AOAC-RI ERP Micro June 2016

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

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Matrix Study Results

For each method, the probability of detection (POD) was calculated as the number of positive outcomes divided by the total number of trials. [13] The following were calculated: the candidate

presumptive results, POD CP ;

the candidate confirmatory results, POD CC

; the difference in the

candidate presumptive and confirmatory results, dPOD CP,

; the presumptive candidate results that

confirmed positive, POD C

(=POD CC

); the reference method, POD R

, and the difference in the

confirmed candidate and reference methods, dPOD C

. POD analyses were conducted for the

MDA 2 - Listeria test points and compared to the appropriate reference method results. The pre- validation target analyte background screen results and APC results are presented in Table 5. The heat stress data for selected matrixes are presented in Table 6. The inoculum levels for each environmental surface are presented in Table 7. A summary of POD analyses [14] are presented in Tables 8-15. As per criteria outlined in Appendix J of the Official Methods of Analysis

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Manual [15], fractional positive results were obtained for all matrixes.

Internal Study

Raw chicken leg pieces (25 g)

For the low inoculation level of the MDA 2 - Listeria assay, there were 4 presumptive positives and 9 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure resulting in 5 false negative samples. There were 5 observed positives for the reference method. For the high inoculation level, there were 3 presumptive positives and 3 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure. There was 1 confirmed positive following the reference method. Even though 5 false negatives were confirmed, analysis show there to be no statistical difference when compared to the reference method. Detailed results of the POD analyses are presented in Tables 8 and 12. This matrix analysis was conducted using Demi Fraser with FAC brand X. For the low inoculation level of the MDA 2 - Listeria assay, there were 4 presumptive positives and 4 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure. There were 5 observed positives for the reference method. For the high inoculation level, there were 2 presumptive positives and 2 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure. There were 5 confirmed positives following the reference method. Detailed results of the POD analyses are presented in Tables 8 and 12. This matrix analysis was conducted using Demi Fraser with FAC brand Z. Raw chicken fillet (25 g)

AOAC Research Institute Expert Review Panel Use Only

Bagged raw spinach

Compared to FDA-BAM

For the low inoculation level of the MDA 2 - Listeria assay, there were 6 presumptive positives and 6 confirmed positives following the FDA/BAM Chapter 10 reference method confirmation