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3.

AOAC Official Method 993.12

Listeria monocytogenes

in Milk and Dairy Products: Selective

1

Enrichment and Isolation Method, First Action 1993, Final Action 1996. (Accessed January

2

2015)

3

4

4.

ISO 11290-1/A1 (2004) - Microbiology of food and animal feeding stuffs - Horizontal

5

method for the detection and enumeration of

Listeria monocytogenes

- Part 1: detection of

6

Listeria monocytogenes

in foods

7

8

5.

U.S. Food and Drug Administration, and U.S. Food Safety and Inspection Service. 2003.

9

Quantitative Assessment of the Relative Risk to Public Health from Foodborne

Listeria

10

monocytogenes

Among Selected Categories of Ready-to-Eat Foods. Available in Docket No.

11

1999N-1168, Vols. 23 through 28, and at

Quantitative Assessment of Relative Risk to Public

12

Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat

13

Foods

14

6.

Doyle ME, Mazzotta AS, Wang T, Wiseman DW, and Scott VN. 2001. Heat resistance of

15

Listeria monocytogenes

.

Journal of Food Protection

64 (3): 410-429.

16

7.

ISO 18593. Microbiology of food and animal feeding stuffs – Horizontal methods for

17

sampling techniques from surfaces using contact plates and swabs.

18

19

8.

AOAC Research Institute

Performance Tested Methods

SM

Program

validation outline

20

protocol:

Comparative Evaluation of the 3M

Molecular Detection Assay Listeria

21

monocytogenes 2 and of the 3M

Molecular Detection Assay Listeria

2 (February 2015)

22

23

9.

U. S. Food and Drug Administration

Bacteriological Analytical Manual

, Chapter 3

Aerobic

24

Plate Count (

January 2001) (Accessed January 2015)

25

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm063346.m

26

27

10. Least Cost Formulations, Ltd., MPN Calculator Version 1.6

28

www.lcfltd.com/customer/LCFMPNCalculator.exe(

Accessed January 2015)

29

30

11. AOAC International,

Evaluation of the

VITEK 2

Gram Positive (GP) Microbial

31

Identification Test Card: Collaborative Study

, Journal of AOAC International, 95, 1425

32

(2012)

33

34

12. Wehling, P., LaBudde, R., Brunelle, S., Nelson, M.

Probability of Detection (POD) as a

35

Statistical Model for the Validation of Qualitative Methods.

Journal of AOAC

36

International, Vol. 94, No. 1, 2011.

37

38

13. Least Cost Formulations, Ltd., AOAC Binary Data Interlaboratory Study Workbook Version

39

2.2 (2011)

-http://lcfltd.com/aoac/aoac-binary-v2-2.xls(

Accessed January 2015)

40

41

14. Official Methods of Analysis of AOAC INTERNATIONAL (2012) 19th Ed., Appendix J:

42

AOAC INTERNATIONAL Methods Committee Guidelines for Validation of

43

Microbiological Methods for Food and Environmental Surfaces, AOAC INTERNATIONAL,

44

Gaithersburg, MD,http:/

/http://www.eoma.aoac.org/app_j.pdf

(Accessed January 2015)

45

AOAC Research Institute

Expert Review Panel Use Only

OMAMAN-30 D/ PTM Validation Report 081501

OMA ERP - June 2016

ERP Use Only