AOAC ERP MICRO AUGUST 2018

OMAMAN-31 E: AOAC RI PTM Report 091501 ERP Use Only - March 2016

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For the low inoculation level of the MDA 2 Salmonella method, there were 6 presumptive positives and 6 confirmed positives following the FDA/BAM Chapter 5 reference method confirmation procedure. There were 9 observed positives for the reference method. For the high inoculation level, there were 5 presumptive positives and 5 confirmed positives following the FDA/BAM Chapter 5 reference method confirmation procedure. There were 5 confirmed positives following the reference method. Detailed results of the POD analyses are presented in

Tables 15 and 23 of the Appendix.

All five uninoculated control test portions were negative by both the MDA 2 - Salmonella assay

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and the corresponding reference method for each matrix above.

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

Methodology

The 3M ™ MDA 2 - Salmonella was evaluated for both stability and robustness. The stability was evaluated by examining three separate lots from different production stages: (1) a lot near or passed expiration (2) a lot in the middle of its expiration (3) a newly produced lot. All stability (lot-to-lot) and robustness parameters were evaluated using raw ground chicken inoculated at a level expected to yield fractional positive results (2 to 8 positive samples out of 10 replicates). A bulk sample of raw ground chicken was inoculated with Salmonella Heidelberg NCTC 5717, mixed thoroughly, and separated into 25g test portions. For each operational parameter, 10 inoculated replicates were analyzed along with 5 non-target organism ( Klebsiella

pneumonia ATCC 10031) replicates.

Results

For the stability (lot-to-lot) consistency, the 3 different lots analyzed detected the target analyte with no observed effect on the results. There were 6 presumptive positives out of 10 replicates for all three lots at the low inoculation level. For the 5 non-target organism test portions, there

were 0 presumptive positives out of 5 replicates for all three lots.

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For the low inoculation level, a POD value of 0.60 was obtained with a 95% confidence interval of (0.31, 0.83) for all three lots that were analyzed. All 5 non-target organism test portions were negative with a POD value of 0.00 with a 95% confidence interval of (0.00, 0.43) for all three

lots analyzed. A summary of results is displayed below in Table 24.

Robustness Study

Methodology

The robustness was evaluated by examining the performance of the assay when small changes to the operating conditions were made. The following parameters were evaluated: (1) heat lysis duration, (2) volume of sample to lysis solution, and (3) volume of lysis solution to reaction

tubes.