AOAC ERP MICRO AUGUST 2018
OMAMAN-30 D/ PTM Validation Report 081501 OMA ERP - June 2016 ERP Use Only
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
Made with FlippingBook Learn more on our blog