Microbiology Methods for ERP Review 3-2020

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GENE-UP SLM Matrix Extension

June 19, 2017

presumptive and the confirmed or between the GENE ‐ UP method and the reference method results using 1 probability of detection (POD) statistical model (see Tables 10 ‐ 12). 2 3 Creamy peanut butter : Creamy peanut butter had <10 CFU/g of background organisms and was negative 4 for natural occurring Salmonella . Analysis was performed on three levels of S.enterica serovar Potsdam 5 inoculation: 0 and 0.22 (0.13, 0.50) and >10 (2.34, >10) MPN/test portion for the GENE ‐ UP and the BAM 6 reference methods. The un ‐ inoculated samples resulted in 0 positives out of 5 replicates for both methods. 7 The >10 CFU level samples resulted in 5 positives out of 5 replicates for both methods. For the 0.22 CFU 8 level of inoculation, the method had 6 out of 20 samples presumptive and confirmed (by both alternative 9 and reference methods) positives and 8 out of 20 for the BAM reference method. There was no significant 10 difference between the GENE ‐ UP Salmonella detection assay presumptive and the confirmed or between 11 the GENE ‐ UP method and the reference method results using probability of detection (POD) statistical 12 model (see Tables 10 ‐ 12). 13 14 Dark chocolate : Dark chocolate had <10 CFU/g of background organisms and was negative for natural 15 occurring Salmonella . Analysis was performed on three levels of S.enterica serovar Cerro inoculation: 0 and 16 0.16 (0.05, 0.23) and >10 (2.34, >10) MPN/test portion for the GENE ‐ UP and the BAM reference methods. 17 The un ‐ inoculated samples resulted in 0 positives out of 5 replicates for both methods. The >10 CFU level 18 samples resulted in 5 positives out of 5 replicates for both methods. For the 0.16 CFU level of inoculation, 19 the method had 6 out of 20 samples presumptive and confirmed (by both alternative and reference 20 methods) positives and 3 out of 20 for the BAM reference method. There was no significant difference 21 between the GENE ‐ UP Salmonella detection assay presumptive and the confirmed or between the GENE ‐ 22 UP method and the reference method results using probability of detection (POD) statistical model (see 23 Tables 10 ‐ 12). 24 25 Garlic powder : Garlic powder had >2500 CFU/g of background organisms and was negative for natural 26 occurring Salmonella . Analysis was performed on three levels of S.enterica serovar Arizonae inoculation: 0 27 and 0.22 (0.13, 0.50) and 0.69 (0.43, >10) MPN/test portion for the GENE ‐ UP and the BAM reference 28 methods. The un ‐ inoculated samples resulted in 0 positives out of 5 replicates for both methods. The 0.69 29 CFU level samples resulted in 5 positives out of 5 replicates for both methods. For the 0.22 CFU level of 30 inoculation, the method had 5 out of 20 samples presumptive and confirmed (by both alternative and 31 reference methods) positives and 8 out of 20 for the BAM reference method. There was no significant 32 difference between the GENE ‐ UP Salmonella detection assay presumptive and the confirmed or between 33 the GENE ‐ UP method and the reference method results using probability of detection (POD) statistical 34 model (see Tables 10 ‐ 12). 38 39 Raw ground chicken: Fresh raw ground chicken had 1.9 x 10 6 CFU/g of background organisms and was 40 negative for natural occurring Salmonella . Analysis was performed on three levels of S.enterica serovar 41 Enteritidis inoculation: 0, 0. 0.55 (0.30, 0.93) and 5.42 (1.61, 18.25) MPN/test portion for the GENE ‐ UP and 42 the MLG reference methods using both BPW and mTSB primary enrichment media. The un ‐ inoculated 43 samples resulted in 0 positives out of 5 replicates for both methods (BPW and mTSB). The 5.42 CFU level 44 samples resulted in 5 positives out of 5 replicates for both methods (BPW and mTSB). For the 0.55 CFU 45 level of inoculation, the method had 10 out of 20 samples presumptive and confirmed (by both alternative 46 and reference methods) positives for both media and 8 out of 20 for the MLG reference method. There was 47 no significant difference between the GENE ‐ UP Salmonella detection assay presumptive and the confirmed 48 35 36 Independent Validation Study 37 The independent evaluation of five matrixes was performed as outlined above.

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