Product Manual

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SofiaInfluenzaA+BFIA
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EveryyearintheUnitedStates,onaverage5%‐20%ofthepopulation contractinfluenza;morethan200,000
people are hospitalized from influenza complications; and, about 36,000 people die from influenza‐related
causes.Somepeople,such asadults65yearsofageandolder,youngchildren,andpeoplewithcertai nhealth
conditions,areathighriskforseriousinfluenzacomplications.
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PRINCIPLEOFTHETEST
The Sofia Influenza A+B FIA employs immunofluorescence technology that is used with the Sofia analyzer
(Sofia)todetectinfluenzavirusnucleoproteins.ThistestallowsforthedifferentialdetectionofinfluenzaAand
influenzaBantigens.
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The patient sample is placed in the Reagent Tube, during which time the virus particles in the sample are
disrupte
d,exposing internal viral nucleoproteins. After disruption,thesampleis dispensed into the Cassette
sample well. From the sample well, the sample migrates through a test strip containing various unique
chemicalenvironments.Ifinfluenzaviralantigenispresent,theywillbetrappedinaspecificlocation.
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Note:Dependinguponth
euser’schoice,theCassetteiseitherplacedinsideofSofiaforautomaticallytimed
development(WALKAWAYMode)orplacedonthecounterorbenchtopforamanuallytimeddevelopment
andthenplacedintoSofiatobescanned(READNOWMode).
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Sofiawillscantheteststripandmeasur
ethefluorescentsignalbyprocessingtheresultsusingmethod‐specific
algorithms.Sofiawilldisplaythetestresults(Positive,Negative,orInvalid)onthescreen.Theresultscanalso
beautomaticallyprintedonanintegratedprinterifthisoptionisselected.
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REAGENTSANDMATERIALSSUPPLIED
25‐TestKit:
 IndividuallyPackagedCassettes(25):Mousemonoclonalanti‐influenzaAandanti‐influenzaBantibodies
 ReagentTubes(25):Lyophilizedbufferwithdetergentsandreducingagents
 ReagentSolution(25):Ampouleswithsaltsolution
 SterileNasalSwabs(25)
 Small(120µL),ClearFixedVolumePipettes(25)
 Large(250µL),PinkFixedVolumePipettes(25
)
 Influenza A and Influenza B Positive Control Swab (1): Swab is coated with non‐infectious recombinant
influenzaAandinfluenzaBantigens
 NegativeControlSwab(1):Swabiscoatedwithheat‐inactivated,non‐infectiousStreptococcusCantigen
 PackageInsert(1)
 QuickRefere
nceInstructions(1)
 QCCard(locatedonkitbox)
 PrinterPaper(1)
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MATERIALSNOTSUPPLIEDINKIT
 Timerorwatch
 Sofiaanalyzer
 Sample/Specimencontai ner
 Sterilesalineforsamplecollection
 EquipmentusedforcollectionofNasopharyngealAspirateorNasopharyngealWash
 Nylonflockednasopharyngealswab
 CalibrationCassette(suppliedwiththeSofiainstallationpack)