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6.
System suitability tests and/or analytical quality control:
78
Suitable methods will include blank check samples, and check standards at the lowest point
79
and midrange point of the analytical range.
80
81
7.
Potential Reference Material(s):
82
83
Whole Egg
84
•
NIST 8445
85
•
LGC SAL-RSM-5 (Check for characterization level)
86
87
Nonfat Milk Powder
88
•
89
•
NIST SRM 1549a (whole milk powder)
90
91
Peanut
92
•
NIST SRM 2387 (peanut butter)
93
•
LGC
FAL-RFM1017-XXX94
95
Hazelnut
96
•
LGC
FAL-RFM1015-50 or FAL-RFM1015-50Âor
FAL-RFM1015-597
Additional materials can be found at the LGC and FAPAS websites
98
LGC
= http://www.lgcstandards.com/HK/en/search/?q=allergen:relevance:category:CEFP_7724399
FAPAS
= http://fapas.com/quality-control-materials/Available-quality-control-materials.cfm100
101
Refer to Annex F:
Development and Use of In-House Reference Materials
in
Appendix F:102
Guidelines for Standard Method Performance Requirements
, 19
th
Edition of the AOAC
103
INTERNATIONAL Official Methods of Analysis (2012). Available at:
104
http://www.eoma.aoac.org/app_f.pdf105
106
NIST = National Institute for Standards and Technology.
107
LGC = formerly the UK
Laboratory of the Government Chemist
, now simply “LGC Standards”.
108
FAPAS = formerly the
Food Analysis Performance Assessment Scheme
in the UK, now simply
109
“FAPAS”.
110
111
112
8.
Validation Guidance
:
113
114
Method developers shall submit LOQ, MDL, recovery and precision data for the matrices in
115
Table 2.
116
117
Appendix D:Guidelines for Collaborative Study Procedures To Validate Characteristics of a
118
Method of Analysis; 19
th
Edition of the AOAC INTERNATIONAL Official Methods of Analysis
119
(2012). Available at:
http://www.eoma.aoac.org/app_d.pdf120
121
Appendix F:Guidelines for Standard Method Performance Requirements; 19
th
Edition of the
122
AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at:
123
http://www.eoma.aoac.org/app_f.pdf124
125
9.
Maximum Time-To-Result:
None
126
127
Table 1: Method performance requirements.
128