Description:
QuidelMolecularTrichomonasControlSetFeatures&Benefits:
TheSolanaTrichomonasAssayisarapidinvitrodiagnostictestforthequalitativedetectionofnucleicacidsisolatedfromclinician-collectedvaginalswabspecimensorurinespecimensobtainedfromasymptomaticorsymptomaticpatientstoaidinthediagnosisofTrichomoniasis.
TheSolanaTrichomonasAssay,whenperformedontheSolanainstrument,allowsfortherapid,accuratedetectionofTrichomonas.Theassayutilizeshelicase-dependentamplification(HDA)andfluorescentprobe-baseddetectionintheSolanainstrumenttodetermineassayresults.
Avaginalswabspecimenoraurinespecimenislysedbysimpleheattreatment,diluted,andaddedtoaReactionTubecontainingthelyophilizedHDAreagentsincludingprimersspecificfortheamplificationofaT.vaginalis-specifictargetsequence,aswellassequencespecificprobes.Competitiveprocesscontrol(PRC)isincludedintheLysisTubetomonitorsampleprocessing,inhibitorysubstancesinclinicalsamples,reagentfailureorinstrumentfailure.
Resultsaredisplayedonthetouchscreen,canbesavedtotheinstrument,printed,andarecapableofbeingsenttotheLISandexportedthroughoneofSolana’sfiveUSBports.SolanaTrichomonasissupportedbythepowerofVirena®.
| Feature | Benefit |
|---|---|
HDAtechnology | Rapidmethodofnucleicacidamplificationthatdoesnotrequirethermalcycler |
LyophilizedMasterMixreagent | Easy-to-useformat,justaddprocessedsampletorehydrate |
Small,easy-to-useinstrument | Eliminatestheneedfordedicatedmolecularspaceandcostlycapitalequipment,allowingfortestinginsmallerlabs |
CLIAmoderatelycomplex | Requiresminimaltraining |
Refrigeratedstorage | Nofreezerneeded,2˚Cto8˚Cstorage |
Longshelflife | Currently12monthsfromdateofmanufacture |
Multiplesampletypes | Kitsavailableforvaginalswabsandurinesamples |
Roomtemperaturesetup | Noiceorcoolingblockrequired |
ProductSpecifications:
| ProductSpecName | ProductSpecData |
|---|---|
Sampletype | Clinician-collectedvaginalswabsandfemaleurinespecimensobtainedfromasymptomaticorsymptomaticfemalepatients |
Timetoresults | Approximately35minutes |
Specimentransportandstorage | Transportandstoretheswabspecimensat2°Cto8°Cforupto7daysorroomtemperature(upto30°C)forupto48hourspriortotesting.Ortransportandstoreurinespecimensat2°Cto8°Cfor7daysorroomtemperature(upto30°C)forupto24hours |
SwabClinicalSensitivity | Asymptomatic–100%(95%CI92.9%to100%) |
SwabClinicalSpecificity | Asymptomatic–98.9%(95%CI97.4%to99.5%) |
UrineClinicalSensitivity | Asymptomatic–98.0%(95%CI89.5%to99.6%) |
UrineClinicalSpecificity | Asymptomatic–98.4%(95%CI96.8%to99.2%) |
SwabLOD | G3–102trophozoite/mL |
UrineLOD | G3–4trophozoite/mL |
