ACCREDITATION

N°1-0144
PORTEE DISPONIBLE
SUR WWW.COFRAC.FR

NF VALIDATION
Validation of alternative analytical methods
Application in food microbiology

Summary Report
Validation study according to the EN ISO 16140-2:2016

3MTM PetrifilmTM Enterobacteriaceae Count Plate

(Certificate number: 3M 01/06 - 09/97)
for the enumeration of Enterobacteriaceae in all human food
products, animal feed and production environmental samples

Quantitative method

Expert Laboratory: ADRIA Développement

ZA Creac’h Gwen
29196 Quimper Cedex (France)
For: 3M Health Care
2501 Hudson Road
Building 275 5 W 05
MN 55144 - IWO - St Paul (USA)

This report consists of 52 pages, including 8 appendices.

Only copies including the totality of this report are authorised.

Competencies of the laboratory are certified by COFRAC accreditation for the

analyses marked with the symbol.

Version 0
February 2, 2018

ADRIA DEVELOPPEMENT  Creac’h Gwen - F. 29196 QUIMPER Cedex  Tél. (33) 02.98.10.18.18 - Fax (33) 02.98.10.18.99
[email protected]  http://www.adria.tm.fr
ASSOCIATION LOI DE 1901 - N° SIRET 306 964 271 00036 - N° EXISTENCE 53290006329 - N°TVA FR45306964271
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1 INTRODUCTION _______________________________________________ 4

2 METHODS DESCRIPTION _______________________________________ 4

2.1 Alternative method ______________________________________________ 4

2.1.1 Principle ________________________________________________________ 4
2.1.2 Protocol ________________________________________________________ 4
2.1.3 Restrictions______________________________________________________ 4

2.2 Reference methods ______________________________________________ 5

3 INITIAL VALIDATION STUDY AND EXTENSION / RENEWAL STUDIES:

RESULTS ____________________________________________________ 5

3.1 Method comparison study ________________________________________ 5

3.1.1 Relative trueness study ____________________________________________ 5
3.1.2 Accuracy profile study ____________________________________________ 16
3.1.3 Inclusivity and exclusivity studies ____________________________________ 19
3.1.4 Practicability ____________________________________________________ 20
3.1.5 Method comparison study conclusion ________________________________ 20

3.2 Inter-Laboratory study organization and results _____________________ 21

3.2.1 Study organisation _______________________________________________ 21
3.2.2 Analysis results _________________________________________________ 21
3.2.3 Calculations and interpretation _____________________________________ 23

3.3 General conclusion _____________________________________________ 25

Appendix 1 – Flow diagram of the alternative method: 3MTM PetrifilmTM

Enterobacteriaceae Count Plate _______________________________________________________ 27
Appendix 2 – Flow diagrams of the reference method _______________________________________ 28
Appendix 3 – Artificial contaminations of samples __________________________________________ 30
Appendix 4 - Relative trueness study: raw data ____________________________________________ 32
Appendix 5 - Relative trueness study: summarized results and calculations ______________________ 40
Appendix 6 - Accuracy profile study: raw data _____________________________________________ 43
Appendix 7 - Accuracy profile study: summarized results ____________________________________ 50
Appendix 8 – Inclusivity / Exclusivity: raw data (initial validation and extension study) ______________ 51

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Quality Assurance documents related to this study can be consulted upon request
from 3M Health Care.

The technical protocol and the result interpretation were carried out according to the
EN ISO 16140-2:2016 and the AFNOR technical rules (Draft revision 6).

Validation protocols EN ISO 16140-2 (June 2016) : Microbiology of the food

chain - Method validation
Part 1: Vocabulary
Part 2: Protocol for the validation of alternative
(proprietary) methods against a reference method

AFNOR Technical Rules (Draft Revision n° 6)

Reference methods NF ISO 21528-2 (December 2004) - Microbiology of

food and animal feeding stuffs - Horizontal methods for
the detection and enumeration of Enterobacteriaceae -
Part 2: colony-count method

NF ISO 21528-2 (June 2017) - Microbiology of food

and animal feeding stuffs - Horizontal methods for the
detection and enumeration of Enterobacteriaceae -
Part 2: colony-count method

Alternative method 3MTM PetrifilmTM Enterobacteriaceae Count Plate

Scope  All human food

 Animal feed
 Production environmental samples

Certification organism AFNOR Certification (http://nf-validation.afnor.org/)


Analyses performed according to the COFRAC accreditation
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1 INTRODUCTION

3M would like to renew the certification of the 3MTM PetrifilmTM

Enterobacteriaceae Count Plate (EB); the method was validated in
September 1997 (Certificate number 3M 01/06 - 09/97), according to the
requirements for validation studies. Renewals were granted in December
2001, June 2005, July 2009 and July 2013, together with an extension in
April 2010 for animal food products and an extension in February 2015 for
production environmental samples.

The method was renewed in October 2017.

2 METHODS DESCRIPTION

2.1 Alternative method

The flow diagram of the alternative method is provided in Appendix 1.

2.1.1 Principle

The 3MTM PetrifilmTM Enterobacteriaceae Count (EB) Plate is a sample-

ready-culture medium system which contains modified Violet Red Bile
Glucose (VRBG) nutrients, a cold-water soluble gelling agent, and a
tetrazolium indicator that facilitates colony enumeration. 3M Petrifilm EB
Plates are used for the enumeration of Enterobacteriaceae in the food and
beverage industries. Enterobacteriaceae are oxidase-negative, Gram-
negative rods that ferment glucose to produce acid and/or gas. On 3M
Petrifilm EB Plates, Enterobacteriaceae will appear as red colonies with
yellow zones, red colonies with gas bubbles, or red colonies with yellow
zones and gas bubbles.

2.1.2 Protocol

The flow diagram is provided in Appendix 1.

2.1.3 Restrictions

There is no restriction.

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2.2 Reference methods

The reference method used for the initial validation and extension study was
the NF ISO 21528 (December 2004) - Microbiology of food and animal
feeding stuffs - Horizontal methods for the detection and enumeration of
Enterobacteriaceae - Part 2: colony-count method.

The reference method used for the renewal study was the NF ISO 21528-2
(June 2017) - Microbiology of food and animal feeding stuffs - Horizontal
methods for the detection and enumeration of Enterobacteriaceae - Part 2:
colony-count method.

The main modification between the two reference methods concerns the
confirmation step; this is considered as a minor modification according to ISO
17468.

The flow diagrams are provided in Appendix 2.

3 INITIAL VALIDATION STUDY AND EXTENSION / RENEWAL

STUDIES: RESULTS

The method comparison study is a study performed by the expert laboratory to

compare the alternative method with the reference method.

3.1 Method comparison study

The method comparison study is a study performed by the expert laboratory to

compare the alternative method with the reference method.

3.1.1 Relative trueness study

The relative trueness is the degree of correspondence between the response obtained by the
reference method and the response obtained by the alternative method on identical sample.

3.1.1.1 Number and nature of the samples

Seven categories were tested. The repartition per tested category and type is
provided in Table 1.


Analysis performed according to the COFRAC accreditation
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Table 1 – Categories and types

Number of Number of
analyzed interpretable
Category Type samples results
a Poultry meat raw and cooked 7 7
Meat products b Pork , beef, veal raw and cooked 7 7
1
c Delicatessen 15 15
Total 29 29
a Milk and cream 5 5
Dairy products b Cheeses 16 16
2
c Dairy desserts 5 5
Total 26 26
a Raw 10 6
Seafood b Cooked 5 5
3
c Ready to eat or to reheat 6 6
Total 21 17
a Fresh and frozen raw products 9 9
Fresh and frozen seasoned raw
Vegetables b 5 5
4 products
c Cooked vegetables 5 5
Total 19 19
a Composite food 5 5
Miscellaneous and egg
b Pastries, chocolate 5 5
5 based products
c Egg based products 6 6
Total 16 16
a Fresh product 6 6
Feed stuff b Cooked or dehydrated product 5 5
6
c Raw materials 9 5
Total 20 16
a Surfaces 18 6
Production
b Process water 10 5
7 environmental samples
c Dusts 7 5
Total 35 16
TOTAL 166 139

166 samples were analyzed, leading to 139 exploitable results.

3.1.1.2 Artificial and natural contamination of the samples

Artificial contaminations were realized by spiking or seeding protocols. The

inoculated strains, the contamination protocols, the injured protocols of the
inoculated vegetative cells and the injury evaluation are provided in
Appendix 3. Injury efficiency was evaluated by enumerating the pure culture
on selective and non-selective agars. The observed injury measurements
vary from 0.4 to more than 3.40 Log CFU/ml difference.

107 samples were naturally contaminated and 44 samples were artificially

contaminated; 32 gave interpretable results.

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3.1.1.3 Raw data

The raw data are provided in Appendix 4.

The samples were analyzed by the reference and the alternative methods in
order to have 15 interpretable results per incubation protocol, and
5 interpretable results per tested type.

The data are classified in three categories (See Table 2):

- Interpretable results by the two methods;

- Results with less than 4 colonies per plate with one of the two methods
(indicated with “*” in the data). These results were not kept for calculation.
- Results below or above the quantification limit.

Table 2 - Classification of the data

Number Number of
Number of Number of
Number of samples
samples samples below
Category of samples samples with
with or above the
analysed with no interpretable
<4 CFU/plate detection limit
result results
1 Meat products 29 0 0 0 29
2 Dairy products 26 0 0 0 26
3 Seafood 21 0 4 0 17
4 Vegetables 19 0 0 0 19
Miscellaneous and egg
5 16 0 0 0 16
based products
6 Feed stuff 20 0 4 0 16
Production environmental
7 35 2 17 0 16
samples
TOTAL 166 2 25 0 139

The samples, which were not used in the calculations, are provided in
Table 3.

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Table 3 - Samples which were not used in the calculations

Sample Reference method: Alternative method :

Product (french name)
number ISO 21528-2 Petrifilm Enterobacteriaceae Caregory type

154 Raw material <4,27 5,47 6 c

441 Raw material <0,85 1,30* 6 c
3676 Dusts from egg industry <1,00 <1,00 7 c
3677 Dusts <1,00 <1,00 7 c
3841 Process water (peas) <1,00 <1,00 7 b
3844 Wipe (peas industry) 1,30* 2,15 7 a
3845 Process water (peas) <1,00 2,01 7 b
3904 Wipe (pastry industry) 2,00* 3,53 7 a
3905 Wipe (bechamel sauce) <2,00 3,17 7 a
3906 Wipe (cheese industry) <1,00 <1,00 7 a
3907 Process water (milk industry) <2,00 <2,00 7 b
4007 Process water (fish industry) <0,00 <0,00 7 b
4009 Process water (fish industry) <2,00 3,63 7 b
4011 Swab after cleaning (fish industry) <1,00 <1,00 7 a
4012 Swab after cleaning (fish industry) <1,00 <1,00 7 a
4013 Wipe after cleaning(fish industry) >4,13 >4,00 7 a
4015 Wipe after cleaning(fish industry) <1,00 <1,00 7 a
4494 Wipe (dishwasher) >4,18 >4,00 7 a
4495 Wipe (table) >4,18 >4,00 7 a
4496 Wipe (cutter) >4,18 >4,00 7 a
4497 Wipe (push-button) >5,18 >5,00 7 a
6160 Raw fish <2,00 3,69 3 a
6161 Raw fish <3,00 4,18 3 a
6163 Poultry proteins dehydrated <1,00 <1,00 6 c
6164 Poultry proteins dehydrated <1,00 <1,00 6 c
6884 Hake fillet <1,00 <1,00 3 a
6885 Cod fillet <1,00 <1,00 3 a

3.1.1.4 Statistical interpretation

The calculations are provided in Appendix 5.

The obtained data were analyzed using the scatter plot. The graphs are
provided with the line of identity (y = x).
The Figures 1 to 7 show the data plotted for the different studied categories,
and the Figure 8 for all the products.

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Figure 1 - Data plotted for the Meat products

Cat 1
8,00
Alternative method (log CFU/g)

6,00 Type a

Type b
4,00
Type c

corrected values
2,00
<4 colonies/plate

0,00
0,00 2,00 4,00 6,00 8,00
Reference method (log CFU/g)

Figure 2- Data plotted for Dairy products

Cat 2
8,00
Alternative method (log CFU/g)

6,00 Type a

Type b
4,00
Type c

corrected values
2,00
<4 colonies/plate

0,00
0,00 2,00 4,00 6,00 8,00
Reference method (log CFU/g)

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Figure 3- Data plotted for Seafood

Cat 3

6,00
Alternative method (log CFU/g) Type a

4,00 Type b

Type c

2,00 corrected values

<4 colonies/plate

0,00
0,00 1,00 2,00 3,00 4,00 5,00 6,00
Reference method (log CFU/g)

Figure 4- Data plotted for Vegetables

Cat 4
6,00
Alternative method (log CFU/g)

Type a
4,00
Type b

Type c
2,00
corrected values

<4 colonies/plate
0,00
0,00 1,00 2,00 3,00 4,00 5,00 6,00
Ref
Rerence method (log CFU/g)

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Figure 5- Data plotted for Miscellaneous and egg-based products

Cat 5
6,00

Alternative method (log CFU/g) Type a

4,00
Type b

Type c
2,00 corrected values

<4 colonies/plate

0,00
0,00 1,00 2,00 3,00 4,00 5,00 6,00
Reference method (log CFU/g)

Figure 6- Data plotted for Feed stuff

Cat 6
8,00
Alternative method (log CFU/g)

6,00 Type a

Type b
4,00
Type c

corrected values
2,00
<4 colonies/plate

0,00
0,00 2,00 4,00 6,00 8,00
Reference method (log CFU/g)

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Figure 7- Data plotted for Production environmental samples

Cat 7
8

Alternative method (log CFU/g) Type a

6

Type b
4
Type c

corrected values
2
<4 colonies/plate

0
0,00 2,00 4,00 6,00 8,00
Reference method (log CFU/g)

Figure 8 - Data plotted for all the products

All categories

10,00
Cat1
Alternative method (log cfu/g))

8,00 Cat2
Cat 3
6,00 Cat 4
Cat 5
4,00 Cat 6
Cat 7
2,00 Corrected values
< 4 colonies /plate
0,00 y=x
0,00 2,00 4,00 6,00 8,00 10,00
reference method (log cfu/g)

The calculated values for Average difference and Standard deviation

differences per category are provided in Table 4.

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Table 4 - Calculated values per incubation protocol

Category n SD Linear bias 95% lower limit 95% upper limit

1 29 0,31 0,32 / / /
2 26 0,32 0,33 / / /
3 17 0,12 0,38 / / /
4 19 0,14 0,25 / / /
5 16 0,26 0,46 / / /
6 16 0,07 0,14 / / /
7 16 0,16 0,30 / / /
All categories 139 0,22 0,33 0,22 -0,44 0,88

: Average difference
SD: Standard deviation of differences

The Bland-Altman difference plot for all the samples is given Figure 9.

Figure 9 – Bland-Altman difference plot for all the samples

Cat 1
3,00
Cat 2
2,50 Cat 3
2,00 Cat 4
Cat 5
1,50
Difference

Cat 6
1,00
Cat 7
0,50 Corrected values

0,00 <4 colonies/plate

Linear (95% lower limit)
-0,50
Linear (95 upper limit)
-1,00
Linear (bias)
0,00 2,00 4,00 6,00 8,00 10,00 12,00
Mean log CFU/g

The average difference observed varies from 0.07 log to 0.32 log.
Samples for which the difference between the result observed with the
reference and the alternative methods is above or lower than the limits are
listed in Table 5.
When the difference observed between the reference and the alternative
methods were above or lower than the 95 % confidence limit of agreement,
the tests described in the reference method were applied (the information is
provided in Table 5).

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Table 5 - Disagreements observed between the reference and the alternative method

Values in green: differences in favor of the alternative method Values in red: differences in favor of the reference method
Values in black: equivalent enumeration observed with both methods

Values before Lower / Result before

Cate- N° Reference Alternative Diffe-
Type Product correction Mean Upper Comments and after confirmation
gory Sample method method rence
(Ref/Alt) limits (VRBG/Petrifilm)
1 a 210 Poultry meat 2,30 3,23 / 2,76 0,93 Colonies confirmed for both methods 2,30-2,30/3,22-3,00
1 b 212 Brain 2,39 3,34 / 0,95 0,95 Colonies confirmed for both methods 2,39-2,39/3,33-3,33
1 c 125 Rillettes 1,54 2,46 / 0,92 0,92 Colonies confirmed for both methods 1,54-1,54/2,46-2,46
1 c 129 Smoked chest 1,00 1,97 / 0,97 0,97 Colonies confirmed for both methods 1,00-1,00/1,97-1,97
2 a 106b Cream 6,18 7,29 / 1,12 1,12 Colonies confirmed for both methods 6,18-6,18/7,29-7,25
Presence of characteristic colonies in VRBG not
2 a 119 Raw milk 3,71 4,89 / 1,18 1,18 4,28-3,71/4,89-4,79
confirmed. Colonies confirmed for Petrifilm
3 a 124 Sardines 1,55 2,70 / 2,12 1,16 Colonies confirmed for both methods 2,28-1,55/2,70-2,14
Characteristic colonies in VRBG plates , oxidase
3 a 6160 Raw fish 1,00 3,69 <2,00 2,35 2,69 +, colonies from Petrifilm identified as Aeromonas 3,62-<2,00/3,69-<2,00
hydrophila
Characteristic colonies in VRBG plates , oxidase
3 a 6161 Raw fish 2,00 4,18 <3,00 3,09 2,18 +, colonies from Petrifilm identified as Aeromonas 4,26-<3,00/4,18-<3,00
hydrophila
-0,44/
3 c 144 Smoked salmon 5,36 4,51 / 4,93 -0,85 Enumeration in favor of the reference method 5,36-5,36/4,51-4,51
0,88
Colonies on Petriflm not confirmed as
5 b 122 Pastry 2,24 3,66 / 2,95 1,42 2,24-2,24/3,66-<2,04
Enterobacteria
Characteristic colonies in VRBG plates ,not 5,38-<4,27/5,47-
6 c 154 Raw material 3,27 5,47 <4,27 4,37 2,20
confirmed not tested
<1,00-<1,00/1,30
6 c 441 Raw material 0,00 1,30 <0,85 0,65 1,30 Same result with both methods
-not tested
Sample inoculated with Citrobacter farmeri, less 2,60-2,60/
7 a 3904 Wipe (pastry industry) 2,00 3,53 / 3,07 1,53
colonies in VRGB not tested
Sample inoculated with Serratia fonticola, no <2,00-<2,00/
7 a 3905 Wipe (bechamel sauce) 1,00 3,17 <2,00 2,09 2,17
growth in VRBG not tested (inoculation)
Sample inoculated with Escherichia coli, no growth <2,00-<2,00/
7 b 3845 Process water (peas) 0,00 2,01 <1,00 1,01 2,01
in VRBG not tested (inoculation)
3,67-<2,00/3,63-
7 b 4009 Process water (fish industry) 0,00 3,63 <1,00 1,82 3,63 Characteristic colonies in VRBG plates , oxidase +
not tested
Corrected value
Results calculated using enumeration lower than 4 CFU/plate

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3.1.1.5 Discordant results

The samples are classified in three categories (See Table 6).

