170 / 453
CONFIDENTIAL INFORMATION
Page 10 of 17
Table 5. POD
CP
, POD
CC
, and dPOD
CP
Values for the Candidate Method (200 g
Spinach Analyzed via the 3M
TM
MDA) and POD
R
, POD
C
, and dPOD
C
Values
for Candidate Method vs. the Reference Method (200 g Spinach Analyzed via
the FDA BAM Ch. 4A)
POD
CP
, Probability of Detection for Candidate Method “Screening Stage” Positive Results; POD
CC
, Probability of
Detection for Candidate Method “Confirmation Stage” Results; dPOD
CP
, POD
CP
Minus POD
CC
; POD
R
, Probability
of Detection for Reference Method Confirmed Results; POD
C
, Probability of Detection for Candidate Method
Confirmed Results (i.e. Combined “Screening Stage” and “Confirmation Stage” Results); dPOD
C
, POD
R
Minus
POD
C
. 95% Confidence Interval Values are Generated from the AOAC International POD Calculator.
Method / Inoculation Level
Measure Value
95% CI
POD
CP
1.000 (0.5655, 1.000)
POD
CC
1.000 (0.5655, 1.000)
dPOD
CP
0.000 (-0.434, 0.434)
POD
CP
0.350 (0.1812, 0.5672)
POD
CC
0.350 (0.1812, 0.5672)
dPOD
CP
0.000 (-0.275, 0.275)
POD
CP
0.000 (0.000, 0.4345)
POD
CC
0.000 (0.000, 0.4345)
dPOD
CP
0.000 (-0.434, 0.434)
POD
R
1.000 (0.5655, 1.000)
POD
C
1.000 (0.5655, 1.000)
dPOD
C
0.000 (-0.434, 0.434)
POD
R
0.450 (0.2582, 0.6579)
POD
C
0.350 (0.1812, 0.5672)
dPOD
C
-0.100 (-0.368, 0.190)
POD
R
0.000 (0.000, 0.4345)
POD
C
0.000 (0.000, 0.4345)
dPOD
C
0.000 (-0.434, 0.434)
Candidate Method Screening vs. Confirmation High Level
Inoculation
Candidate Method Screening vs. Confirmation Low Level
Inoculation
Candidate Method Screening vs. Confirmation Un-inoculated
Reference Method vs. Candidate Method High Level
Inoculation
Reference Method vs. Candidate Method Low Level Inoculation
Reference Method vs. Candidate Method Un-inoculated