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25

Table 2016.1D

:Summary of Results for the Detection of

E. coli

O157:H7in 73% Lean Raw Ground Beef (325g)

1

Method

a

mericon

E. coli STEC O-Type

Extraction Method

Automated QIAsymphony

Inoculation Level

Un-inoculated

Low

High

Candidate Presumptive Positive/

Total # of Samples Analyzed

1/144

63/144

141/144

Candidate Presumptive POD (CP)

0.01(0.00, 0.04)

0.44(0.35, 0.52)

0.98(0.94, 0.99)

s

r

b

0.08(0.07, 0.16)

0.51(0.45, 0.52)

0.14(0.13, 0.16)

s

L

c

0.00(0.00, 0.03)

0.00(0.00, 0.16)

0.00 (0.00, 0.15)

s

R

d

0.08(0.08, 0.10)

0.51 (0.46, 0.52)

0.14(0.13, 0.16)

P Value

e

0.4368

0.8105

0.6042

Candidate Confirmed Positive/

Total # of Samples Analyzed

0/144

65/144

144/144

Candidate Confirmed POD (CC)

0.00 (0.00, 0.03)

0.45 (0.37, 0.54)

1.00 (0.97, 1.00)

s

r

0.00 (0.00, 0.16)

0.51 (0.45, 0.52)

0.00 (0.00, 0.16)

s

L

0.00 (0.00, 0.16)

0.00 (0.00, 0.15)

0.00 (0.00, 0.16)

s

R

0.00 (0.00, 0.22)

0.51 (0.46, 0.52)

0.00 (0.00, 0.22)

P Value

1.0000

0.8479

1.0000

Candidate Confirmed Positive/

Total # of Samples Analyzed

0/144

63/144

141/144

Candidate Presumptive Positive that

Confirmed POD (C)

0.00 (0.00, 0.03)

0.44 (0.35, 0.52)

0.98 (0.94, 0.99)

s

r

0.00 (0.00, 0.16)

0.51 (0.45, 0.52)

0.14 (0.13, 0.16)

s

L

0.00 (0.00, 0.16)

0.00 (0.00, 0.16)

0.00 (0.00, 0.15)

s

R

0.00 (0.00, 0.22)

0.51 (0.46, 0.52)

0.14 (0.13, 0.16)

P Value

1.0000

0.8105

0.6042

Positive Reference Samples/ Total #

of Samples Analyzed

0/144

65/144

144/144

Reference POD

0.00 (0.00, 0.03)

0.45 (0.37, 0.54)

1.00 (0.97, 1.00)

s

r

0.00 (0.00, 0.16)

0.51 (0.45, 0.52)

0.00 (0.00, 0.16)

s

L

0.00 (0.00, 0.16)

0.00 (0.00, 0.15)

0.00 (0.00, 0.16)

s

R

0.00 (0.00, 0.22)

0.51 (0.46, 0.52)

0.00 (0.00, 0.22)

P Value

1.0000

0.8479

1.0000

dLPOD (Candidate vs. Reference)

f

0.00 (-0.03, 0.03)

-0.01(-0.13, 0.10)

-0.02(-0.06, 0.01)

dLPOD (Candidate Presumptive vs.

Candidate Confirmed)

f

0.01(-0.02, 0.04)

-0.01(-0.13, 0.10)

-0.02(-0.06, 0.01)

a

Results include 95% Confidence Intervals,

r

Repeatability Standard Deviation,

c

Among-Laboratory Standard Deviation,

d

Reproducibility Standard Deviation

2

e

P Value = Homogeneity test of laboratory PODs;

f

A confidence interval for dLPOD that does not contain the value 0 indicates a statistical significant difference between

3

the two methods

4

5

6

7

8

9

OMAMAN-36 A : Collaborative Study Manuscript

For ERP Use Only

January 2017

AOAC Research Institute

Expert Review Panel Use Only