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15

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39

3.

Precision

Precision was assessed by both the analysis of 10 days of independent duplicate sample preparations (using

6-7 analysts and 4-5 instruments in 2-3 labs, AN internal control analyzed at a third lab by an additional analyst on an

additional instrument) as well as the overall assessment of additional analyses of the AN internal control (using 7

analysts and 9 instruments in 3 labs). This data is summarized in Tables 2-10 and 2-11.

a.

Precision was additionally assessed for 6 fructan fortified SPIFAN matrices by six days of duplicate testing

(Table 2-12).

Table 2-10

AN Product Precision (fructan amount g/100g as-fed basis)

AN Internal Control

Soy Powder Adult Powder Pediatric Powder

average

0.370

0.152

0.433

0.230

SD

0.101

0.0391

0.104

0.0795

Run-to-Run RSD

2.33

2.37

2.31

3.18

Repeatability RSD

1.09

1.64

1.38

2.24

Intermediate Precision RSD

2.57

2.89

2.69

3.88

MIN

0.352

0.143

0.410

0.202

MAX

0.398

0.162

0.464

0.246

N

60

40

40

40

RSD = ANOVA component calculated

Table 2-11

AN Internal Control at 3 Labs (fructan amount g/100g as-fed basis)

AN Internal Control

average

0.370

SD

0.0873

RSD

2.62%

MIN

0.352

MAX

0.398

N

80

(N=20 at Covance Labs, 20 at Abbott Singapore, and 40 at Abbott Columbus)

Table 2-12

SPIFAN Product Precision (fructan amount g/100g as-fed basis)

Placebo

Child

formula

powder

Toddler formula

powder milk

based

Infant formula

powder, milk

based

Child

formula

powder

Infant formula

powder FOS/GOS

based

Adult

nutritional

RTF high fat

average

0.270

0.233

0.283

0.277

0.0356

0.500

SD 0.134

0.0725

0.0620

0.108

0.0103

0.0328

Run-to-Run

RSD 5.36

0.510

1.31

3.63

2.50

5.71

Repeatability

RSD 2.03

3.42

2.087

2.61

2.136

3.67

Intermediate

Precision RSD 5.73

3.46

2.46

4.47

3.29

6.79

MIN 0.242

0.221

0.273

0.259

0.0340

0.460

MAX 0.289

0.245

0.299

0.289

0.0370

0.558

N 12

12

12

12

12

12

Fos-04 (February 2016)

FOR ERP USE ONLY

DO NOT DISTRIBUTE