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14

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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