AOAC-RI ERP Book Micro Jan 19 2017

OMAMAN-35 A : Collaborative Study Manuscript For ERP Use Only January 2017

1

Inclusivity/Exclusivity (Internal Studies)

Table 3: Source of Test Organisms Used for Testing of Inclusivity and Exclusivity 2

Strains

#s

Testing Lab

Q Laboratories Inc., (Cincinnati Ohio)

1 through 15

Inclusives

16 through 50

3M (St. Paul, Minnesota)

ALL (1 through 50)

3M (St. Paul, Minnesota)

Exclusives

3

Inclusivity Methodology 4 5 Fifty frozen E. coli O157strain suspensions were thawed and sub-cultured on blood agar plates and 6 incubated at 41.5 °C ± 1°C for 18-24 hours. Single isolated colonies were sub-cultured from agar 7 intoBPW ISO broth and incubated for eight (8) hours at 41.5 °C ± 1°C. The cultures were diluted in fresh 8 BPW ISO broth in order to obtain concentrations of approximately E+05 to E+06 CFU/mL and were then 9 tested immediately using the 3M MDA2ECO96 kit. 12 13 Fifty frozen non- E. coli O157strain suspensions were thawed and sub-cultured on blood agar plates and 14 incubated at 37 0 C for approximately 24 hours. Single isolated colonies were sub-cultured from agar into 15 Tryptic® soy broth (TSB) broth and incubated at 35-37 0 C for 18-24 hours.The cultures were diluted in 16 fresh BPW ISO in order to obtain concentrations of approximately E+07 to E+08 CFU/mL and were then 17 tested immediately using the 3M MDA2ECO96 kit. 20 1. All 50 E. coli O157strains were correctly detected as positives by the 3MMDA2ECO96 kit/method. 21 2. None of the 50 non- E. coli O157strains were detected by the 3MMDA2ECO96 kit/method. 22 3. See Tables 4 and 5 for key to culture collection ID #s. 23 4. See Tables 5 and 6 for culture details and results. 10 11 ExclusivityMethodology 18 19 Results

Table 4. Culture Collection Key AOAC Re earch Institute Expert Review Panel Use Only Acronym Collection / obtained from ATCC American Type Culture Collection US Centers for Disease Control and Prevention

24 25 26

CDC FDA FSD MSU

US Food and Drug Administration 3M Food Safety Culture Collection Michigan State University STEC Center National Collection of Type Cultures

NCTC

Pennsylvania State University E. coli Reference Center Q Laboratories, Inc., Cincinnati, Ohio 45214

PSU

QL

TICC

3M Tecra™ Culture Collection

27 28

Table 5. Escherichia coli O157 – Inclusive Cultures

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