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VIDAS LMX & LPT Collaborative Study
April 19, 2013
OMA-2013-Apr-XXX
For the detection of
Listeria
species in a Variety of Foods.
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Caution
:
Listeria monocytogenes
is of particular concern for pregnant
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women, the aged and the infirmed. It is recommended that these concerned
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groups avoid handling this organism. Dispose of all reagents and other
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contaminated materials by acceptable procedures for potentially
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biohazardous materials.
Some reagents in the kit contain 1 g/L
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concentrations of sodium azide. Check local regulations prior to disposal.
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Disposal of these reagents into sinks with copper or lead plumbing should be
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followed immediately with large quantities of water to prevent potential
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hazards.
This kit contains products of animal origin. Certified knowledge of
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the origin and/or sanitary state of the animals does not totally guarantee the
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absence of transmissible pathogenic agents. It is therefore recommended that
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these products be treated as potentially infectious and handled observing the
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usual safety precautions (do not ingest or inhale).
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6.2
Test Kit Components
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6.2.1
60 LPT Strips.
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6.2.2
60 LPT SPR®s
.-Interior of SPR®s coated with proteins specific for
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Listeria
receptors.
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6.2.3
LPT Standard (1 x 6 mL).-
Ready-to-use. Purified and inactivated
L.
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monocytogenes
antigen + preservative + protein stabilizer. The
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confidence interval is indicated on the MLE card after the following
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mention: "Standard (S1) RFV Range".
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6.2.4
LPT Positive Control (1 x 6 mL)
.-Purified and inactivated
L.
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monocytogenes
antigen + preservative + protein stabilizer. The
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confidence interval is indicated on the MLE card after the following
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mention: "Control C1 (+) Test Value Range".
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6.2.5
Negative Control (1 x 6 mL)
.-TRIS buffered saline (TBS) (150 mmol/L) -
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Tween pH 7.6 + preservative. The maximum acceptable value for the test
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is indicated on the MLE card after the following mention: "Control C2 (-)
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Test Value Range".
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6.2.6
1 MLE Card (Master Lot Entry)
.-Specifications for the factory master
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calibration data required to calibrate the test: to read the MLE data, please
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refer to the Operator’s Manual.
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6.3
Reagents
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6.3.1
LPT Broth 225mL (bioMerieux 410848)
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6.3.2
LPT Broth 10mL (bioMerieux 410845)
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6.4
Selective agar
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6.4.1
ALOA
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6.4.2
Oxford Agar (OX)
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6.4.3
Horse blood overlay agar (HL)
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6.5
Apparatus
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6.5.1
Pipette with disposable tip – to dispense 500 μL.
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DRAFT DOCUMENT
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