AOAC-RI ERP Micro June 2016

OMAMAN-29 D/ PTM Validation Report 111501 OMA ERP - June 2016 ERP Use Only

Table 16: Lot-to-Lot/Stability Study Results

Expiration Date Lot #: 012715

Expiration Date Lot #: 081914

Expiration Date Lot #: 050114

Sample #

Result

Sample #

Result

Sample #

Result

Listeria monocytogenes ATCC 2 7644

Low Level

6/10

Low Level

6/10

Low Level

6/10

Uninoculated Target Organism ( Enterococcus faecalis ATCC 29212)

Uninoculated Target Organism ( Enterococcus faecalis ATCC 29212)

Uninoculated Target Organism ( Enterococcus faecalis ATCC 29212)

0/5

0/5

0/5

1 All samples were analyzed from a common lysate 2 ATCC- American Type Culture Collection

Table 17: Robustness Results Robustness 1

Robustness 1

13 Minute Lysis 18 µL 2 , 18 µL 3

13 Minute Lysis 22 µL 2 , 18 µL 3

18 µL 2 , 22 µL 3

22 µL 2 , 22 µL 3

Sample #

Sample #

Listeria monocytogenes ATCC 4 7644

Low Level

6/10

6/10

Low Level

7/10

7/10

Uninoculated Target Organism ( Enterococcus faecalis ATCC 29212)

Uninoculated Target Organism ( Enterococcus faecalis ATCC 29212)

0/5

0/5

0/5

0/5

Robustness 1 AOAC Research Institute Expert Review Panel Use Only 17 Minute Lysis 22 µL 2 , 18 µL 3 18 µL 2 , 22 µL 3 Sample # 22 µL 2 , 22 µL 3 Listeria monocytogenes ATCC 4 7644

Robustness 1

17 Minute Lysis 18 µL 2 , 18 µL 3

Sample #

Low Level

6/10

6/10

Low Level

6/10

6/10

Uninoculated Target Organism ( Enterococcus faecalis ATCC 29212)

Uninoculated Target Organism ( Enterococcus faecalis ATCC 29212)

0/5

0/5

0/5

0/5

1 All samples were analyzed from a common lysate 2 Volume of enrichment to lysis 3 Volume of lysis to assay 4 ATCC- American Type Culture Collection