92 / 166
Repeatability (reference ISO 5725)
47
Variation arising when all efforts are made to keep conditions constant by using the same
48
instrument and operator (in the same laboratory) and repeating during a short time period.
49
Expressed as the repeatability standard deviation (SD
r
); or % repeatability relative standard
50
deviation (%RSD
r
).
51
52
Reproducibility
53
Variation arising when identical test materials are analyzed in different laboratory by
54
different operators on different instruments. The standard deviation or relative standard
55
deviation calculated from among-laboratory data. Expressed as the reproducibility standard
56
deviation (SD
R
); or % reproducibility relative standard deviation (% RSD
R
).
57
58
Recovery
59
The fraction or percentage of analyte that is recovered when the test sample is analyzed
60
using the entire method.
61
62
Egg
63
A combination of [chicken] egg whites and egg yolks in their entirety, in natural
64
proportions.
2For the purposes of this SMPR, egg is referred to in its dry form as represented
65
by existing reference materials
66
67
5.
Method Performance Requirements
:
68
See table 1.
69
70
6.
System suitability tests and/or analytical quality control:
71
See antibody information, cross reactivity, information on calibrators and information on
72
matrices in section “Required Allergen-Specific Information to be Provided on the ELISA
73
Method” of Appendix M.
74
75
Method developers should clearly identify what component(s) of the egg they are
76
measuring and provide the conversion factor used to equate to dried egg.
77
78
Method developers should provide applicability statement for intended use and claimed
79
matrices.
80
81
7.
Reference Material(s):
82
Refer to Annex F:
Development and Use of In-House Reference Materials
in
Appendix F:83
Guidelines for Standard Method Performance Requirements
, 20
th
Edition of the AOAC
84
INTERNATIONAL Official Methods of Analysis (2016). Available at:
85
http://www.eoma.aoac.org/app_f.pdf86
87
Chicken Egg
88
•
NIST 8445 (Spray dried whole egg for allergen detection)
89
90
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.