Product Manual

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SofiaInfluenzaA+BFIA
  Page15of25
Table2
SofiaInfluenzaA+BFIANasalSwabResultsVersusCulture
(AllAgeGroups)
TYPEA TYPEB

Culture Sens= 124/138=90%

Culture Sens= 100/112=89% 
 Pos Neg 
(95%C.I.84%‐94%)
 Pos Neg 
(95%C.I.82%‐94%)
SofiaPos 124 27
Spec= 500/527=95%
 SofiaPos 100 23
Spec= 530/553=96%
SofiaNeg 14 500 
(95%C.I.93%‐96%)
 SofiaNeg 12 530 
(95%C.I.94%‐97%)
  

Table3
SofiaInfluenzaA+BFIANasopharyngealSwabResultsVersusCulture
(AllAgeGroups)
TYPEATYPEB

Culture Sens= 100/103=97% 

Culture Sens= 101/112=90% 
 Pos Neg 
(95%C.I.91%‐99%)
 Pos Neg 
(95%C.I.83%‐95%)
SofiaPos 100 34
Spec= 596/630=95%
 SofiaPos 101 19
Spec= 602/621=97%
SofiaNeg 3 596 
(95%C.I.93%‐96%)
 SofiaNeg 11 602 
(95%C.I.95%‐98%)
  

Table4
SofiaInfluenzaA+BFIANasopharyngealAspirate/WashResultsVersusCulture
(AllAgeGroups)
TYPEA
 TYPEB

Culture Sens= 68/69=99%

Culture Sens= 46/52=88%

Pos Neg 
(95%C.I.91%‐100%)

Pos Neg 
(95%C.I.77%‐95%)
SofiaPos 68 26
Spec= 554/580=96%

SofiaPos 46 22
Spec= 575/597=96%
SofiaNeg 1 554 
(95%C.I.93%‐97%)

SofiaNeg 6 575 
(95%C.I.94%‐98%)
   

Table5
PerformanceComparedtoCultureforEachSampleTypebyAgeGroupforInfluenzaA
NasalSwabs NasopharyngealSwabs NasopharyngealAspirate/Wash
Sensitivity Specificity Sensitivity Specificity Sensitivity Specificity
AllAges
90%(124/138)
(95%CI=84%‐94%)
95%(500/527)
(95%CI=93%‐96%)
97%(100/103)
(95%CI=91%‐99%)
95%(596/630)
(95%CI=93%‐96%)
99%(68/69)
(95%CI=91%‐100%)
96%(554/580)
(95%CI=93%‐97%)
<6years
95%(62/65)
(95%CI=87%‐99%)
95%(210/221)
(95%CI=91%‐97%)
97%(61/63)
(95%CI=89%‐100%)
94%(444/470)
(95%CI=92%‐96%)
99%(68/69)
(95%CI=91%‐100%)
95%(544/570)
(95%CI=93%‐97%)
6to21
years
87%(46/53)
(95%CI=75%‐94%)
95%(193/204)
(95%CI=91%‐97%)
97%(35/36)
(95%CI=85%‐100%)
94%(136/144)
(95%CI=89%‐97%)
N/A(0/0)
100%(10/10)
(95%CI=68%‐100%)
22to59
years
78%(14/18)
(95%CI=54%‐92%)
96%(82/85)
(95%CI=90%‐99%)
100%(4/4)
(95%CI=45%‐100%)
100%(15/15)
(95%CI=76%‐100%)
N/A(0/0) N/A(0/0)
60Years
andup
100%(2/2)
(95%CI=29%‐100%)
88%(15/17)
(95%CI=64%‐98%)
N/A(0/0)
100%(1/1)
(95%CI=17%‐100%)
N/A(0/0) N/A(0/0)