Product Manual

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SofiaInfluenzaA+BFIA
  Page3of25
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WARNINGSANDPRECAUTIONS
 Forinvitrodiagnosticuse.
 Donotusethekitcontentsbeyondtheexpirationdateprintedontheoutsideofthebox.
 Useappropriateprecautions inthecollection,handling,storage,anddisposalofpatientsamplesandused
kitcontents.
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 UseofNitrile,Latex(orequivalent)glovesisrecommendedwhenhandlingpatientsamples.
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 DisposeofcontainersandusedcontentsinaccordancewithFederal,State,andLocalrequirements.
 DonotreusetheusedCassette,FixedVolumePipettes,ReagentTubes,solutions,orControlSwabs.
 The user should never open the foil pouch of the test Cassette exposing it to the ambient environment
untilth
eCassetteisreadyforimmediateuse.
 DiscardanddonotuseanydamagedCassetteormaterial.
 TheReagent Solution contains a saltsolution(saline).Ifthe solutioncontacts the skinoreye, flushwith
copiousamountsofwater .
 Toobtainaccurateresults,thePackageInsertinstructionsmustbefollowed.
 TheCalibrati
onCassettemustbekeptintheprovidedstoragepouchbetweenuses.
 Inadequateorinappropriatesamplecollection,storage,andtransportmayyieldfalsetestresults.
 Samplecollectionandhandlingproceduresrequirespecifictrainingandguidance.
 Toobtainaccurateresults,usetheViralTransportMe
dium(VTM)recommendedinthisPackageInsert.
 Whencollectinganasalswabsample,usethenasalswabsuppliedinthekit.
 Whencollectinganasopharyngealswabsample,useanylonflockednasopharyngealswab.
 UsetheappropriateFixedVolumePipetteinaccordancewithtestprocedures:
 OnlytheSm
all,Clear120µLFixedVolumePipetteistobeusedforadding pati entsampletothetest
Cassetteforallsampletypes.
 OnlytheLarge,Pink250µLFixedVolumePipetteistobeusedwiththeaspirate/washorviral
transportmediatestprocedurewhentransferringthepatientsamplefromthecollectioncu
pintothe
ReagentTube.
 DonotpoursamplefromtheReagent Tube into  the testCassette sample well. Use theprovided  Small,
Clear120µLFixedVolumePipettewhenaddingthesampletothetestCassette.
 Toobtainaccurateresults,donotusevisuallybloodyoroverlyviscoussamples.
 Donotwriteonthebarco
deoftheCassette.ThisisusedbySofiatoidentifythetypeoftestbeingrunand
toidentifytheindividualCassettesoastopreventasecondreadoftheCassettebythesameSofia.
 If infection with a novel influenza A virus is susp
ected, based on current clinical and epidemiological 
screening criteria recommended by public health authorities, samples should be collected with
appropriate infection control precautions for novel virulent influenza viruses and sent to state or local
healthdepartmentsfortesting.Viralcultureshouldnotbeat
temptedinthesecasesunlessaBSL3+facility
isavailabletoreceiveandculturesamples.
 Althoughthistesthasbeenshownto detectcultured avianinfluenzaviruses,including avianInfluenza A
subtypeH5N1virus,theperformancecharacteristicsofthistestwithsamplesfromhumansinfectedwith
H5N1orotheravianinflue
nzavirusesareunknown.
 As the detection reagent is a fluorescent compound, no visible results will form on the test strip. Sofia
mustbeusedforresultinterpretation.
 Toobtainaccurateresults,anopenedandexposedCassetteshouldnotbeusedinsidealaminarflowhood
orinaheavilyventila
tedarea.
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KITSTORAGEANDSTABILITY
Storethekitatroomtemperature,59°Fto86°F(15°Cto30°C),outofdirectsunlight.Kitcontentsarestable
untiltheexpirationdateprintedontheouterbox.Donotfreeze.
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