Table 6 - Classification of the samples

Number of samples with

Number of samples with Number of samples
equivalent results with the
higher results with the with higher results with
reference and the
reference method the alternative method
alternative methods
1 15 1

For 10 samples, the difference is clearly in favor of the alternative method

(confirmatory tests positive or inoculated samples).

For 3 samples (6160, 6161 and 122), the enumeration obtained with the
alternative method is higher than the enumeration obtained with the ISO
method but the enumerated colonies were not confirmed as Enterobacteria
using the tests described in the reference method.

For 2 samples (154 and 4009), no test was applied on the colonies
enumerated on Petrifilm; it is thus impossible to know if the enumerated
colonies were really Enterobacteria.

For one sample (144), the enumeration was slightly higher with the reference
method.

For one sample (441), the enumerations were similar with both methods
(Ref.: < 1.00; Alt.: 1.30).

3.1.1.6 Conclusion

The relative trueness study of the alternative method is satisfying. The

3MTM PetrifilmTM Enterobacteriaceae Count Plate method is reliable
when compared to the ISO 21528-2 method.

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3.1.2 Accuracy profile study

The accuracy profile is a graphical representation of the capacity of measurement of the quantitative
method, obtained by combining acceptability intervals and β-expectation tolerance intervals, both
reported to different levels of the reference value.

3.1.2.1 Matrices

Seven matrix/strain pairs were tested. A minimum of one type per category
and two different batches were selected, using six samples per type. Two
samples were contaminated at a low level, two at intermediate level, and two
at a high level. For each sample, five replicates (five different test portions)
were tested. In the end, thirty samples were tested per matrix type.

The tested categories, types, matrix and inoculated strains are provided in
Table 7.

Table 7 - Categories, types and matrices

Inoculation
Category Type Matrix Inoculated strain Origin
level (CFU/g)
b: Pork, beef, veal Enterobacter
1 Meat products Pork pâté Pork liver
raw and cooked agglomerans 135
Pasteurized
2 Dairy products a: Milk and cream Hafnia alvei 130 Raw milk
milk
Salmon Klebsiella oxytoca
3 Seafood c: Raw RTE
fillet 179
a: Fresh and frozen Green Escherichia hermani
4 Vegetables Spinach 300
raw products beans Ad1457
10 000
Miscellaneous and c: Egg based Whole Serratia liquefaciens Egg
5 100 000
egg products products liquid egg 26 product
b: Cooked or Citrobacter braakii
6 Feed Pâté for cat Beef meat
dehydrated products Ad833
b: Process water
Production
(Batch 1: zucchini Process
7 environmental Escherichia coli 93 Dish
and split peas water
samples
Batch 2: pilchards)

3.1.2.2 Calculation and interpretation

The raw data are provided in Appendix 6. The summary tables (in log
CFU/g) and calculations are provided in Appendix 7. The statistical results
and the accuracy profiles are provided Figure 12.

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The calculations were done using the AP Calculation Tool MCS (Clause
6-1-3-3 calculation and interpretation of accuracy profile study)
ver 2027-01-2015 available on http://standards.iso.org/iso/16140.

The lower and upper .ETI are within the acceptability limits for all the
matrix/strain pairs tested. The acceptability limits are fixed at + 0.5 log and -
0.5 log for all the matrices tested.

3.1.2.3 Conclusion

The observed profiles are comprised within the AL. All the accuracy
profiles fulfill the performance criteria.

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Figure 10 – Accuracy profile

(Food) Category Meat products (Food) Category Dairy products
(Food) Type Pork,beef,veal raw and cooked (Food) Type Milk and cream(Pasteurized
(Food) Category Meat products (Food) Category Dairy products
(Food) Type Pork,beef,veal raw and cooked (Food) Type Milk and cream(Pasteurized
Pork,beef,veal raw and cooked (Pork pâté) Milk and cream(Pasteurized milk)
0,60 0,60
Pork,beef,veal raw and cooked (Pork pâté) Milk and cream(Pasteurized milk)
0,60
0,40 0,60
0,40

0,40
0,20 0,40
0,20

Bias Bias
0,20 0,20
Bias

Bias
0,00 0,00
β-ETI β-ETI
0,00 1,00 2,00 3,00 4,00 5,00 6,00 Bias 0,00 1,00 2,00 3,00 4,00 5,00 6,00 Bias
Bias

Bias
0,00 AL = +/- 0.5 0,00 AL = +/- 0.5
-0,20 β-ETI -0,20 β-ETI
0,00 1,00 2,00 3,00 4,00 5,00 6,00 0,00 1,00 2,00 3,00 4,00 5,00 6,00
AL = +/- 0.5 AL = +/- 0.5
-0,20 -0,20
-0,40 -0,40

-0,40 -0,40
-0,60 -0,60
Reference Median Reference Median
-0,60 -0,60
Reference Median Reference Median
β-ETI β-ETI β-ETI β-ETI
Reference compared to compared to Reference compared to compared to
Sample Name Bias Lower β-ETI Upper β-ETI Sample Name Bias Lower β-ETI Upper β-ETI
central value β-ETI
AL=±0.5 β-ETI
final AL Central value β-ETI
AL=±0.5 β-ETI
final AL
Reference compared to
Acceptable compared
Acceptableto Reference compared to
Acceptable compared
Acceptableto
Sample Name Bias Lower β-ETI Upper β-ETI Sample Name Bias Lower β-ETI Upper β-ETI
6862-6866 central
2,20value 0,176 0,076 0,276 AL=±0.5
YES final
YESAL 5403-5407 Central
2,45value -0,016 -0,107 0,075 AL=±0.5
YES final
YESAL
6867-6871 2,38 0,018 -0,082 0,117 Acceptable
YES Acceptable
YES 5418-5422 2,40 0,000 -0,091 0,091 Acceptable
YES Acceptable
YES
6862-6866
4818-4822 2,20
4,15 0,176
0,030 0,076
-0,070 0,276
0,130 YES YES 5403-5407
5408-5412 2,45
3,67 -0,016
-0,019 -0,107
-0,110 0,075
0,072 YES YES
6867-6871
4843-4847 2,38
4,20 0,018
0,026 -0,082
-0,073 0,117
0,126 YES YES 5418-5422
5423-5427 2,40
3,62 0,000
0,067 -0,091
-0,024 0,091
0,158 YES YES
4818-4822
4828-4832 4,15
4,38 0,030
0,018 -0,070
-0,082 0,130
0,117 YES
YES YES
YES 5408-5412
5413-5417 3,67
4,93 -0,019
0,030 -0,110
-0,061 0,072
0,121 YES
YES YES
YES
4843-4847
4853-4857 4,20
4,40 0,026
0,064 -0,073
-0,035 0,126
0,164 YES
YES YES
YES 5423-5427
5428-5432 3,62
4,93 0,067
0,015 -0,024
-0,076 0,158
0,106 YES
YES YES
YES
4828-4832 4,38 0,018 -0,082 0,117 YES YES 5413-5417 4,93 0,030 -0,061 0,121 YES YES
4853-4857 4,40
Reference 0,064
Alternative -0,035 0,164
SD repeatability of reference YES YES 5428-5432 4,93
Reference 0,015
Alternative -0,076 0,106
SD repeatability of reference YES YES
Final AL Final AL
method method method <= 0.125 method method method <= 0.125
Reference Alternative SD repeatability of reference Reference Alternative SD repeatability of reference
SD Repeatability 0,074 0,069 YES +/- 0,500
Final AL SD Repeatability 0,068 0,063 YES +/- 0,500
Final AL
method method method <= 0.125 method method method <= 0.125
SD Repeatability 0,074 0,069 YES +/- 0,500 SD Repeatability 0,068 0,063 YES +/- 0,500

(Food) Category Seafood (Food) Category Vegetables

(Food) Type Raw seafood (Salmon fillet) (Food) Type Fresh and frozen products
(Food) Category Seafood (Food) Category Vegetables
(Food) Type Raw seafood (Salmon fillet) (Food) Type Fresh and frozen products

Raw seafood (Salmon fillet) Fresh and frozen products (Green beans)
0,60 Raw seafood (Salmon fillet) Fresh and frozen products (Green beans)
0,60
0,60
0,60
0,40
0,40
0,40
0,40
0,20
0,20
0,20 Bias Bias
0,20
Bias Bias

0,00

Bias Bias
Bias
β-ETI 0,00 Bias
β-ETI
0,00 0,00 1,00 2,00 3,00 4,00 5,00 6,00
β-ETI
AL = +/- 0.5 0,000,00 1,00 2,00 3,00 4,00 5,00 6,00 β-ETI
AL = +/- 0.5
-0,20 0,00 1,00 2,00 3,00 4,00 5,00 6,00
AL = +/- 0.5 -0,20 0,00 1,00 2,00 3,00 4,00 5,00 6,00 AL = +/- 0.5
-0,20
-0,20
-0,40
-0,40
-0,40
-0,40
-0,60
Reference Median -0,60
-0,60 Reference Median
Reference Median -0,60
Reference Median
β-ETI β-ETI β-ETI β-ETI
Reference compared
β-ETI to compared
β-ETI to Reference compared
β-ETI to compared
β-ETI to
Sample Name Bias Lower β-ETI Upper β-ETI Sample Name Bias Lower β-ETI Upper β-ETI
Central value
Reference AL=±0.5
compared to final
comparedAL to Central value
Reference AL=±0.5
compared to final
comparedAL to
Sample Name Bias Lower β-ETI Upper β-ETI Sample Name Bias Lower β-ETI Upper β-ETI
Central value Acceptable
AL=±0.5 Acceptable
final AL Central value Acceptable
AL=±0.5 Acceptable
final AL
5626-5630 2,59 -0,129 -0,217 -0,041 YES
Acceptable YES
Acceptable 4544-4548 2,40 0,049 -0,029 0,127 YES
Acceptable YES
Acceptable
5824-5828
5626-5630 2,72
2,59 -0,053
-0,129 -0,141
-0,217 0,035
-0,041 YES YES 4559-4563
4544-4548 2,38
2,40 -0,018
0,049 -0,096
-0,029 0,059
0,127 YES YES
5631-5635
5824-5828 3,68
2,72 -0,009
-0,053 -0,097
-0,141 0,079
0,035 YES YES 4549-4553
4559-4563 3,56
2,38 0,097
-0,018 0,019
-0,096 0,175
0,059 YES YES
5829-5833
5631-5635 3,69
3,68 -0,009 -0,097 0,079 YES YES 4564-4568
4549-4553 3,46
3,56 0,171
0,097 0,093
0,019 0,249
0,175 YES YES
5636-5640
5829-5833 5,04
3,69 -0,041
-0,009 -0,129
-0,097 0,047
0,079 YES YES 4554-4558
4564-4568 4,84
3,46 0,080
0,171 0,002
0,093 0,158
0,249 YES YES
5834-5838
5636-5640 4,99
5,04 0,009
-0,041 -0,079
-0,129 0,097
0,047 YES YES 4569-4573
4554-4558 4,79
4,84 0,137
0,080 0,059
0,002 0,215
0,158 YES YES
5834-5838 4,99 0,009 -0,079 0,097 YES YES 4569-4573 4,79 0,137 0,059 0,215 YES YES
Reference Alternative SD repeatability of reference Reference Alternative SD repeatability of reference
Final AL Final AL
Reference
method Alternative
method SD repeatability
method <= of reference
0.125 Reference
method Alternative
method SD repeatability
method <= of reference
0.125
Final AL Final AL
SD Repeatability method
0,061 method
0,061 method
YES<= 0.125 +/- 0,500 SD Repeatability method
0,071 method
0,054 method
YES<= 0.125 +/- 0,500
SD Repeatability 0,061 0,061 YES +/- 0,500 SD Repeatability 0,071 0,054 YES +/- 0,500

(Food) Category Miscellaneous and egg products (Food) Category Feed

(Food) Category
(Food) Type Miscellaneous and egg(Whole
Egg based products products (Food) Category
(Food) Type Feed
Cooked or dehydrated products
(Food) Type Egg based products (Whole (Food) Type Cooked or dehydrated products

Egg based products (Whole liquid egg) Cooked or dehydrated products (Pâté for cat)
Egg based products (Whole liquid egg) Cooked or dehydrated products (Pâté for cat)
0,60
0,60 0,60
0,60
0,40
0,40 0,40
0,40
0,20
0,20 0,20
0,20
Bias Bias
Bias

0,00 Bias Bias

Bias
Bias

0,00 β-ETI 0,00 β-ETI

Bias

0,00 1,00 2,00 3,00 4,00 5,00 6,00 β-ETI 0,00 β-ETI
0,00 1,00 2,00 3,00 4,00 5,00 6,00 0,00 1,00 2,00 3,00 4,00 5,00 6,00 AL = +/- 0.5
AL = +/- 0.5 0,00 1,00 2,00 3,00 4,00 5,00 6,00
-0,20 AL = +/- 0.5 AL = +/- 0.5
-0,20 -0,20
-0,20
-0,40 é
-0,40 é -0,40
-0,40
-0,60
-0,60 Reference Median -0,60
Reference Median -0,60 Reference Median
Reference Median

β-ETI β-ETI β-ETI β-ETI

β-ETI β-ETI β-ETI β-ETI
Reference compared to compared to Reference compared to compared to
Sample Name Reference Bias Lower β-ETI Upper β-ETI compared to compared to Sample Name Reference Bias Lower β-ETI Upper β-ETI compared to compared to
Sample Name Central Bias Lower β-ETI Upper β-ETI Sample Name Bias Lower β-ETI Upper β-ETI
Central value
value AL=±0.5
AL=±0.5 final
final AL
AL Central
Central value
value AL=±0.5
AL=±0.5 final
final AL
AL
Acceptable
Acceptable Acceptable
Acceptable Acceptable
Acceptable Acceptable
Acceptable
6428-6432
6428-6432 2,15
2,15 0,109
0,109 -0,064
-0,064 0,282
0,282 YES
YES YES
YES 4758-4762
4758-4762 2,40
2,40 0,107
0,107 0,028
0,028 0,187
0,187 YES
YES YES
YES
6857-6861
6857-6861 2,34
2,34 -0,041
-0,041 -0,215
-0,215 0,132
0,132 YES
YES YES
YES 4773-4777
4773-4777 2,51
2,51 -0,043
-0,043 -0,122
-0,122 0,037
0,037 YES
YES YES
YES
5093-5097
5093-5097 3,46
3,46 0,069
0,069 -0,104
-0,104 0,242
0,242 YES
YES YES
YES 4763-4767
4763-4767 3,67
3,67 0,084
0,084 0,004
0,004 0,163
0,163 YES
YES YES
YES
5118-5122
5118-5122 3,26
3,26 0,263
0,263 0,090
0,090 0,436
0,436 YES
YES YES
YES 4778-4782
4778-4782 3,63
3,63 -0,010
-0,010 -0,090
-0,090 0,069
0,069 YES
YES YES
YES
5103-5107
5103-5107 4,68
4,68 0,082
0,082 -0,091
-0,091 0,255
0,255 YES
YES YES
YES 4768-4772
4768-4772 4,97
4,97 0,009
0,009 -0,070
-0,070 0,089
0,089 YES
YES YES
YES
5128-5132
5128-5132 4,46
4,46 0,270
0,270 0,097
0,097 0,443
0,443 YES
YES YES
YES 4783-4787
4783-4787 4,94
4,94 -0,036
-0,036 -0,115
-0,115 0,043
0,043 YES
YES YES
YES

Reference
Reference Alternative
Alternative SD
SD repeatability
repeatability of
of reference
reference Reference
Reference Alternative
Alternative SD
SD repeatability
repeatability of
of reference
reference
Final
Final AL
AL Final
Final AL
AL
method
method method
method method
method <=
<= 0.125
0.125 method
method method
method method
method <=<= 0.125
0.125
SD
SD Repeatability
Repeatability 0,092
0,092 0,120
0,120 YES
YES +/-
+/- 0,500
0,500 SD
SD Repeatability
Repeatability 0,079
0,079 0,055
0,055 YES
YES +/-
+/- 0,500
0,500

(Food) Category Environmental samples (Food) Category Category 8

(Food) Type Process water (Batch 1: (Food) Type Type 8

Process water (Batch 1: Zuchhini and split peas; Batch Type 8

2: Pilchards) 0,60
0,60
0,40
0,40

0,20
0,20
Bias
Bias
Bias
Bias
Bias
Bias

β-ETI
Bias

0,00 β-ETI
Bias

0,00
0,00 0,00
β-ETI
β-ETI -1,00
-1,00 0,00
0,00 1,00
1,00 2,00
2,00 3,00
3,00 4,00
4,00 5,00
5,00 6,00
6,00 7,00
7,00
0,00
0,00 1,00
1,00 2,00
2,00 3,00
3,00 4,00
4,00 5,00
5,00 6,00
6,00 AL == +/-
AL +/- 0.5
0.5
-0,20 AL == +/-
AL +/- 0.5
0.5 -0,20
-0,20 -0,20

-0,40
-0,40 é
é -0,40
-0,40

-0,60
-0,60 Reference Median
Reference Median -0,60
-0,60 Reference Median
Reference Median

β-ETI
β-ETI β-ETI
β-ETI β-ETI
β-ETI β-ETI
β-ETI
Reference compared to compared to Reference compared to compared to
Sample Name Reference Bias Lower β-ETI Upper β-ETI compared to compared to Sample Name Reference Bias Lower β-ETI Upper β-ETI compared to compared to
Sample Name Central value Bias Lower β-ETI Upper β-ETI AL=±0.5 final AL Sample Name Central value Bias Lower β-ETI Upper β-ETI AL=±0.5 final AL
Central value AL=±0.5 final AL Central value AL=±0.5 final AL
Acceptable Acceptable Acceptable Acceptable
Acceptable Acceptable Acceptable Acceptable
5183-5187 2,53 -0,117 -0,215 -0,018 YES YES
5183-5187 2,53 -0,117 -0,215 -0,018 YES YES
5208-5212 2,36 0,070 -0,029 0,168 YES YES
5208-5212 2,36 0,070 -0,029 0,168 YES YES
5188-5192 3,63 0,020 -0,078 0,118 YES YES
5188-5192 3,63 0,020 -0,078 0,118 YES YES
5213-5217 3,60 0,097 -0,001 0,195 YES YES
5213-5217 3,60 0,097 -0,001 0,195 YES YES
5198-5202 4,92 0,025 -0,073 0,123 YES YES
5198-5202 4,92 0,025 -0,073 0,123 YES YES
5223-5227 4,87 0,006 -0,092 0,104 YES YES
5223-5227 4,87 0,006 -0,092 0,104 YES YES

Reference Alternative SD repeatability of reference Reference Alternative SD repeatability of reference

Reference Alternative SD repeatability of reference Final AL Reference Alternative SD repeatability of reference Final AL
method method method <= 0.125 Final AL method method method <= 0.125 Final AL
method method method <= 0.125 method method method <= 0.125
SD Repeatability 0,079 0,068 YES +/- 0,500 SD Repeatability +/-
SD Repeatability 0,079 0,068 YES +/- 0,500 SD Repeatability +/-

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3.1.3 Inclusivity and exclusivity studies

The inclusivity study is a study involving pure target strains to be detected or enumerated by the
alternative method.

