96 / 166
47
Repeatability (reference ISO 5725)
48
Variation arising when all efforts are made to keep conditions constant by using the same
49
instrument and operator (in the same laboratory) and repeating during a short time period.
50
Expressed as the repeatability standard deviation (SD
r
); or % repeatability relative standard
51
deviation (%RSD
r
).
52
53
Reproducibility
54
Variation arising when identical test materials are analyzed in different laboratory by
55
different operators on different instruments. The standard deviation or relative standard
56
deviation calculated from among-laboratory data. Expressed as the reproducibility standard
57
deviation (SD
R
); or % reproducibility relative standard deviation (% RSD
R
).
58
59
Recovery
60
The fraction or percentage of analyte that is recovered when the test sample is analyzed
61
using the entire method.
62
63
Egg
64
A combination of [chicken] egg whites and egg yolks in their entirety, in natural
65
proportions.
2For the purposes of this SMPR, egg is referred to in its dry form as represented
66
by existing reference materials
.
67
68
69
6.5.
Method Performance Requirements
:
70
See table 1.
71
72
7.6.
System suitability tests and/or analytical quality control:
73
74
75
See antibody information, cross reactivity, information on calibrators and information on
76
matrices in
section “Required Allergen-Specific Information to be Provided on the ELISA
77
Method” of
Appendix M.
78
79
Method developers should clearly identify what component(s) of the egg they are
80
measuring and provide the conversion factor used to equate to dried egg.
81
82
Method developers should provide applicability statement for intended use and claimed
83
matrices.
84
85
8.7.
Reference Material(s):
86
87
Refer to Annex F:
Development and Use of In-House Reference Materials
in
Appendix F:88
Guidelines for Standard Method Performance Requirements
, 20
th
Edition of the AOAC
89
INTERNATIONAL Official Methods of Analysis (2012). Available at:
90
http://www.eoma.aoac.org/app_f.pdf91
92
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.