OMB Meeting Book_9-11-14

Table 24: Reproducibility data for whey-based infant formula test sample

Sample ID: Sample 5 K-5692/V-4737 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 0.03 a

Rep-2 0.02 a

Rep-1

Rep-2

1 2

5.20 4.55

5.25 4.40

3.47 3.25

3.51 3.26

1.01 1.06

1.01 1.05

3.69 3.15

3.69 3.06

0.00

0.00

3

6.23

5.98

2.97

2.90

1.13

1.13

0.00

0.00

3.35

3.52

4

6.00 5.86 c

6.10 6.41 c

3.60

3.60

1.10

1.10

0.00 0.00 b

0.00 0.22 b

3.70

3.60

5

3.78

3.93

1.07

1.09

3.48

3.52

6

5.48

5.43

3.87

3.84

1.06

1.03

0.00

0.00

3.46

3.40

7

5.30

5.26

3.70

3.56

0.98

0.98

0.00

0.00

3.64

3.51

8

5.41

5.39

3.64

3.66

1.06

1.05

0.00

0.00

3.42

3.39

9

5.44

5.47

3.58

3.55

1.05

1.08

0.00

0.00

3.39

3.39

10

5.58

5.59

3.53

3.59

1.07 1.10 c

1.06 1.00 c

0.00

0.00

3.68

3.71

11

5.50

5.20

3.00

3.00

0.00

0.00

3.60

3.50

12

5.13

5.23

3.75

3.87

1.03

1.00

0.00

0.00

3.67

3.70

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

Table 25: Reproducibility analysis for whey-based infant formula test sample

Sample ID: Sample 5 K-5692/V-4737

CMP

UMP

GMP

IMP

AMP

Analyte Symbol

Seq.

Item

Value

Value

Value

Value

Value

10 a

1

Total number of laboratories

n

12

12

12

12

2

Total number of replicates

2n

24

24

24

18

24

3

Overall mean of all data (grand mean)

5.47

3.52

1.05

n/a

3.51

4

Repeatability standard deviation

Sr

0.15

0.05

0.02

n/a

0.06

5

Reproducibility standard deviation

SR

0.48

0.31

0.04

n/a

0.18

6

Repeatability limit in SMPR

≤6%

≤6%

≤6%

n/a

≤6%

7

Repeatability relative standard deviation

RSDr

2.7%

1.5%

2.2%

n/a

1.7%

8

Reproducibility limit in SMPR

≤11%

≤11%

≤11%

n/a

≤11%

9

Reproducibility relative standard deviation

RSDR

8.7%

8.8%

4.1%

n/a

5.0%

10

HorRat value

1.0

0.9

0.4

n/a

0.5

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

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