Microbiology Methods for ERP Review 3-2020

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statistically significant difference between the two methods. A dLPOD CP value of 0.00 with 95% confidence intervals of (-0.02, 0.02) was obtained between presumptive and confirmed results indicating no statistically significant difference. Detailed results of the POD statistical analysis for the GENE-UP Salmonella 2 method with alternative confirmation are presented in Table 2020.2A and Figures 1A – 1D. GENE-UP Salmonella with Traditional Confirmation For the low inoculation level, 51 out of 132 test portions (POD CP of 0.39) were reported as presumptive positive by the candidate method with 51 out of 132 test portions (POD CC of 0.39) confirming positive. For the candidate method true positives, 49 out of 132 test portions (POD C of 0.37) were both presumptive positive and confirmed positive. For the reference method, 51 out of 132 test portions were reported as positive (POD R of 0.0.39). A dLPOD C value of -0.02 with 95% confidence interval of (-0.15, 0.12) was obtained between the candidate and reference method, indicating no statistically significant difference between the two methods. A dLPOD CP value of 0.00 with 95% confidence intervals of (-0.04, 0.04) was obtained between presumptive and confirmed results indicating no statistically significant difference. For the high inoculation level, 132 out of 132 test portions (POD CP of 1.00) were reported as presumptive positive by the candidate method with 130 out of 132 test portions (POD CC of 0.98) confirming positive. For the candidate method true positives, 130 out of 132 test portions (POD C of 0.98) were both presumptive positive and confirmed positive. For the reference method, 127 out of 132 test portions were reported as positive (POD R of 0.96). A dLPOD C value of 0.02 with 95% confidence interval of (-0.03, 0.09) was obtained between the candidate and reference method, indicating no statistically significant difference between the two methods. A dLPOD CP value of 0.02 with 95% confidence intervals of (-0.01, 0.04) was obtained between presumptive and confirmed results indicating no statistically significant difference.

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