ERP Micro December 2019

AOAC EXPERT REVIEW PANEL FOR MICROBIOBIOLOGY FOR FOODS AND ENVIRONMENTAL SURFACES MARCH 11, 2019 REFERENCE METHOD TABLE FOR DISCUSSION Appendix J: AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces • 4.2.2 Reference Method If there is a reference method, then the candidate method is compared to a reference method. The reference method should be the same as that used in the Method Developer Study.  Issue: Does the reference method in the SLV and MLV have to match? • 4.3.5 Analyte Level Estimation Refer to Section 4.1.3.4. Use the reference method (or candidate method if there is no reference method) test portions with additional levels to estimate the MPN using the formula in Annex A. The levels of contamination are one high level, one level where fractional recovery is expected, and one uninoculated level.  Issue: the method developer should have all data to include the omission of laboratories for estimation of the incidence of fractional positives as prescribed by Appendix J.

Method POD – CP POD – C POD – R POD – CP POD – C POD – R

CRO

SAL

LIS

LMO

ECO

0.75 (0.68, 0.84) 0.75 (0.68, 0.84) 0.84 (0.77, 0.91)

0.95 (0.88, 0.98) 0.95 (0.88, 0.98) 0.95 (0.88, 0.98)

0.91 (0.83, 0.96) 0.90 (0.81, 0.95) 0.95 (0.88, 0.98) 0.79 (0.62, 0.97) 0.78 (0.61, 0.94) 0.87 (0.80, 0.92)

0.83 (0.65, 1.00) 0.83 (0.65, 1.00) 0.89 (0.80, 0.94) 0.78 (0.61, 0.94) 0.78 (0.61, 0.94) 0.85 (0.69, 1.00)

0.90 (0.82, 0.95) 0.90 (0.82, 0.95) 0.63 (0.41, 0.84)

# of Replicates POD Low Level

8

8

8

8

8

Ok

(outside)

(outside)

(outside)

Ok

Criteria for Lab Omission Reference Method- CS Reference Method - PTM Reference Method – AFNOR/MICROVAL

ISO

ISO

ISO

ISO

ISO

ISO

BAM; MLG

BAM; MLG

BAM; MLG

BAM; MLG

ISO

ISO

ISO

ISO

ISO