Product Manual

using the coded samples following the test protocol given in the package insert as if they are testing
patient sample including the sample extraction step.
The results obtained at each site agreed 100% with the expected results. No differences were observed
within run (15 replicates), between runs (five different days), or between sites (two POL sites and one
lab).
Analytical Sensitivity
Limit of Detection (LOD)
The LODs were determined for each of the two strains selected from the influenza type A and type B
strains listed in the analytical inclusivity (sensitivity) section below. The sensitivity level of each selected
viral strain established in the above study analytical inclusivity (sensitivity) study was tested 60 times to
confirm the sensitivity level as LOD level, which gives 95% detection rate. All four viral strains tested were
detected 96.7% of the time in 60 replicates.
Influenza
Type
Viral Strain TCID
50
/ML
#Positive/
#TOTAL
% Positive
A A/PR/8/34 (H1N1) 1.05 X 10
2
58/60 96.7
A A/Victoria/3/75 (H3N2) 9.95 X 10
1
58/60 96.7
B B/Taiwan/2/62 1.58 X 10
3
58/60 96.7
B B/Maryland/1/59 1.99 X 10
1
58/60 96.7
Analytical Inclusivity
The analytical inclusivity (sensitivity) was established for a total of 37 influenza strains: 26 strains of
influenza A type and 11 strains of influenza B type. The results are shown in the tables below.
Influenza
Type
Viral Strain TCID
50
/ML
Influenza
Type
Viral Strain TCID
50
/mL
A A/PR/8/34(H1N1) 1.05 x 10
2
A
A/Virginia/ATCC2/
2009(H1N1)
2.32 x 10
3
A A/FM/1/47(H1N1) 1.73 X 10
1
A
A/Virginia/
ATCC3/200 9(H1N1)
5.00 x 10
4
A A/NWS/33(H1N1) 4.10 x 10
3
A A/Indiana/10/2011(H3N2)v** 2.34 x 10
3
A
A/Hong Kong/8/68
(H3N2)
8.50 X 10
2
A
A/Indiana/08/2011 (H3N2)
v**
2.87 x 10
6
A A/Denver/1/57(H1N1) 7.20 X 10
0
A
A/Minnesota/11/2010
(H3N2)v**
2.13 x 10
6
A A/Aichi/2/68(H3N2) 9.95 X 10
0
A
A/Minnesota/11/2010
X-203(H3N2)v**
2.28 x 10
3
A A/Port Chalmers/1/73 1.99 X 10
2
B B/Lee/40 5.00 x 10
0
A
A/Victoria/3/75
(H3N2)
9.95 X 10
1
B B/Allen/45 1.58 x 10
0
A
A/New Jersey/8/76
(H1N1)
9.95 X 10
1
B B/GL/1739/5 4 9.95 x 10
2
A A/WS/33 (H1N1) 5.00 X 10
1
B B/Taiwan/2/62 1.58 x 10
3
A A/Swine/1976/31 1.58 X 10
2
B B/Maryland/1/59 1.99 x 10
1
A
2009 H1N1 Clinical
Isolate* (Swine Origin
Influenza A)
1.00 X 10
3
B B/Mass/3/66 5.00 x 10
1
A A/CA/07/20 09 (H1N1) 6.15 X 10
3
B B/R22 Barbara 1.60 x 10
-1
A A/CA/08/2009 (H1N1) 9.31 X 10
3
B B/R75 2.94 x 10
3
A A/NY/18/2009 (H1N1) 2.5 X 10
3
B B/Russia/69 3.16 x 10
3
A
A/Mexico/4108/2009
(H1N1)
8.51 X 10
3
B B/Hong Kong/5/72 2.88 x 10
1
A
A/CA/07/2009 NYC,
X-179A (H1N1)
1.08 X 10
3
B B/Texas/39/2006** 2.34 x 10
4