Download BactiCard Strep - Thermo Scientific

ENGLISH
QUALITY CONTROL
®
All lot numbers of BactiCard Strep have been tested using the
following quality control organisms and have been found to be
acceptable. Testing of control organisms should be performed in
accordance with established laboratory quality control procedures. If
aberrant quality control results are noted, patient results should not
be reported.
RESULTS
PYR LAP ESC
BIBLIOGRAPHY
1.
2.
3.
4.
CONTROL
INCUBATION
Enterococcus faecalis
®
ATCC 29212
Aerococcus viridans
®
ATCC 11563
Pediococcus acidilactici
®
ATCC 33314
Aerobic, 10 min. @ RT
+
+
+
5.
Aerobic, 10 min. @ RT
+
–
–
Aerobic, 10 min. @ RT
–
+
+
6.
7.
8.
PERFORMANCE CHARACTERISTICS
®
Remel BactiCard Strep was evaluated with 109 strains of
streptococci and related genera. Greater than 98% agreement with
9
expected values was obtained.
Genus
Aerococcus
Enterococcus
Gemella
Lactococcus
Leuconostoc
Pediococcus
Streptococcus
No. Tested
No. in Agreement
3
23
2
2
5
1
73
3
23
2
2
4*
1
72
*Leuconostoc paramesenteroides ATCC® 33313 is consistently positive for LAP.10
9.
10.
Godsey, J., R. Schulman, and L. Eriquez. 1981. Annual Meeting of
the American Society for Microbiology. Abstract C84.
Fertally, S. and R.R. Facklam. 1987. J. Clin. Microbiol. 25:18451850.
Bosley, G.S., P.L. Wallace, C.W. Moss, A.G. Steigerwalt, D.J.
Brenner, J.M. Swenson, G.A. Herbert, and R.R. Facklam. 1990. J.
Clin. Microbiol. 28:416-421.
Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A.
Pfaller. 2007. Manual of Clinical Microbiology. 9th ed. ASM Press,
Washington, D.C.
Forbes, B.A., D.F. Sahm, and A.S. Weissfeld. 2007. Bailey and Scott’s
Diagnostic Microbiology. 12th ed. Mosby Elsevier, St. Louis, MO.
Facklam, R.R. and J.A. Elliott. 1995. Clin. Microbiol. Rev. 8:479-495.
Facklam, R.R. 2001. Clin. Microbiol. Newsl. 23:1-7.
Winn, W.C., Jr., S.D. Allen, W.M Janda, E.W. Koneman, G.W.
Procop, P.C. Schreckenberger, and G.L. Woods. 2006. Koneman’s
Color Atlas and Textbook of Diagnostic Microbiology. 6th ed.
Lippincott Williams and Wilkins, Philadelphia, PA.
Data on file. Remel Inc., Lenexa, KS.
Ruoff, K.L., D.R. Kuritzkes, J.S. Wolfson, and M.J. Ferraro. 1988. J.
Clin. Microbiol. 26:2064-2068.
PACKAGING
®
REF R21112, BactiCard Strep ......................................... 25 Tests/Kit
Symbol Legend
REF
Catalog Number
IVD
In Vitro Diagnostic Medical Device
LAB
For Laboratory Use
Consult Instructions for Use (IFU)
LIMITATIONS
1. Disregard color development in the LAP and PYR test circles
that occurs more than 60 seconds after the addition of the Color
Developer.
2. False-negative reactions may occur if inadequate inoculum is
used or if inoculum is removed from selective media, such as
9
Columbia CNA or PEA agars.
3. This test is only part of the overall scheme for identification of
streptococci and related genera. Additional testing may be
required for definitive identification.
Consult appropriate
4,5,8
references for further instructions.
4. A vancomycin susceptibility screen may be performed to aid in
the differentiation of those organisms with overlapping profiles
for the enzymes assayed by this test.
5. The test for esculin hydrolysis does not incorporate bile
tolerance of the organism and thus, does not directly correlate to
results obtained with bile esculin agars or broths.
6. Some enterococcal strains (particularly E. faecalis) produce a
pseudocatalase that is responsible for the weak positive
catalase reaction that is seen with some strains, particularly on
primary isolation. The strength of this reaction may diminish
8
upon subculture.
Temperature Limitation (Storage Temp.)
LOT
Batch Code (Lot Number)
Use By (Expiration Date)
EC REP
European Authorized Representative
BactiCard® is a registered trademark of Remel Inc.
ATCC® is a registered trademark of American Type Culture Collection.
IFU 21112, Revised April 16, 2009
12076 Santa Fe Drive, 2
Lenexa, KS 66215, USA
General Information: (800) 255-6730 Technical Services: (800) 447-3641 Order Entry: (800) 447-3635
Local/International Phone: (913) 888-0939 International Fax: (913) 895-4128
Website: www.remel.com Email: [email protected]
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