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31
Markus Lacorn, R-
Biopharm
Definiton: LoQ is not defined in an acceptable way since sufficient
precision and acceptable recovery should be mentioned. The
terms “sufficient” and “acceptable” depends on the method
developer and shall be stated with numbers.
Change: to be discussed by the group
The Appendix M definition was used for LOQ.
32
Girdhari Sharma,
US FDA
Line 50, LOD: would this be 90 or 95% certainty? LOD calculation is
presented in Appendix M. Can the false-positive at minimum
concentration of analyte be distinguishable from true-positive
expected at the LOD concentration? The false-positive would be
due to matrix interference.
Appendix M guidance was used, the certainty level will be
specified in Table 1
32
Lisa Monteroso
(3M)
Include proposed LOD text and strike MDL;
Agreed.
33
Terry Koerner,
Health Canada Same as LOQ. Be more specific to total egg protein
Egg comment was revised to be more specific
34
Lisa Monteroso
(3M)
The statement on allowing spikes at no less than LLA x2 or less is
confusing when you truly need to have the spiking done at the
LOD and LOQ to confirm the LOD and LOQ.
35
Lisa Monteroso
(3M)
LOD should be estimated by a statistical analysis of the calibration
data according to the ISO
36
Lisa Monteroso
(3M)
Add LOD ISO references: standard ISO 11843-2 (6) for linear data,
or ISO 11843-5 (7) (Cut and paste from Appendix M)
Section: Definition - Reproducibility
37
67 Markus Lacorn, R-
Biopharm
Definitions: mention that reproducibility is only characterized
when a collaborative test was performed
Change: include collaborative tests in the definition
There are actually other ways to collect reproducibility data
other than collaorative study. RSDR can be calculated
using proficiency data or a combination of collaborative
and proficiency data.
38
Markus Lacorn, R-
Biopharm
Definition “recovery”: Recovery may be characterized by spiking
experiments because incurred materials are not available; this
SMPR should allow spiked samples if there is no other possibilities;
incurred should be preferred in any case
39
Yumin Chen,
PepsiCo
Spiking – According to the AOAC appendix M, the best spiking samp
40
Melanie Downs.
Univ of Neb
The definition given in this section seems too specific to a
particular product for the purposes of this SMPR. The definition
given is that of refrigerated liquid whole eggs, as defined by the
USDA FSIS. Given the complicated regulatory authority for eggs in
the United States (i.e. the FDA regulates in shell eggs, while the
USDA FSIS regulates egg products), it may be difficult to apply a
regulatory definition of whole egg for the purposes of this SMPR.
(The FDA also does not have a regulatory definition for "eggs", per
21 CFR 160.100.) It would be beneficial for this working group to
agree upon a simple definition for egg that suits the purposes of
the SMPR.
The definition was adjusted to refer to consider egg
powder as the basis for reference material used in practical
food testing
41
Terry Koerner,
Health Canada
We should be clear on how this whole egg definition, which comes
from a food inspection service will carry over to the reporting units
of total egg protein.
Agreed and considered in the requirement set for Table 1.
42
Virginie Barrere,
Université Laval
Yes. FAO CXP_015e
Pasteurization – a microbiocidal control measure where eggs or
egg products are subjected to a process, using heat to reduce the
load of pathogenic microorganisms to an acceptable level to
ensure safety.
The working group agreed to remove the term
"pasterurized".
43
44
81 Markus Lacorn, R-
Biopharm
System suitability: Quantitative ELISA systems always contain
calibrators therefore it is not necessary to deliver an additional
check sample; instead: It is recommended that every user of these
kits establish his own control samples that fits his needs best.
Agreed, draft amended accordingly.
45
84 Terry Koerner,
Health Canada Appendix M is clear about what the testing levels should be.
Agreed, draft amended accordingly.
46
85 Laura Allred,
GFCO/GIG
Section 6 (line 85). Would this section be a good place to list
required cross-reactivity checks, perhaps by referencing Table 1 of
Appendix M?
Agreed, draft amended accordingly.
47
85 Markus Lacorn, R-
Biopharm
Reference Materials: Delete LGC materials since they are produced
by a lab which is NOT ACCREDITED according to ISO Guides! Please
refer to the “certificates” this lab delivers (only ISO 9001 is
mentioned). Certifcates are available on request. The NIST
materials are valuable.
Agreed, draft amended accordingly.
LOD/LOQ were revised in accordance with Appendix M.
69
Addressed in section 8 - validation guidance
50
Section: Definition - Recovery
Section: Definition - Whole Egg
76
Section: System Suitability
Section: Reference Materials