AOAC ISPAM Meeting eBook, March 17 2015

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 1. Method Performance Requirements

Parameter 

Parameter Requirements 

Target Test  Concentration*

Minimum  Acceptable Results  25 to 75%  positive  rate; and   dPOD ≥ 0   ,  

Acceptable  Minimum  

SLV:  Minimum of 20 replicates per food  type, artificially inoculated as outlined in  internationally accepted method validation  guidelines.   SLV:  Minimum of 5 replicates per food type  artificially inoculated as outlined in  internationally accepted method validation  guidelines at 10x the AMDL 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. 

1 to 5  cfu /   test portion

Detection  Level (AMDL)   

LCL < 0,   UCL > 0 ** 

High  concentration  

10 to 50  cfu /    test portion

100% correct analyses  are expected per food  type ‡

Zero  concentration 

0  cfu /    test portion

1 – 10  cfu /    test portion  10 to 50  cfu /     test portion 0  cfu /    Test portion

0.15 ≥ LPOD C

≥ 0.85 

 dLPOD †   =  

LPOD

Multi laboratory study ‐ .

LPOD §  ≥ 0.95   dLPOD †   =   

LPOD ‡‡  ≤ 0.05 

LPOD  (0)

Multi‐laboratory study. 

RLOD =TBD  RLOD = TBD

Single laboratory study  Multi‐laboratory study 

Combined  levels 

RLOD