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C

ONS

/W

EAKNESSES

:

The study experienced a number of issues that prohibit interpretation of results. Mold contamination of

NIST 2383 compromised the samples resulting in an average measurement ~1/2 of the certified value.

Also, only four of the eleven labs have replicate data, therefore repeatability cannot be reliably

calculated. For future consideration, the study needs to be repeated. A discussion about the forms

analyzed is missing in the manuscript. Intermediate Folic acid solution: gram is probably not the correct

unit. (2.5 g/100 ml). Also concentration is expressed in micro liter/mil. The report states that on

request of the General Referee a blank sample was included. However, AOAC's Collaborative Study

protocol describes the need of a blank sample. This should be corrected. The bias between the

certification value of IRMM CRM BCR 421 and the Biacore value needs to be explained.

This might be related to the fact that the certified value is based on total folate determined by

microbiological assay. However, when mentioned this should be properly described and discussed.

EXPERT REVIEW PANEL VOTE

AND

RECOMMENDATION

MOTION: Not to move forward to First Action Official Method

status.

Entered By:

Szpylka

Second By:

Konings

Vote:

7 Approved

0

Opposed

0

Abstain

M

OTION PASSED

ERP PROFILE SUMMARIES

191