStreptococcuspyogenesandStreptococcusdysgalactiae | 8.48x104CFU/mLand7.07x105CFU/mL |
