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VIDAS LMX – Summary 2012 v01

1.5 Background of certification

The VIDAS LMX method was validated with the certificate number BIO 12/27-02/10, on December 2009 for all

human food products (except raw milk cheeses) and environmental samples

Reference protocols :

- EN ISO 16140 : 2003

-

Reference method : EN ISO 11290-1/A1 : 2005 : « Horizontal method for the detection and the

enumeration of

Listeria monocytogenes

. Part 1 : Detection method – Amendment 1 : modification of

isolation media, of haemolysis detection and introduction of fidelity data.

2 Comparative study of methods

2.1 Relative accuracy, relative specificity and relative sensitivity

The aim of the study, according to the reference document EN ISO 16140, is to compare the performances of the

two methods :

-

the reference method EN ISO 11290-1/A1 :2005,

-

the VIDAS LMX method,

on samples naturally contaminated and not contaminated with

Listeria monocytogenes

.

2.1.1 Number and nature of the samples

According to the EN ISO 16140 standard, a minimum of 60 products per category must be analysed, with around

50% of positive products (at least 30 results) and 50% of negative products.

During the initial validation study (December 2009) 323 samples were analysed, and 61 raw milk cheeses during

the extension.

Each category was divided into various types and the results are displayed as follows :

Category

Types

Positive results* Negative results

Total

Meat products

Raw meat

9

11

20

Raw seasoned meat

10

10

20

Delicatessen

11

11

22

Total

30

32

62

Dairy products

Raw milks and pasteurized milk cheeses (cow)

12

5

17

Pasteurized milk cheeses (goat, ewe)

13

13

26

Raw milk cheeses

33

28

61

Desserts, powders of milk

9

12

21

Total

67

58

125

Fish products

Fish fillets and shellfish

13

3

16

Smoked fish

10

24

34

Ready-made meal with fish

8

8

16

Total

31

35

66

Vegetables

Frozen

9

12

21

Raw vegetables (fresh) or 4th range ones

13

13

26

Seasoned

10

14

24

Total

32

39

71

Environment

Various waters

9

10

19

Surface samples

11

9

20

Residues and scraps

10

11

21

Total

30

30

60

TOTAL

190

194

384

*these are positive results by either one or two methods

2.1.2 Artificial contamination of the samples and percentage

Artificial contamination was achieved by using stressed bacterial suspensions, the stress treatment and efficiency

of which have been determined according to EN ISO 16140 and AFNOR validation rules.

80 samples were positive after artificial contamination on a total of 190 positive results of

Listeria monocytogenes.

Overall, 42.1% of positive results were due to artificial contamination.