The exclusivity study is a study involving pure non-target strains, which can be potentially cross-
reactive, but are not expected to be detected or enumerated by the alternative method.

3.1.3.1 Protocol

Inclusivity

23 target strains were tested for the initial validation study. The study was
completed by testing 27 target strains. Each test was performed once with
the alternative method, the reference method and a non-selective agar. The
inoculation level shall obtain a countable number on the plate.

Exclusivity

13 non-target strains were tested for the initial validation study. The study
was completed by testing 17 strains. The pure culture was grown in a
suitable non-selective broth under optimal growth conditions for at least 24 h
and diluted at an appropriate level before testing. Each test was performed
once with the alternative method, the reference method and a non-selective
agar. The inoculation level shall obtain a countable number on the plate.

3.1.3.2 Results

The raw data are provided in Appendix 8.

Inclusivity

Among the 50 strains tested; one strain (Erwinia carotovora CIP 103762) did
not grow on VRBG and 3MTM Petrifilm plates. The second Erwinia carotovora
(CIP 8289) grew on 3MTM Petrifilm plates but did not grow on VRBG plates.

Exclusivity

30 strains were tested; 4 strains gave typical colonies by both methods:

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- Aeromonas hydrophila CIP 5750,

- Aeromonas bestiarum CIP 7430,
- Xanthamonas maltophilia CIP 6077,
- Plesiomonas shigelloïdes Ad673.

3.1.3.3 Conclusion

Similar results were observed with the reference and the alternative
methods.

The 3MTM PetrifilmTM Enterobacteriaceae Count Plate is specific and

selective.

3.1.4 Practicability

The alternative method practicability was evaluated according to the AFNOR

criteria.

Criteria to be control Communication on criteria Expert lab checking procedure

Store the unopened 3M Petrifilm
pouches at frozen or refrigerated
Storage conditions Mentioned on the instruction for use
temperature less than or equal to
8°C (46°F)
Shelf-life and modalities Store resealed pouches in a cool
of utilization after first dry place for no longer than four Mentioned in the kit insert
use weeks
Time to result 24 h ± 2 h Mentioned in the kit insert
Common step with the
Initial suspensions and dilutions
reference method

3.1.5 Method comparison study conclusion

The observed data and interpretation confirm the performances of the

alternative method:

- 139 samples were tested in the relative trueness study, which clearly
satisfied the required criteria for quantitative method comparison per ISO
16140-2;

- The observed profiles are comprised within the AL actually set at

0.5 Log CFU/g in the EN ISO 16140-2:2016.

- The inclusivity and exclusivity testing shows satisfying results.

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3.2 Inter-Laboratory study

The inter-laboratory study is a study performed by multiple laboratories testing

identical samples at the same time, the results of which are used to estimate
alternative-method performance parameters.

3.2.1 Study organisation

The inter-laboratory stud was run according to the ISO 16140 (2003) in 2001
for the renewal stud. The study was run on pasteurized skimmed milk
inoculated with Escherichia coli 94.

15 collaborators participated to the study; the results from 14 laboratories

were kept for interpretation (late reception for one laboratory).

3.2.2 Analysis results

3.2.2.1 Results obtained by the expert Lab.

The results obtained by the expert Lab. are the following (See table 8).

Table 8 – Results obtained by the expert Lab.

Reference method Alternative method

Level
Rep 1 Rep 2 Rep 1 Rep 2
L0 <1 <1 <1 <1
L1 2.18 2.26 2.26 2.15
L2 3.18 3.30 3.23 3.20
L3 4.11 4.23 4.08 4.15

3.2.2.2 Results obtained by the collaborators

Samples were sent to 15 collaborators.

A summary of the test results is given in Table 9 (CFU/ml) and Table 10 (log
CFU/ml).

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Table 9 - Summary of data (CFU/ml)

Level 0 Level 1 Level 2 Level 3
Collaborator
Reference method Alternative method Reference method Alternative method Reference method Alternative method Reference method Alternative method
A <1 <1 <1 <1 300 260 120 220 1800 1900 2000 2900 21000 15000 17000 27000
B <1 <1 <1 <1 250 210 260 100 1200 1300 2100 1300 24000 16000 19000 23000
C <1 <1 <1 <1 180 160 110 150 1700 1500 2100 1200 15000 14000 21000 11000
D <1 <1 <1 <1 150 140 220 210 1400 1300 1500 2400 13000 13000 14000 14000
E <1 <1 <1 <1 190 164 150 130 1700 1800 1300 1600 15000 22000 14000 17000
F <1 <1 <1 <1 140 190 160 140 1900 1700 2100 1800 23000 20000 21000 19000
G <1 <1 <1 <1 180 240 160 160 2300 2600 2100 2000 12000 15000 13000 12000
I <1 <1 <1 <1 130 150 140 220 1200 1300 2200 1400 13000 12000 18000 20000
J <1 <1 <1 <1 130 130 100 160 1300 1400 2100 2200 15000 14000 20000 21000
K <1 <1 <1 <1 200 290 210 180 2100 2300 1800 1500 17000 14000 27000 14000
L <1 <1 <1 <1 220 230 190 260 2200 2400 1700 2400 25000 23000 23000 13000
M <1 <1 <1 <1 160 170 160 100 2000 2700 1400 2700 20000 12000 15000 17000
N <1 <1 <1 <1 180 280 230 200 1700 1700 1600 1500 14000 11000 22000 16000
O <1 <1 <1 <1 210 190 210 230 1400 2000 1100 900 16000 7000 9100 9400

Table 10 - Summary of data (log CFU/ml)

Level 0 Level 1 Level 2 Level 3
Collaborator
Reference method Alternative method Reference method Alternative method Reference method Alternative method Reference method Alternative method
A <0,00 <0,00 <0,00 <0,00 2,477 2,415 2,079 2,342 3,255 3,279 3,301 3,462 4,322 4,176 4,230 4,431
B <0,00 <0,00 <0,00 <0,00 2,398 2,322 2,415 2,000 3,079 3,114 3,322 3,114 4,380 4,204 4,279 4,362
C <0,00 <0,00 <0,00 <0,00 2,255 2,204 2,041 2,176 3,230 3,176 3,322 3,079 4,176 4,146 4,322 4,041
D <0,00 <0,00 <0,00 <0,00 2,176 2,146 2,342 2,322 3,146 3,114 3,176 3,380 4,114 4,114 4,146 4,146
E <0,00 <0,00 <0,00 <0,00 2,279 2,215 2,176 2,114 3,230 3,255 3,114 3,204 4,176 4,342 4,146 4,230
F <0,00 <0,00 <0,00 <0,00 2,146 2,279 2,204 2,146 3,279 3,230 3,322 3,255 4,362 4,301 4,322 4,279
G <0,00 <0,00 <0,00 <0,00 2,255 2,380 2,204 2,204 3,362 3,415 3,322 3,301 4,079 4,176 4,114 4,079
I <0,00 <0,00 <0,00 <0,00 2,114 2,176 2,146 2,342 3,079 3,114 3,342 3,146 4,114 4,079 4,255 4,301
J <0,00 <0,00 <0,00 <0,00 2,114 2,114 2,000 2,204 3,114 3,146 3,322 3,342 4,176 4,146 4,301 4,322
K <0,00 <0,00 <0,00 <0,00 2,301 2,462 2,322 2,255 3,322 3,362 3,255 3,176 4,230 4,146 4,431 4,146
L <0,00 <0,00 <0,00 <0,00 2,342 2,362 2,279 2,415 3,342 3,380 3,230 3,380 4,398 4,362 4,362 4,114
M <0,00 <0,00 <0,00 <0,00 2,204 2,230 2,204 2,000 3,301 3,431 3,146 3,431 4,301 4,079 4,176 4,230
N <0,00 <0,00 <0,00 <0,00 2,255 2,447 2,362 2,301 3,230 3,230 3,204 3,176 4,146 4,041 4,342 4,204
O <0,00 <0,00 <0,00 <0,00 2,322 2,279 2,322 2,362 3,146 3,301 3,041 2,954 4,204 3,845 3,959 3,973

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3.2.3 Calculations and interpretation

3.2.3.1 Visual linearity checking

The figure 11 shows the data points after log10 transformation. The visual
inspection shows that the alternative method gives results, which are
proportional to those of the reference method. The data are distributed
closely to the first bisecting lines with a slope equal to 1.

Figure 11 - Visual linearity checking

Visual linearity checking

7,00

6,00
Log (Alternative)

5,00

4,00

3,00

2,00

1,00
1,00 2,00 3,00 4,00 5,00 6,00 7,00
Log (Reference)

3.2.3.2 Accuracy profile calculations

Statistical calculations were done according to the Excel spreadsheet

available on http://standards.iso.org/ISO/16140. A summary of the statistical
test is provided in Table 11.

These values are collected in a graphical representation together with the

acceptability limits (AL). This representation is given Figure 12

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Table 11 - Summary of statistical tests

Accuracy profile 0,5

Application of clause 6.2.3
Study Name 3M Petrifilm Enterobacteriaceae
Step 8: If any of the values for
Date the β-ETI fall outside the
Coordinator FAUX acceptability limits, calculate
Tolerance probability (beta) 80% 80% 80% the pooled average
reproducibility standard
Acceptability limit in log (lambda) 0,50 0,50 0,50
deviation of the reference
method.
Alternative Reference method
Step 9: Calculate new
method
acceptability limits as a
Levels Low Medium High Low Medium Highof this standard
function
Target value 2,274 3,238 4,191 deviation.
Number of participants (K) 14 14 14 14 14 14
Average for alternative method 2,224 3,244 4,223 2,274 3,238 4,191
Repeatability standard deviation (sr) 0,122 0,110 0,104 0,065 0,045 0,102
Between-labs standard deviation (sL) 0,031 0,052 0,071 0,088 0,095 0,070
Reproducibility standard deviation
(sR) 0,126 0,122 0,126 0,109 0,105 0,124
Corrected number of dof 26,745 25,758 23,978 18,466 15,645 23,988
Coverage factor 1,339 1,343 1,349
Interpolated Student t 1,314 1,315 1,318
Tolerance interval standard deviation 0,1283 0,1245 0,1291
Lower TI limit 2,056 3,080 4,053
Upper TI limit 2,393 3,408 4,393
Bias -0,050 0,006 0,032
Relative Lower TI limit (beta = 80%) -0,218 -0,158 -0,138 FAUX
Relative Upper TI limit (beta = 80%) 0,119 0,169 0,203 FAUX
Lower Acceptability Limit -0,50 -0,50 -0,50
Upper Acceptability Limit 0,50 0,50 0,50
New acceptability limits may be based on reference method pooled
variance
Pooled repro standard dev of
reference 0,113

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Figure 12 - Accuracy profile

Bias Relative Lower TI limit (beta = 80%)

Relative Upper TI limit (beta = 80%) Lower Acceptability Limit
0,6 Upper Acceptability Limit

0,4
Accuracy (difference of Log)

0,2

0,0
2,0 2,5 3,0 3,5 4,0 4,5

-0,2

-0,4

-0,6 Levels Log(cfu/g)

It is observed that for all the levels, the tolerance interval limits of the
alternative method are within the acceptable limits of 0.5 log.

The alternative method is equivalent to the reference method.

3.3 General conclusion

The method comparison study conclusions are:

The observed data and interpretation confirm the performances of the

alternative method:

- 139 samples were tested in the relative trueness study, which clearly
satisfied the required criteria for quantitative method comparison per ISO
16140-2;

- The observed profiles are comprised within the AL actually set at

0.5 Log CFU/g in the EN ISO 16140-2:2016.

- The inclusivity and exclusivity testing shows satisfying results.

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The inter-laboratory study conclusions are:

The data interpretations were done according to the EN ISO 16140-

2:2016. For the three contamination levels, the alternative method is
accepted as equivalent to the reference method.

Based on the results obtained for the method comparison study and
the inter-laboratory study, the 3MTM PetrifilmTM Enterobacteriaceae is
considered equivalent to the reference method.

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Appendix 1 – Flow diagram of the alternative method:

3MTM PetrifilmTM Enterobacteriaceae Count Plate

xg + 9x ml appropriate diluent

Stomach

Decimal dilutions

1 ml per Petrifilm


Incubation for 24 h  2 h at 37°C*  1°C or at 30°C*  1°C


Characteristic colonies enumeration:
- Red-colonies with yellow zones
- Red-colonies with gas bubbles
- Red-colonies with yellow zones and gas bubbles

*During the NF Validation study, the 37°C temperature was used.

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Appendix 2 – Flow diagrams of the reference method

NF ISO 21528-2 (December 2004) - Microbiology of food and animal feeding

stuffs - Horizontal methods for the detection and enumeration of
Enterobacteriaceae - Part 2: colony-count method

xg + 9x ml appropriate diluent

Stomach

Decimal dilutions

Inoculate 1 ml per plate

Add VRBG + double layer

Incubation for 24 h  2 h at 37°C  1°C

Enumeration of characteristic colonies (red, pink, with or without a precipitation halo)

Confirmation: pick up 5 colonies per plate retained for enumeration

TSA incubation for 24 h  2 h at 37°C  1°C

Oxidase test BCP Glucose

(-) (24 h ± 2 h at 37°C ± 1°C)
(Fermentation, +)

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NF ISO 21528-2 (June 2017) - Microbiology of food and animal feeding stuffs -
Horizontal methods for the detection and enumeration of Enterobacteriaceae -
Part 2: colony-count method

xg + 9x ml appropriate diluent

Stomach

Decimal dilutions

Inoculate 1 ml per plate

Add VRBG + double layer

Incubation for 24 h  2 h at 37°C  1°C

Enumeration of characteristic colonies (red, pink, with or without a precipitation halo)

Confirmation: pick up 5 colonies per plate retained for enumeration

TSA incubation for 24 h  2 h at 37°C  1°C

Oxidase test OF Glucose

(-) (24 h ± 2 h at 37°C ± 1°C)
(Fermentation, +)

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Appendix 3 – Artificial contaminations of samples

Artificial contaminations
Date of Sample
Product (French name) Product Injury
analyse number Strain Origin Injury protocol
measurement
2010 763 Saucisson pour chien Sausage for dog Escherichia coli 12 Turkey meat TT 30min 55°C 0,66
2010 765 Saucisson pour chien Sausage for dog Escherichia coli 101 Pork brain TT 30min 55°C 0,47
2010 774 Mini filets pour chat au lapin Pâté for cat Escherichia coli Ad233 Veal -20°C 0,54
2015 3844 Chiffonnette Microcut petits pois Wipe (peas industry) Escherichia coli 19 Grated carrots HT 56°C 30min 1,20
2015 3845 Eau de cuisson petits pois Process water (peas) Escherichia coli 19 Grated carrots HT 56°C 30min 1,20
Chiffonnette balance après désinfection
2015 3903 Wipe (rice industry) Citrobacter farmerii Ad 1116 Environment pH4 during 11 days 1,90
cuisson riz
Chiffonnette plan de travail fabrication
2015 3904 Wipe (pastry industry) Citrobacter farmerii Ad 1116 Environment pH4 during 11 days 1,90
madeleine après désinfection
2015 3905 Chiffonnette table de cuisson béchamel Wipe (bechamel sauce) Serratia fonticola Ad 1376 Water HT 56°C 25 min 3,40
2015 3906 Chiffonnette table découpe emmenthal Wipe (cheese industry) Escherichia coli Ad 1395 Water HT 56°C 25 min 1,44
2015 3907 Eau de rinçage becher (PDL+eau) Process water (milk industry) Serratia fonticola Ad 1376 Water HT 56°C 25 min 3,40
Enterobacter fergusonii
2015 4494 Chiffonnette local vaisselle atelier Wipe (dishwasher) Environment 16 days pH4 0,42
2876
Enterobacter fergusonii
2015 4495 Chiffonnette table atelier Wipe (table) Environment 16 days pH4 0,42
2876
2015 4496 Chiffonnette cutter Wipe (cutter) Citrobacter youngae Ad1372 Water HT 50°C 10 min 0,5
2015 4497 Chiffonnette poussoir Wipe (push-button) Citrobacter youngae Ad1372 Water HT 50°C 10 min 0,5
2015 4562 Chiffonnette table préparation pâte Wipe Escherichia coli Ad1388 Water 16 days pH4 0,42
Chiffonnette cuve broyeur après
2015 4563 Wipe after cleaning Escherichia coli 101 Pork meat 16 days 4°C 1,07
nettoyage
Chiffonnette grille four fumage après
2015 4564 Wipe after cleaning Escherichia coli Ad1828 Beef meat HT 50°C 10 min 0,4
nettoyage
Chiffonnette table découpe après
2015 4565 Wipe after cleaning Escherichia coli Ad1388 Water 16 days pH4 0,42
nettoyage
2017 6226 Crème dessert à la vanille Dairy dessert E.kobei Ad706 Milk powder Seeding 48h 2-8°C /
2017 6227 Riz au lait Dairy dessert E.kobei Ad706 Milk powder Seeding 48h 2-8°C /
2017 6228 Nem au crabe RTRH Seafood E.Cloacae Ad230 Tuna
2017 6229 Beignets de crevettes RTRH Seafood E.Cloacae Ad230 Tuna
2017 6230 Parmentier de poisson ciboulette RTRH seafood E.coli Ad228 Fish
2017 6231 Betteraves rouges assaisonnées Seasoned red beetroot E.Hermanii Ad457 Spinash
2017 6232 Carottes râpées au citron Seasoned grated carrots E.Hermanii Ad457 Spinash

