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ManualsBrandsQuidel ManualsFlu/Influenza A+B TestSofia Influenza A+B FIA Test Kit
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SofiaInfluenzaA+BFIA
 Page17of25
Table8
SofiaInfluenzaA+BReproducibilityStudyIntra‐LaboratoryAgreement
Lab.
Site
Neg
(novirus)
FluA
HighNeg
(C
5
)
FluA
LowPos
(C
95
)
FluA
ModPos
(C
3X
)
FluB
HighNeg
(C
5
)
FluB
LowPos
(C
95
)
FluB
ModPos
(C
3X
)
%Overall
Agreement
withExpected
Result
(95%CI)
1 30/30 29/30 30/30 30/30 28/30 29/30 30/30
98%
(206/210)
(95%‐99%)
2 30/30 29/30 30/30 30/30 30/30 29/30 30/30
99%
(208/210)
(96%‐100%)
3 30/30 30/30 30/30 30/30 27/30 30/30 30/30
99%
(207/210)
(96%‐100%)
LimitofDetection
Thelimitofdetection(LOD)fortheSofiaInfluenzaA+BFIAwasdeterminedusingatotaloffour(4)strainsof
humaninfluenzaviruses,two(2)influenzaAandtwo(2)influenzaBviruses(Table9).
Table9
LimitofDetectionwithHumanIsolatesofInfluenzaAandB
ViralStrain
Viral
Type Sub‐Type
MinimumDetectable
Level(TCID
50
/mL)
A/California/07/2009 A 2009H1N1 202
A/HongKong/8/68 A H1N1 105
B/Allen/45 B 40
B/Malaysia/2506/04 B 24
TCID
50
levelsweredeterminedbyeithertheReed‐MuenchmethodorRoweELISA.
AnalyticalReactivity
Analyticalreactivitywasdemonstratedusingatotalof30strainsofhumaninfluenzavirusescomprisedof21
InfluenzaAand9influenzaBviruses(Table10).