ISPAM Stakeholder Panel Meeting Book 3-14-17

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 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.

Markus Lacorn, R- Biopharm

31

The Appendix M definition was used for LOQ.

Appendix M guidance was used, the certainty level will be specified in Table 1

Girdhari Sharma, US FDA

32

Lisa Monteroso (3M)

50

Include proposed LOD text and strike MDL;

Agreed.

32

Terry Koerner, Health Canada Same as LOQ. Be more specific to total egg protein

33

Egg comment was revised to be more specific

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. LOD should be estimated by a statistical analysis of the calibration data according to the ISO Add LOD ISO references: standard ISO 11843-2 (6) for linear data, or ISO 11843-5 (7) (Cut and paste from Appendix M)

Lisa Monteroso (3M)

34

Lisa Monteroso (3M) Lisa Monteroso (3M)

LOD/LOQ were revised in accordance with Appendix M.

35

36

Section: Definition - Reproducibility

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.

Definitions: mention that reproducibility is only characterized when a collaborative test was performed Change: include collaborative tests in the definition

37

67 Markus Lacorn, R- Biopharm

Section: Definition - Recovery

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

Markus Lacorn, R- Biopharm

38

69

Addressed in section 8 - validation guidance

Yumin Chen, PepsiCo

39

Spiking – According to the AOAC appendix M, the best spiking samp

Section: Definition - Whole Egg

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. 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. 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 definition was adjusted to refer to consider egg powder as the basis for reference material used in practical food testing

Melanie Downs. Univ of Neb

40

76

Terry Koerner, Health Canada

41

Agreed and considered in the requirement set for Table 1.

The working group agreed to remove the term "pasterurized".

Virginie Barrere, Université Laval

42

43

Section: System Suitability

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.

81 Markus Lacorn, R- Biopharm

44

Agreed, draft amended accordingly.

Agreed, draft amended accordingly.

45

84 Terry Koerner, Health Canada Appendix M is clear about what the testing levels should be.

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.

46

85 Laura Allred, GFCO/GIG

Section: Reference Materials

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.

47

85 Markus Lacorn, R- Biopharm

Page 4