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The probability of detection (POD) was calculated as the number of positive outcomes
divided by the total number of trials [12]. The POD was calculated for the candidate
presumptive results, POD
CP,
the candidate confirmatory results, POD
CC
, the difference in
the candidate presumptive and confirmatory results, dPOD
CP,
presumptive candidate
results that confirmed positive, POD
C,
the reference method, POD
R
, and the difference in
the confirmed candidate and reference methods, dPOD
C
. POD analyses were conducted
for the
mericon
test points and compared to the appropriate reference method results. The
POD analysis between the
mericon
methods presumptive and confirmed results for all
matricies indicated that there was no significant difference at the 5% level. A summary of
the POD analyses [13] is presented in Tables 13-20 of the Appendix. As per criteria
outlined in Appendix J of the Official Methods of Analysis Manual, fractional positive results
were obtained.[13].
Table 5: Summary of Results for
mericon
E. coli
O157
Screen Plus
Matrix
Inoculation
Level
mericon
E.coli
O157
Screen Plus Pathogen
Detection Assay
mericon
E.coli
O157
Screen Plus Pathogen
Detection Assay
Reference
Method
Confirmed
Manual
Automated
Manual
Automated
Presumptive
Presumptive
Confirmed
Confirmed
Fresh Spinach
Un-inoculated
0/5
0/5
0/5
0/5
0/5
Low
7/20
7/20
7/20
7/20
9/20
High
5/5
5/5
5/5
5/5
5/5
Raw Ground
Beef (70%
Lean)
Un-inoculated
0/5
0/5
0/5
0/5
0/5
Low
9/20
9/20
9/20
9/20
9/20
High
5/5
5/5
5/5
5/5
5/5
Raw Beef Trim
Un-inoculated
0/5
0/5
0/5
0/5
0/5
Low
13/20
13/20
13/20
13/20
13/20
High
5/5
5/5
5/5
5/5
5/5
Table 6: Summary of Results for
mericon
E. coliSTEC O-Type Pathogen Detection
Matrix
Inoculation
Level
mericon
E.coli
STEC O-Type Pathogen
Detection Assay
mericon
E.coli
STEC O-Type Pathogen
Detection Assay
Reference
Method
Confirmed
Manual
Automated
Manual
Automated
Presumptive
Presumptive
Confirmed
Confirmed
Fresh Spinach
Un-inoculated
0/5
0/5
0/5
0/5
0/5
Low
7/20
7/20
7/20
7/20
9/20
High
5/5
5/5
5/5
5/5
5/5
Raw Ground
Beef (70%
Lean)
Un-inoculated
0/5
0/5
0/5
0/5
0/5
Low
9/20
9/20
9/20
9/20
9/20
High
5/5
5/5
5/5
5/5
5/5
Raw Beef Trim
Un-inoculated
0/5
0/5
0/5
0/5
0/5
Low
13/20
13/20
13/20
13/20
13/20
High
5/5
5/5
5/5
5/5
5/5
OMAMAN-36 E/ AOAC PTM Report
ERP Use Only
January 2017
AOAC Research Institute
Expert Review Panel Use Only