ERP Micro December 2019

statistically significant difference between the two methods. A dLPOD CP value of 0.00 with 95% confidence intervals of (-0.03, 0.03) was obtained between presumptive and confirmed results indicating no statistically significant difference between the presumptive and confirmed results. For the non-inoculated controls, 3 out of 120 samples (POD CP of 0.03) produced a presumptive positive result by the candidate method with 2 out of 120 test portions (POD CC and POD C of 0.02) confirming positive. For the reference method, 4 out of 120 test portions were reported as positive (POD R of 0.03). A dLPOD C value of -0.02 with 95% confidence interval of (-0.07, 0.03) 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 (-0.04, 0.06) was obtained between presumptive and confirmed results indicating no statistically significant difference between the presumptive and confirmed results. Detailed results of the POD statistical analysis are presented in Table 2019.2A and Figures 1A and 1B. The results of the collaborative study indicate that the candidate method was both reliable and accurate in detection of Listeria from the test matrix. Sixteen collaborators participated in the study and 11 of the collaborators provided feedback upon completion. All 11 collaborators remarked positively on the ease of use of the GENE-UP ® methodology. Two collaborators did indicate dissatisfaction with the ease of use of the software, which has been updated since the completion of the study. Several collaborators also indicated the accessibility of the PCR curves was beneficial in aiding final determination of results. Fifteen (15) of the 16 sets of data were used for the statistical analysis. One collaborator received samples that were damaged and did not conduct testing (collaborator 11). Two Discussion

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