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Quidel/Sofia RSV FIA/20242 XUS/25/12

Description:

TestKit

Features&Benefits:

ForusewithSofia2andSofia

TheSofiaRSVFluorescentImmunoassay(FIA)usesadvancedimmunofluorescence-basedlateral-flowtechnologytodetectrespiratorysyncytialvirus(RSV)nucleoproteinantigendirectlyfromnasopharyngealswabandnasopharyngealaspirate/washspecimensfromsymptomaticpatients. ThehighsensitivityoftheSofiaRSVFIAoffersconfidenceinrapidRSVtesting.

Sofia2withAdvanceResultTechnology(ART)deliversaccurate,objectiveandautomatedresultsinasfewasthreeminutes.


FeatureBenefit
CLIAwaivedforchildrenlessthan7yearsofage

Easytoperformtesting

CompatIBLewithInfluenzaA+BExtractionReagent

AsinglespecimencanbeusedtorunbothSofiaRSVFIAandSofiaInfluenzaA+BFIA

Dualworkmodes

Adjuststoyourvolumefluctuations

Self-containedtestcassette

Clean,easytouseanddisposible

Fixed-volumePipette

Collectsanddispensescorrectamountofsampleneededfortesting

Objectiveresult

Eliminatesthesubjectivityofavisualresultinterpretation

Allcomponentsincludedinkit

ReadytousewithSofiaorSofia2,noneedforadditionalequipment

Roomtemperaturestorage

Norefrigeratorspaceneeded.Noneedtowaitforreagentstowarmup

ProductSpecifications:

ProductSpecNameProductSpecData
Sampletype

Nasopharyngealswab,aspirate/wash

Timetoresults
Sofia2:Positiveresultinasfewas3minutes,negativeresult15minutes
Sofia:15minutes
Kitstorageconditions

Roomtemperature(15°Cto30°C/59°Fto86°F)

Controls

Positiveandnegative

Nasopharyngealswabsensitivity*

86%[Ages0tolessthan19years];(CLIAWaiverStudies:87%[Ages0tolessthan7years])

Nasopharyngealswabspecificity*

97%[Ages0tolessthan19years];(CLIAWaiverStudies:96%[Ages0tolessthan7years])

Aspirate/washsensitivity*

89%[Ages0tolessthan19years];(CLIAWaiverStudies:92%[Ages0tolessthan7years])

Aspirate/washspecificity*

98%[Ages0tolessthan19years];(CLIAWaiverStudies:98%[Ages0tolessthan7years])

Shelflife

24monthsfromdateofmanufacture

*RefertoPackageInsertforadditionalperformanceclaims.

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