576 / 670
Page
14
of
39
2.
Accuracy
–
Accuracy was determined by testing the spiked placebos described in Table 2-2. Mean recoveries ranged
from 96-102% for in-house Abbott Matrices. The results are summarized in Table 2-8.
a.
Accuracy was additionally assessed for 6 fructan containing SPIFAN matrices by three days of duplicate over-
spike testing (Table 2-9) and 3 days of duplicate spikes into 2 unfortified matrices. Mean recoveries ranged from
93-108%.
Table 2-8
Accuracy/Spike Results
0.03% FOS spike (9%
sucrose)
0.3% FOS
spike
0.3% P95
spike
0.3% Synergy 1
spike
3% FOS
spike
3% P95
spike
3% Synergy 1
spike
min%
recovery
90.8%
91.7% 93.9% 94.1% 92.6% 92.5% 95.3%
avg %
recovery
102%
100% 99.0% 98.4% 96.2% 96.0% 97.2%
max %
recovery
115%
107%
113%
104%
101% 99.0% 101%
%RSD
7.12%
5.43%
6.09%
2.85% 2.85% 2.35% 2.04%
0.03%, 0.3%, and 3% are nominal spike values, N=9 (three replicates in each of three independent runs) for all levels and fructans.
Table 2-9
SPIFAN Product Accuracy
Overspiked 50%
Name
Batch#
Avg. % of expected
Child formula powder
00847RF00
97.2%
Toddler formula powder milk based
4052755861
108%
Infant formula powder, milk based
4044755861
101%
Child formula powder
00866RF00
102%
Infant formula powder FOS/GOS based
50350017W1
97.4%
Adult nutritional RTF high fat
00729RF00
92.9%
Overspiked 100%
Name
Batch#
Avg. % of expected
Child formula powder
00847RF00
100%
Toddler formula powder milk based
4052755861
105%
Infant formula powder, milk based
4044755861
98.7%
Child formula powder
00866RF00
96.0%
Infant formula powder FOS/GOS based
50350017W1
97.6%
Adult nutritional RTF high fat
00729RF00
94.2%
Unfortified, spiked 50%
Infant formula powder partially hydrolyzed soy based
(HP spike)
41457651Z
97.4%
Adult Nutritional powder low fat
00859RF00
98.1%
Unfortified, spiked 150%
Infant formula powder partially hydrolyzed soy based
(HP spike)
41457651Z
102%
Adult Nutritional powder low fat
00859RF00
95.9%
Fos-04 (February 2016)
FOR ERP USE ONLY
DO NOT DISTRIBUTE