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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