OMB Meeting Book_9-11-14

Table 26: Reproducibility data for whey-based infant formula test sample

Sample ID: Sample 6 W-7638/R-8320 Analyte CMP

UMP

GMP

IMP

AMP

(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 0.02 a

Rep-2 0.05 a

Rep-1

Rep-2

1 2

5.17 3.94 a

5.21 3.56 a

3.60 3.26

3.60 3.11

0.99 0.70 a

1.02 1.02 a

3.68 2.58 a

3.70 3.09 a

0.00

0.00

3

5.05

4.81

2.70

3.11

1.12

1.17

0.00

0.00

3.41

3.35

4

6.20

6.00

3.60

3.80

1.10

1.10

0.00

0.00

3.70

3.70

5

6.24

6.14

3.85

3.78

1.08

1.02

0.00

0.00

3.52

3.49

6

5.47

5.41

3.83

3.87

1.05

1.05

0.00

0.00

3.43 3.63 b

3.40 3.48 b

7

5.27

5.15

3.49

3.73

0.91

1.01

0.00

0.00

8

5.36

5.41

3.69

3.60

1.05

1.06

0.00

0.00

3.36

3.39

9

5.44

5.46

3.67

3.64

1.08

1.09

0.00

0.00

3.35

3.32

10

5.63

5.60

3.60

3.61

1.08

1.06

0.00

0.00

3.73

3.72

11

5.30

5.50

3.10

3.10

1.00

1.10

0.00 0.35 a

0.00 0.24 a

3.60

3.60

12

4.80

4.83

3.78

3.89

1.02

1.04

3.30

3.43

a Identified as Grubbs outlier; results removed from data set for statistical analysis. b Identified as Cochran outlier; results kept in data set for statistical analysis.

Table 27: Reproducibility analysis for whey-based infant formula test sample

Sample ID: Sample 6 W-7638/R-8320

CMP

UMP

GMP

IMP

AMP

Analyte Symbol

Seq.

Item

Value

Value

Value

Value

Value

11 a

11 a

10 a

11 a

1 2

Total number of laboratories

n

12 24

Total number of replicates

2n

22

22

22

22

3

Overall mean of all data (grand mean)

5.43

3.54

1.05

n/a

3.51

4

Repeatability standard deviation

S r

0.09

0.11

0.04

n/a

0.05

5

Reproducibility standard deviation

S R

0.43

0.32

0.05

n/a

0.15

6

Repeatability limit in SMPR

≤6%

≤6%

≤6%

n/a

≤6%

7

Repeatability relative standard deviation

RSD r

1.6%

3.2

3.4%

n/a

1.3%

8

Reproducibility limit in SMPR

≤11%

≤11%

≤11%

n/a

≤11%

9

Reproducibility relative standard deviation

RSD R

7.9%

9.0%

5.2%

n/a

4.3%

10

HorRat value

0.9

1.0

0.5

n/a

0.5

a Less than 2/9 laboratories removed from statistical analysis.

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