BD Veritor System Bedienungsanleitung Seite 122

• The analytical reactivity of this device has not been established for avian or swine origin influenza strains other than those
included in the "strain reactivity" tables.
• The performance of this test has not been evaluated for use in patients without signs and symptoms of respiratory infection.
• The BD Veritor System Instrument reports dual positive influenza A and influenza B results as "Result Invalid." True
dual positives are exceptionally rare. Specimens generating a "Result Invalid" should be retested. Upon retesting, if the
specimen produces a "Result Invalid" the user may want to consider other methods to determine whether the sample is
positive or negative for influenza virus.
EXPECTED VALUES
The rate of positivity observed in respiratory testing will vary depending on the method of specimen collection, handling/
transport system employed, detection method utilized, the time of year, age of the patient, geographic location and most
importantly, local disease prevalence. The overall prevalence observed with an FDA-cleared Influenza A and B molecular
assay in the U.S. during the 2010–2011 clinical study was 29.9% for Influenza A and 19.7% for influenza B. The overall
prevalence observed with the same FDA-cleared Influenza A and B molecular assay in Japan during the 2010–2011 clinical
study was 32.2% for Influenza A and 31.7% for influenza B.
Analytical Studies
Analytical Sensitivity (Limit of Detection)
The limit of detection (LOD) for the BD Veritor System for Rapid Detection of Flu A+B test was established for a total of
8 influenza strains: 5 influenza A and 3 influenza B. The LOD for each strain represents the lowest concentration producing a
positivity rate of ≥95% based on testing 20 to 60 replicates.
Type Influenza Viral Strain
A A/Brisbane/10/2007 H3N2
A A/Brisbane/59/2007 H1N1
A A/California/7/2009 H1N1
A A/Victoria/3/75 H3N2
A A/Anhui/1/2013 H7N9
B B/Brisbane/60/2008
B B/Florida/4/2006
B
TCID /mL = 50% Tissue Culture Infectious Dose
50
EID /mL= 50% Egg Infectious Dose
50
Strain Reactivity with Influenza A and B Viruses
The BD Veritor System for Rapid Detection of Flu A+B test was evaluated using a panel of influenza strains. Each strain was
diluted and tested in triplicate until a point where not all of the replicates were positive. The dilution prior to that is provided in
the table below as a minimal detected concentration. All influenza A strains showed positive Flu A test results and negative
Flu B test results. Conversely, all of the influenza B strains showed positive Flu B test results and negative Flu A test results.
Although this test has been shown to detect novel avian influenza A (H7N9) and H3N2v cultured viruses the performance
characteristics of this device with clinical specimens that are positive for novel avian influenza A (H7N9) and H3N2v influenza
viruses has not been established. The BD Veritor System Flu A+B assay can distinguish between influenza A and B viruses,
but it cannot differentiate influenza A subtypes.
B/Lee/40
Calculated LOD Calculated LOD
(TCID /mL)
50
7.27 x 10 2
3.30 x 10 2
5.00 x 10 3
3.11 x 10 3
N/A
7.42 x 10 3
1.30 x 10 3
4.44 x 10 4
12
No. Positive /
(EID /mL) Total
50
N/A 57/60
N/A 57/60
N/A 57/60
N/A 59/60
5.42 x 10 59/60
6
N/A 58/60
N/A 58/60
N/A 20/20
% Positive
95%
95%
95%
98.3%
98.3%
96.7%
96.7%
100%