Quality Control; Performance Characteristics - Remel Rapid Str System Bedienungsanleitung

ENGLISH
Table 2. Interpretation of RapID STR System Tests*
Cavity # Test Code Reagent
Before Reagent Addition:
1 ARG None
2 ESC None
3 MNL
4 SBL None
5 RAF
6 INU None
7 GAL
8 GLU
None
9 NAG
10 PO
4
After Reagent Addition:
7 TYR
RapID STR Reagent
8 HPR
9 LYS
RapID STR Reagent
10 PYR
*NOTE: Panels should be read by looking down through the reaction cavities against a white background.

QUALITY CONTROL

All lot numbers of RapID STR System 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. Expected
results for selected quality control organisms are listed in Table 3.
Notes
• RapID STR Reagent quality control is accomplished by obtaining the
expected reactions for tests requiring the addition of the reagent (cav. 7-10).
Table 3. Quality Control Chart for RapID STR Panels
Organism
Enterococcus faecalis
®
ATCC 29212
Enterococcus durans
®
ATCC 11576 or 49479
a,b
Streptococcus gallolyticus
®
ATCC 9809
a
Streptococcus pyogenes
®
ATCC 19615
+, positive; –, negative; V, variable; (–), usually negative; (+), usually positive
a
Key indicator strains demonstrate acceptable performance of the most labile substrate in the system and reactivity in a significant number of wells, according to Clinical and
Laboratory Standards Institute recommendations for streamlined quality control.
b
Previously Streptococcus bovis
*Note: Enterococcus durans may yield a very weak positive reaction in the HPR cavity. Gemella morbillorum ATCC
reaction. However, E. durans should still be used to quality control the GLU and LYS cavities.
LIMITATIONS
1. The use of RapID STR System and interpretation of results requires
the knowledge of a competent laboratorian who is trained in general
microbiological methods and who judiciously makes use of training,
experience, specimen information, and other pertinent procedures
before reporting the identification obtained using this system.
2. Characteristics such as Gram stain reaction, hemolysis, and cellular
morphology must be considered when using the RapID STR System.
3. RapID STR System must be used with pure cultures of test
organisms. The use of mixed microbial populations or direct testing of
clinical material without culture will result in aberrant results.
4. RapID STR System is designed for use with the taxa listed in the
RapID STR Differential Chart. The use of organisms not specifically
listed may lead to misidentifications.
5. Expected values listed for RapID STR System tests may differ from
conventional test results or previously reported information.
6. The accuracy of RapID STR System is based on the statistical use
of a multiplicity of specially designed tests and an exclusive,
proprietary database. The use of any single test found in the RapID
STR System to establish the identification of a test isolate is subject
to the error inherent in that test alone.
Positive
Red or dark orange
Black
Yellow or yellow-
orange
Yellow, yellow-
orange, or orange
Yellow
Light purple or
purple
Very dark purple
ARG ESC MNL SBL
+ + + +
+ + – –
– + + –
+ – – –
36
Reaction
Negative
Yellow or yellow- Only a red or dark orange color should be scored as
orange positive.
Clear, tan, or light Any development of a dark black color should be scored
brown deposit as positive.
Any significant yellow or yellow-orange color should be
Red or orange
scored as positive.
Any significant change from red should be scored as
Red
positive.
Only the development of a significant yellow color should
Clear, tan, or very
be scored as positive. Very pale or questionable colors
pale yellow
should be scored as negative.
Clear, tan, or
Any shade of purple should be scored as positive.
yellow
Only the development of a distinct, very dark purple color
Clear, tan, or light
should be scored as positive. Very pale or questionable
to medium purple
colors should be scored as negative.
• Organisms which have been repeatedly transferred on agar media for
prolonged periods may provide aberrant results.
• Quality control strains should be stored frozen or lyophilized. Prior to use,
quality control strains should be transferred 2-3 times from storage on an
agar medium that is recommended for use with RapID STR System.
• Formulations, additives, and ingredients of culture media vary from
manufacturer to manufacturer and may vary from batch to batch. As a
result, culture media may influence constitutive enzymatic activity of
designated quality control strains. If quality control strain results differ
from the patterns indicated, a subculture onto medium from a different
batch or from another manufacturer will often resolve quality control
discrepancies.
RAF INU GAL GLU
– – – +
– – + –
+ + + +
– – – (+)
®
27824 can also be used as a quality control strain for the HPR

PERFORMANCE CHARACTERISTICS

The RapID STR System performance characteristics have been estab-
lished by laboratory testing of reference and stock cultures at Remel and
by clinical evaluations using fresh clinical and stock isolates.
BIBLIOGRAPHY
1. Lennette, E.H., A. Balows, W.J. Hausler, Jr., and J.P. Truant. 1980. Manual of Clinical
rd
Microbiology. 3 ed. ASM, Washington, D.C.
2. Balows, A., W.J. Hausler, Jr., K.L. Herrmann, H.D. Isenberg, and H.J. Shadomy. 1991.
Manual of Clinical Microbiology. 5
3. Poole, P.M. and G. Wilson. 1976. J. Clin. Microbiol. 29:740-745.
4. Facklam, R.R. 1977. J. Clin. Microbiol. 5:184-201.
5. Ruoff, K.L. and L.J. Kunz. 1982. J. Clin. Microbiol. 15:920-925.
6. Berlutti, F., M.C. Thaller, S. Schippa, F. Pantanella, and R. Pompei. 1993. Int. J. Syst.
Bacteriol. 43:63-68.
7. Collins, M.D., D. Jones, J.A. Farrow, R. Klipper-Balz, and K.H. Schleifer. 1984. Int. J.
Syst. Bacteriol. 34:220-223.
8. Facklam, R.R. and M.D. Moody. 1970. Appl. Microbiol. 20:245-250.
9. Holt J.G., N.R. Krieg, P.H. Sneath, J.T. Staley, and S.T. Williams. 1994. Bergey's
Manual of Determinative Bacteriology. 9
10. Isenberg, H.D., E.M. Veilozzi, J. Shapiro, and L.G. Rubin. 1988. J. Clin. Microbiol.
26:479-483.
11. Blazevic, D.J. and G.M. Ederer. 1975. Principles of Biochemical Tests in Diagnostic
Microbiology. John Wiley & Sons, New York, NY.
12. Facklam, R.R. 1976. Crit. Rev. Clin. Lab. Sci. 6:287-317.
13. Gross, K.D, N.P. Houghton, and L.B. Senterfit. 1975. J. Clin. Microbiol. 1:54-60.
3
Comments
NAG PO TYR HPR
4
+ (–) V –
+ – V +*
V – – –
– + + –
th
ed. ASM, Washington, D.C.
th
ed. Williams and Wilkins, Baltimore, MD.
LYS PYR
+ +
(–) +
+ –
+ +
22-25