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Dual Lab Validation of a Method for the Determination of Fructans in Infant 

Formula & Adult Nutritionals /        

25 Jul 2016

37 

e.

Accuracy (Trueness) 

The SPIFAN demands for the determination of the accuracy or trueness the determination of the 

spiked recovery of an appropriate sampling of SPIFAN matrices. In this study 6 fructan containing 

samples (after reconstition) in the SPIFAN sample kit are selected for the accuracy study. In section 6d, 

results of the precision study, the overall means of the fructan content in these samples have been 

established already and those values will be applied in this part of the accuracy study. According to the 

AOAC SLV instructions, the samples will be spiked at about  50% and 150% level of the original fructan 

content as determined in precision study. The spiked  and unspiked samples will be analyzed in 

duplicate on each of 3 different days.  

Each of the 3 days of this accuracy study another pure fructan ingredient will be applied for spiking. 

The purity of the respective fructan ingredients are established by subjecting these three pure fructan 

ingredients to the AOAC 997.08 analysis. 

And each day another HPAEC‐PAD instrument will be applied for the analyses. 

f.

Specificity 

There are no specific SPIFAN demands concerning the determination of specificity of the method. In 

principle all kind of glucose and/or fructose containing carbohydrates (oligo‐ and polysaccharides) 

which are susceptible for hydrolysis into their corresponding monosaccharides by (side) activities of 

the used fructanase in last enzymatic hydrolysis step in the protocol, are potential interfering 

constituents. And also disaccharides/oligosaccharides which chromatographically show coinciding 

peaks with fructose or glucose will interfere.  Thus potentially interfering carbohydrates in the new 

developed fructan method are amongst others free disaccharides (e.g. sucrose, maltitol, palatinose) 

and oligosaccharides, (resistant) malto‐oligosaccharides (e.g. polydextrose), (soluble) starch,  and GOS. 

Therefore the specificity of the method is demonstrated by showing that the above mentioned 

constituents don’t interfere with the FOS quantitation. 

6.

Results 

a.

Introduction 

The SPIFAN sample kit contains 19 samples. It is known that not all samples contain fructan. In order 

to establish which samples contain fructan and which not, the whole series of 19 samples are analyzed 

in duplicate, being as two independent analyses performed at two different days by two different 

technicians. The samples have been analyzed as received, thus no reconstitution has been applied 

preceding these single analyses. 

The results are summarized in table 2. 

VALIDATION REPORT

FOR ERP USE ONLY

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