Technical Support - BD Veritor System Bedienungsanleitung

Sample Type
High Negative B/Lee/40
Low Positive B/Lee/40
Negative
*Two (2) samples were excluded from the analysis due to errors in data recording.
Using risk analysis as a guide, analytical flex studies were conducted. The studies demonstrated that the test is insensitive to
stresses of environmental conditions and potential user errors.
In support of the CLIA waiver, an additional reactivity study was performed at an independent laboratory to demonstrate
reactivity of the BD Veritor System for the Rapid Detection of Flu A+B with a broad range of contemporary influenza A and
influenza B viruses. The BD Veritor System yielded positive results with all 18 influenza A viruses and 7 influenza B viruses
included in the test panel at acceptable viral load levels.

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
256045 BD Veritor™ System for Rapid Detection of Flu A+B, 30 tests
256051 BD Veritor™ System Flu A+B 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
256038 BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV)
To network a BD Veritor Plus Analyzer to an LIS, contact BD Technical Services for details.
REFERENCES
1. Simonsen L., Fukuda K, Schonberger LB, Cox NJ. Impact of influenza epidemics on hospitalizations. J. Infect. Dis. 2000;
181:831–7
2. 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
3. Treanor, J.J., Hayden, F.G., Vrooman, P.S., et al. 2000. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir
in treating acute influenza: a randomized controlled trial. JAMA. 283:1016–1024.
4. Kaiser, L., Couch, R.B., Galasso, G.J., Glezen, W.P., Webster, R.G., Wright, P.F., and Hayden, F.G. 1999. First
international symposium on influenza and other respiratory viruses: summary and overview Kapalua, Maui, Hawaii,
December 4–6, 1998. Antiviral Res., 42:149–176
5. Cox, N.J., and Bender, C.A. 1995. The molecular epidemiology of influenza viruses. Virology, 6:359–370.
6. Todd, S.J., Minnich, L., and Waner, J.L. 1995. Comparison of rapid immunofluorescence procedure with TestPack RSV
and Directigen Flu A for diagnosis of respiratory syncytial virus and influenza A virus. J. Clin. Microbiol.33:1650–1651.
7. Harris, P.O. 1989. Clinical relevance and efficient detection of seven major respiratory viruses. ACL. p. 15–19.
8. McElhaney, J.E., Gravenstein, S., Krause, P., Hooton, J.W., Upshaw, C.M., and Drinka, P. 1998. Assessment of markers of
the cell-mediated immune response after influenza virus infection in frail older adults. Clin. Diag. Lab. Immunol. 5:840–844.
9. Fan, J., Henrickson, K.J., and Savatski, L.L. 1998. Rapid simultaneous diagnosis of infections with respiratory syncytial
viruses A and B, influenza viruses A and B, and human parainfluenza virus types 1, 2, and 3 by multiplex quantitative
reverse transcription-polymerase chain reaction-hybridization assay (hexaplex). Clin. Infect. Disease 26:1397–1402.
10. Wright, K.E., Wilson, G.A.R., Novosad, D., Dimock, C., Tan, D., and Weber, J.M. 1995. Typing and subtyping of influenza
viruses in clinical samples by PCR. J. Clin. Microbiol.33:1180–1184.
11. Kendal, A.P. 1985. Influenza Viruses. p. 341–357. Laboratory Diagnosis of Viral Infections, In H. Lennette, (ed.) Marcel
Dekker, Inc., New York.
12. McQuillen, J., Madeley, C.R., and Kendal, A.P. 1985. Monoclonal antibodies for the rapid diagnosis of influenza A and B
virus infections by immunofluorescence. Lancet.ii: 911–914.
Influenza B Viral Strain
Untrained Intended Users
Percent Detection
11.7% (7/60)
72.4% (42/58)*
0.0% (0/240)
21
95% Confidence Interval
(5.8%, 22.2%)
(59.8%, 82.2%)
(0.0%, 1.6%)