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Whole Egg
42
A combination of pasteurized
[
chicken
] (
Gallus gallus domesticus
)
egg whites and egg
43
yolks from the same production batch blended together in their entirety, in natural
44
proportions
. 245
46
Limit of Quantitation (LOQ)
47
The minimum concentration or mass of analyte in a given matrix that can be reported as a
48
quantitative result.
LOQ = average (blank) + 10 * s0 (blank).*
49
50
Method detection limit (MDL)
51
Method detection limit (MDL)
is the minimum concentration of a substance than can be
52
measured and reported with 99% confidence that the analyte concentration is greater than
53
zero. It is determined from analysis of a sample in a given matrix containing the analyte.
354
55
The minimum concentration of a substance that can be measured (detected) and reported
56
with 99% confidence that the analyte concentration is greater than zero and is determined
57
from analysis of a sample in a given matrix containing the analyte using at least two ion
58
MS/MS transitions.
See 4 (a) of 40 CFR Part 136, Appendix B to Part 136 - Definition and
59
Procedure for the Determination of the Method Detection Limit-Revision.
460
61
Repeatability
62
Variation arising when all efforts are made to keep conditions constant by using the same
63
instrument and operator and repeating during a short time period. Expressed as the
64
repeatability standard deviation (SD
r
); or % repeatability relative standard deviation
65
(%RSD
r
).
*
66
67
Reproducibility
68
The standard deviation or relative standard deviation calculated from among-laboratory
69
data. Expressed as the reproducibility standard deviation (SD
R
); or % reproducibility relative
70
standard deviation (% RSD
R
).
*
71
72
Recovery
73
The fraction or percentage of spiked analyte that is recovered when the test sample is
74
analyzed using the entire method.
**
75
76
5.
Method Performance Requirements
:
77
See table 1.
78
79
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
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