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27

of

76

presumptive and confirmed results. Detailed results of the POD analyses

are presented in Tables 13 and 17 of the Appendix.

Raw Beef Trim

For the low inoculation level of the

mericon

E. coli O157 Screen

PlusPathogen Detection Assay, there were 13 presumptive positives and

13 confirmed positives following the USDA/FSIS-MLG 5B.05 reference

method confirmation procedure. There were 13 observed positives for the

reference method. For the high inoculation level, there were 5

presumptive positives and 5 confirmed positives following the

USDA/FSIS-MLG 5B.05 reference method confirmation procedure. There

were 5 confirmed positives following the reference method.

For the low inoculation level, a dPOD

C

value of 0.00 was obtained with a

95% confidence interval of (-0.28, 0.28), indicating no significant

difference between the candidate and reference methods. A dPOD

CP

value of 0.00 was obtained with a 95% confidence interval of (-0.28,

0.28), indicating no significant difference between the candidate

presumptive and confirmed results.

For the high inoculation level, a dPOD

C

value of 0.00 was obtained with a

95% confidence interval of (-0.43, 0.43), indicating no significant

difference between the candidate and reference methods. A dPOD

CP

value of 0.00 was obtained with a 95% confidence interval of (-0.43,

0.43), indicating no significant difference between the candidate

presumptive and confirmed results. Detailed results of the POD analyses

are presented in Tables 13 and 17 of the Appendix.

Manual mericonDNA Extraction Procedure - E. coli STEC O-Type

Fresh Spinach

For the low inoculation level of the

mericon

E. coliSTEC O-Type Pathogen

Detection Assay, there were 7 presumptive positives and 7 confirmed

positives following the FDA/BAM Chapter 4A reference method

confirmation procedure. There were 9 observed positives for the

reference method. For the high inoculation level, there were 5

presumptive positives and 5 confirmed positives following the FDA/BAM

Chapter 4A reference method confirmation procedure. There were 5

confirmed positives following the reference method.

For the low inoculation level, a dPOD

C

value of -0.10 was obtained with a

95% confidence interval of (-0.37, 0.19), indicating no significant

difference between the candidate and reference methods. A dPOD

CP

value of 0.00 was obtained with a 95% confidence interval of (-0.28,

0.28), indicating no significant difference between the candidate

presumptive and confirmed results.

OMAMAN-36 E/ AOAC PTM Report

ERP Use Only

January 2017

AOAC Research Institute

Expert Review Panel Use Only