SPIFAN Expert Review Panel Report
March 19, 2014
Final
I.
WELCOME AND INTRODUCTIONS
Darryl Sullivan welcomed all participants to the ERP meeting and introduced the ERP members.
II.
REVIEW ACTIONS FROM PREVIOUS MEETING
Darryl Sullivan reviewed previous actions/items from past meetings.
III.
REVIEW OF METHODS BY EXPERT REVIEW PANEL (ERP) FOR FIRST ACTION
OFFICIAL METHOD
SM
STATUS
For each method, the ERP/Working Group Co-Chairs discussed methods submitted.
Carnitine –
Co‐Chairs:
John Austad (Covance) & Guenther Raffler (CLF-Eurofins)
Choline –
Co‐Chair:
Sneh Bhandari (Silliker) & Nick Cellar (Abbott)
To study directors, methods should be able to detect both carnitine and choline, but evaluate the methods
independently.
IV.
REVIEW OF MODIFICATION FOR OMA# 2011.08 (Vitamin B
12
)
V.
The Expert Review Panel (ERP) reviewed the modification to OMA method 2011.08. The primary
(Christiansen/Sliva) and secondary (Kneeteman) reviewers provided their evaluation along with other
members of the ERP.
This is a new method, it contains significant changes. Should check if it should be major or minor
modification
For AOAC First Action, the method must have SPIFAN SLV data
For publication, reference the previous method
Vote the current modified method as AOAC First Action
HPLC/ULC – have data reflect both HPLC & ULC
Have a dispute resolution method, but keep as a back-up
Caveat – back up method if study director doesn’t want to continue
Re-introduce as a new method
VI.
REPEAL OF FIRST ACTION METHODS
The Expert Review Panel (ERP) members collectively discussed the next steps on the remaining First Action
Official Methods
SM
currently in the SPIFAN system.
Method
Method Title
Reviewer(s)
Vote
Comments
Folate
2011.05 - Folate in Infant Formula
and Adult/Pediatric Nutritional
Formula Optical Biosensor Assay
Sneh Bhandari
Melissa Phillips
*Motion to repeal
Yes- 11/ No-0 /Abstain-1
◊
Method is being used, but no
SLV data to be produced
2011.06 - Total Folates in Infant
Formula and Adult Nutritionals by
Trienzyme Extraction and UPLC-
MS/MS Quantitation: First Action
2011.06
Adrienne McMahon
Matt Sliva for Scott
Christiansen
*Motion to extend
method for one (1) year
Yes- 10/ No-0 /Abstain-1
◊
No further work will be done
◊
Extend method for one(1) year
◊
If method is kept, someone
should take it on
◊
1
st
Action status should have
meaning
o
Proprietary method (single
source)
4
◊
Nucleotides
2011.21 - Development and
Application of an HILIC-MS/MS
Method for the Quantitation of
Nucleotides in Infant Formula
Estela Kneeteman
Min Huang
*Motion to keep
Yes- 11/ No-0 /Abstain-1
◊
Keep as a back-up method
4
◊
ERP PROFILE SUMMARIES
28