OMB Meeting Book_9-11-14

Table 22: Reproducibility data for soy-based infant formula test sample

Sample ID: Sample 4 P-3972/M-1598 Analyte CMP a

UMP a

GMP a

AMP a

IMP

(mg hg -1 )

(mg hg -1 )

(mg hg -1 )

(mg hg -1 )

(mg hg -1 )

Laboratory

Rep-1

Rep-2

Rep-1

Rep-2

Rep-1

Rep-2

Rep-1

Rep-2

Rep-1

Rep-2

1 2

0.49 0.00

0.47 0.00

0.29 0.00

0.32 0.00

0.26 0.00

0.32 0.00

0.21 0.00

0.13 0.00

0.57 0.71

0.97 1.00

3

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

4

1.00

1.10

0.20

0.20

0.00

0.00

0.00

0.00

0.60

0.60

5

0.58

0.78

0.19

0.00

0.25

0.41

0.29

0.60

0.41

0.59

6

0.88

0.89

0.28

0.25

0.23

0.25

0.16

0.13

0.44

0.43

7

0.56

0.46

0.32

0.28

0.23

0.20

0.00

0.00

0.51

0.50

8

0.44

0.48

0.38

0.38

0.37

0.54

0.22

0.26

0.74

0.86

9

0.59

0.47

0.35

0.22

0.29

0.30

0.00

0.00

0.63

0.61

10

0.66

0.62

0.22

0.23

0.36

0.35

0.13

0.13

0.86

0.88

11

0.90

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

12

0.30

0.35

0.27

0.29

0.49

0.45

0.89

0.76

0.54

0.55

Table 23: Reproducibility analysis for soy-based infant formula test sample

Sample ID: Sample 4 P-3972/M-1598

CMP a

UMP a

GMP a

IMP a

AMP a

Analyte

Seq.

Item

Symbol

Value

Value

Value

Value

Value

1 2

Total number of laboratories

n

12 24

12 24

12 24

12 24

12 24

Total number of replicates

2n

3

Overall mean of all data (grand mean)

0.50

0.19

0.22

0.16

0.54

4

Repeatability standard deviation

S r

0.19

0.05

0.05

0.07

0.11

5

Reproducibility standard deviation

S R

0.34

0.14

0.18

0.25

0.30

6

Repeatability limit in SMPR

≤8%

≤10%

≤10%

≤10%

≤8%

7

Repeatability relative standard deviation

RSD r

38.5%

25.0%

22.9

43.7%

20.4%

8

Reproducibility limit in SMPR

≤16%

≤20%

≤20%

≤20%

≤16%

9

Reproducibility relative standard deviation

RSD R

67.1%

72.0%

82.7%

156.2%

55.7%

10

HorRat value

5.3

5.0

5.8

10.5

4.5

a Several labs reported 0 for these analytes which contributed significantly to poor precision.

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