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Artificial contaminations
Date of Sample
Product (French name) Product Injury
analyse number Strain Origin Injury protocol
measurement
2017 6233 Duo carottes céleri assaisonnés Seasoned grated celeri carrots K.pneumoniae 139 Soya
Boulettes aux légumes carottes petits
2017 6234 RTRH beef E.hermanii Ad457 Spinash
pois mais
Boulettes aux légumes carottes petits
2017 6235 RTRH beef K.pneumoniae 139 Soya
pois mais
2017 6236 Galettes gourmandes lentilles carottes RTRH vegetables K.pneumoniae 139 Soya
Falafels pois chiches fèves coriandre
2017 6237 RTRH vegetables K.pneumoniae 139 Soya
menthe
2017 6238 Cannelloni pur bœuf RTRH beef E.kobei Ad342 Ham
2017 6239 Pizza jambon fromage RTRH pizza E.kobei Ad342 Ham
2017 6240 Flan pâtissier Custard pastry E.hermanii Ad461 Custard
2017 6241 Eclair au chocolat Pastry E.hermanii Ad461 Custard
2017 6242 Saucisson pour chien Sausage for dog E.kobei Ad342 Ham
2017 6243 Eau de rinçage (industrie porc) Rinced water (Pork industry) H.alvei 167 Sausages
Eau de lavage sciage viande (industrie
2017 6244 Wash water (pork industry) H.alvei 167 Sausages
porc)
2017 6884 Filet de colin Hake fillet Rhanella aquatilis 67 Delicatessen Seeding 48h 2-8°C /
2017 6885 Filet de cabillaud Cod fillet Rhanella aquatilis 67 Delicatessen Seeding 48h 2-8°C /
2017 6907 Protéines déshydratées de volaille Dehydrated poultry proteins E.aerogenes Ad889 Meat meal Spiking-HT 8 min 56°C /
2017 6908 Protéines déshydratées de volaille Dehydrated poultry proteins E.aerogenes Ad889 Meat meal Spiking-HT 8 min 56°C /

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Appendix 4 - Relative trueness study: raw data

Ne: estimated number *: less than 4 colonies/plate N: arithmetic average

MEAT PRODUCTS
Reference method: ISO 21528-2 Alternative method : 3MTM Petrifilm Enterobacteriaceae Count Plate
pH Rep 2

Category
Date of Sample Product (French Rep 1 (confirmed) Rep 1 Rep 2 Rep 1 Rep 2 Log Rep 1 Rep 2 Rep 1 Rep 2 Rep 1 Rep 2 Log

Type
Product

Dilution

Dilution
analyse number name) (confirmed)
cfu/g cfu/g
cfu/ cfu/ cfu/ cfu/ Total Gaz + Total Gaz + log log
before after cfu/g cfu/g log cfu/g log cfu/g Mean cfu/g cfu/g Mean
plate a plate b plate a plate b cfu/plate cfu/plate cfu/plate cfu/plate cfu/g cfu/g
1997 11 Escalope de dinde Poultry meat 4,03 3,95 3,99 4,02 3,95 3,99 1 a
1997 206 Foie de poulet Poultry liver 4,19 4,19 4,19 4,5 4,66 4,58 1 a
1997 207 Foie de lapin Rabbit liver 2,60 2,30 2,45 2,78 3,08 2,93 1 a
1997 210 Pilons de poulet Poultry meat 2,00 2,60 2,30 3,26 3,19 3,23 1 a
1997 211 Ailes de poulet Poultry meat 4,62 4,60 4,61 5,13 5,1 5,12 1 a
Caille aux raisins Ready to reheat meat
1997 68 2,84 2,96 2,90 3,28 3,32 3,30 1 a
based product
Gésiers de canard Shredded duck confit
1997 113 4,75 4,95 4,85 5 4,91 4,96 1 a
confits
1997 50 Steak haché Ground beef 4,96 4,48 4,72 4,96 4,96 4,96 1 b
1997 116 Minerai Trimmings 3,90 3,87 3,89 3,95 3,89 3,92 1 b
1997 208 Foie de porc Pork liver 3,48 3,41 3,45 3,59 3,46 3,53 1 b
1997 212 Cervelle Brain 2,48 2,30 2,39 3,41 3,26 3,34 1 b
Rognons au Madère Ready to reheat meat
1997 4 1,30 1,30 1,30 1,48 1,48 1,48 1 b
based product
Côte de veau à la Ready to reheat meat
1997 70 1,00 1,30 1,15 1 1,3 1,15 1 b
crème based product
Bœuf carottes Ready to reheat meat
1997 101 4,49 4,49 4,49 4,23 4,26 4,25 1 b
based product
1997 17 Chair à tomates Sausage 5,90 5,74 5,82 5,87 5,89 5,88 1 c
1997 19 Poitrine demi-sel Half-salt chest 3,48 3,76 3,62 4 3,94 3,97 1 c
1997 20 Rillettes Rillettes 4,41 4,28 4,35 4,41 4,66 4,54 1 c
1997 23 Jambon blanc Ham 2,38 2,40 2,39 2,65 2,71 2,68 1 c
1997 25 Chipolatas Chipolatas 2,13 1,95 2,04 2,46 2,62 2,54 1 c
1997 48 Chipolatas Chipolatas 3,21 3,10 3,16 3,15 3,45 3,30 1 c
1997 90 Boudin noir Black sausage 1,95 1,60 1,78 2 1,9 1,95 1 c
1997 91 Rillettes Rillettes 4,7 4,64 4,67 4,67 4,57 4,62 1 c
1997 92 Poitrine crue Raw chest 1,00 1,30 1,15 1,48 1,3 1,39 1 c
1997 121 Chipolatas Chipolatas 5,76 5,56 5,66 5,76 5,65 5,71 1 c
1997 125 Rillettes Rillettes 1,60 1,48 1,54 2,19 2,73 2,46 1 c
1997 126 Jambon Ham 3,90 4,00 3,95 4,05 4,11 4,08 1 c
1997 129 Poitrine fumée Smoked chest 1,00 1,00 1,00 2,04 1,9 1,97 1 c
1997 130 Boudin noir Black sausage 2,81 2,72 2,77 3,58 3,41 3,50 1 c
1997 205 Chipolatas Chipolatas 3,49 3,19 3,34 3,65 3,58 3,62 1 c


Analyses performed according to the COFRAC accreditation
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DAIRY PRODUCTS
Reference method: ISO 21528-2 Alternative method : 3MTM Petrifilm Enterobacteriaceae Count Plate
pH Rep 2

Category
Date of Sample Product (French Rep 1 (confirmed) Rep 1 Rep 2 Rep 1 Rep 2 Log Rep 1 Rep 2 Rep 1 Rep 2 Rep 1 Rep 2 Log

Type
Product

Dilution

Dilution
analyse number name) (confirmed)
cfu/g cfu/g
cfu/ cfu/ cfu/ cfu/ Total Gaz + Total Gaz + log log
before after cfu/g cfu/g log cfu/g log cfu/g Mean cfu/g cfu/g Mean
plate a plate b plate a plate b cfu/plate cfu/plate cfu/plate cfu/plate cfu/g cfu/g
1997 38 Lait cru Raw milk 2,74 2,85 2,80 3 2,96 2,98 2 a
1997 106b Crème fraîche Cream 6,19 6,16 6,18 7,4 7,18 7,29 2 a
1997 107b Crème fraîche Cream 7,41 7,28 7,35 7,46 7,63 7,55 2 a
1997 119 Lait cru Raw milk 3,91 3,51 3,71 4,82 4,95 4,89 2 a
2017 6159 Lait cru Raw milk 7,02 / 100 134 14000 / 4,15 / 4,15 100 109 97 / / 11000 / 4,04 / 4,04 2 a
1000 18 1000 14 12 / / 2 a
1997 9 Fromage de chèvre Goat milk cheese 3,13 3,04 3,09 3,48 3,45 3,47 2 b
1997 10 Tomme de brebis Ewe milk cheese 4,16 4,30 4,23 4,83 4,8 4,82 2 b
1997 42 Munster Munster 6,59 6,55 6,57 6,75 6,72 6,74 2 b
1997 75 Fromage de chèvre Goat milk cheese 2,93 3,01 2,97 2,8 3,19 3,00 2 b
1997 85 Raclette au lait cru Raw milk cheese 3,08 3,06 3,07 3,39 3,36 3,38 2 b
1997 86 Brie de Meaux au lait Brie de Meaux (raw
7,16 7,21 7,19 7,23 7,28 7,26 2 b
cru milk)
1997 110 Brebis demi-sec Ewe milk cheese 3,39 3,44 3,42 4,12 4,08 4,10 2 b
1997 111 Tomme Mont d’Arrée Cheese 5,41 5,41 5,41 5,73 5,81 5,77 2 b
1997 120 Brie Brie 4,37 4,28 4,33 4,19 4,34 4,27 2 b
1997 128 Vieux pané Cheese 1,95 2,11 2,03 2,77 2,81 2,79 2 b
1997 131 Livarot Livarot 2,82 2,87 2,85 3,28 3,19 3,24 2 b
1997 132 Munster Munster 5,55 5,54 5,55 5,85 5,86 5,86 2 b
1997 201 Camembert Camembert 7,71 7,82 7,77 7,81 7,88 7,85 2 b
1997 202 Reblochon Reblochon 7,48 7,46 7,47 7,43 7,3 7,37 2 b
1997 203 Camembert Camembert 7,19 7,12 7,16 7,23 7,27 7,25 2 b
1997 204 Camembert Camembert 6,19 6,00 6,10 6,28 6,39 6,34 2 b
1997 140 Nougat glacé Iced nougat 1,30 1,00 1,15 1,95 1,3 1,63 2 c
1997 141 Nougat glacé Iced nougat 1,00 1,48 1,24 1,56 1,44 1,50 2 c
1997 142 Nougat glacé Iced nougat 1,48 1,60 1,54 1,66 1,86 1,76 2 c
2017 6226 Crème dessert à la Dairy dessert 6,95 / 10 15 140 / 2,15 / 2,15 10 23 23 / / 210 / 2,32 / 2,32 2 c
vanille 100 0 100 0 0 / / 2 c
2017 6227 Riz au lait Dairy dessert 6,98 / 1000 21 21000 / 4,32 / 4,32 1000 63 63 / / 61000 / 4,79 / 4,79 2 c
10000 2 100100 4 4 / / 2 c

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Analyses performed according to the COFRAC accreditation
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SEAFOOD
Reference method: ISO 21528-2 Alternative method : 3MTM Petrifilm Enterobacteriaceae Count Plate
pH Rep 2

Category
Date of Sample Product (French Rep 1 (confirmed) Rep 1 Rep 2 Rep 1 Rep 2 Log Rep 1 Rep 2 Rep 1 Rep 2 Rep 1 Rep 2 Log

Type
Product

Dilution

Dilution
analyse number name) (confirmed)
cfu/g cfu/g
cfu/ cfu/ cfu/ cfu/ Total Gaz + Total Gaz + log log
before after cfu/g cfu/g log cfu/g log cfu/g Mean cfu/g cfu/g Mean
plate a plate b plate a plate b cfu/plate cfu/plate cfu/plate cfu/plate cfu/g cfu/g
1997 124 Sardines Sardines 1,58 1,51 1,55 2,67 2,73 2,70 3 a
1997 163 Maquereau Mackerel 3,04 2,73 2,89 3,02 2,98 3,00 3 a
Lieu noir cru Raw fish Positive oxidase-
7,06 / 100 A.hydrophila/V.fluvialis
<100 / <2,00 / <2,00 100 51 8 / / 4900 / 3,69 / 3,69 3 a
2017 6160 Positive oxidase-
1000 A.hydrophila/V.fluvialis
1000 3 2 / / 3 a

Darne de saumon cru Raw fish Positive oxidase-

7,05 / 1000 A.hydrophila/V.fluvialis
<1000 / <3,00 / <3,00 1000 16 4 / / 15000 / 4,18 / 4,18 3 a
2017 6161
Positive oxidase-
10000 A.hydrophila/V.fluvialis
10000 1 0 / / 3 a

Filet de saumon Frozen salmon 6,93 / 10 73 750 / 2,88 / 2,88 10 65 46 / / 640 / 2,81 / 2,81 3 a
2017 6162
surgelé 100 9 100 5 2 / / 3 a
Filet de colin Hake fillet 7,01 / 10 0 <10 / <1,00 / <1,00 10 0 0 <10 / <1,00 / <1,00 3 a
2017 6884
100 0 100 0 0 3 a
Filet de cabillaud Cod fillet 7,03 / 100 0 <10 / <1,00 / <1,00 100 0 0 <10 / <1,00 / <1,00 3 a
2017 6885
1000 0 1000 0 0 3 a
Cocktail de fruits de Precooked seafood
1997 88 1,60 1,70 1,65 1,7 1,78 1,74 3 b
mer
1997 36 Moules Mussels 1,30 1,30 1,30 1,84 1,6 1,72 3 b
Nem au crabe RTRH Seafood 6,90 / 100 27 2500 / 3,40 / 3,40 100 34 34 / / 3500 / 3,54 / 3,54 3 b
2017 6228
1000 1 1000 4 4 / / 3 b
Beignets de RTRH Seafood 6,82 / 1000 9 10000 / 4,00 / 4,00 1000 24 24 / / 25000 / 4,40 / 4,40 3 b
2017 6229
crevettes 10000 2 10000 3 3 / / 3 b
Parmentier de RTRH seafood 6,79 / 1000 108 110000 / 5,04 / 5,04 1000 91 91 / / 92000 / 4,96 / 4,96 3 b
2017 6230
poisson ciboulette 10000 11 10000 10 10 / / 3 b
Feuilleté fruits de merReady to reheat
1997 60 4,49 4,46 4,48 4,39 4,39 4,39 3 c
seafood product
Coquille à la bretonne Ready to reheat
1997 62 1,00 1,30 1,15 1 1,48 1,24 3 c
seafood product
Filet de julienne en Ready to reheat
1997 67 2,85 2,58 2,72 2,53 2,76 2,65 3 c
sauce seafood product
1997 73 Saumon fumé Smoked salmon 3,56 3,34 3,45 3,6 3,49 3,55 3 c
1997 105b Saumon fumé Smoked salmon 5,26 5,00 5,13 5,28 5,39 5,34 3 c
1997 144 Saumon fumé Smoked salmon 5,26 5,45 5,36 4,54 4,48 4,51 3 c

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VEGETABLES
Reference method: ISO 21528-2 Alternative method : 3MTM Petrifilm Enterobacteriaceae Count Plate
pH Rep 2

Category
Date of Sample Product (French Rep 1 (confirmed) Rep 1 Rep 2 Rep 1 Rep 2 Log Rep 1 Rep 2 Rep 1 Rep 2 Rep 1 Rep 2 Log

Type
Product

Dilution

Dilution
analyse number name) (confirmed)
cfu/g cfu/g
cfu/ cfu/ cfu/ cfu/ Total Gaz + Total Gaz + log log
before after cfu/g cfu/g log cfu/g log cfu/g Mean cfu/g cfu/g Mean
plate a plate b plate a plate b cfu/plate cfu/plate cfu/plate cfu/plate cfu/g cfu/g
1997 39 Courgette Zucchini 1,30 1,84 1,57 2 1,7 1,85 4 a
1997 81 Chou rouge râpé Grated red cabbage 2,20 2,15 2,18 2,51 2,56 2,54 4 a
1997 154 Brocolis surgelés Frozen broccolis 1,48 1,90 1,69 1,7 1,7 1,70 4 a
1997 155 Brocolis surgelés Frozen broccolis 1,85 1,90 1,88 1,7 1,6 1,65 4 a
1997 156 Brocolis surgelés Frozen broccolis 2,58 2,54 2,56 3,09 3,06 3,08 4 a
1997 159 Carottes surgelées Frozen carrots 3,18 3,18 3,18 3,61 3,48 3,55 4 a
1997 160 Tomates surgelées Frozen tomatoes 2,00 1,95 1,98 2,34 2,41 2,38 4 a
1997 161 Tomates surgelées Frozen tomatoes 2,44 2,42 2,43 2,9 2,86 2,88 4 a
Pommes de terre Frozen potatoes
1997 162 1,78 1,90 1,84 2,08 2,04 2,06 4 a
surgelées
1997 82 Céleri râpé Grated celery 3,08 3,04 3,06 2,62 2,83 2,73 4 b
1997 102 Salade primavera Salad 3,67 3,61 3,64 3,74 3,79 3,77 4 b
Betteraves rouges Seasoned red beetroot 6,81 / 10 26 270 / 2,43 / 2,43 10 22 22 / / 250 / 2,40 / 2,40 4 b
2017 6231
assaisonnées 100 4 100 5 5 / / 4 b
Carottes râpées au Seasoned grated 6,78 / 10 41 440 / 2,64 / 2,64 10 38 0 / / 360 / 2,56 / 2,56 4 b
2017 6232
citron carrots 100 7 100 2 0 / / 4 b
Duo carottes céleri Seasoned grated 6,75 / 10 16 160 / 2,20 / 2,20 10 15 15 / / 170 / 2,23 / 2,23 4 b
2017 6233
assaisonnés celery carrots 100 2 100 4 4 / / 4 b
1997 35 Pomme de terre Potatoes 4,53 3,81 4,17 4,72 4,8 4,76 4 c
Boulettes aux RTRH beef 7,00 / 100 62 6000 / 3,78 / 3,78 100 67 67 / / 6500 / 3,81 / 3,81 4 c
2017 6234 légumes carottes
1000 4 1000 4 4 / / 4 c
petits pois mais
Boulettes aux RTRH beef 7,00 / 10 24 230 / 2,36 / 2,36 10 21 21 / / 210 / 2,32 / 2,32 4 c
2017 6235 légumes carottes
100 1 100 2 2 / / 4 c
petits pois mais
Galettes RTRH vegetables 6,97 / 10 62 640 / 2,81 / 2,81 10 73 73 / / 740 / 2,87 / 2,87 4 c
2017 6236 gourmandes
100 8 100 8 8 / / 4 c
lentilles carottes
Fallafels pois RTRH vegetables 6,80 / 100 90 9200 / 3,96 / 3,96 100 98 98 / / 9700 / 3,99 / 3,99 4 c
2017 6237 chiches fèves
1000 11 1000 9 9 / / 4 c
coriandre menthe


