BD Veritor System Handbuch Seite 15

Another study was designed to assess the capability of untrained users to test weakly reactive samples and deliver results
with accuracy. This study was conducted at three CLIA waived intended use sites using simulated swab samples. The
samples were spiked with RSV virus targeting three concentrations (high negative =~5% positivity, low positive =~95%
positivity and moderate positive =~100% positivity). The swabs were provided to the operators in panels that were masked
and randomized prior to shipment to the sites. The samples were also tested by trained laboratorians at one clinical site.
Each site had two operators who each tested the panel on each of ten days. Each swab was processed and tested in a
single device according to the test procedure.
The table below shows the rate of RSV detection for weakly reactive samples when the test was used by untrained intended
users. The rate of RSV detection for weakly reactive samples when the test was used by trained laboratorians at one clinical
laboratory site is also provided.
Sample
% Pos
High
5.0%
negative
(1/20)
RSV
Low positive 75.0%
RSV (15/20)
Moderate
100%
positive
(20/20)
RSV
Using risk analysis as a guide, analytical flex studies were conducted. The studies demonstrated that the test is insensitive to
stresses due to environmental conditions or from potential user errors.
Technical Support
For questions, or to report a problem please call Technical Support at 1.800.638.8663. Test system problems may
also be reported to the FDA using the MedWatch reporting system (phone: 1.800.FDA.1088; fax: 1.800.FDA.1078;
or http://www.fda.gov/medwatch).
AVAILABILITY
Cat. No. Description
256038 BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV), CLIA waived kit, 30 tests
256042 BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) Laboratory kit, 30 tests
256045 BD Veritor™ System for Rapid Detection of Flu A+B, CLIA Waived kit, 30 tests
256041 BD Veritor™ System for Rapid Detection of Flu A+B, Laboratory kit, 30 tests
256061 BD Veritor™ System RSV Control Swab Set, 10 pairs of swabs
220252 COPAN Flexible Minitip Flocked Swab, 100 swabs
256066 BD Veritor™ Plus Analyzer
256068 BD Veritor™ InfoScan Module
443907 USB Printer Cable for BD Veritor™ Analyzer
To network a BD Veritor Plus Analyzer to an LIS, contact BD Technical Services for details.
REFERENCES
1. Hall CB, Weinberg GA, Iwane MK, et al.,The Burden of Respiratory Syncytial Virus Infection in Young Children.
N Engl J Med 2009;360:588–98.
2. Nair H, Nokes DJ, Gessner BD, et al., Global burden of acute lower respiratory infections due to respiratory syncytial
virus in young children: a systematic review and meta-analysis. Lancet 2010;375:1545–55.
3. Falsey AR and EE Walsh, Respiratory syncytial virus infection in adults. Clin Microbiol Rev 2000;13:371–84.
4. Murata Y and AR Falsey, RSV Infection in Elderly Adults, In: Patricia Cane, Editor(s), Perspectives in Medical Virology,
2006, Elsevier, Volume 14, Pages 163–82.
5. Crowcroft NS, Cutts F and Zambon MC, Respiratory syncytial virus: an underestimated cause of respiratory infection,
with prospects for a vaccine. Commun Dis Public Health. 1999;2:234–41.
6. Thompson WW, Shay DK, Weintraub E, et al., Mortality associated with influenza and respiratory syncytial virus in the
United States. JAMA. 2003;289:179–86.
7. Henrickson KJ and CB Hall, Diagnostic assays for respiratory syncytial virus disease. Pediatr Infect Dis J
2007;26 (Suppl):S36–40.
8. Popow-Kraupp, T and JH Aberle, Diagnosis of Respiratory Syncytial Virus Infection. Open Microbiol J 2011;5:128–34.
Published online 2011 December 30.
9. Barenfanger J, Drake C, Leon N, et al., Clinical and financial benefits of rapid detection of respiratory viruses:
an outcomes study. J Clin Microbiol 2000;38:2824–8.
Untrained Users
POC 1
95% CI % Pos
0.0%
0.9%, 23.6%
(0/20)
75.0%
53.1%, 88.8%
(15/20)
100%
83.9%, 100%
(20/20)
POC 2
95% CI % Pos
5.0%
0.0%, 16.1%
(1/20)
70.0%
53.1%, 88.8%
(14/20)
100%
83.9%, 100%
(20/20)
15
Trained Users
POC 3
95% CI % Pos
15.0%
0.9%, 23.6%
(3/20)
75.0%
48.1%, 85.5%
(15/20)
100%
83.9%, 100%
(20/20)
Clinical Site
95% CI
5.2%, 36.0%
53.1%, 88.8%
83.9%, 100%