Description:
TestKitFeatures&Benefits:
TheQuickVueRSVTestisadipstickimmunoassaythatdetectsrespiratorysyncytialvirus(RSV)antigen(viralfusionprotein)directlyfromnasopharyngealswab,nasopharyngealaspirate,ornasal/nasopharyngealwashspecimensforsymptomaticpediatricpatients(eighteenyearsofageandyounger).AsinglesamplecanbeusedtorunboththeQuickVueRSVTestandQuickVuebrandInfluenzatests.
| Feature | Benefit |
|---|---|
Dipstick | Easytouse,approx.30secondsto1minutehands-ontime |
Resultsin15minutes | Testandtreatinthesameofficevisit |
Onereagent | Fewersteps,easytoperform,requiresminimaltraining |
Two-colorresult | Easytoreadandinterpret |
3stepprocedure | Easytouse,fewerproceduralerrors |
QuickReferenceInstructions | ClearandsimpleillustrationstoguidetheRSVtestprocedureandinterpretationofresults |
Allcomponentsincludedinkit | Readytouse,noneedforadditionalequipment |
Internalcontrolsincluded | Providesverificationofteststripfunctionalintegrity,increasingconfidenceinresults |
Externalcontrolsincluded | Facilitatesinternallaboratoryqualitycontrol |
Roomtemperaturestorage | Norefrigeratorspaceneeded.Noneedtowaitforreagentstowarmup.RapidRSVtestscanberunimmediatelyasneeded |
ProductSpecifications:
| ProductSpecName | ProductSpecData |
|---|---|
Sampletype | Nasopharyngealswab,nasopharyngealaspirate,nasal/nasopharyngealwash |
Timetoresults | 15minutesorless |
Kitstorageconditions | Roomtemperature(15°Cto30°C/59°Fto86°F) |
Internalcontrols | Positiveandnegativeincluded |
Externalcontrols | Positiveandnegativeincluded |
Sensitivity* | 92%-Nasopharyngealswab;99%-Nasopharyngealaspirate;83%-Nasal/nasopharyngealwash |
Specificity* | 92%-Nasopharyngealswab;92%-Nasopharyngealaspirate;90%-Nasal/nasopharyngealwash |
PPV* | 56%-Nasopharyngealswab;84%-Nasopharyngealaspirate;86%-Nasal/nasopharyngealwash |
NPV* | 99%-Nasopharyngealswab;99%-Nasopharyngealaspirate;88%-Nasal/nasopharyngealwash |
Overallaccuracy* | 92%-Nasopharyngealswab;94%-Nasopharyngealaspirate87%-Nasal/nasopharyngealwash |
Shelflife | 24monthsfromdateofmanufacture |
CLIAcomplexity | Waived |
*RefertoPackageInsertforadditionalperformanceclaims.
