AOAC-RI ERP Micro June 2016

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

Combination

(Enrichment to lysis)

(Lysis to assay)

1 2 3 4 5 6 7 8

13 minutes 13 minutes 13 minutes 13 minutes 17 minutes 17 minutes 17 minutes 17 minutes

18 µL 18 µL 22 µL 22 µL 18 µL 18 µL 22 µL 22 µL

18 µL 22 µL 18 µL 22 µL 18 µL 22 µL 18 µL 22 µL

10 10 10 10 10 10 10 10

1 2 3 4 5 6 7 8 9

Results

Treatment combinations 1 and 2

For the 13 minute lysis and the 18 µL aliquot of enrichment to lysis robustness analysis of the MDA 2 - Listeria assay, there were 6 presumptive positives out of 10 replicates at the low level inoculation. For the 5 uninoculated control test portions, there were 0 presumptive positives out of 5 replicates. All 5 uninoculated control test portions were negative. For the low inoculation level, a POD value of 0.60 was obtained with a 95% confidence interval of (0.31, 0.83). All 5 non-target test portions were negative with a POD value of 0.00 with a 95%

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

confidence interval of (0.00,0.43).

Treatment combinations 3 and 4

For the 13 minute lysis and the 22 µL aliquot of enrichment to lysis robustness analysis of the MDA 2 - Listeria assay, there were 7 presumptive positives out of 10 replicates at the low level inoculation. For the 5 uninoculated control test portions, there were 0 presumptive positives out

of five replicates.

AOAC Research Institute Expert Review Panel Use Only

For the low invocation level, a POD value of 0.70 was obtained with a 95% confidence interval of (0.40, 0.89). All 5 non-target test portions were negative with a POD value of 0.00 with a 95%

confidence interval of (0.00, 0.43).

Treatment combinations 5, 6, 7 and 8

For both 17 minutes lysis procedures robustness analysis of the MDA 2 - Listeria assay, there were 6 presumptive positives out of 10 replicates at the low level inoculation. For the 5 uninoculated control test portions, there were 0 presumptive positives out of 5 replicates. See

Table 17 for robustness results.

For the low invocation level, a POD value of 0.50 was obtained with a 95% confidence interval of (0.24, 0.76). All 5 non-target test portions were negative with a POD value of 0.00 with a 95%

confidence interval of (0.00, 0.43).