BD Veritor System Bedienungsanleitung Seite 14

• 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.
PERFORMANCE CHARACTERISTICS
Clinical Performance:
Performance characteristics for the BD Veritor System for Rapid Detection of Flu A+B test were established in multi-center
Point-of-Care (POC) studies conducted at five U.S. trial sites and eight Japan trial sites during the 2010–2011 respiratory
season. A total of 736 prospective specimens (515 in the U.S. and 221 in Japan) were tested using the BD Veritor System for
Rapid Detection of Flu A+B test. These specimens consisted of nasal and nasopharyngeal swabs from symptomatic patients.
In the U.S., 54% of the samples were from females and 46% from males. 20.3% of the samples were from patients less than
or equal to 5 years of age, 40.8% were from patients in the 6-21 year age group, 35.6% were from 22–59 years of age, and
the remaining 3.3% were obtained from people greater than or equal to age 60. In Japan, 43.3% of the samples were from
females and 56.7% from males. 27.3% of the samples were from patients less than or equal to 5 years of age, 58.4% were
from patients in the 16–21 year age group, 13.1% from 22–59 years of age, and 1.3% were obtained from people greater
than or equal to age 60.
The performance of the BD Veritor System for Rapid Detection of Flu A+B test at the U.S. sites were compared to an
FDA-cleared Influenza A and B molecular assay (PCR).
Explanation of Terms:
PPA: Positive Percent Agreement = a / (a+c)
NPA: Negative Percent Agreement = d / (b+d)
P: Positive
N: Negative
C.I: Confidence Interval
New Test Method
P
N
Total
The performance is presented in Table 1 through Table 4 below.
Table 1: Summary of the Performance Data for the BD Veritor System for Rapid Detection of Flu A+B Test Compared
to PCR for All Swabs - All Sites
POC: BD Flu A P
P 189
N 37
Total 226
Reference Method: PCR
PPA: 83.6% (76.1%, 89.1%)
NPA: 97.5% (95.7%, 98.5%)
Wald 95% Confidence intervals corrected for over-dispersion, where needed, due to potential variability between sites.
×
Comparator Method
P N
a b
c d
(a+c) (b+d)
Reference PCR
N Total
13 202
497 534
510 736
100%
100%
×
POC: BD Flu B
P
N
Total
Reference Method: PCR
PPA: 81.3% (71.1%, 88.5%)
NPA: 98.2% (95.7%, 99.3%)
14
Reference PCR
P N Total
139 10 149
32 555 587
171 565 736