Product Manual
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SofiaInfluenzaA+BFIA
Page5of25
Built‐inProceduralControls
The Sofia Influenza A+B FIA contains a built‐in procedural
controlfeature.EachtimeatestisruninSofia,thep r ocedural
controlzoneisscannedbySofiaandtheresultisdisplayed
ontheSofiascreen.
The manufacturer's recommendation for daily control is to
documenttheresultsofthesebuilt‐inproceduralcontrolsfor
the first sample test
ed each day. This documentation is
automaticallyloggedintoSofiawitheachtestresult.
A valid result obtained from the procedural control
demonstratesthatthetestflowedcorrectlyandthefunctional
integrity of the Cassette was maintained. The procedural
control is interpreted by Sofia af
ter the Cassette has
developedfor15minutes.Ifthetestdoesnotflowcorrectly,
Sofiawillindicatethattheresultisinvalid.Shouldthisoccur,
reviewtheprocedureandrepeatthetestwithanewpatient
sampleandanewtestCassette.
ExternalQualityControl
ExternalControlsmayalsobeusedtodemonstratethatthereagentsandassayprocedureperformproperly.
QuidelrecommendsthatPositiveandNegativeExternalControlsberun:
onceforeachuntrainedoperator
once for each new shipment of kits – provided that each different lot received in the shipment is
tested
asdeemedadditionallynecessarybyyourinternalqualitycontrolprocedures,andinaccordancewith
Local,StateandFederalregulationsoraccreditationrequirements.
The user must first select Run QC on the Main Menu of Sofia and then, whenprompted, scan the QC Card
(locatedonkitbox).Thiscardprovidesinformationspecifictothekitlot,includinglotnum
berandexpiration
date.
Sofia will prompt the user to select the desired mode (WALK AWAY or READ NOW) and then to run the
ExternalControlswabs.
ExternalPositiveandNegativeControlswabsaresuppliedinthekitandshouldbeteste
dusingtheSwabTest
ProcedureprovidedinthisPackageInsertorintheQuickReferenceInstructions.TheInfluenzaPositiveControl
SwabcontainsbothinfluenzaA andinfluenzaBantigen.ThePositiveControlSwabmustberunfirst,followed
bytheNegativeControlSwab.
WhentheQCtestiscomplete,eachres
ultwillbedisplayedas“Passed”or“Failed”forthePositiveControland
theNegativeControl.
DonotperformpatienttestsorreportpatienttestresultsifeitheroftheQCtestresultsfail.Repeatthetestor
contactQuidelTechnicalSupportbeforetestingpatientsamples.
AdditionalExternalControlswabsmaybeobtainedseparatelybycontactingQu
idelCustomerSupportServices
at800.874.1517(intheU.S.)or858.552.1100.
Forexample:Thisdisplayshowsan
invalidresult.