AOAC CASP Meeting

Comments Submitted Line 190:  Add "Which if possible, should  include the replicates run in the validation  study"

See Next Comment for change made regarding Line 190

Line 191:  Right before "See appendix"  please add a new statement, if possible,  regarding the use of matrix study test  portions in the MPN study.

The following sentence has been added to the SMPR: If possible, the use  of test portions included in the matrix study  should be included as a level in the MPN study.   Contamination levels have been modified to be broader and not as  prescriptive.   AMDL has been changed to Fractional Concentration (Low Level) in  column one.   The minimum acceptance criteria has been reworded to be more  straightforward:   Fractional positive results 25‐75%  (5 to 15 positive test  replicates).  No change to the dPODCP criteria as it matches Appendix J Table 1 has been updated to indicate 12 replicates are required for each  contamination level for an MLV

Method performance table:  Review the  number of CFUs and dPOD in AMDL 

Method Performance table: Include the  number of test replicates per  contamination level for the MLV

Comments Submitted

Table 5 ‐ Conditions of inoculating culture  needs more details

Additional details have been added to describe the inoculating cells state  prior to inoculation (ex. Liquid non‐stressed) Table 6 has been updated to indicate ‐ Minimum # of strains (50) needed  to test for inclusivity;           Final test concentration of inclusivity organisms has been changed to 10‐ 100x the LOD of the candidate method.  Requirement for exclusivity cultures to be grown in non‐selective media  (and not following candidate method enrichment process) has been  added.   A footnote has been included to reference that positive exclusivity  strains may be recultured following the candidate method enrichment  procedure and analyzed a second time. Both sets of data will be  reported. All changes align the SMPR with Appendix J Use of confidence intervals for inclusivity and exclusivity testing is not  established in international validation guidelines.   ATCC strains have been kept in the table, but a footnote indicating that  the strains are recommended due to previous misidentification as one of  the four target strains.  Alternative strains for the same genus/species  may be substituted

Table 6 Inclusivity does not align with  Appendix J.

Table 6 Inclusivity:  Use of POD and 95% CI  to determine acceptance criteria

Table 8:  Remove ATCC designations