ERP Micro December 2019

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, 4 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 0.02 with 95% confidence intervals of (-0.03, 0.07) 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 this evaluation demonstrate that the candidate method performed equivalent to the ISO reference method when studied collaboratively. Sixteen collaborators participated in the study and 11 of the collaborators provided feedback on the method upon completion. All 11 collaborators provided positive feedback on the ease of use of the GENE-UP ® method including the ability to investigate sample analysis through the CT and melting peak curves. Two collaborators did indicate that the software was not intuitive. The most recent PTM modification in December of 2018 included an update to the software taking note of the collaborator feedback received. 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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