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Comments Received
•
66 comments received and addressed byWG
•
General comments regarding footnotes, typos and clarification
•
Revised definition of Baby Spinach and Romaine Lettuce
•
Eliminated Annex I: Controls (positive, negative, inhibition control)
•
Specified MaximumTime to Determination as ≤ 24 hours.
•
Content-specific
•
Inclusivity specify “must test” and minimum representation of
-
-
subspecies (
salamae, houtenae, bongori, arizonae, diarizonae
)
•
Follow-up question needed to be addressed by ISPAM
•
RLOD
Comments Received
Parameter
Parameter Requirements
Target Test
Concentration*
Minimum
Acceptable Results
Acceptable
Minimum
SLV: Minimum of 20 replicates per food
type, artificially inoculated as outlined in
1 to 5
cfu /
25 to 75% positive
rate; and
dPOD ≥ 0
1. Method Performance Requirements
Detection
Level (AMDL)
internationally accepted method validation
guidelines.
test portion
,
LCL < 0,
UCL > 0 **
High
concentration
SLV: Minimum of 5 replicates per food type
artificially inoculated as outlined in
internationally accepted method validation
guidelines at 10x the AMDL concentration.
10 to 50
cfu /
test portion
100% correct analyses
are expected per food
type
‡
Zero
concentration
SLV: Minimum of 5 replicates per food type
that have tested negative with the reference
method in the validation study and have not
been artificially inoculated.
0
cfu /
test portion
LPOD
Multi laboratory study
1 – 10
cfu /
test portion
0.15 ≥ LPOD
C
≥ 0.85
dLPOD
†
=
‐
.
10 to 50
cfu /
test portion
LPOD
§
≥ 0.95
dLPOD
†
=
LPOD
(0)
Multi‐laboratory study.
0
cfu /
Test portion
LPOD
‡‡
≤ 0.05
RLOD
Single laboratory study
Combined
levels
RLOD =TBD
Multi‐laboratory study
RLOD = TBD