AOAC ISPAM Food Allergen WG Meeting Book (12-15-16)

Lisa Monteroso (3M)

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Limit of Detection (LOD)

Limit of detection (LOD).—The minimum concentration or mass of analyte that can be detected in a given matrix with no greater than 5% false-positive risk and 5% false-negative

risk.

Method detection limit (MDL)

The minimum concentration of a substance that can be measured (detected) and reported with 99% confidence that the analyte concentration is greater than zero and is determined from analysis of a sample in a given matrix containing the analyte using at least two ion

MS/MS transitions. 1

Repeatability

Variation arising when all efforts are made to keep conditions constant by using the same instrument and operator and repeating during a short time period. Expressed as the

repeatability standard deviation (SD r

); or % repeatability relative standard deviation

(%RSD r

).

Reproducibility

The standard deviation or relative standard deviation calculated from among-laboratory

data. Expressed as the reproducibility standard deviation (SD R

); or % reproducibility relative

standard deviation (% RSD R ).

Recovery

The fraction or percentage of spiked incurred analyte that is recovered when the test

sample is analyzed using the entire method.

Comment [D2]: In performance table, be specific or clarify so that it is clear what is meant as to type of egg. Comment [D3]: Do we need to add a footnote for a definition/reference for “pasteurized”?

Whole Egg

A combination of pasteurized [chicken] egg whites and egg yolks from the same production

batch blended together in their entirety, in natural proportions. 2

5.

Method Performance Requirements :

See table 1.

6. System suitability tests and/or analytical quality control:

Suitable methods will include blank check samples, and check standards at the lowest point

and midrange point of the analytical range.

7. Reference Material(s):

Refer to Annex F: Development and Use of In-House Reference Materials in Appendix F: Guidelines for Standard Method Performance Requirements , 20 th Edition of the AOAC

1 40 CFR Part 136, Appendix B to Part 136 - Definition and Procedure for the Determination of the Method Detection Limit-Revision 1.11

2 Introduction to Egg Products, USDA Food Safety and Inspection Service, website: http://www.fsis.usda. gov/wps/wcm/connect/c5c85914-5055-4f09-8098-1a179a1c6e14/EPT_Introduction.pdf?MOD=AJPERES, accessed 12/15/2015.