AOAC SPSFAM ERP for SELECTED FOOD ALLERGENS

2. Is there

information

demonstrating that

the method meets the

SMPR Method

Performance

Requirements using

the Reference

Materials stated in

the SMPR? If not,

then specify what is

missing and how this

impacts

demonstration of

performance of the

method.

Yes

3. Is there

information

demonstrating that

the method performs

within the SMPR

Method Performance

Requirements table

specifications for all

analytes in the

SMPR applicability

statement? If not,

please specify what

is missing and

whether or not the

method’s

applicability should

be modified.

Again: the calculation of MDL and MQL is not

correct. The calculation should not use a

commercial software for the estimation of S/N ratio

and consequently final sensitivity of the method.

Such approach is not correct and would never apply

to other instruments since it is instrument and brand

specific. Please carefully check the proper Anal

chem guidance for the correct estimation of MDL

and MQL.

This value should be recalculated and also the

recovery according to what stated in the SMPR

guidelines (n of independent analyses for each

concentration level).

III.

General Submission Package

1. Based on the

supporting

information, were

there any additional

steps in the

evaluation of the

method that

indicated the need

for any additional

precautionary