6 / 65
FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
4
Recommendation:
The method is well written and all the required validation data are collected and clearly presented for
review. Though the method is very promising and showed good repeatability there are following method
performance problems that need to be addressed before this method could be recommended for first
action official method:
1.
Intermediate reproducibility data for majority of amino acids don’t meet SMPR requirements with
some RSDiR exceeding 10 or even 20%. Providing that repeatability data were within SMPR
specifications and the chromatograms look very clean with well separated peaks explanation for
such variations in results is needed or this will be a problem if the method moves to multi-lab
study.
2.
Results of analysis for SRM 1849a don’t meet SMPR with 3 amino acids falling outside the certified
range.
3.
The method has narrow analytical range that doesn’t meet SMPR. It was noted by the authors that
several results from the SPIFAN kit matrices were falling outside the calibration range. This
limitation should be clearly noted in the method and recommendations provided of how to deal
with the samples outside the linear calibration range.
This method is not recommend as the first action at this time