AOAC OMB Final Action Recommendation (December 2019)-2016.14

2016.14 (October 2019) – FOS-03 MANUSCRIPT

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participants were provided with a new bottle of sucrase mixture of a known satisfactory batch. At 1 that time, several labs had already shared their results on the practice sample. They were asked to 2 communicate the batch of the sucrase mixture used for this analysis. The labs that reported results 3 of practice sample with an unsatisfactory batch of sucrase mixture were asked to repeat the analysis 4 with the enzyme batch provided, if this was feasible. Two labs did not repeat this analysis; one lab 5 repeated the analysis with one replicate with MLT samples Day 1 and the second replicate with 6 MLT samples Day 2. A third participant repeated the analysis but with no duplicate and another 7 lab repeated the analysis twice, one duplicate with MLT samples Day 1 and another duplicate 8 determination with MLT samples Day 2. Average results on practice sample analysis can be found 9 in Table 2 . 10 Because of the problems encountered with the sucrase enzyme mixture and other 11 chromatographic problems, the study was delayed by several months for some participating labs. 12 In order to keep the momentum going, it was decided to let all the participants continue with the 13 full set of MLT samples, even if not all practice sample results had been received. Two participants 14 had to drop out because of instrumentation problems and resource availability. The whole set of 15 data from practice sample analysis was split in two parts and statistically evaluated separately. One 16 evaluation was done with all the results obtained with satisfactory batches of sucrase enzyme 17 mixture and another evaluation was done with the results obtained with the unsatisfactory batch. 18 Both evaluations fulfill the Standard Method Performance Requirements (SMPR 2014.002) and 19 can be found in Table 3 .

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