Microbiology Methods for ERP Review 3-2020

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only presumptive positive results that confirmed positive). For the reference method, 48 out of 132 test portions were reported as positive (LPOD R of 0.36). A dLPOD C value of 0.07 with 95% confidence interval of (-0.12, 0.17) was obtained between the candidate and reference method, indicating no statistically significant difference between the two methods. A dLPOD CP value of - -0.01 with 95% confidence intervals of (-0.20, 0.15) was obtained between presumptive and confirmed results indicating no statistically significant difference between the presumptive and confirmed results (following both the alternative confirmation and the FDA/BAM Chapter 5 reference method). For the high inoculation level, 132 out of 132 test portions (LPOD CP of 1.00) were reported as presumptive positive by the Solus One Salmonella . There were 132 out of 132 reported test portions (LPOD CC of 1.00) that confirmed positive (following both the alternative confirmation and the FDA/BAM Chapter 5 reference method). For samples that produced presumptive positive results by the Solus One Salmonella , 132 out of 132 samples confirmed positive (LPOD C of 1.00). For the reference method, 132 out of 132 test portions were reported as positive (LPOD R of 1.00). A dLPOD C value of 0.00 with 95% confidence interval of (-0.06, 0.06) 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 (-0.06, 0.06) was obtained between presumptive and confirmed results indicating no statistically significant difference between the presumptive and confirmed results (following both the alternative confirmation and the FDA/BAM Chapter 5 reference method). For the uninoculated controls, 0 out of 132 samples (LPOD CP of 0.00) produced a presumptive positive result by the Solus One Salmonella with 0 out of 132 test portions (LPOD CC of 0.00) confirming positive (following both the alternative confirmation and the FDA/BAM Chapter 5 reference method). There were 0 out of 132 samples that produced a presumptive positive result by the Solus One Salmonella assay that confirmed positive (LPOD C of 0.00). For the reference method, 1 out of 132 test portions were reported as positive (LPOD R of 0.01). A dLPOD C value of -0.01 with 95% confidence interval of (-0.02, 0.04) 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 (-0.02, 0.02) was obtained between presumptive and confirmed results indicating no statistically significant difference between the presumptive and confirmed results (following both the alternative confirmation and the FDA/BAM Chapter 5 reference method).

Discussion

No negative feedback was provided with regard to the performance of the Solus One Salmonella . One (1) false negative (FN) result was observed from the analysis of the Solus One Salmonella assay. The FN result was observed on the low level. The FN rate was 1.72%.

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