AOAC ISPAM Food Allergen WG Meeting Book (12-15-16)
Diana Kavolais (The Hershey Co.)
50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91
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.
Made with FlippingBook