91 / 166
DRAFT AOAC Allergen SMPR Version 6; March 13, 2017
1
2
3
Quantitation of Chicken Egg by ELISA-based* Methods
4
5
Intended Use
: Method for quantitation of chicken egg in the context of food manufacturing.
6
7
1.
Purpose:
AOAC SMPRs describe the minimum recommended performance characteristics to
8
be used during the evaluation of a method. The evaluation may be an on-site verification, a
9
single-laboratory validation, or a multi-site collaborative study. SMPRs are written and
10
adopted by AOAC Stakeholder Panels composed of representatives from the industry,
11
regulatory organizations, contract laboratories, test kit manufacturers, and academic
12
institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their evaluation of
13
validation study data for method being considered for
Performance Tested Methods
or AOAC
14
Official Methods of Analysis
, and can be used as acceptance criteria for verification at user
15
laboratories.
16
17
2.
Applicability
:
18
Quantitation of chicken egg in one or more food(s) such as those listed in OMA Appendix M
19
(see Table 3). Add Journal reference
20
21
3.
Analytical Technique
:
22
Enzyme-linked immunosorbent assay (ELISA)-based assays (see definition in section 4).
23
24
4.
Definitions
:
25
26
Enzyme-linked immunosorbent assay (ELISA)
27
For the purposes of this document, ELISA is defined as “an analytical procedure
28
characterized by the recognition and binding of specific antigens by antibodies”
1. This
29
definition is not meant to be restrictive and encompasses other related binding based
30
technologies.
31
32
Limit of Detection (LOD) (reference Appendix M)
33
LOD is defined as the lowest concentration or mass of analyte in a test sample that can be
34
distinguished from a true blank sample at a specified probability level
.
35
36
Limit of Quantitation (LOQ) (reference Appendix M)
37
LOQ is the lowest level of analyte in a test sample that can be quantified at a specified level
38
of precision.
39
40
Limit of Application (LLA) (reference Appendix M)
41
A level below which the method developer does not support or recommend use of the
42
method.
43
44
45
46
1
AOAC Appendix M
*See section 4 – Definitions - Enzyme-linked immunosorbent assay (ELISA)