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VIDAS LMX & LPT Collaborative Study

April 19, 2013

OMA-2013-Apr-XXX

disposal. Disposal of these reagents into sinks with copper or lead

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plumbing should be followed immediately with large quantities of

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water to prevent potential hazards.

This kit contains products of animal

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origin. Certified knowledge of the origin and/or sanitary state of the

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animals does not totally guarantee the absence of transmissible

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pathogenic agents. It is therefore recommended that these products be

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treated as potentially infectious and handled observing the usual safety

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precautions (do not ingest or inhale).

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5.2

Test Kit Components

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5.2.1

LMX Strips

(60)

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5.2.2

LMX SPR®

(60) – Interior of SPR®s coated with antibodies directed

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against

L. monocytogenes

specific antigens.

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5.2.3

LMX Standard (1 x 6mL)

- 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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5.2.4

LMX Positive Control (1 x 3 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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5.2.5

Negative Control (1 x 6mL)

- 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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5.2.6

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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5.3

Reagents

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5.3.1

Supplement for LMX Broth (LMX SUPP) - (bioMérieux ref.

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42648)

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5.3.2

LMX Broth

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5.3.2.1

3-liter bag (bioMérieux ref. 42649)

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5.3.2.2

225 mL in a 250 mL bottle (bioMérieux ref. 42647)

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5.3.2.3

225 mL mini-bag (bioMérieux ref. 42749)

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5.3.3

LPT Broth

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5.3.3.1

10 ml tubes (réf. bioMérieux 410845)

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5.3.3.2

225 mL in a 250 mL bottle (bioMerieux 410848)

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5.4

Selective agar

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5.4.1

ALOA

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5.4.2

Oxford Agar (OX)

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5.4.3

Horse blood overlay agar (HL)

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DRAFT DOCUMENT

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