Product Manual

ManualsBrandsQuidel ManualsFlu/Influenza A+B TestSofia Influenza A+B FIA Test Kit

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SofiaInfluenzaA+BFIA

  Page13of25

NegativeResults:

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InvalidResults:

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LIMITATIONS

 ThecontentsofthiskitaretobeusedforthequalitativedetectionofinfluenzatypeAandBantigensfrom

nasalswab,nasopharyngealswab,andnasopharyngealaspirate/washsamples.

 This test detects both viable (live) and non‐viable influenza A and B. Test performance depends on the

amountofvirus(antigen)inth

esampleandmayormaynotcorrelatewithviralcultureresultsperformed

onthesamesample.

 TheclinicalperformanceoftheSofiaInfluenzaA+BFIAfornasopharyngealaspirate/washsampleshasnot

been established in patients 22 years of age and older  and may not be consistent wi

th the clinical

performanceobtainedwithyoungerpatients.

 Anegativetestresultmayoccurifthelevelofantigeninasampleisbelowthedetectionlimitofthetest

orifthesamplewascollectedortransportedimpro perly.

 Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the tes

t

result.

 Testresultsmustbeevaluatedinconjunctionwithotherclini caldataavailabletothephysician.

 Positivetestresultsdonotruleoutco‐infectionswithotherpathogens.

 PositivetestresultsdonotidentifyspecificinfluenzaAvirussubtypes. 

 Negativetestresultsarenotintende

dtoruleinothernon‐influenzaviralorbacterialinfections.

 Childrentendtoshedvirusmoreabundantlyandforlongerperiodsoftimethanadults.Therefore,testing

samplesfromadultswilloftenyieldlowersensitivitythantestingsa mplesfromchildren.

 Positiveandnegativepredictivevaluesarehighlydepende

ntonprevalence.Falsenegativetestresultsare

more likely during peak activity when prevalence  of disease is  high. False positive test results are more

likelyduringperiodsoflowinfluenzaactivitywhenprevalenceismoderatetolow.

 Individualswhoreceivednasallyadmi nistered influenzaAvaccinemayhaveposit

ivetestresultsforupto

3daysaftervaccination.

Forexample:Thisdisplayshowsavalidnegativeresult

forInfluenzaAandInfluenzaB.

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NOTE:Anegativeresultdoesnotexcludeinfluenzaviral

infection.Negativeresultsshouldbeconfirmedbyvirus

cultureoranFDA‐clearedinfluenzaAandBmolecular

assay.

Forexample:Thisdisplayshowsaninvalidresult.

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InvalidResult:Ifthetestisinvalid,anewtestshould

beperformedwithanewpatientsampleandanew

testCassette.