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Compiled Comments for VIDAS Listeria monocytogenes Xpress (LMX) for the

Detection of Listeria monocytogenes in a Variety of Foods

TECHNICAL EVALUATION CRITERIA

Reviewer #

1.

Is the test kit scientifically sound?

1

Yes

2

Yes

3

4

Yes

5

Yes

6

Yes

7

Yes

Reviewer #

2.

Have sufficient controls been used, including those required to calculate the rate of

false‐positive and false‐negative results where appropriate?

1

Yes

2

Yes

3

4

Yes

5

Yes

6

Yes

7

Yes

Reviewer #

3.

Is sufficient information included for system suitability determination and product

performance or acceptance testing?

1

Yes

2

Yes

3

4

Yes

5

Yes

6

Yes

7

Yes

Reviewer #

4.

Are the conclusions statements valid based upon data presented?

1

Yes

2

Yes

3

4

Yes

5

Yes

6

Yes

7

Yes

Reviewer #

5.

Do you agree that the evidence or data from this and previous studies support the

1

21 June 2013