Klinisk Biokemi i Norden · 1 2017
| 15
time. Full diagnostic validation of the entire conglo-
merates of laboratories may become increasingly in
demand as healthcare becomes increasingly aware of
the need to make sure that the diagnostic properties
including reference intervals and decision limits are
optimal within conglomerates of laboratories. The
use of patient samples in split-sample techniques is
especially valuable in this contexts in order to avoid
compatibility issues.
References
1. Theodorsson E. Validation and verification
ofmeasurement methods in clinical chemistry.
Bioanalysis 2012;4:305-20.
2.
Theodorsson E, Magnusson B, Leito I. Bias in
clinical chemistry. Bioanalysis 2014;6:2855-75.
3.
CLSI. EP15-A2 User Verification of Perfor-
mance for Precision and Trueness; Approved
Guideline Clinical and Laboratory Standards
Institute; 2006.
4.
Braga F, Panteghini M. Verification of in vitro
medical diagnostics (IVD) metrological tra-
ceability: responsibilities and strategies. Clin
Chim Acta 2014;432:55-61.
5.
Dybkaer R. 'Verification' versus 'validation':
a terminological comparison. Accredit Qual
Assur 2011;16:105-8.
6. Jansen R, Schumann G, Baadenhuijsen H,
Franck P, Franzini C, Kruse R, et al. Trueness
verification and traceability assessment of
results from commercial systems for measu-
rement of six enzyme activities in serum: an
international study in the EC4 framework of
the Calibration 2000 project. Clin ChimActa
2006;368:160-7.
7. Sutarno R, Steger H. The use of certified refe-
rence materials in the verification of analyti-
cal data andmethods. Talanta 1985;32:439-45.
8. Haeckel R. Verification, validation and eva-
luation of analytical procedures in laboratory
medicine. Clin Chem LabMed 2004;42:111-2.
9. Burnett D. Measurement verification in the
clinical laboratory: A guide to assessing ana-
lytical performance during the acceptance
testing of methods (quantitative examination
procedures) and/or analysers. London: The
Association for Clinical Biochemistry, http://
mittees/scientific/guidelines/measurement-
verification/David_Burnett_Editorial.pdf;
2010.
10. Kallner A. On the comparison and verifica-
tion of measurement results. Klinisk Biokemi
i Norden. 2011;4:40-6.
11. Khatami Z, Hill R, Sturgeon C, Kearney E,
Breadon P, Kallner A. Measurement veri-
fication in the clinical laboratory: A guide
to assessing analytical performance during
the acceptance testing of methods (quanti-
tative examination procedures) and/or ana-
lysers. London: The Scientific Committee of
the Association for Clinical Biochemistry,
/
committees/scientific/guidelines/measure-
ment-verification/Measurement_verifica-
tion_final_090608.pdf; 2010.
12. JCGM. International vocabulary of met-
rology – Basic and general concepts and
associated terms (VIM 3),
.
bipm.org/utils/common/documents/jcgm/
JCGM_200_2008.pdf. 3 edition ed: Bureau
International des Poids et Mesures; 2008.
13. FDA. Guidance for Industry. Bioanalyti-
cal Method Validation: U.S. Department of
Health and Human Services, Food and Drug
Administration (FDA) 2001. Available from:
-
danceComplianceRegulatoryInformation/
Guidances/ucm070107.pdf.
14. Viswanathan CT, Bansal S, Booth B, DeSte-
fano AJ, Rose MJ, Sailstad J, et al. Workshop/
conference report - Quantitative bioanalytical
methods validation and implementation: Best
practices for chromatographic and ligand bin-
ding assays. Aaps J 2007;9:E30-E42.
15. Viswanathan CT, Bansal S, Booth B, DeSte-
fano AJ, Rose MJ, Sailstad J, et al. Quantitative
bioanalytical methods validation and imple-
mentation: best practices for chromatograp-
hic and ligand binding assays. Pharm Res
2007;24:1962-73.
16. Agency EM. Guideline on bioanalytical met-
hod validation. London 2011.
17. Magnusson B, Örnemark U. EurachemGuide:
