64 / 71
Limit of Detection (LOD)
50
Limit of detection (LOD).—The minimum concentration or mass of analyte that can be
51
detected in a given matrix with no greater than 5% false-positive risk and 5% false-negative
52
risk.
53
54
Method detection limit (MDL)
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.
1
59
60
Repeatability
61
Variation arising when all efforts are made to keep conditions constant by using the same
62
instrument and operator and repeating during a short time period. Expressed as the
63
repeatability standard deviation (SD
r
); or % repeatability relative standard deviation
64
(%RSD
r
).
65
66
Reproducibility
67
The standard deviation or relative standard deviation calculated from among-laboratory
68
data. Expressed as the reproducibility standard deviation (SD
R
); or % reproducibility relative
69
standard deviation (% RSD
R
).
70
71
Recovery
72
The fraction or percentage of
spiked incurred
analyte that is recovered when the test
73
sample is analyzed using the entire method.
74
75
Whole Egg
76
A combination of pasteurized [chicken] egg whites and egg yolks from the same production
77
batch blended together in their entirety, in natural proportions.
2
78
79
80
5.
Method Performance Requirements
:
81
See table 1.
82
83
6.
System suitability tests and/or analytical quality control:
84
Suitable methods will include blank check samples, and check standards at the lowest point
85
and midrange point of the analytical range.
86
87
7.
Reference Material(s):
88
89
Refer to Annex F:
Development and Use of In-House Reference Materials
i
n Appendix F:90
Guidelines for Standard Method Performance Requirements
, 20
th
Edition of the AOAC
91
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.
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”?
Lisa Monteroso (3M)