AOAC OMB Final Action Recommendation (December 2019)-2016.14

2016.14 (October 2019) – FOS-03 MANUSCRIPT

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clarification were also required. After review by the study director, the results found to be within a 1 range of expected levels qualified the laboratories for the second part of the study. 2 All qualified participants were asked to analyse the 16 coded MLT samples (one single 3 determination per sample) on 2 days (8 samples per day). Each sample was assigned to either day 4 1 or day 2, the blind duplicates being assigned to the same day. Results were communicated to the 5 study director by filling a reporting template provided with the protocol. The information to be 6 filled in this template was similar to the one used in part 1 of the MLT. 7 8 Table 1. Reconstitution rates and dilution factors to be applied on MLT samples 9

Sample

Code

Day

Reconstitution Rate

Dilution Factor

MLT Sample 1 MLT Sample 2 MLT Sample 3 MLT Sample 4 MLT Sample 5 MLT Sample 6 MLT Sample 7 MLT Sample 8 MLT Sample 9 MLT Sample 10 MLT Sample 11 MLT Sample 12 MLT Sample 13 MLT Sample 14 MLT Sample 15 MLT Sample 16

GBAN911 ACGY733

1 1 1 1 1 1 1 1 2 2 2 2 2 2 2 2

10 g + 90 g water

1

As is

10

PTLO721

10 g + 90 g water

1

FJVP596

As is As is As is As is As is

10

YEJA706 DPLR873 TSWX969

1

10 10

NSIG474

1 1 1 1 1 1 1 1 1

RQXQ518

25 g + 200 g water 25 g + 200 g water 25 g + 200 g water 25 g + 200 g water 25 g + 200 g water 25 g + 200 g water 25 g + 200 g water 25 g + 200 g water

EFXN778 URTF231 GVPE615 NSRB999 WKHN288

BFAO941

JSDT587

10

All data received were subjected to statistical analysis as described in the “Appendix D: 11 Guidelines for Collaborative Study Procedures To Validate Characteristics of a Method of 12

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