Analyses performed according to the COFRAC accreditation
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MISCELLANEOUS AND EGG-BASED PRODUCTS

Reference method: ISO 21528-2 Alternative method : 3MTM Petrifilm Enterobacteriaceae Count Plate
pH Rep 2

Category
Date of Sample Product (French Rep 1 (confirmed) Rep 1 Rep 2 Rep 1 Rep 2 Log Rep 1 Rep 2 Rep 1 Rep 2 Rep 1 Rep 2 Log

Type
Product

Dilution

Dilution
analyse number name) (confirmed)
cfu/g cfu/g
cfu/ cfu/ cfu/ cfu/ Total Gaz + Total Gaz + log log
before after cfu/g cfu/g log cfu/g log cfu/g Mean cfu/g cfu/g Mean
plate a plate b plate a plate b cfu/plate cfu/plate cfu/plate cfu/plate cfu/g cfu/g
Bouchée à la reine Ready to reheat meat
1997 54 3,28 3,37 3,33 3,26 3,07 3,17 5 a
based product
1997 64 Croque-monsieur Croque-monsieur 3,57 3,78 3,68 3,75 3,8 3,78 5 a
1997 117 Raviolis Raviolis 2 2 2,00 2,78 2,78 2,78 5 a
Cannelloni pur bœuf RTRH beef 7,05 / 10 55 560 / 2,75 / 2,75 10 67 67 / / 680 / 2,83 / 2,83 5 a
2017 6238
100 7 100 8 8 / / 5 a
Pizza jambon RTRH pizza 7,03 / 100 48 5000 / 3,70 / 3,70 100 57 57 / / 6100 / 3,79 / 3,79 5 a
2017 6239
fromage 1000 7 1000 10 10 / / 5 a
1997 122 Eclair vanille Pastry 2,48 2 2,24 3,66 3,66 3,66 5 b
1997 78 Chocolats Chocolates 1,78 1,48 1,63 2,26 2,23 2,25 5 b
1997 118 Chou chantilly Pastry 4,34 4,48 4,41 4,51 4,62 4,57 5 b
2017 6240 Flan pâtissier Custard pastry 7,10 / 1000 10 10000 / 4,00 / 4,00 1000 10 10 / / 11000 / 4,04 / 4,04 5 b
10000 1 10000 2 2 / / 5 b
2017 6241 Eclair au chocolat Pastry 7,11 / 1000 22 23000 / 4,36 / 4,36 1000 28 28 / / 26000 / 4,41 / 4,41 5 b
10000 3 10000 1 1 / / 5 b
1997 29 Crème pâtissière Custard 1 1,3 1,15 1,95 1,84 1,90 5 c
1997 56 Œuf en gelée Egg in jelly 2,89 2,89 2,89 2,78 2,91 2,85 5 c
1997 58 Mayonnaise Mayonnaise 2,71 2,86 2,79 2,3 2,39 2,35 5 c
1997 84 Crème pâtissière Custard 1,78 1,7 1,74 2,13 1,84 1,99 5 c
1997 104 Mayonnaise Mayonnaise 3,15 3,21 3,18 3,76 3,8 3,78 5 c
1997 112 Coule d’œuf Whole egg 4,48 4,54 4,51 4,49 4,44 4,47 5 c


Analyses performed according to the COFRAC accreditation
ADRIA Développement 36/52 February 2, 2018
Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

FEED PRODUCTS
Reference method: ISO 21528-2 Alternative method : 3MTM Petrifilm Enterobacteriaceae Count Plate
pH Rep 2

Category
Date of Sample Product (French Rep 1 (confirmed) Rep 1 Rep 2 Rep 1 Rep 2 Log Rep 1 Rep 2 Rep 1 Rep 2 Rep 1 Rep 2 Log

Type
Product

Dilution

Dilution
analyse number name) (confirmed)
cfu/g cfu/g
cfu/ cfu/ cfu/ cfu/ Total Gaz + Total Gaz + log log
before after cfu/g cfu/g log cfu/g log cfu/g Mean cfu/g cfu/g Mean
plate a plate b plate a plate b cfu/plate cfu/plate cfu/plate cfu/plate cfu/g cfu/g
Viande bovine hachée Beef meat for animals 1000 44 66 48 54 53000 50000 4,72 4,70 4,71 10000 5 5 9 7 45000 82000 4,65 4,91 4,78 6 a
2010 150
pour animaux 10000 5 1 6 2 100000 0 0 0 0 Ne Ne Ne Ne Ne 6 a
2010 151 Viande bovine pour Beef meat for animals 100 >150 >150 >150 >150 25000 26000 4,40 4,41 4,41 100 >150 77 >150 81 36000 31000 4,56 4,49 4,52 6 a
animaux en morceaux 1000 20 30 23 28 N' N' N' N' 1000 36 17 31 17 N' N' N' N' N' 6 a
2010 152 Viande bovine pour Beef meat for animals 100 >150 >150 >150 >150 49000 27000 4,69 4,43 4,56 100 illisible 22000 35000 4,34 4,54 4,44 6 a
animaux 1000 57 41 22 32 N' N' N' N' 1000 22 16 35 26 N' N' N' N' N' 6 a
2010 153 Abats frais pour Fresh offal for animals 1000 15 18 23 13 17000 17000 4,23 4,23 4,23 1000 41 15 20 8 38000 19000 4,58 4,28 4,43 6 a
animaux 10000 2 2 1 0 10000 1 0 1 1 6 a
2010 657 Flanchet sans os pour Beef meat for animals 1000 >150 >150 >150 >150 850000 1100000 5,93 6,04 5,99 1000 >150 >150 >150 >150 660000 840000 5,82 5,92 5,87 6 a
animaux 10000 87 82 >150 110 N' N' 10000 66 36 84 53 N' N' N' N' N' 6 a
2010 659 Cous de volaille pour Poultry neck for animals 1000 >150 >150 >150 >150 620000 520000 5,79 5,72 5,75 1000 >150 >150 >150 >150 650000 710000 5,81 5,85 5,83 6 a
animaux 10000 83 41 41 63 N' N' N' N' 10000 65 12 71 20 N' N' N' N' N' 6 a
2010 440 Brisures de riz pour Broken rice for dog 100 >150 117 >150 >150 12000 19000 4,08 4,28 4,18 100 94 0 >150 0 9500 26000 3,98 4,41 4,20 6 b
chien 1000 24 5 14 24 N' N' 1000 11 0 26 0 N' N' N' 6 b
2010 763 Saucisson pour Sausage for dog 10 4 6 6 4 50 50 1,70 1,70 1,70 10 6 6 4 4 55 45 1,74 1,65 1,70 6 b
chien 100 0 0 0 0 100 0 0 1 1 Ne Ne Ne Ne Ne 6 b
2010 765 Saucisson pour Sausage for dog 10 61 61 44 52 600 480 2,78 2,68 2,73 10 56 56 61 61 540 590 2,73 2,77 2,75 6 b
chien 100 4 6 4 5 100 3 3 4 4 6 b
2010 774 Mini filets pour chat Pâté for cat 10 56 52 49 42 510 470 2,71 2,67 2,69 10 55 55 70 70 560 680 2,75 2,83 2,79 6 b
au lapin 100 1 2 7 6 100 7 7 5 5 6 b
2017 6242 Saucisson pour Sausage for dog 6,60 6,93 100 24 2300 / 3,36 / 3,36 100 26 26 / / 2700 / 3,43 / 3,43 6 b
chien 1000 1 1000 4 4 / / 6 b
2010 154 Matières premières Raw material 1000 >150 >150 >150 >150 <10000 35000 <4,00 4,54 <4,27 1000 >150 1 >150 0 260000 340000 5,41 5,53 5,47 6 c
pour alimentation
10000 0 0 0 7 N' N' 10000 26 0 34 0 N' N' N' N' N' 6 c
animale
2010 155 Matières premières Raw material 100 54 52 23 0 5300 1100 3,72 3,04 3,38 100 59 0 89 0 6000 8800 3,78 3,94 3,86 6 c
pour alimentation
1000 4 7 1 1 1000 7 0 8 0 6 c
animale
2010 441 Matières premières Raw material 10 0 1 0 0 <5 <10 0,70* <1,00 <0,85 10 1 1 4 4 10 40 1,00 1,60 1,30* 6 c
pour alimentation
100 0 0 0 0 100 0 0 0 0 Ne Ne 6 c
animale
2010 661 Matières premières Raw material 10 7 13 14 12 95 140 1,98 2,15 2,06 10 17 15 14 12 160 140 2,20 2,15 2,18 6 c
pour alimentation
100 1 0 3 2 100 0 0 1 1 6 c
animale
2010 662 Matières premières Raw material 1000 134 140 >150 143 130000 140000 5,11 5,15 5,13 1000 111 0 132 0 120000 121000 5,08 5,08 5,08 6 c
pour alimentation
10000 10 11 15 10 10000 16 0 1 1 6 c
animale
2017 6163 Protéines Poultry proteins 6,76 / 10 0 <10 / <1,00 / <1,00 10 0 0 / / <10 / <1,00 / <1,00 6 c
déshydratées de dehydrated
100 0 100 0 0 / / 6 c
volaille
2017 6164 Protéines Poultry proteins 6,76 / 10 0 <10 / <1,00 / <1,00 10 0 0 / / <10 / <1,00 / <1,00 6 c
déshydratées de dehydrated
100 0 100 0 0 / / 6 c
volaille
2017 6907 Protéines Dehydrated poultry 6,71 / 100 >150 62000 / 4,79 / 4,79 100 >150 >150 73000 / 4,86 / 4,86 6 c
déshydratées de proteins
1000 62 N' N' 1000 73 73 N' N' 6 c
volaille
2017 6908 Protéines Dehydrated poultry 6,83 / 1000 >150 800000 / 5,90 / 5,90 1000 >150 >150 950000 / 5,98 / 5,98 6 c
déshydratées de proteins
10000 80 N' N' 10000 95 95 N' N' 6 c
volaille


Analyses performed according to the COFRAC accreditation
ADRIA Développement 37/52 February 2, 2018
Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

ENVIRONMENTAL SAMPLES
Reference method: ISO 21528-2 Alternative method : 3MTM Petrifilm Enterobacteriaceae Count Plate
pH Rep 2

Category
Date of Sample Product (French Rep 1 (confirmed) Rep 1 Rep 2 Rep 1 Rep 2 Log Rep 1 Rep 2 Rep 1 Rep 2 Rep 1 Rep 2 Log

Type
Product

Dilution

Dilution
analyse number name) (confirmed)
cfu/g cfu/g
cfu/ cfu/ cfu/ cfu/ Total Gaz + Total Gaz + log log
before after cfu/g cfu/g log cfu/g log cfu/g Mean cfu/g cfu/g Mean
plate a plate b plate a plate b cfu/plate cfu/plate cfu/plate cfu/plate cfu/g cfu/g
2015 3844 Chiffonnette Wipe (peas industry) 7,00 / 10 2 / 2 / 20 20 1,30* 1,30* 1,30* 10 13 / 14 / 130 150 2,11 2,18 2,15 7 a
Microcut petits pois 100 0 / 0 / 100 1 / 2 / 7 a
2015 3903 Chiffonnette balance Wipe (rice industry) 7,20 / 10 6 / 13 / 60 120 1,78 2,08 1,93 10 56 / 47 / 600 500 2,78 2,70 2,74 7 a
après désinfection
100 0 / 0 / Ne 100 10 / 8 / 7 a
cuisson riz
2015 3904 Chiffonnette plan de Wipe (pastry industry) 7,16 / 100 1 / 1 / 100 100 2,00* 2,00* 2,00* 100 31 / 40 / 2900 4000 3,46 3,60 3,53 7 a
travail fabrication
madeleine après 1000 0 / 0 / 1000 1 / 4 / 7 a
désinfection
2015 3905 Chiffonnette table de Wipe (bechamel 7,00 / 100 0 / 0 / <100 <100 <2,00 <2,00 <2,00 100 21 / 12 / 2000 1100 3,30 3,04 3,17 7 a
cuisson béchamel sauce) 1000 0 / 0 / 1000 1 / 0 / 7 a
2015 3906 Chiffonnette table Wipe (cheese 6,97 / 10 0 / 1 / <10 10 <1,00 1,00* <1,00 10 1 / 0 / 10 <10 1,00* <1,00 <1,00 7 a
découpe emmenthal industry) 100 0 / 0 / 100 0 / 0 / Detection 7 a
2015 4011 Ecouvillon tapis Swab after cleaning 7,08 / 10 0 / 0 / <10 <10 <1,00 <1,00 <1,00 10 0 / 0 / <10 <10 <1,00 <1,00 <1,00 7 a
entrée peleuse après (fish industry)
100 0 / 0 / 100 0 / 0 / 7 a
désinfection
2015 4012 Ecouvillon tapis Swab after cleaning 7,06 / 10 0 / 0 / <10 <10 <1,00 <1,00 <1,00 10 0 / 0 / <10 <10 <1,00 <1,00 <1,00 7 a
diviseur après (fish industry)
100 0 / 0 / 100 0 / 0 / 7 a
désinfection
2015 4013 Lingette tapis parage Wipe after cleaning(fish 7,19 / 10 >150 / >150 / >15000 12000 >4,18 4,08 >4,13 10 >100 / >100 / >10000 >10000 >4,00 >4,00 >4,00 7 a
après désinfection industry) 100 >150 / 124 / 100 >100 / >100 / 7 a
2015 4014 Lingette maille sortie Wipe after cleaning(fish 7,19 / 10 >150 / >150 / 3800 4800 3,58 3,68 3,63 10 >100 / >100 / 4800 4800 3,68 3,68 3,68 7 a
parage après industry)
100 38 / 48 / 100 48 / 48 / 7 a
désinfection
2015 4015 Lingette tapis parage Wipe after cleaning(fish 7,18 / 10 0 / 0 / <10 <10 <1,00 <1,00 <1,00 10 0 / 0 / <10 <10 <1,00 <1,00 <1,00 7 a
après désinfection industry) 100 0 / 0 / 100 0 / 0 / 7 a
2015 4494 Chiffonnette local Wipe (dishwasher) 7,01 / 10 >1500 / >1500 / >15000 >15000 >4,18 >4,18 >4,18 10 >1000 / >1000 / >10000 >10000 >4,00 >4,00 >4,00 7 a
vaisselle atelier 100 >15000 / >15000 / 100 >10000 / >10000 / 7 a
2015 4495 Chiffonnette table Wipe (table) 6,97 / 10 >1500 / >1500 / >15000 >15000 >4,18 >4,18 >4,18 10 >1000 / >1000 / >10000 >10000 >4,00 >4,00 >4,00 7 a
atelier 100 >15000 / >15000 / 100 >10000 / >10000 / 7 a
2015 4496 Chiffonnette cutter Wipe (cutter) 7,00 / 10 >1500 / >1500 / >15000 >15000 >4,18 >4,18 >4,18 10 >1000 / >1000 / >10000 >10000 >4,00 >4,00 >4,00 7 a
100 >15000 / >15000 / 100 >10000 / >10000 / 7 a
2015 4497 Chiffonnette Wipe (push-button) 7,03 / 100 >15000 / >15000 / >150000 >150000 >5,18 >5,18 >5,18 100 >10000 / >10000 / >100000 >100000 >5,00 >5,00 >5,00 7 a
poussoir >10000
1000 >150000 / >150000 / 1000 >100000 / / 7 a
0
2015 4562 Chiffonnette table Wipe 6,92 / 10 11 / 8 / 120 80 2,08 1,90 1,99 10 29 / 24 / 270 250 2,43 2,40 2,41 7 a
préparation pâte 100 2 / 1 / Ne 100 1 / 3 / 7 a
2015 4563 Chiffonnette cuve Wipe after cleaning 7,05 / 10 71 / 61 / 670 610 2,83 2,79 2,81 10 123 / 132 / 1200 1300 3,08 3,11 3,10 7 a
broyeur après
100 3 / 6 / 100 13 / 15 / 7 a
nettoyage
2015 4564 Chiffonnette grille Wipe after cleaning 6,94 / 10 36 / 29 / 330 270 2,52 2,43 2,47 10 15 / 23 / 140 220 2,15 2,34 2,24 7 a
four fumage après
100 0 / 1 / 100 0 / 1 / 7 a
nettoyage
2015 4565 Chiffonnette table Wipe after cleaning 6,91 / 10 22 / 26 / 220 240 2,34 2,38 2,36 10 46 / 46 / 460 440 2,66 2,64 2,65 7 a
découpe après
100 2 / 0 / 100 5 / 2 / 7 a
nettoyage
2015 3841 Eau de rinçage n°2 Process water (peas) 7,01 / 10 0 / 0 / <10 <10 <1,00 <1,00 <1,00 10 0 / 0 / <10 <10 <1,00 <1,00 <1,00 7 b
petits pois après
100 0 / 0 / 100 0 / 0 / 7 b
cuisson
2015 3845 Eau de cuisson Process water (peas) 7,00 / 10 0 / 0 / <10 <10 <1,00 <1,00 <1,00 10 8 / 13 / 80 130 1,90 2,11 2,01 7 b
petits pois 100 0 / 0 / 100 0 / 1 / Ne 7 b
2015 3907 Eau de rinçage Process water (milk 6,98 / 100 0 / 0 / <100 <100 <2,00 <2,00 <2,00 100 1 / 0 / 100 <100 2,00* <2,00 <2,00 7 b
bécher (PDL+eau) industry) 1000 0 / 0 / 1000 0 / 0 / 7 b


