Microsoft Word - 3M Petrifilm REC Plate OMA Manuscript 09121

ERP Methods Book

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1 Difference of means values (0.00, -0.02, -0.01 and -0.02) for the uninoculated, low, medium 2 and high contamination levels, indicated that no statistically significant difference existed 3 between the candidate and reference method. Repeatability (0.00, 0.22, 0.12 and 0.14) and 4 reproducibility (0.00, 0.31, 0.26 and 0.22) values for each contamination level indicate that the 5 method performed similarly within sample replicates and between laboratories throughout the 6 range of contamination levels. 7 8 3M Petrifilm Rapid E. coli/Coliform Count Plate & ISO Coliform 37 o C 9 10 Difference of means values (0.00, 0.08, -0.03, -0.01) for the uninoculated, low, medium and 11 high contamination levels, indicated that no statistically significant difference existed between 12 the candidate and reference method. Repeatability (0.00, 0.28, 0.09, 0.09) and reproducibility 13 (0.00, 0.34, 0.19, 0.16) values for each contamination level indicate that the method performed 14 similarly within sample replicates and between laboratories throughout the range of 15 contamination levels. 16 17 3M Petrifilm Rapid E. coli/Coliform Count Plate & ISO E. coli 37 o C 20 and high contamination levels, indicated that no statistically significant difference existed 21 between the candidate and reference method. Repeatability (0.00, 0.28, 0.12 and 0.11) and 22 reproducibility (0.00, 0.28, 0.19 and 0.14) values for each contamination level indicate that the 23 method performed similarly within sample replicates and between laboratories throughout the 24 range of contamination levels. 25 26 3M Petrifilm Rapid E. coli/Coliform Count Plate & ISO E. coli 42 o C 29 and high contamination levels, indicated that no statistically significant difference existed 30 between the candidate and reference method. Repeatability (0.00, 0.27, 0.13 and 0.14) and 31 reproducibility (0.00, 0.27, 0.15 and 0.14) values for each contamination level indicate that the 32 method performed similarly within sample replicates and between laboratories throughout the 33 range of contamination levels. 38 in regard to the performance of the candidate method. No statistically significant difference was 39 observed between the candidate method and the reference methods, when compared using a 40 difference of means of < 0.5 and a confidence interval between -0.5 and 0.5. Based on the data 41 presented, the reproducibility values obtained for all contamination levels were generally similar 42 between the candidate and reference methods, indicating that both the between-laboratory 43 variations and within-laboratory variations were consistent between the candidate and reference 44 method. These values indicate that for reproducibility, no meaningful statistical differences 45 (absolute value of <0.50 Log 10 ) were observed in the data between the candidate and reference 46 methods when test portions were analyzed by different analysts at each laboratory or within each 47 sample set at a given laboratory . 48 18 19 Difference of means values (0.00, 0.12, 0.01 and 0.04) for the uninoculated, low, medium 27 28 Difference of means values (0.00, 0.14, -0.05 and 0.05) for the uninoculated, low, medium 34 35 36 37 Discussion No negative feedback was reported to the study directors from the collaborating laboratories

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December 6, 2018