AOAC OMA# 2011.06 Final Action Review-OMB

2011.06 (September 2017)-Fol-22 MLT Report

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Merieux NutriSciences, Crete, IL 60417, USA 2. Study Design:

Extensive campaign was carried out in a variety of ways, personal as well as through AOAC and ISO/IDF/AACC contacts and meetings to recruit potential laboratories for the multi-lab testing. Each laboratory received a detailed study protocol which was agreed in advance by the AOAC SPIFAN Review team. The AOAC arranged through the Covance laboratory to send the practice samples as well as the MLT samples to each lab agreed to participate. We sent one of the internal standard to each participating lab because of its cost issue. We also sent one of the reagent to each participating lab. Many of the participants could not get that reagent because of the lack of local suppliers or import issues. 2.1 THE MLT OVERVIEW The study is divided in two parts: method set up and qualification of participants (Part 1) and multi-laboratory testing (MLT) by the qualified participants (Part 2). 2.2. Method set up and qualification of participants The participating laboratories were requested to analyze two practice samples using the method provided and report the results to the study director. It was communicated to the laboratories that any deviation, such as necessity to substitute reagents, columns, apparatus or instruments, must be duly recorded and reported. Electronic templates were provided to the participants for data reporting. Moreover raw data was requested wherever necessary. After review, the study director identified the laboratories which have the capability to run the analysis successfully. 2.3. Multi laboratory testing by qualified participants The qualified laboratories were then asked to analyze the MLT samples on two different days following the protocols. The results were submitted to the study director for evaluation. Unless otherwise specified in the protocol, all powdered samples were analyzed on a reconstituted basis, using about 25 grams of sample into about 225 grams with water, as stated in the attached method. The liquid samples were analyzed “as is” after a thorough mixing. 2.4 Reporting: An electronic template was provided for data reporting. Detailed information on different weights and volumes used during sample preparation was reported in the reporting template. Laboratories were asked to report final folate results in μg/100 g and associated calculations. Upon completion of the full sample analysis, each participating laboratory reported results as well as raw data such as sample identification, weights, volumes, and raw concentrations provided by the LC-MS data acquisition or data processing software. Participants were requested to document any deviation from the method.

Collaborative Study Report: Method AOAC 2011.06 (Folate by LC-MS/MS) 4