Analyses performed according to the COFRAC accreditation
ADRIA Développement 38/52 February 2, 2018
Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

ENVIRONMENTAL SAMPLES
Reference method: ISO 21528-2 Alternative method : 3MTM Petrifilm Enterobacteriaceae Count Plate
pH Rep 2

Category
Date of Sample Product (French Rep 1 (confirmed) Rep 1 Rep 2 Rep 1 Rep 2 Log Rep 1 Rep 2 Rep 1 Rep 2 Rep 1 Rep 2 Log

Type
Product

Dilution

Dilution
analyse number name) (confirmed)
cfu/g cfu/g
cfu/ cfu/ cfu/ cfu/ Total Gaz + Total Gaz + log log
before after cfu/g cfu/g log cfu/g log cfu/g Mean cfu/g cfu/g Mean
plate a plate b plate a plate b cfu/plate cfu/plate cfu/plate cfu/plate cfu/g cfu/g
2015 4006 Eau dessalage Process water (fish 6,95 / 10 25 / 11 / 230 100 2,36 2,00 2,18 10 20 / 22 / 180 200 2,26 2,30 2,28 7 b
industry) 100 0 / 0 / 100 0 / 0 / 7 b
2015 4007 Eau peleuse Process water (fish 7,20 / 1 0 / 0 / <1 <1 <0,00 <0,00 <0,00 1 0 / 0 / <1 <1 <0,00 <0,00 <0,00 7 b
industry) 10 0 / 0 / 10 0 / 0 / 7 b
2015 4008 Eau pareuse Process water (fish 7,14 / 10 >150 / >150 / 5500 11000 3,74 4,04 3,89 10 >100 / >100 / 3500 3300 3,54 3,52 3,53 7 b
industry) 100 55 / 106 / 100 35 / 33 / 7 b
2015 4009 Eau laveuse poissons Process water (fish 7,12 / 10 >150 / >150 / <2,00 <2,00 <2,00 <2,00 <2,00 10 >100 / >100 / 3200 5600 3,51 3,75 3,63 7 b
industry) 100 57 / 37 / 100 32 / 56 / 7 b
2015 4010 Eau épineuse Process water (fish 7,20 / 10 >150 / >150 / 2800 1300 3,45 3,11 3,28 10 78 / 98 / 860 1000 2,93 3,00 2,97 7 b
industry) 100 28 / 13 / 100 17 / 14 / 7 b
2017 6243 Eau de rinçage Rinsed water (Pork 7,01 / 10 35 340 / 2,53 / 2,53 10 38 38 / / 360 / 2,56 / 2,56 7 b
(industrie porc) industry) 100 2 100 1 1 / / 7 b
2017 6244 Eau de lavage Wash water (pork 7,03 / 1000 33 32000 / 4,51 / 4,51 1000 67 67 / / 64000 / 4,81 / 4,81 7 b
sciage viande (porc industry)
10000 2 10000 3 3 / / 7 b
industrie)
2015 3676 Poussières industrie Dusts from egg industry 6,76 / 10 0 / 0 / <10 <10 <1,00 <1,00 <1,00 10 0 / 0 / <10 <10 <1,00 <1,00 <1,00 7 c
ovoproduits 100 0 / 0 / 100 0 / 0 / 7 c
2015 3677 Poussières Dusts 6,93 / 10 0 / 0 / <10 <10 <1,00 <1,00 <1,00 10 0 / 0 / <10 <10 <1,00 <1,00 <1,00 7 c
d'aspirateur (atelier) 100 0 / 0 / 100 0 / 0 / 7 c
2015 3678 Poussières industrie Dusts from dairy 6,36 / 10 5 / 4 / 50 40 1,70 1,60 1,65 10 11 / 13 / 110 130 2,04 2,11 2,08 7 c
laitière industry 100 0 / 0 / Ne Ne 100 1 / 1 / 7 c
2015 3679 Poussières industrie Dusts from dairy 6,48 / 100 32 / 26 / 3500 3700 3,54 3,57 3,56 1000 9 / 9 / 9000 9000 3,95 3,95 3,95 7 c
laitière industry 1000 6 / 4 / 10000 1 / 1 / Ne Ne 7 c
2017 6165 Déchets au sol Dusts n°1 (pork 7,17 / 10 9 90 / 1,95 / 1,95 10 17 12 / / 160 / 2,20 / 2,20 7 c
découpe porc n°1 industry) 100 1 Ne 100 0 0 / / 7 c
2017 6166 Déchets au sol Dusts n°2 (pork 7,14 / 1000 21 19000 / 4,28 / 4,28 1000 24 0 / / 25000 / 4,40 / 4,40 7 c
découpe porc n°2 industry) 10000 0 10000 4 0 / / 7 c
2017 6167 Déchets au sol Dusts n°3 (pork 7,16 / 10 35 330 / 2,52 / 2,52 10 36 0 / / 340 / 2,53 / 2,53 7 c
découpe porc n°3 industry) 100 1 100 1 1 / / 7 c

ADRIA Développement 39/52 February 2, 2018

Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

Appendix 5 - Relative trueness study: summarized results and calculations

Incubation : 48h
Log cfu/g Alternative method
<or> Average Difference Average Difference
Category Type N°sample
Reference Alternative Mean Difference <4 threshold <4 <4 corrected Corrected
method method CFU/plate corrected CFU/plate CFU/plate values values
values
1 a 11 3,99 3,99 3,99 -0,01 #N/A #N/A
a 206 4,19 4,58 4,39 0,39 #N/A #N/A
a 207 2,45 2,93 2,69 0,48 #N/A #N/A
a 210 2,30 3,23 2,76 0,93 #N/A #N/A
a 211 4,61 5,12 4,86 0,51 #N/A #N/A
a 68 2,90 3,30 3,10 0,40 #N/A #N/A
a 113 4,85 4,96 4,90 0,11 #N/A #N/A
b 50 4,72 4,96 4,84 0,24 #N/A #N/A
b 116 3,89 3,92 3,90 0,04 #N/A #N/A
b 208 3,45 3,53 3,49 0,08 #N/A #N/A
b 212 2,39 3,34 2,86 0,95 #N/A #N/A
b 4 1,30 1,48 1,39 0,18 #N/A #N/A
b 70 1,15 1,15 1,15 0,00 #N/A #N/A
b 101 4,49 4,25 4,37 -0,25 #N/A #N/A
c 17 5,82 5,88 5,85 0,06 #N/A #N/A
c 19 3,62 3,97 3,80 0,35 #N/A #N/A
c 20 4,35 4,54 4,44 0,19 #N/A #N/A
c 23 2,39 2,68 2,54 0,29 #N/A #N/A
c 25 2,04 2,54 2,29 0,50 #N/A #N/A
c 48 3,16 3,30 3,23 0,15 #N/A #N/A
c 90 1,78 1,95 1,86 0,18 #N/A #N/A
c 91 4,67 4,62 4,65 -0,05 #N/A #N/A
c 92 1,15 1,39 1,27 0,24 #N/A #N/A
c 121 5,66 5,71 5,68 0,04 #N/A #N/A
c 125 1,54 2,46 2,00 0,92 #N/A #N/A
c 126 3,95 4,08 4,02 0,13 #N/A #N/A
c 129 1,00 1,97 1,49 0,97 #N/A #N/A
c 130 2,77 3,50 3,13 0,73 #N/A #N/A
c 205 3,34 3,62 3,48 0,28 #N/A #N/A
Average category 1 0,31
Standard deviation of differences category 1 0,32
2 a 38 2,80 2,98 2,89 0,19 #N/A #N/A
a 106b 6,18 7,29 6,73 1,12 #N/A #N/A
a 107b 7,35 7,55 7,45 0,20 #N/A #N/A
a 119 3,71 4,89 4,30 1,18 #N/A #N/A
a 6159 4,15 4,04 4,09 -0,10 #N/A #N/A
b 9 3,09 3,47 3,28 0,38 #N/A #N/A
b 10 4,23 4,82 4,52 0,58 #N/A #N/A
b 42 6,57 6,74 6,65 0,16 #N/A #N/A
b 75 2,97 3,00 2,98 0,03 #N/A #N/A
b 85 3,07 3,38 3,22 0,31 #N/A #N/A
b 86 7,19 7,26 7,22 0,07 #N/A #N/A
b 110 3,42 4,10 3,76 0,69 #N/A #N/A
b 111 5,41 5,77 5,59 0,36 #N/A #N/A
b 120 4,33 4,27 4,30 -0,06 #N/A #N/A
b 128 2,03 2,79 2,41 0,76 #N/A #N/A
b 131 2,85 3,24 3,04 0,39 #N/A #N/A
b 132 5,55 5,86 5,70 0,31 #N/A #N/A
b 201 7,77 7,85 7,81 0,08 #N/A #N/A
b 202 7,47 7,37 7,42 -0,11 #N/A #N/A
b 203 7,16 7,25 7,20 0,09 #N/A #N/A
b 204 6,10 6,34 6,22 0,24 #N/A #N/A
c 140 1,15 1,63 1,39 0,48 #N/A #N/A
c 141 1,24 1,50 1,37 0,26 #N/A #N/A
c 142 1,54 1,76 1,65 0,22 #N/A #N/A
c 6226 2,15 2,32 2,23 0,18 #N/A #N/A
c 6227 4,32 4,79 4,55 0,46 #N/A #N/A
Average category 2 0,32
Standard deviation of differences category 2 0,33
3 a 124 1,55 2,70 2,12 1,16 #N/A #N/A
a 163 2,89 3,00 2,94 0,12 #N/A #N/A
a 6160 1,00 #N/A 3,69 #N/A 2,35 2,69
a 6161 2,00 #N/A 4,18 #N/A 3,09 2,18
a 6162 2,88 2,81 2,84 -0,07 #N/A #N/A
a 6884 0,00 #N/A 0,00 #N/A 0,00 0,00
a 6885 0,00 #N/A 0,00 #N/A 0,00 0,00
a 6909 2,56 2,81 2,68 0,25 #N/A #N/A
a 6910 3,73 3,92 3,83 0,19 #N/A #N/A
a 6911 4,88 5,00 4,94 0,12 #N/A #N/A
b 88 1,65 1,74 1,70 0,09 #N/A #N/A
b 36 1,30 1,72 1,51 0,42 #N/A #N/A
b 6228 3,40 3,54 3,47 0,15 #N/A #N/A
b 6229 4,00 4,40 4,20 0,40 #N/A #N/A
b 6230 5,04 4,96 5,00 -0,08 #N/A #N/A
c 60 4,48 4,39 4,43 -0,09 #N/A #N/A
c 62 1,15 1,24 1,20 0,09 #N/A #N/A
c 67 2,72 2,65 2,68 -0,07 #N/A #N/A
c 73 3,45 3,55 3,50 0,09 #N/A #N/A
c 105b 5,13 5,34 5,23 0,21 #N/A #N/A
c 144 5,36 4,51 4,93 -0,85 #N/A #N/A
Average category 3 0,12
Standard deviation of differences category 3 0,38

ADRIA Développement 40/52 February 2, 2018

Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

Incubation : 48h
Log cfu/g Alternative method
<or> Average Difference Average Difference
Category Type N°sample
Reference Alternative Mean Difference <4 threshold <4 <4 corrected Corrected
method method CFU/plate corrected CFU/plate CFU/plate values values
values
4 a 39 1,57 1,85 1,71 0,28 #N/A #N/A
a 81 2,18 2,54 2,36 0,36 #N/A #N/A
a 154 1,69 1,70 1,70 0,01 #N/A #N/A
a 155 1,88 1,65 1,76 -0,23 #N/A #N/A
a 156 2,56 3,08 2,82 0,52 #N/A #N/A
a 159 3,18 3,55 3,36 0,37 #N/A #N/A
a 160 1,98 2,38 2,18 0,40 #N/A #N/A
a 161 2,43 2,88 2,66 0,45 #N/A #N/A
a 162 1,84 2,06 1,95 0,22 #N/A #N/A
b 82 3,06 2,73 2,89 -0,34 #N/A #N/A
b 102 3,64 3,77 3,70 0,13 #N/A #N/A
b 6231 2,43 2,40 2,41 -0,03 #N/A #N/A
b 6232 2,64 2,56 2,60 -0,09 #N/A #N/A
b 6233 2,20 2,23 2,22 0,03 #N/A #N/A
c 35 4,17 4,76 4,47 0,59 #N/A #N/A
c 6234 3,78 3,81 3,80 0,03 #N/A #N/A
c 6235 2,36 2,32 2,34 -0,04 #N/A #N/A
c 6236 2,81 2,87 2,84 0,06 #N/A #N/A
c 6237 3,96 3,99 3,98 0,02 #N/A #N/A
Average category 4 0,14
Standard deviation of differences category 4 0,25
5 a 54 3,33 3,17 3,25 -0,16 #N/A #N/A
a 64 3,68 3,78 3,73 0,10 #N/A #N/A
a 117 2,00 2,78 2,39 0,78 #N/A #N/A
a 6238 2,75 2,83 2,79 0,08 #N/A #N/A
a 6239 3,70 3,79 3,74 0,09 #N/A #N/A
b 122 2,24 3,66 2,95 1,42 #N/A #N/A
b 78 1,63 2,25 1,94 0,62 #N/A #N/A
b 118 4,41 4,57 4,49 0,15 #N/A #N/A
b 6240 4,00 4,04 4,02 0,04 #N/A #N/A
b 6241 4,36 4,41 4,39 0,05 #N/A #N/A
c 29 1,15 1,90 1,52 0,75 #N/A #N/A
c 56 2,89 2,85 2,87 -0,05 #N/A #N/A
c 58 2,79 2,35 2,57 -0,44 #N/A #N/A
c 84 1,74 1,99 1,86 0,25 #N/A #N/A
c 104 3,18 3,78 3,48 0,60 #N/A #N/A
c 112 4,51 4,47 4,49 -0,04 #N/A #N/A
Average category 5 0,26
Standard deviation of differences category 5 0,46
6 a 150 4,71 4,78 4,75 0,07 #N/A #N/A
a 151 4,41 4,52 4,47 0,12 #N/A #N/A
a 152 4,56 4,44 4,50 -0,12 #N/A #N/A
a 153 4,23 4,43 4,33 0,20 #N/A #N/A
a 657 5,99 5,87 5,93 -0,11 #N/A #N/A
a 659 5,75 5,83 5,79 0,08 #N/A #N/A
b 440 4,18 4,20 4,19 0,02 #N/A #N/A
b 763 1,70 1,70 1,70 0,00 #N/A #N/A
b 765 2,73 2,75 2,74 0,02 #N/A #N/A
b 774 2,69 2,79 2,74 0,10 #N/A #N/A
b 6242 3,36 3,43 3,40 0,07 #N/A #N/A
c 154 3,27 #N/A 5,47 #N/A 4,37 2,20
c 155 3,38 3,86 3,62 0,48 #N/A #N/A
c 441 0,00 #N/A 1,30 #N/A 0,65 1,30
c 661 2,06 2,18 2,12 0,11 #N/A #N/A
c 662 5,13 5,08 5,11 -0,05 #N/A #N/A
c 6163 0,00 #N/A 0,00 #N/A 0,00 0,00
c 6164 0,00 #N/A 0,00 #N/A 0,00 0,00
c 6907 4,79 4,86 4,83 0,07 #N/A #N/A
c 6908 5,90 5,98 5,94 0,07 #N/A #N/A
Average category 6 0,07
Standard deviation of differences category 6 0,14

ADRIA Développement 41/52 February 2, 2018

Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

Incubation : 48h
Log cfu/g Alternative method
<or> Average Difference Average Difference
Category Type N°sample
Reference Alternative Mean Difference <4 threshold <4 <4 corrected Corrected
method method CFU/plate corrected CFU/plate CFU/plate values values
values
7 a 3844 1,30 #N/A 2,15 1,72 0,85 #N/A
a 3903 1,93 2,74 2,33 0,81 #N/A #N/A
a 3904 2,00 #N/A 3,53 3,07 1,53 #N/A
a 3905 1,00 #N/A 3,17 #N/A 2,09 2,17
a 3906 0,00 #N/A 0,00 #N/A 0,00 0,00
a 4011 0,00 #N/A 0,00 #N/A 0,00 0,00
a 4012 0,00 #N/A 0,00 #N/A 0,00 0,00
a 4013 5,13 #N/A 5,13 #N/A 5,13 0,00
a 4014 3,63 3,68 3,66 0,05 #N/A #N/A
a 4015 0,00 #N/A 0,00 #N/A 0,00 0,00
a 4494 5,18 #N/A 5,00 #N/A 5,09 -0,18
a 4495 5,18 #N/A 5,00 #N/A 5,09 -0,18
a 4496 5,18 #N/A 5,00 #N/A 5,09 -0,18
a 4497 5,18 #N/A 5,00 #N/A 5,09 -0,18
a 4562 1,99 2,41 2,20 0,42 #N/A #N/A
a 4563 2,81 3,10 2,95 0,29 #N/A #N/A
a 4564 2,47 2,24 2,36 -0,23 #N/A #N/A
a 4565 2,36 2,65 2,51 0,29 #N/A #N/A
b 3841 0,00 #N/A 0,00 #N/A 0,00 0,00
b 3845 0,00 #N/A 2,01 #N/A 1,00 2,01
b 3907 1,00 #N/A 1,00 #N/A 1,00 0,00
b 4006 2,18 2,28 2,23 0,10 #N/A #N/A
b 4007 0,00 #N/A 0,00 #N/A 0,00 0,00
b 4008 3,89 3,53 3,71 -0,36 #N/A #N/A
b 4009 1,00 #N/A 3,63 #N/A 2,31 2,63
b 4010 3,28 2,97 3,12 -0,31 #N/A #N/A
b 6243 2,53 2,56 2,54 0,02 #N/A #N/A
b 6244 4,51 4,81 4,66 0,30 #N/A #N/A
c 3676 0,00 #N/A 0,00 #N/A 0,00 0,00
c 3677 0,00 #N/A 0,00 #N/A 0,00 0,00
c 3678 1,65 2,08 1,86 0,43 #N/A #N/A
c 3679 3,56 3,95 3,76 0,40 #N/A #N/A
c 6165 1,95 2,20 2,08 0,25 #N/A #N/A
c 6166 4,28 4,40 4,34 0,12 #N/A #N/A
c 6167 2,52 2,53 2,52 0,01 #N/A #N/A
Average category 7 0,16
Standard deviation of differences category 7 0,30
Average all categories Dall 0,22
Standard deviation of differences all categories SDAll 0,33

n all 139
β=95% T(0,05;70)= 1,977303512
0,657832398 Upper limit Lower limit Linear
Average (minimal value) 0,00 0,88 -0,44 0,22
Average (maximale value) 10,00 0,88 -0,44 0,22

