Description:
AssayKitFeatures&Benefits:
TheLyraDirectC.difficileAssayisaqualitative,multiplexedinvitrodiagnostictestforthedetectionoftoxinAgene(tcdA)ortoxinBgene(tcdB)sequencesoftoxigenicstrainsofClostridiumdifficilefromunformed(liquidorsoft)stoolspecimenscollectedfrompatientssUSPectedofhavingClostridiumdifficile-AssociatedDisease(CDAD).
Amultiplexreal-timePCRreactionisperformedunderoptimizedconditionsinasinglewellgeneratingampliconsforeachofthetargetspresentinthesample.IdentificationoccursbytheuseofoligonucleotideprimersandprobesthatarecomplementarytoconservedregionsinthetcdAandtcdBgenesofthepathogenicitylocus.
TheLyraDirectC.difficileAssayhasone-stepreagentset-upandathree-stepsampleprep.Testresultsareavailableinlessthan70minutes.LyraDirectC.difficileisaqualityreal-timePCRavailableforuseonAppliedBiosystems®7500FastDxReal-TimePCRInstrument,QuantStudioTMDxReal-TimePCRInstrumentandCepheid®SmartCycler®II.
TheLyraDirectC.difficiletestisoneinagrowingmenuofreal-timePCRassaysandintendedtoaidinthediagnosisofCDADinhumans.
| Feature | Benefit |
|---|---|
One-stepreagentset-up | RehydrationsolutionissimplyaddedtothelyophilizedMasterMix |
Speed | Resultsinlessthan70minutes |
Easytraining | Simplifiedanduniformworkflowwithstandardpipettingvolumes |
Refrigeratedstorage | Nofreezerneeded.2°Cto8°Cstorage |
Longshelflife | 2yearsfromdateofmanufacture |
Roomtemperaturesetup | Noiceorcoolingblockrequired |
FlexIBLe96-testformat | Kitincludesvialsof12x8MasterMix,RehydrationSolutionandliquidProcessControls.Samplepreparationkitincludesallconsumables |
ProductSpecifications:
| ProductSpecName | ProductSpecData |
|---|---|
Sampletype | Unformed(liquidorsoft)stoolsamples |
Timetoresults | Lessthan70minutes |
Reagentstorageconditions | 2°Cto8°C |
Controlsstorageconditions | 2°Cto8°C |
Samplepreparationstorageconditions | 2°Cto25°C |
Sensitivity* | 94.3%AB7500FastDx,93.3%QuantStudioDx;89.7%SmartCyclerII |
Specificity* | 94.2%AB7500FastDx;93.4%QuantStudioDx;93.3%SmartCyclerII |
LOD | 0.2to1CFU |
Processedsampleneededtotest | 5µL |
Shelflife | 24months |
*RefertoPackageInsertforadditionalperformanceclaims.
