Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMAMAN-30 D/ PTM Validation Report 081501 OMA ERP - June 2016 ERP Use Only

OMB Meeting 4-11-2019 Pre-read Materials

439

1 2 3 4 5 6 7 8 9

following the reference method.Detailed results of the POD analyses are presented in Tables 11

and 15.

All five uninoculated control test portions were negative by both the MDA2 - Listeria monocytogenes assay and the corresponding reference method for each matrix above.

Product Consistency (Lot-to-Lot) and Stability Studies

10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46

Methodology

Three lots of MDA2 – Listeriamonocytogenes test kits, 1 newly manufactured, 1 at the middle of its expiration, and 1 at or slightly beyond expiration was analyzed to determine the stability of the assay. For the MDA2 – Listeriamonocytogenes test kit, one Listeria monocytogenes ATCC 7644 isolate was analyzed at a fractional positive level (2-8 positives), and testing 10 replicates. One non- Listeriamonocytogenes isolate, Enterococcus faecalis ATCC 29212, was analyzed at the

growth level achieved in a non-selective broth, testing 5 replicates.

Results

For the lot-to-lot/stability evaluation of the MDA2 - Listeria monocytogenes assay, there were 6 presumptive positives out of 10 replicates for all three lots at the low inoculation level. For the 5 uninoculated control test portions, there were 0 presumptive positives out of 5 replicates for all three lots.The five control test portions were negative. See Tables 16 for lot-to-lot/stability

results.

Robustness Study

Methodology

The robustness evaluated the ability of the method to remain unaffected by minor variations in method parameters that might be expected to occur when the method is performed by an end user. Three different parameters were evaluated, which are presented in Table 17.For each parameter, one Listeria monocytogenes ATCC 7644isolate was analyzed at a fractional positive level (2-8 positives), testing 10 replicates. One non- Listeriamonocytogenes isolate, Enterococcus faecalis ATCC 29212, was analyzed at the growth level achieved in a non-selective broth, testing

AOAC Research Institute Expert Review Panel Use Only

5 replicates.

Results

For the robustness analysis of the MDA2 - Listeria monocytogenes assay, there were 6 presumptive positives out of 10 replicates for each variation evaluated. For the 5 control test portions, there were 0 presumptive positives out of 5 replicates. See Table 17 for robustness

results.

Independent Laboratory Observations

The results of this study demonstrate the ability of the MDA2 Listeria monocytogenes to detect the presence of Listeria monocytogenes in various food matrices and select environmental

04/05/2019