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| 4 | 2003
Klinisk Biokemi i Norden
• Verify that the corrected mean value of X is
within acceptable limits (i.e. certified/indicative
value of X ± 0.375 x total biological variation).
• If the certified values are found within stated
bias goals, the NORIP reference intervals can
be applied.
• If the certified value cannot be found further
investigation should start; e.g. by contacting
other laboratories using the same equipment
to agree on a common approach or contacting
the manufacturer.
If the laboratory decides to apply a factor to be able
to use the NORIP reference intervals, the laboratory
should be aware that it might void the legal respon-
sibility from the IVD-manufacturer. The ’normal’ or
slightly low (i.e. enzymes) concentrations of the
components in X could introduce difficulties for
calibration of higher values, e.g. cut-off values.
References
(1) Scandinavian Society for Clinical Chemistry.
Certificate of analysis. NFKK Reference Serum
X, Clinical components in human serum. Lot
Number: NFKK2002a. 20-11-2003.
(2) Rustad P. Nordic Reference Interval Project.
Klinisk Biokemi i Norden 2003; 15(2):10-17.
(3) Pedersen MM, Örnemark U, Rustad P, Steensland
H, Loikkanen M, Ólafsdóttir E et al. The Nordic
Trueness Project 2002 – Use of Reference
Measurement Procedure Values in a General
Clinical Chemistry Survey. Scand J Clin Lab
Invest. Submitted.
(4) Institute for Reference Materials and
Measurements. IMEP-17 Certified reference
values, Material 1. IM/L/062/02. 2002. Belgium.
2002.
(5) Henriksen GM, Pedersen MM, Nørgaard I, Blom
M, Blaabjerg O, Uldall A. Preparation and testing
of minimally processed fresh frozen human ref-
erence sera. Applications to international EQA.
Scand J Clin Lab Invest. Submitted.
(6) Pedersen MM. Stability of NFKK reference sera
X, CAL and Reference Individual Samples.
Summary of a draft protocol (in Danish). 2003.
Denmark, DEKS. 2003.
(7) Örnemark U, Uldall A, Van Nevel L, Aregbe Y,
Taylor PDP. IMEP-17 Trace and minor con-
stituents in human serum. Certification report,
Internal report. GE/R/IM/36/01[EUR 20243 EN].
2003. Geel, IRMM.
(8) Örnemark U, Van Nevel L, Smeyers P, Harper
C, Taylor PDP. IMEP-17 Trace and Minor
Constituents in Human Serum. Report to
Participants, Part 2: Methodology and quality
specifications. EUR 20694 EN[GE/R/IM/04/03],
1-44. 3-6-2003. Geel, IRMM.
(9) ISO Guide 31:2000, Reference materials -
Contents of certificates and labels. Second edi-
tion. 2000. Geneva, Switzerland, International
Organization for Standardization.
(10) European Committee for Standardization. EN
12287, In vitro diagnostic medical devices
- Measurement of quantities in samples of bio-
logical origin - Description of reference materi-
als. 1999. Brussels, Belgium.
(11) Directive 98/79/EC of the European parliament
and of the Council of 27 Oct. 1998 on in vitro
diagnostic medical devices. Official Journal of
the European Communities 1998; L 331/1.
(12) Van Nevel L, Örnemark U, Smeyers P, Harper
C, Taylor PDP. IMEP-17 Trace and Minor
Constituents in Human Serum. Report to
Participants. Part 1: International comparability.
GE/R/IM/42/02. 2003.
(13) Rustad P. Evaluation of method bias using NFKK
Reference Serum X. http://www.furst.no/norip/
x_spreadsheet.xls. 26-11-2003.
