Product Manual
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SofiaInfluenzaA+BFIA
Page18of25
Table10
AnalyticalReactivitywithHumanIsolatesofInfl uenzaAandB
ViralStrain
Viral
Type Sub‐Type
Minimum
Detectable
Level
(TCID
50
/mL) ViralStrain
Viral
Type Sub‐Type
Minimum
Detectable
Level
(TCID
50
/mL)
A/FortMonmouth/1/47 A H1N1 50 A/Wisconsin/67/05 A H3N2 20
A/NewCaledonia/20/1999 A H1N1 200 A2/Aichi/2/68 A H3N2 1.25
A/NewJersey/8/76 A H1N1 500 A/Anhui/01/2005 A H5N1 5
A/NWS/33 A H1N1 0.63 A/GWT/LA/169GW/88 A H10N7 20
A/PuertoRico/8/34 A H1N1 100 A/Shearwater/
Australia2576/79
A H15N9 10
A/SolomonIslands/3/06 A H1N1 0.31
A/Taiwan/42/06 A H1N1 200 B/Brisbane/60/2008 B 10
A/WI/629‐9/2008 A H1N1 200 B/Florida/04/2006 B 250
A1/Denver/1/57 A H1N1 20 B/Florida/07/2004 B 500
Influenza/Mexico/4108/2009 A 2009H1N1 200 B/GL/1739/54 B 2000
A/WI/629(D02312)/2009 A 2009H1N1 50 B/HongKong/5/72 B 20
A/WI/629(D02473)/2009 A 2009H1N1 25 B/Lee/40 B 5
A/PortChalmers/1/73 A H3N2 1000 B/Maryland/1/59 B 50
A/Victoria/3/75 A H3N2 200 B/Ohio/1/2005 B 50
A/WI/629‐2/2008 A H3N2 20 B/Taiwan/2/62 B 50
ViralStrain
Viral
Type Sub‐Type
Minimum
Detectable
Level
(EID
50
/mL)
A/Anhui/1/2013* A H7N9 3.95x10
6
TCID
50
/mL=50%tissuecultureinfectiousdose.EID
50
/mL=50%egginfectivedose.TCID
50
andEID
50
levelsweredeterminedbytheReed‐
Muenchmethod.
*Although this test has been shown to detect H7N9 virus cultured from a positive human respiratory sample, the performance
characteristicsofthisdevicewithclinicalsamplesthatarepositiveforH7N9influenzavirushavenotbeenestablished.TheSofiaInfluenza
A+BFIAcandistinguishbetweeninfluenzaAandBviruses,butitcannotdifferentiateinfluenzasubtypes.