remel RapID STR System Bedienungsanleitung

ENGLISH
RapID™ STR System
INTENDED USE
Remel RapID STR System is a qualitative micromethod employing con-
ventional and chromogenic substrates for the identification of medically
important streptococci and related organisms which have been isolated
from human clinical specimens. The RapID STR System is intended to aid
in the identification of Lancefield groups A, B, C, D, and G streptococci,
viridans streptococci, and Streptococcus pneumoniae, Enterococcus spp.,
Aerococcus spp., Gemella spp., Leuconostoc spp., Pediococcus spp.,
Weisella confusa, and Listeria monocytogenes.
the organisms addressed by the RapID STR System is provided in the
RapID STR Differential Chart.
SUMMARY AND EXPLANATION
RapID STR System is comprised of (1) RapID STR Panels and (2) RapID
STR Reagent. Each RapID STR Panel has several reaction cavities
molded into the periphery of a plastic disposable tray. Reaction cavities
contain dehydrated reactants and the tray allows simultaneous inoculation
of each cavity with a predetermined amount of inoculum. A suspension of
the test organism in RapID Inoculation Fluid is used as the inoculum
which rehydrates and initiates test reactions. After incubation of the panel,
each test cavity is examined for reactivity by noting the development of a
color. In some cases, reagents must be added to the test cavities to
provide a color change. The resulting pattern of positive and negative test
scores is used as the basis for identification of the test isolate by
comparison of results to reactivity patterns stored in the Electronic RapID
Compendium (ERIC™) database or by use of the RapID STR Differential
Chart.
PRINCIPLE
The tests used in RapID STR System are based on microbial degradation
of specific substrates detected by various indicator systems. The reactions
employed are a combination of conventional tests and single-substrate
chromogenic tests, described in Table 1.
REAGENTS*
RapID STR Reagent (provided with kit)
Reactive ingredient per liter:
σ-Dianisidine ................................................................................... 0.9 ml
RapID Inoculation Fluid (R8325102, supplied separately)
KCl .................................................................................................. 6.0 g
CaCl .............................................................................................. 0.5 g
2
Demineralized Water ................................................................. 1000.0 ml
*Adjusted as required to meet performance standards.
Table 1. Principles and Components of the RapID STR System
Cavity # Test Code Reactive Ingredient
Before Reagent Addition:
1 ARG L-arginine
2 ESC Esculin
3 MNL Mannitol
4 SBL Sorbitol
5 RAF Raffinose
6 INU Inulin
ρ-Nitrophenyl-α,D-galactoside
7 GAL
ρ-Nitrophenyl-α,D-glucoside
8 GLU
ρ-Nitrophenyl-n-acetyl-
9 NAG
β,D-glucosaminide
ρ-Nitrophenyl phosphate
10 PO
4
After Reagent Addition:
Tyrosine β-naphthylamide
7 TYR
Hydroxyproline β-naphthylamide
8 HPR
Lysine β-naphthylamide
9 LYS
Pyrrolidine β-naphthylamide
10 PYR
PRECAUTIONS
This product is for In Vitro diagnostic use and should be used by properly
trained individuals. Precautions should be taken against the dangers of
microbiological hazards by properly sterilizing specimens, containers,
media, and test panels after use. Directions should be read and followed
carefully.
Caution!
1.
2.
1-10
A complete listing of
STORAGE
The RapID STR System should be stored in its original container at 2-8°C
until used. Allow product to equilibrate to room temperature before use.
DO NOT interchange reagents among different RapID systems. Remove
only the number of panels necessary for testing. Reseal the plastic pouch
and promptly return to 2-8°C. Panels must be used the same day they are
removed from storage. RapID Inoculation Fluid should be stored in its
original container at room temperature (20-25°C) until used.
PRODUCT DETERIORATION
This product should not be used if (1) the color of the reagent has
changed, (2) the expiration date has passed, (3) the plastic tray is broken
or the lid is compromised, or (4) there are other signs of deterioration.
SPECIMEN COLLECTION, STORAGE, AND TRANSPORT
Specimens should be collected and handled following recommended
guidlines.
MATERIALS SUPPLIED
(1) 20 RapID STR Panels, (2) 20 report forms, (3) RapID STR Reagent (one
plastic dropper-bottle containing reagent sufficient for 20 panels), (4) 2
chipboard incubation trays, (5) Instructions for Use (IFU).
MATERIALS REQUIRED BUT NOT SUPPLIED
(15 ml/Bottle)
(1) Loop sterilization device, (2) Inoculating loop, swabs, collection
containers,
(4) Supplemental media, (5) Quality control organisms, (6) Gram
stain reagents, (7) Microscope slides, (8) Cotton swabs, (9) RapID
(1 ml/Tube)
Inoculation Fluid-1 ml (R8325102), (10) McFarland #1 turbidity standard or
equivalent (R20411), (11) Pipettes, (12) ERIC (Electronic RapID
Compendium, R8323600).
Quantity Principle
Hydrolysis of arginine releases basic products which raise
2.0%
the pH and change the indicator.
Hydrolysis of glucoside releases esculetin which reacts
0.5%
with ferric ion forming a black compound.
1.5%
1.5%
Utilization of the carbohydrate substrate produces acidic
products which lower the pH and change the indicator.
1.2%
1.5%
0.1%
0.1%
Hydrolysis of colorless ρ-nitrophenyl-substituted glycoside
or phosphoester releases yellow ρ-nitrophenol.
0.1%
0.2%
0.05%
Hydrolysis of arylamide releases free β-naphthylamine
0.08%
which is detected with RapID STR Reagent.
0.08%
0.1%
1
RapID STR Reagent is toxic and may cause harm to the environment.
Harmful by inhalation, contact with skin or eyes, or if swallowed. May
cause cancer, impair fertility, or cause harm to unborn child. Danger
of serious irreversible effects.
Refer to Material Safety Data Sheet for detailed information on
reagent chemicals.
20,21
(3) Incubators, alternative environmental systems,
Bibliography #
11-13
12
1, 2, 11
14-16
15, 17-19