ADRIA Développement 42/52 February 2, 2018

Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

Appendix 6 - Accuracy profile study: raw data

Alternative method:
Reference method : 3MTM Petrifilm Enterobacteriaceae Count Plate
Matrix Strain Level N°sample ISO 21528-2
24h ± 2h at 37°C ± 1°C
Dilution cfu/plate cfu/g log cfu/g Dilution cfu/Petrifilm test cfu/g) log cfu/g
6862 10 14 140 2,15 10 24 240 2,38
100 1 100 2
6863 10 16 160 2,20 10 22 230 2,36
100 2 100 3
1 6864 10 15 140 2,15 10 27 280 2,45
100 0 100 4
6865 10 16 170 2,23 10 30 320 2,51
100 3 100 5
6866 10 24 260 2,41 10 25 240 2,38
Aerobic mesophilic flora: 20 CFU/g

100 4 100 1
4818 100 136 14000 4,15 100 135 13000 4,11
1000 16 1000 12
4819 100 111 11000 4,04 100 153 15000 4,18
1000 13 1000 12
Pork pâté
Batch 1

4820 100 140 14000 4,15 100 150 15000 4,18

2 1000 11 1000 18
4821 100 133 14000 4,15 100 165 16000 4,20
1000 17 1000 15
4822 100 112 12000 4,08 100 105 11000 4,04
1000 15 1000 11
4828 1000 27 26000 4,41 1000 26 25000 4,40
10000 2 10000 1
4829 1000 26 25000 4,40 1000 28 27000 4,43
10000 2 10000 2
4830 1000 19 18000 4,26 1000 20 20000 4,30
3
Enterobacter agglomerans 135

10000 1 10000 2
4831 1000 24 24000 4,38 1000 32 31000 4,49
10000 2 10000 2
4832 1000 22 23000 4,36 1000 22 22000 4,34
10000 3 10000 2
6867 10 20 190 2,28 10 25 250 2,40
100 1 100 2
6868 10 33 340 2,53 10 26 250 2,40
100 4 100 1
1 6869 10 20 200 2,30 10 31 300 2,48
100 2 100 2
6870 10 29 290 2,46 10 30 290 2,46
100 3 100 2
6871 10 21 240 2,38 10 16 160 2,20
100 5 100 2
Aerobic mesophilic flora: 0 CFU/g

4843 1000 18 18000 4,26 100 178 18000 4,26

10000 2 1000 16
4844 1000 13 15000 4,18 100 169 17000 4,23
10000 3 1000 18
Pork pâté
Batch 2

4845 1000 16 15000 4,18 100 159 15000 4,18

2 10000 1 1000 11
4846 1000 17 17000 4,23 100 178 17000 4,23
10000 2 1000 12
4847 1000 16 16000 4,20 100 143 15000 4,18
10000 2 1000 17
4853 1000 28 29000 4,46 1000 31 33000 4,52
10000 4 10000 5
4854 1000 24 24000 4,38 1000 30 29000 4,46
10000 2 10000 2
4855 1000 25 25000 4,40 1000 27 26000 4,41
3
10000 2 10000 2
4856 1000 26 25000 4,40 1000 29 32000 4,51
10000 2 10000 6
4857 1000 24 23000 4,36 1000 30 28000 4,45
10000 1 10000 1


Analyses performed according to the COFRAC accreditation
ADRIA Développement 43/52 February 2, 2018
Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

Reference method : Alternative method:

ISO 21528-2 3MTM Petrifilm Enterobacteriaceae Count Plate
Matrix Strai Leve N°sampl
n l e 24h ± 2h at 37°C ± 1°C
Dilutio cfu/plat cfu/g log Dilutio cfu/Petrifilm cfu/g log
n e cfu/g n test cfu/g
5403 10 24 240 2,38 10 28 260 2,41
100 2 100 1
5404 10 23 220 2,34 10 24 220 2,34
100 1 100 0
5405 10 34 340 2,53 10 25 270 2,43
1 100 3 100 5
5406 10 31 310 2,49 10 34 310 2,49
100 3 100 0
5407 10 27 280 2,45 10 33 320 2,51
100 4 100 2
Aerobic mesophilic flora: 0 CFU/g

5408 100 53 5200 3,72 100 43 4500 3,65

1000 4 1000 6
5409 100 48 4700 3,67 100 49 4900 3,69
Pasteurized milk

1000 4 1000 5
5410 100 41 3700 3,57 100 46 4400 3,64
Batch 1

2
1000 0 1000 2
5411 100 46 4700 3,67 100 45 4500 3,65
1000 6 1000 4
5412 100 34 3400 3,53 100 36 3600 3,56
1000 3 1000 4
10000
5413 1000 104 0 5,00 1000 90 93000 4,97
10000 6 10000 12
5414 1000 88 85000 4,93 1000 87 86000 4,93
10000 6 10000 8
3 5415 1000 85 83000 4,92 1000 96 91000 4,96
10000 6 10000 4
5416 1000 88 87000 4,94 1000 81 83000 4,92
Hafnia alvei 130

10000 8 10000 10
5417 1000 81 77000 4,89 1000 94 95000 4,98
10000 4 10000 10
5418 10 32 310 2,49 10 28 270 2,43
100 2 100 2
5419 10 28 280 2,45 10 38 360 2,56
100 3 100 1
5420 10 24 240 2,38 10 21 210 2,32
1
100 2 100 2
5421 10 17 170 2,23 10 27 250 2,40
100 2 100 0
5422 10 22 250 2,40 10 22 210 2,32
Aerobic mesophilic flora: 10 CFU/g

100 5 100 1
5423 100 52 5100 3,71 100 46 4300 3,63
1000 4 1000 1
Pasteurized milk

5424 100 43 4200 3,62 100 63 6300 3,80

1000 3 1000 6
Batch 2

2 5425 100 39 3900 3,59 100 50 4900 3,69

1000 4 1000 4
5426 100 41 4000 3,60 100 41 3900 3,59
1000 3 1000 2
5427 100 51 5000 3,70 100 55 5200 3,72
1000 4 1000 2
5428 1000 84 82000 4,91 1000 85 85000 4,93
10000 6 10000 9
5429 1000 86 85000 4,93 1000 95 98000 4,99
10000 7 10000 13
5430 1000 91 87000 4,94 1000 89 92000 4,96
3 10000 5 10000 12
5431 1000 93 97000 4,99 1000 87 88000 4,94
10000 14 10000 10
5432 1000 83 84000 4,92 1000 85 87000 4,94
10000 9 10000 11


Analyses performed according to the COFRAC accreditation
ADRIA Développement 44/52 February 2, 2018
Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

Alternative method:
Reference method : 3MTM Petrifilm Enterobacteriaceae Count Plate
Matrix Strain Level N°sample ISO 21528-2
24h ± 2h at 37°C ± 1°C
Dilution cfu/plate cfu/g log cfu/g Dilution cfu/Petrifilm test cfu/g log cfu/g
5626 10 39 390 2,59 10 22 240 2,38
100 4 100 4
5627 10 42 430 2,63 10 38 360 2,56
100 5 100 2
1 5628 10 32 360 2,56 10 26 310 2,49
100 8 100 8
5629 10 42 400 2,60 10 32 290 2,46
100 2 100 0
5630 10 30 300 2,48 10 19 210 2,32
Aerobic mesophilic flora: 20 CFU/g

100 3 100 4
5631 100 39 4000 3,60 100 35 3500 3,54
1000 5 1000 3
Frozen salmon fillet

5632 100 60 5600 3,75 100 48 4500 3,65

1000 2 1000 1
Batch 1

5633 100 64 6300 3,80 100 53 5200 3,72

2 1000 5 1000 4
5634 100 45 4500 3,65 100 48 4700 3,67
1000 5 1000 4
5635 100 49 4800 3,68 100 52 4800 3,68
1000 4 1000 1
5636 1000 88 83000 4,92 1000 98 100000 5,00
10000 3 10000 12
5637 1000 110 110000 5,04 1000 104 97000 4,99
10000 11 10000 3
5638 1000 116 110000 5,04 1000 120 120000 5,08
3
10000 8 10000 10
5639 1000 89 91000 4,96 1000 114 110000 5,04
Klebsiella oxytoca 179

10000 11 10000 10
5640 1000 110 110000 5,04 1000 92 93000 4,97
10000 8 10000 10
5824 10 53 520 2,72 10 45 460 2,66
100 4 100 5
5825 10 37 360 2,56 10 37 380 2,58
100 2 100 5
1 5826 10 50 520 2,72 10 51 490 2,69
100 7 100 3
5827 10 45 430 2,63 10 42 410 2,61
100 2 100 3
5828 10 50 520 2,72 10 57 580 2,76
Aerobic mesophilic flora: 50 CFU/g

100 7 100 7
5829 100 40 3700 3,57 100 54 5500 3,74
1000 1 1000 7
Frozen salmon fillet

5830 100 51 4800 3,68 100 49 4800 3,68

1000 2 1000 4
Batch 2

5831 100 50 4900 3,69 100 46 4700 3,67

2 1000 4 1000 6
5832 100 52 5000 3,70 100 55 5300 3,72
1000 3 1000 3
5833 100 54 5100 3,71 100 53 4800 3,68
1000 2 1000 0
5834 1000 100 98000 4,99 1000 92 92000 4,96
10000 8 10000 9
5835 1000 107 100000 5,00 1000 99 100000 5,00
10000 8 10000 12
5836 1000 112 110000 5,04 1000 111 110000 5,04
3
10000 10 10000 12
5837 1000 93 93000 4,97 1000 113 110000 5,04
10000 9 10000 6
5838 1000 93 92000 4,96 1000 89 90000 4,95
10000 8 10000 10


Analyses performed according to the COFRAC accreditation
ADRIA Développement 45/52 February 2, 2018
Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

Alternative method:
Reference method : 3MTM Petrifilm Enterobacteriaceae Count Plate
Matrix Strain Level N°sample ISO 21528-2
24h ± 2h at 37°C ± 1°C
Dilution cfu/plate cfu/g log cfu/g Dilution cfu/Petrifilm test cfu/g log cfu/g
4544 10 25 250 2,40 10 35 330 2,52
100 2 100 1
4545 10 26 250 2,40 10 25 240 2,38
100 1 100 1
4546 10 25 230 2,36 10 34 310 2,49
1
100 0 100 0
4547 10 24 250 2,40 10 28 270 2,43
100 3 100 2
4548 10 25 240 2,38 10 29 280 2,45
Aerobic mesophilic flora: <10 CFU/g

100 1 100 2
4549 100 25 2600 3,41 100 41 4200 3,62
1000 4 1000 5
4550 100 37 3600 3,56 100 52 5200 3,72
Grean beans

1000 3 1000 5
Batch 1

4551 100 39 3800 3,58 100 45 4300 3,63

2
1000 3 1000 2
4552 100 32 3300 3,52 100 47 4500 3,65
1000 4 1000 3
4553 100 44 4300 3,63 100 48 4600 3,66
1000 3 1000 3
4554 1000 64 60000 4,78 1000 80 74000 4,87
10000 2 10000 1
4555 1000 71 71000 4,85 1000 88 85000 4,93
10000 7 10000 5
4556 1000 79 79000 4,90 1000 89 83000 4,92
3
Escherichia hermanii Ad1457

10000 8 10000 2
4557 1000 68 69000 4,84 1000 75 72000 4,86
10000 8 10000 4
4558 1000 50 51000 4,71 1000 83 84000 4,92
10000 6 10000 9
4559 10 21 240 2,38 10 26 270 2,43
100 5 100 4
4560 10 14 150 2,18 10 21 210 2,32
100 2 100 2
4561 10 32 310 2,49 10 22 230 2,36
1
100 2 100 3
4562 10 19 200 2,30 10 33 320 2,51
100 3 100 2
4563 10 24 240 2,38 10 19 200 2,30
Aerobic mesophilic flora: <10 CFU/g

100 2 100 3
4564 100 34 3300 3,52 100 47 4400 3,64
1000 2 1000 1
4565 100 25 2500 3,40 100 43 4400 3,64
Grean beans

1000 3 1000 5
Batch 2

4566 100 28 2900 3,46 100 43 4300 3,63

2
1000 4 1000 4
4567 100 32 3300 3,52 100 29 3200 3,51
1000 4 1000 6
4568 100 29 2900 3,46 100 41 4000 3,60
1000 3 1000 3
4569 1000 52 51000 4,71 1000 75 77000 4,89
10000 4 10000 10
4570 1000 61 62000 4,79 1000 84 82000 4,91
10000 7 10000 6
4571 1000 56 55000 4,74 1000 87 85000 4,93
3
10000 5 10000 7
4572 1000 63 63000 4,80 1000 90 95000 4,98
10000 6 10000 15
4573 1000 65 64000 4,81 1000 100 95000 4,98
10000 5 10000 4


Analyses performed according to the COFRAC accreditation
ADRIA Développement 46/52 February 2, 2018
Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

Alternative method:
Reference method : 3MTM Petrifilm Enterobacteriaceae Count Plate
Matrix Strain Level N°sample ISO 21528-2
24h ± 2h at 37°C ± 1°C
Dilution cfu/plate cfu/g log cfu/g Dilution cfu/Petrifilm test cfu/g log cfu/g
6428 10 14 140 2,15 10 23 230 2,36
100 1 100 2
6429 10 15 150 2,18 10 19 180 2,26
100 1 100 1
1 6430 10 12 110 2,04 10 14 140 2,15
100 0 100 1
6431 10 10 91 1,96 10 21 220 2,34
100 0 100 3
6432 10 15 140 2,15 10 16 160 2,20
100 0 100 1
Aerobic mesophilic flora: 0 CFU/g
Whole pasteurized liquid egg

5093 100 27 2700 3,43 100 27 2700 3,43

1000 3 1000 3
5094 100 29 2800 3,45 100 31 3400 3,53
1000 2 1000 6
Batch 1

5095 100 34 3400 3,53 100 36 3600 3,56

2 1000 3 1000 4
5096 100 30 2900 3,46 100 15 1500 3,18
1000 2 1000 2
5097 100 28 3000 3,48 100 37 3900 3,59
1000 5 1000 6
5103 1000 25 28000 4,45 1000 45 44000 4,64
10000 6 10000 3
5104 1000 49 48000 4,68 1000 55 60000 4,78
10000 4 10000 11
5105 1000 40 39000 4,59 1000 33 32000 4,51
3
10000 3 10000 2
Serratia liquefaciens 26

5106 1000 56 55000 4,74 1000 53 58000 4,76

10000 4 10000 11
5107 1000 64 66000 4,82 1000 73 75000 4,88
10000 9 10000 10
6857 10 23 220 2,34 10 22 200 2,30
100 1 100 0
6858 10 22 230 2,36 10 16 160 2,20
100 3 100 1
1 6859 10 27 280 2,45 10 15 150 2,18
100 4 100 1
6860 10 20 190 2,28 10 22 240 2,38
100 1 100 4
6861 10 21 210 2,32 10 29 290 2,46
100 2 100 3
Aerobic mesophilic flora: 0 CFU/g
Whole pasteurized liquid egg

5118 100 18 1800 3,26 100 47 4500 3,65

1000 2 1000 3
5119 100 17 1500 3,18 100 30 3300 3,52
1000 0 1000 6
Batch 2

5120 100 18 1600 3,20 100 42 3900 3,59

2 1000 0 1000 1
5121 100 27 2700 3,43 100 33 3200 3,51
1000 3 1000 2
5122 100 21 1900 3,28 100 31 3100 3,49
1000 0 1000 3
5128 1000 29 29000 4,46 1000 69 67000 4,83
10000 3 10000 5
5129 1000 29 29000 4,46 1000 63 62000 4,79
10000 3 10000 5
5130 1000 35 34000 4,53 1000 35 37000 4,57
3
10000 2 10000 6
5131 1000 40 39000 4,59 1000 51 54000 4,73
10000 3 10000 8
5132 1000 25 24000 4,38 1000 49 52000 4,72
10000 1 10000 8


Analyses performed according to the COFRAC accreditation
ADRIA Développement 47/52 February 2, 2018
Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

Alternative method:
Reference method : 3MTM Petrifilm Enterobacteriaceae Count Plate
Matrix Strain Level N°sample ISO 21528-2
24h ± 2h at 37°C ± 1°C
Dilution cfu/plate cfu/g log cfu/g Dilution cfu/Petrifilm test cfu/g log cfu/g
4758 10 25 230 2,36 10 34 320 2,51
100 0 100 1
4759 10 28 270 2,43 10 40 390 2,59
100 2 100 3
1 4760 10 22 220 2,34 10 30 290 2,46
100 2 100 2
4761 10 27 270 2,43 10 31 300 2,48
100 3 100 2
4762 10 25 250 2,40 10 33 320 2,51
Aerobic mesophilic flora: <10CFU/g

100 2 100 2
4763 100 49 4700 3,67 100 60 5700 3,76
1000 3 1000 3
4764 100 52 5300 3,72 100 57 5800 3,76
Pâté for cat

1000 6 1000 7
Batch 1

4765 100 58 5900 3,77 100 38 4200 3,62

2 1000 7 1000 8
4766 100 35 3500 3,54 100 49 5200 3,72
1000 4 1000 8
4767 100 41 4500 3,65 100 56 6000 3,78
1000 9 1000 10
4768 1000 74 75000 4,88 1000 112 110000 5,04
10000 8 10000 9
4769 1000 97 95000 4,98 1000 99 100000 5,00
10000 8 10000 16
4770 1000 91 93000 4,97 1000 90 91000 4,96
3
10000 11 10000 10
Citrobacter braakii Ad833

