APAC SPSFAM Mid Year 2016

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Whole Egg

A combination of pasteurized chicken ( Gallus gallus domesticus ) egg whites and egg yolks from the same production batch blended together in their entirety, in natural

proportions. 2

Limit of Quantitation (LOQ)

The minimum concentration or mass of analyte in a given matrix that can be reported as a

quantitative result. LOQ = average (blank) + 10 * s0 (blank).*

Method detection limit (MDL)

Method detection limit (MDL) is the minimum concentration of a substance than can be measured and reported with 99% confidence that the analyte concentration is greater than zero. It is determined from analysis of a sample in a given matrix containing the analyte. 3 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. See 4 (a) of 40 CFR Part 136, Appendix B to Part 136 - Definition and Procedure for the Determination of the Method Detection Limit-Revision. 4

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 analyte that is recovered when the test sample is

analyzed using the entire method.**

5. Method Performance Requirements :

See table 1.

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. * See Table A3 in Appendix F: Guidelines for Standard Method Performance Requirements for additional guidance. ** See Spiking method in Appendix M in the Official Methods of Analysis. 3 Volume II - Methods, Method Verification and Validation ORA-LAB.5.4.5; DOCUMENT NO.: IV-02; VERSION NO.:1.7; Section 2 – Microbiology; EFFECTIVE DATE: 10-01-03; REVISED: 08-25-14; WEBSITE: http://www.fda.gov/ScienceResearch/FieldScience/ucm171877.htm , ACCESSED: Feb. 22, 16. 4 40 CFR Part 136, Appendix B to Part 136 - Definition and Procedure for the Determination of the Method Detection Limit-Revision ( link )