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When the performance was compared to viral culture:
NP=NasapharyngealNP=Nasapharyngeal
NP=Nasapharyngeal
When the performance was compared to PCR:
INTERPRETATION OF RESULTS
Influenza
Date
ID
C
B
A
C
B
A
C
B
A
C
B
A
C
B
A
C
B
A
C
B
A
C
B
A
C Line only
NEGATIVE
No C Line
INVALID
Any visible A and/or B Line(s)
with C Line is POSITIVE.
Repeat with new
sample and device.
A line:
Influenza
type A
B line:
Influenza
type B
A & B lines:
Influenza
type A & B
A comparison of the Status Flu A & B test with three other commercially available Influenza A & B tests with positive 2009
H1N1 viral clinical samples from the CDC shows that Status Flu A & B had the highest agreement against rRT-PCR.
*Ct intervals is the indication of the amount of virus in a specimen, with lower intervals indicating higher viral titers.
CDC-MMWR August 7, 2009/58(30);826-829 “Evaluation of Rapid Influenza Diagnostic Tests for Detection of Novel Influenza A (H1N1) Virus --- United States, 2009”
No. of positives H1N1 2009 samples by rRT-PCR
(Ct intervals*)
Supplier <20 20 to 25 25 to 30 >30 Total
Status Flu A & B 18/18 23/27 5/17 1/4 47/66 71
Competitor A 8/9 7/17 2/13 1/6 18/45 40
Competitor B 9/9 13/17 6/13 3/6 31/45 69
Competitor C 8/9 10/16 2/12 1/6 21/43 49
Agreement-all
samples tested
%
Printed in USA. All rights reserved.
481-10/20/11
Sample Type
Nasal Swab
NP Swab
NP Aspirate
Nasal Swab
NP Swab
NP Aspirate
Sensitivity
91.6%
89.6%
95.3%
82.3%
86.8%
91.6%
Specificity
75.2%
77.0%
85.7%
88.3%
92.9%
97.5%
Influenza
A
Influenza
B
Sample Type
Nasal Swab
NP Swab
NP Aspirate
Nasal Swab
NP Swab
NP Aspirate
Sensitivity Specificity
Influenza
A
Influenza
B
97.0%
97.1%
98.4%
94.1%
93.1%
94.4%
94.2%
94.5%
95.8%
93.2%
96.6%
100%
Easy and Simple Procedure
Proven Clinical Performance
Extract Incubate Flip Read
Influenza
B
A
C
Date______
ID________
B
A
C
Influenza
Date______
ID________
C
B
A
C
B
A
C
B
A
Fill extraction well
with reagent
Insert collection swab
and incubate for
1 minute
Tip device
allowing liquid to ow
Interpret results
at 10-15 minutes
**See Package Insert For Details