4771 1000 84 81000 4,91 1000 94 95000 4,98

10000 5 10000 10
4772 1000 101 100000 5,00 1000 85 85000 4,93
10000 11 10000 8
4773 10 31 320 2,51 10 24 230 2,36
100 4 100 1
4774 10 19 180 2,26 10 33 320 2,51
100 1 100 3
1 4775 10 31 310 2,49 10 30 290 2,46
100 3 100 2
4776 10 44 420 2,62 10 34 320 2,51
100 2 100 1
4777 10 36 360 2,56 10 24 260 2,41
Aerobic mesophilic flora: <10CFU/g

100 4 100 4
4778 100 41 4000 3,60 100 40 4100 3,61
1000 3 1000 5
4779 100 40 4300 3,63 100 52 5000 3,70
Pâté for cat

1000 7 1000 3
Batch 2

4780 100 39 3900 3,59 100 44 4100 3,61

2 1000 4 1000 1
4781 100 46 5000 3,70 100 44 4200 3,62
1000 9 1000 2
4782 100 47 4800 3,68 100 47 4800 3,68
1000 6 1000 6
4783 1000 84 88000 4,94 1000 79 79000 4,90
10000 13 10000 8
4784 1000 74 73000 4,86 1000 88 83000 4,92
10000 6 10000 3
4785 1000 110 110000 5,04 1000 111 110000 5,04
3
10000 11 10000 10
4786 1000 85 83000 4,92 1000 74 73000 4,86
10000 6 10000 6
4787 1000 98 97000 4,99 1000 82 81000 4,91
10000 9 10000 7


Analyses performed according to the COFRAC accreditation
ADRIA Développement 48/52 February 2, 2018
Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

Alternative method:
Reference method : 3MTM Petrifilm Enterobacteriaceae Count Plate
Matrix Strain Level N°sample ISO 21528-2
24h ± 2h at 37°C ± 1°C
Dilution cfu/plate cfu/g log cfu/g Dilution cfu/Petrifilm test cfu/g log cfu/g
5183 10 38 360 2,56 10 23 230 2,36
100 2 100 2
5184 10 29 290 2,46 10 18 180 2,26
100 3 100 2
1 5185 10 33 340 2,53 10 22 260 2,41
100 4 100 6
5186 10 35 340 2,53 10 27 280 2,45
100 2 100 4
Process water (zucchini and split peas)

5187 10 24 240 2,38 10 32 340 2,53

100 2 100 5
Aerobic mesophilic flora: 0 CFU/g

5188 100 51 5400 3,73 100 51 5100 3,71

1000 8 1000 5
5189 100 42 4000 3,60 100 42 4100 3,61
1000 2 1000 3
Batch 1

5190 100 83 8000 3,90 100 44 4500 3,65

2 1000 5 1000 6
5191 100 41 3800 3,58 100 40 4000 3,60
1000 1 1000 4
5192 100 44 4300 3,63 100 59 5800 3,76
1000 3 1000 5
5198 1000 88 84000 4,92 1000 81 75000 4,88
10000 4 10000 2
5199 1000 88 89000 4,95 1000 84 82000 4,91
10000 10 10000 6
5200 1000 81 84000 4,92 1000 90 95000 4,98
3
10000 11 10000 15
5201 1000 92 90000 4,95 1000 87 91000 4,96
Escherichia coli 93

10000 7 10000 13
5202 1000 81 81000 4,91 1000 89 89000 4,95
10000 8 10000 9
5208 10 16 190 2,28 10 37 370 2,57
100 5 100 4
5209 10 24 230 2,36 10 25 270 2,43
100 1 100 5
1 5210 10 18 180 2,26 10 35 350 2,54
100 2 100 3
5211 10 28 260 2,41 10 22 270 2,43
100 0 100 8
5212 10 33 330 2,52 10 23 260 2,41
100 3 100 5
Aerobic mesophilic flora: 0 CFU/g

5213 100 34 3500 3,54 100 51 5000 3,70

Process water (pilchards)

1000 5 1000 4
5214 100 41 3700 3,57 100 52 5700 3,76
1000 0 1000 11
Batch 2

5215 100 45 4300 3,63 100 59 5600 3,75

2 1000 2 1000 3
5216 100 42 4000 3,60 100 50 4800 3,68
1000 2 1000 3
5217 100 41 4000 3,60 100 44 4500 3,65
1000 3 1000 5
5223 1000 64 68000 4,83 1000 77 75000 4,88
10000 11 10000 5
5224 1000 71 74000 4,87 1000 82 79000 4,90
10000 10 10000 5
5225 1000 66 67000 4,83 1000 63 63000 4,80
3
10000 8 10000 6
5226 1000 90 87000 4,94 1000 77 74000 4,87
10000 6 10000 4
5227 1000 79 76000 4,88 1000 89 92000 4,96
10000 5 10000 12


Analyses performed according to the COFRAC accreditation
ADRIA Développement 49/52 February 2, 2018
Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

Appendix 7 - Accuracy profile study: summarized results

(Food) Category 1 Meat products (Food) Category 2 Dairy products

(Food) Type 1 Pork, beef, veal raw and cooked (pork pâté) (Food) Type 2 Milk and cream (pasteurized milk)
Reference method Alternative method Reference method Alternative method
result result result result
Sample Sample
(Food) item Level rep 1 rep 2 rep 3 rep 4 rep 5 rep 1 rep 2 rep 3 rep 4 rep 5 (Food) item Level rep 1 rep 2 rep 3 rep 4 rep 5 rep 1 rep 2 rep 3 rep 4 rep 5
Name Name
6862-6866 Pork pâté 1 140 160 140 170 260 240 230 280 320 240 5403-5407 Pasteurized milk 1 240 220 340 310 280 260 220 270 310 320
6867-6871 Pork pâté 1 190 340 200 290 240 250 250 300 290 160 5418-5422 Pasteurized milk 1 310 280 240 170 250 270 360 210 250 210
4818-4822 Pork pâté 2 14000 11000 14000 14000 12000 13000 15000 15000 16000 11000 5408-5412 Pasteurized milk 2 5200 4700 3700 4700 3400 4500 4900 4400 4500 3600
4843-4847 Pork pâté 2 18000 15000 15000 17000 16000 18000 17000 15000 17000 15000 5423-5427 Pasteurized milk 2 5100 4200 3900 4000 5000 4300 6300 4900 3900 5200
4828-4832 Pork pâté 3 26000 25000 18000 24000 23000 25000 27000 20000 31000 22000 5413-5417 Pasteurized milk 3 100000 85000 83000 87000 77000 93000 86000 91000 83000 95000
4853-4857 Pork pâté 3 29000 24000 25000 25000 23000 33000 29000 26000 32000 28000 5428-5432 Pasteurized milk 3 82000 85000 87000 97000 84000 85000 98000 92000 88000 87000

(Food) Category 3 Seafood (Food) Category 4 Vegetables

(Food) Type 3 Raw seafood (salmon fillet) (Food) Type 4 Fresh and frozen products (Green beans)
Reference method Alternative method Reference method Alternative method
result result result result
Sample Sample
(Food) item Level rep 1 rep 2 rep 3 rep 4 rep 5 rep 1 rep 2 rep 3 rep 4 rep 5 (Food) item Level rep 1 rep 2 rep 3 rep 4 rep 5 rep 1 rep 2 rep 3 rep 4 rep 5
Name Name
5626-5630 Frozen salmon fillet 1 390 430 360 400 300 240 360 310 290 210 4544-4548 Green beans 1 250 250 230 250 240 330 240 310 270 280
5824-5828 Frozen salmon fillet 1 520 360 520 430 520 460 380 490 410 580 4559-4563 Green beans 1 240 150 310 200 240 270 210 230 320 200
5631-5635 Frozen salmon fillet 2 4000 5600 6300 4500 4800 3500 4500 5200 4700 4800 4549-4553 Green beans 2 2600 3600 3800 3300 4300 4200 5200 4300 4500 4600
5829-5833 Frozen salmon fillet 2 3700 4800 4900 5000 5100 5500 4800 4700 5300 4800 4564-4568 Green beans 2 3300 2500 2900 3300 2900 4400 4400 4300 3200 4000
5636-5640 Frozen salmon fillet 3 83000 110000 110000 91000 110000 100000 97000 120000 110000 93000 4554-4558 Green beans 3 60000 71000 79000 69000 51000 74000 85000 83000 72000 84000
5834-5838 Frozen salmon fillet 3 98000 100000 110000 93000 92000 92000 100000 110000 110000 90000 4569-4573 Green beans 3 51000 62000 55000 63000 64000 77000 82000 85000 95000 95000

(Food) Category 5 Miscellaneous and egg products (Food) Category 6 Feed

(Food) Type 5 Egg based products (whole liquid egg) (Food) Type 6 Cooked or dehydrated products (Pâté for cat)
Reference method Alternative method Reference method Alternative method
result result result result
Sample Sample
(Food) item Level rep 1 rep 2 rep 3 rep 4 rep 5 rep 1 rep 2 rep 3 rep 4 rep 5 (Food) item Level rep 1 rep 2 rep 3 rep 4 rep 5 rep 1 rep 2 rep 3 rep 4 rep 5
Name Name
6428-6432 Whole liquid egg 1 140 150 110 91 140 230 180 140 220 160 4758-4762 Pâté for cat 1 230 270 220 270 250 320 390 290 300 320
6857-6861 Whole liquid egg 1 220 230 280 190 210 200 160 150 240 290 4773-4777 Pâté for cat 1 320 180 310 420 360 230 320 290 320 260
5093-5097 Whole liquid egg 2 2700 2800 3400 2900 3000 2700 3400 3600 1500 3900 4763-4767 Pâté for cat 2 4700 5300 5900 3500 4500 5700 5800 4200 5200 6000
5118-5122 Whole liquid egg 2 1800 1500 1600 2700 1900 4500 3300 3900 3200 3100 4778-4782 Pâté for cat 2 4000 4300 3900 5000 4800 4100 5000 4100 4200 4800
5103-5107 Whole liquid egg 3 28000 48000 39000 55000 66000 44000 60000 32000 58000 75000 4768-4772 Pâté for cat 3 75000 95000 93000 81000 100000 110000 100000 91000 95000 85000
5128-5132 Whole liquid egg 3 29000 29000 34000 39000 24000 67000 62000 37000 54000 52000 4783-4787 Pâté for cat 3 88000 73000 110000 83000 97000 79000 83000 110000 73000 81000

(Food) Category 7 Environmental samples

Process water (Batch 1: Zuchhini and split peas;
(Food) Type 7
Batch 2: Pilchards)
Reference method Alternative method
result result
Sample
(Food) item Level rep 1 rep 2 rep 3 rep 4 rep 5 rep 1 rep 2 rep 3 rep 4 rep 5
Name
5183-5187 Rinced water 1 360 290 340 340 240 230 180 260 280 340
5208-5212 Rinced water 1 190 230 180 260 330 370 270 350 270 260
5188-5192 Rinced water 2 5400 4000 8000 3800 4300 5100 4100 4500 4000 5800
5213-5217 Rinced water 2 3500 3700 4300 4000 4000 5000 5700 5600 4800 4500
5198-5202 Rinced water 3 84000 89000 84000 90000 81000 75000 82000 95000 91000 89000
5223-5227 Rinced water 3 68000 74000 67000 87000 76000 75000 79000 63000 74000 92000

ADRIA Développement 50/52 February 2, 2018

Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

Appendix 8 – Inclusivity / Exclusivity: raw data

(initial validation and extension study)

Initial validation
Positive strains
VRBG Petrifilm
Strain Origin
Characteristic Characteristic
Growth Growth
colonies colonies
1 Shigella flexneri CIP8248 / + + + + G-
2 Shigella sonnei CIP8249 / + + + + G-
3 Salmonella enteritidis CIP8297 / + + + + G+
4 Salmonella typhimurium CIP5858 / + + + + G+
5 Erwinia carotovora CIP8283 / - - + + G-
6 Erwinia carotovora CIP103762 / - - - -
7 Escherichia coli CIP54117 / + + + + G+
8 Escherichia coli CIP54127 / + + + + G+
9 Citrobacter diversus CIP8294 / + + + + G+
10 Citrobacter freundii CIP5732 / + + + + G+
11 Klebsiella pneumoniae CIP8291 / + + + + G+
12 Klebsiella oxytoca CIP7932 / + + + + G+
13 Enterobacter cloacae Adria 10 Raw milk + + + + G+
14 Enterobacter aerogenes CIP 6086 / + + + + G+
15 Serratia liquefaciens Adria 8 Egg product + + + + G-
16 Hafnia alvei Adria 138 Spices + + + + G+
17 Edwarsiella tarda CIP7861 / + + + + G-
18 Proteus mirabilis Adria 54 Poultry meat + + + + G+
19 Proteus vulgaris Adria 56 Food product + + + + G+
20 Providencia rettgeri Adria 112 Egg white + + + + G+
21 Morganella morganii CIPA236 / + + + + G+
22 Yersinia enterocolitica CIP8027 / + + + + G-
23 Kluyvera ascorbata CIP8295 / + + + + G+

Initial validation
Negative strains
VRBG Test Petrifilm
Strain Origin
Characteristic Characteristic
Growth Growth
colonies colonies
1 Aeromonas hydrophila CIP5750 / + + + + G+
2 Aeromonas bestiarum CIP7430 Fish + + + + G-
3 Aeromonas sobria CIP7433 Fish - - - -
4 Xanthomonas maltophilia CIP6077 / + + + + G+
5 Pseudomonas fluorescens CIP5690 / - - - -
6 Pseudomonas putida Adria 4 Poultry meat - - - -
7 Pseudomonas putida Adria 8 Egg product - - - -
8 Pseudomonas aeruginosa CIP22 Clinic - - + (*) -
9 Acinetobacter spp Adria 46-2 Poultry meat - - - -
10 Bacillus circulans ATCC4513 / - - - -
11 Lactobacillus plantarum CIP159 / - - - -
12 Enterococcus faecalis ATCC29212 / - - - -
13 Staphylococcus aureus CIP658 / - - - -

(*) Red colonies without acidification zone and gas

G- : Red colonies surrounded with a yellow zone
G+: Red colonies with red bubbles
ADRIA Développement 51/52 February 2, 2018
Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)
 3M Health Care

INCLUSIVITY (Extension study, 2017)

PEB
PCA VRBG
Strain Reference Origin cfu/ Gas
ufc/plate ufc/plate
Petrifilm (+/-)
1 Buttiauxella agrestis Ad1328 Whole egg 22 107 13 +
2 Citrobacter youngae Ad1372 Water 95 95 81 +
3 Citrobacter braakii Ad833 Beef trim 67 23 41 +
4 Citrobacter farmeri Ad1116 Egg environment 75 31 64 +
5 Cronobacter malonaticus DSM18702 Milk powder 27 149 134 +
6 Cronobacter sakazakii Ad2412 Milk powder 38 65 47 +
7 Enterobacter hormaechei Ad990 Butter 102 96 84 +
8 Enterobacter aerogenes Ad2569 Cheese 49 56 30 +
9 Escherichia hermannii Ad464 Raw milk 33 19 31 +
10 Escherichia fergusonii Ad1381 Tap water 42 23 38 +
11 Escherichia vulneris 134 Pork liver 32 25 20 -
12 Escherichia coli Ad1915 Poultry meat 66 52 61 +
13 Hafnia alvei A00C069 Poultry meat 72 57 52 +
14 Kluyvera intermedia 60 Vegetables 33 27 33 +
15 Leclercia adecarboxylata Ad707 Milk powder 24 20 20 +
16 Lelliottia amnigena 126 Ground beef 120 111 81 +
17 Pantoea agglomerans A00L065 Cheese 117 67 63 +
18 Pluralibacter gergoviae CIP76.1 94 102 68 +
19 Providencia stuartii Ad1575 River water 56 114 57 -
20 Raoultella terrigena Ad1368 Tap water 59 70 39 +
21 Siccibacter turicensis Ad1445 Milk powder 20 16 24 +
22 Salmonella enterica Anatum Ad2727 Seafood 69 74 58 +
23 Serratia fonticola Ad1696 Salmon 30 (-6) 19(-7) 102(-6) -
24 Serratia marcescens Ad2604 Dairy product 78 39 46 -
25 Serratia liquefaciens Ad2601 Dairy product 76 33 48 -
26 Shimwellia blattae ATCC29907 18 10 15 +
27 Yersinia enterocolitica Ad1028 Speck 62 44 60 -

EXCLUSIVITY (Extension study, 2017)

PCA VRBG PEB
Strain Reference Origin
cfu/plate cfu/plate cfu/Petrifilm
1 Acetobacter orientalis DSM15550T Flower 154 0 0
160 µcolonies
2 Acinetobacter baumanii Ad1090 Feeding stuff 280
(µcolonies NC) TNTC
3 Carnobacterium viridans ATCCBAA36 / 14 0 0
4 Agrobacterium tumefasciens Ad1550 Stagnant water 257 0 0
5 Alcaligenes faecalis ATCC8750 / 190 2 brown (NC) 0
6 Arcobacter butzleri Ad1881 Poultry environment 98 0 0
7 Asaia siamensis CIP107278T Flower 112 0 0
8 Burkholderia sp Ad2003 Slaughterhouse 42 0 0
9 Flavobacterium hydratis Ad1323 Whole egg 188 0 0
10 Gluconobacter oxydans Ad997 Sweetened drink 257 0 0
11 Comomonas aquatica Ad1543 Water 213 µcolonies (NC) 0
12 Moraxella sp IB3 Egg white 127 0 0
13 Pandoraea sp Ad1882 Slaughterhouse 300 µcolonies TNTC 0
Plesiomonas
14 shigelloïdes Ad673 Fish 15 49 68
(Aeromonas)
15 Psychrobacter alimentarius Ad2570 Cheese 211 0 0
16 Ralstonia mannitolilytica Ad1059 Poultry meat 38 0 0
17 Sphingobacterium sp Ad1324 Whole egg 95 0 0
TNTC: Too Numerous To Count NC: Non characteristic colonies

ADRIA Développement 52/52 February 2, 2018

Summary Report (Version 0)
3M Petrifilm Enterobacteriaceae (3M 01/06 - 09/97)