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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
2
The qualified laboratories were then asked to analyze the 12 MLT SPIFAN samples on two different days
following carefully designed protocol provided. The results were submitted to the study director for
evaluation. An electronic template was provided for data reporting including system suitability, linearity,
peak areas of the standard curve as well as of the sample extracts. Furthermore, detailed information on
the different weights and volumes used during sample preparation as indicated in the method, as well as
raw data (chromatograms of standards and samples) were requested.
Laboratories were asked to report final biotin and biocytin results in μg/100 g to two decimal places.
Method Clarity:
The MLT procedure is well described, clear and easy to follow
Method Safety Concerns:
It is not necessary to use safety protection.
•
Performance Characteristics:
Analytical Range:
SMPR: 0.1 – 150 µg/100g
0.1 – 300 µg/100g
LOQ:
SMPR: ≤0.1 µg/100g
≤0.1 µg/100g
Accuracy/Recovery:
SMPR: 90 to 110 %
95 to 105 %
Precision (RSD
r
):
SMPR: >1 µg/100g: ≤6%
>1 µg/100g: ≤5%
Reproducibility (RSD
R
):