23 / 97
Page 1 of 23
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 carnitine 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 (Validation Report-Addendum)
FOR ERP USE ONLY
DO NOT DISTRIBUTE