BD Veritor System Bedienungsanleitung Seite 15

BD Veritor Group A Strep Reproducibility
Sample
% Pos
High 5.0%
negative (1/20)
Low 80.0%
positive (16/20)
Moderate 100%
positive (20/20)
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.
Technical Support
Technical Information: In the United States, contact BD Technical Service and Support at 1.800.638.8663 or www.bd.com.
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
256040 BD Veritor™ System for Rapid Detection of Group A Strep, 30 tests
220093 BD BBL™ CultureSwab™ Liquid Amies, 50 Single Swabs
220099 BD BBL™ CultureSwab™ Liquid Stuart, 50 Single Swabs
220105 BD BBL™ CultureSwab™ Liquid Amies, 50 Double Swabs
220109 BD BBL™ CultureSwab™ Liquid Stuart, 50 Double Swabs
256049 BD Veritor™ System Group A Strep Control Swab Set, 10 pairs of swabs
220245 BD™ ESwab Regular Collection Kit – White polypropylene screw-cap tube filled with 1 mL of Liquid
Amies Medium and one regular size flocked applicator swab, 50 units
220246 BD™ ESwab Minitip Collection Kit – Green polypropylene screw-cap tube filled with 1 mL of Liquid Amies
Medium and one minitip flocked applicator swab, 50 units
220532 BD™ ESwab Flexible Minitip Collection Kit – Blue polypropylene screw-cap tube filled with 1 mL of Liquid Amies
Medium and one flexible minitip flocked applicator swab, 50 units
BD Veritor™ System Reader
256055
BD Veritor™ Plus Analyzer,
256066
BD Veritor™ InfoSync Module
256067
BD Veritor™ InfoScan Module
256068
443907 USB Printer Cable for BD Veritor™ Analyzer
REFERENCES
1. Versalovic, J., K.C. Carroll, G. Funke, J.H. Jorgensen, M.L. Landry, and D.W. Warnock (ed.). 2011. Manual of Clinical
Microbiology, 10th ed. American Society for Microbiology, Washington, D.C.
2. Webb, K.H. 1998. Pediatrics, 101:2, 2.
3. Bisno A.L., M.A. Gerber, J.M. Gwaltney, E.L. Kaplan, and R.H. Schwartz.1997. Clin. Infect. Dis., 25: 574–83.
4. Needham, C.A., K.A. McPherson, K.H. Webb. 1998. Clin. Microbiol., 3468–3473.
5. Clinical and Laboratory Standards Institute. 2005. Approved Guideline M29- A3. Protection of laboratory workers from
occupationally acquired infections, 3rd ed. CLSI, Wayne, Pa.
6. Garner, J.S. 1996. Hospital Infection Control Practices Advisory Committee, U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention. Guideline for isolation precautions in hospitals. Infect. Control
Hospital Epidemiol. 17:53–80.
7. U.S. Department of Health and Human Services. 2007. Biosafety in microbiological and biomedical laboratories, HHS
Publication (CDC) 5th ed. U.S. Government Printing Office, Washington, D.C.
8. Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers
from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1)
of Directive 89/391/EEC). Official Journal L262, 17/10/2000, p. 0021–0045.
9. Garcia, L.S. (ed.). 2007. Specimen collection and transport. In Clinical microbiology procedures handbook, 3
American Society for Microbiology, Washington, D.C.
10. American Academy of Pediatrics (2009). Group A streptococcal infections. In LK Pickering et al., eds., Red Book: 2009
Report of the Committee on Infectious Diseases, 28th ed., pp. 616–628. Elk Grove Village, IL: American Academy of
Pediatrics.
11. Nussinovitch, M., Y. Finkelstein, J. Amir, and I. Varsano. 1999. Clinical Pediatrics, 357–360.
12. Woods, W.A., C.T. Carter, M. Stack, A.F. Connors Jr., and T.A. Schlager. 1999. Southern Medical Journal, 491–492.
Technical Information: In the United States contact BD Technical Service and Support at 1.800.638.8663 or www.bd.com.
POC 1
95% CI % Pos
5.0%
0.9%, 23.6%
(1/20)
90.0%
58.4%, 91.9%
(18/20)
100%
83.9%, 100%
(20/20)
POC 2
95% CI % Pos
10.0%
0.9%, 23.6%
(2/20)
80.0%
69.9%, 97.2%
(16/20)
100%
83.9%, 100%
(20/20)
15
POC 3
95% CI % Pos
0.0%
2.8%, 30.1%
(0/20)
80.0%
58.4%, 91.9%
(16/20)
100%
83.9%, 100%
(20/20)
Clinical Site
95% CI
0.0%, 16.1%
58.4%, 91.9%
83.9%, 100%
rd ed.