Product Manual
_________________________________________________________________________________
SofiaInfluenzaA+BFIA
Page22of25
Table14
SofiaInfluenzaA+BFIAVersusCulture(Nasal/NasopharyngealSwabs)
TYPEA TYPEB
Culture Sens= 219/235=93%
Culture Sens= 188/209=90%
Pos Neg
(95%C.I.89%‐96%)
Pos Neg
(95%C.I.85%‐93%)
SofiaPos 219 58
Spec= 1014/1072=95%
SofiaPos 188 40
Spec= 1058/1098=96%
SofiaNeg 16 1014
(95%C.I.93%‐96%)
SofiaNeg 21 1058
(95%C.I.95%‐97%)
Table15
SofiaInfluenzaA+BFIAVersusCulture(NasopharyngealAspirate/Wash)
TYPEA TYPEB
Culture Sens= 68/36=99%
Culture Sens= 46/52=88%
Pos Neg
(95%C.I.91%‐100%)
Pos Neg
(95%C.I.77%‐95%)
SofiaPos 68 26
Spec= 554/580=96%
SofiaPos 46 22
Spec= 575/597=96%
SofiaNeg 1 554
(95%C.I.93%‐97%)
SofiaNeg 6 575
(95%C.I.94%‐98%)
Twostudieswereconductedtodemonstratethatuntrainedintendedusers couldperformthetestconsistently
and accurately using weakly reactive samples. Each study consisted of three (3) distinct CLIA‐waived sites
where the Sofia Influenza A+B FIA was evaluated using coded randomized panels of simulate d samples,
including one (1) weak positive (C
95
—a concentration at the assay cutoff) and one (1) weak negative (C
5
—a
concentrationjustbelowtheassaycutoff)forinfluenzaAandinfluenzaB.Two(2)ormoreoperatorsateach
site(15operatorstotal)testedthepaneloneachof10days,spanningaperiodofapproximately2weeks.
StudyAevaluatedswabsamplesandtheperformanceisshowninTable16.StudyBevaluatedliquidsamples.
Study B was designed to provide contrived samples to untrained operators, which were a mix of liquid and
swabsamples.The purposeof StudyBwastodemonstratetheabilityoftheoperatorto choosethe correct
procedurepe
rthesampletype.Table 17showstheresultsobtainedwithliquidsamplesinStudyB.
Table16
SofiaInfluenzaA+BFIAPerformanceNeartheCutoff—StudyA
SampleLevel
UntrainedIntendedUsers
PercentAgreement
withExpectedResults*
95%ConfidenceInterval
FluA
WeakNegative(C
5
)
87%(52/60) 76%‐93%
FluA
WeakPositive(C
95
)
92%(55/60) 82%‐97%
FluB
WeakNegative(C
5
)
87%(52/60) 76%‐93%
FluB
WeakPositive(C
95
)
92%(55/60) 82%‐97%
*Theexpectedresultsfor“WeakPositive” samplesare“Positive,”whiletheexpectedresults
for“WeakNegative”samplesare“Negative.”