Product Manual
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SofiaInfluenzaA+BFIA
Page21of25
InterferingSubstances
Wholeblood,mucin,andseveralover‐the‐counter(OTC)productsandcom monchemicalswereevaluatedand
didnotinterferewiththeSofiaInfluenzaA+BFIAatthelevelstested(Table13).
Table13
Non‐interferingSubstances
Substance Concentration
WholeBlood 4%
Mucin 0.5%
Ricola(Menthol) 1.5mg/mL
Sucrets(Dyclonin/Menthol) 1.5mg/mL
Chloraseptic(Menthol/Benzocaine) 1.5mg/mL
NasoGEL(NeilMed) 5%v/v
CVSNasalDrops(Phenylephrine) 15%v/v
Afrin(Oxymetazoline) 15%v/v
CVSNasalSpray(Cromolyn) 15%v/v
NasalGel(Oxymetazoline) 10%v/v
Zicam 5%v/v
Homeopathic(Alkalol) 1:10dilution
Fisherman’sFriend 1.5mg/mL
SoreThroatPhenolSpray 15%v/v
Tobramycin 4μg/mL
Mupirocin 10mg/mL
FluticasonePropionate 5%v/v
Tamiflu(OseltamivirPhosphate) 5mg/mL
CLIAWaiverStudies
AspartofalargerprospectivestudydescribedinthePerformanceCharacteristicssectionabove,theaccuracy
oftheSofiaInfluenzaA+B FIA,whenusedbyuntrainedoperators,was compared totheresults obtainedby
viral cell culture. This study was conducted at eleven (11) CLIA waived sites with th
irty‐four (34) untrained
operatorsrepresentativeofCLIAwaivedsettings.Thestudyincluded1,973subjects:fivehundredeighty‐five
(585) subjects provided a pair of nasal swabs, seven hundred twenty‐seven (727) provided a pair of
nasopharyngeal swabs, and six hundred sixty‐one (661) provided a nasopharyngeal aspirate/wash sample.
Seventeen(1
7)subjectswereexcludedduetoSofiaInfluenzaA+BFIAinvalidresults.Theinvalidratewas0.9%
(17/1973)with95%CI:0.5%to1.4%.
Atotalof1,956clinicalsamplesgavevalidresultswhentestedintheSofiaInfluenzaA+BFIA.Theseresultsare
includedinTables14and15.
The cli
nical sensitivity and specificity of the Sofia Influenza A+B FIA, as compared to viral culture (the
comparatormethod),arepresentedbelowinTables14and15.