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Abbreviations and synonyms:

Abbreviations:

NMKL.................Nordisk Metodikk Komité for Næringsmidler

ISO ....................International Organization for Standardization

SOP...................Standard Operating Procedure

ANAVA ..............Analysis of Variance

n ........................Number of replicates

RSD%................Relative Standard Deviation in Percent

CI .......................Confidence intervals

S

r

.......................Repeatability (standard deviation within days)

S

R

......................Reproducibility (standard deviation between days)

Synonyms:

t-test ..................

Student’s t

-test

Quality statement:

This validation report is conducted in accordance to our internal instruction

211.01 “Validering af analysemetoder i Vitamin

center

(in English - Validation of

analytical methods in the Vitamin Centre”

This instruction defines the experimental design used in the current validation,

which is based on NMKL Procedure No. 4: Validation of chemical analytical

methods (2009, 3

rd

edition).

The Eurofins Steins Laboratory in Vejen is accredited according to ISO 17025.

Introduction:

The choline method has been employed on the SPIFAN test kit to investigate the

methods capabilities on this set of samples.

Statistics:

In the current validation report, a p-value < 0.05 is considered statistically signifi-

cant. Consequently, confidence intervals (CI) are calculated at a confidence level

at 95 %. Paired t-testing is performed on normal distributed raw data. Data which

is not within the normal distribution is clearly marked within the text.

Matrices:

The SPIFAN test kit consists of 17 samples providing a representative collection

Carn-06 (Choline Validation Report-Addendum)

FOR ERP USE ONLY

DO NOT DISTRIBUTE