44 / 90
Whole Egg
40
A combination of pasteurized chicken (
Gallus gallus domesticus
) egg whites and egg
41
yolks from the same production batch blended together in their entirety, in natural
42
proportions.
243
44
Limit of Quantitation (LOQ)
45
The minimum concentration or mass of analyte in a given matrix that can be reported as a
46
quantitative result. LOQ = average (blank) + 10 * s0 (blank).*
47
48
Method detection limit (MDL)
49
Method detection limit (MDL)
is the minimum concentration of a substance than can be
50
measured and reported with 99% confidence that the analyte concentration is greater than
51
zero. It is determined from analysis of a sample in a given matrix containing the analyte.
352
53
The minimum concentration of a substance that can be measured (detected) and reported
54
with 99% confidence that the analyte concentration is greater than zero and is determined
55
from analysis of a sample in a given matrix containing the analyte using at least two ion
56
MS/MS transitions. See 4 (a) of 40 CFR Part 136, Appendix B to Part 136 - Definition and
57
Procedure for the Determination of the Method Detection Limit-Revision
. 458
59
Repeatability
60
Variation arising when all efforts are made to keep conditions constant by using the same
61
instrument and operator and repeating during a short time period. Expressed as the
62
repeatability standard deviation (SD
r
); or % repeatability relative standard deviation
63
(%RSD
r
).*
64
65
Reproducibility
66
The standard deviation or relative standard deviation calculated from among-laboratory
67
data. Expressed as the reproducibility standard deviation (SD
R
); or % reproducibility relative
68
standard deviation (% RSD
R
).*
69
70
Recovery
71
The fraction or percentage of spiked analyte that is recovered when the test sample is
72
analyzed using the entire method.**
73
74
5.
Method Performance Requirements
:
75
See table 1.
76
77
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 )