OMB Meeting Book_9-11-14

Table 16: Reproducibility data for lactose-free infant formula test sample

Sample ID: Sample 1 L-2794/F-3353 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

Rep-2

Rep-1

Rep-2

1 2

11.09

11.12

3.94 3.75

3.95 3.83

1.39 1.50 a

1.39 1.40 a

1.52 1.87

1.53 1.82

3.33 3.27 a

3.32 3.09 a

9.52

9.48

3

10.71

10.50

3.27

3.26

1.44

1.40

1.64

1.63

3.29

3.32

4

12.40

12.40

4.00

4.00

1.50

1.50

1.70

1.70

3.40

3.40

5

12.84

13.12

3.51

3.34

1.45

1.45

1.77

1.73

3.52

3.45

6

11.68

11.76

4.32

4.30

1.40

1.45

1.58

1.59

3.35

3.35

7

11.28

11.00

3.93

4.00

1.43

1.40

1.46

1.54

3.32

3.28

8

11.65

11.52

3.66

3.80

1.45

1.46

1.63

1.61

3.43

3.41

9

11.53

11.56

3.97

4.03

1.47

1.45

1.61

1.63

3.26

3.27

10

11.86

11.95

3.84

3.88

1.48

1.50

1.66 1.80 a

1.68 1.60 a

3.42

3.43

11

11.60

11.90

3.50

3.80

1.50

1.50

3.40

3.30

12

10.78

10.94

4.28

4.05

1.42

1.40

1.60

1.59

3.24

3.27

a Identified as Cochran outlier; results kept in data set for statistical analysis.

Table 17: Reproducibility analysis for lactose-free infant formula test sample

Sample ID: Sample 1 L-2794/F-3353

CMP

UMP

GMP

IMP

AMP

Analyte Symbol

Seq.

Item

Value

Value

Value

Value

Value

1 2

Total number of laboratories

n

12 24

12 24

24

12 24

12 24

Total number of replicates

2n

1.45

3

Overall mean of all data (grand mean)

11.42

3.84

0.03

1.65

3.34

4

Repeatability standard deviation

S r

0.12

0.09

0.04

0.05

0.05

5

Reproducibility standard deviation

S R

0.89

0.30

24

0.10

0.09

6

Repeatability limit in SMPR

≤6%

≤6%

≤6%

≤6%

≤6%

7

Repeatability relative standard deviation

RSD r

1.1%

2.4%

1.8%

2.8%

1.4%

8

Reproducibility limit in SMPR

≤11%

≤11%

≤11%

≤11%

≤11%

9

Reproducibility relative standard deviation

RSD R

7.8%

7.9%

2.8%

6.1%

2.7%

10

HorRat value

1.0

0.9

0.3

0.6

0.3