16 |
Klinisk Biokemi i Norden · 1 2017
The Fitness for Purpose of Analytical Met-
hods – A Laboratory Guide toMethod Valida-
tion and Related Topics. Available fromwww.
eurachem.org.”. Eurachem; 2014.
18. FDA. Guidance for Industry. Bioanalytical
Method Validation,
-
ads/ Drugs/GuidanceComplianceRegulato-
ryInformation/ Guidances/UCM070107.pdf.
Rockville: U.S. Department of Health and
Human Services, Food and Drug Adminis-
tration (FDA), Center for Drug Evaluation
and Research (CDER),Center for Veterinary
Medicine (CVM); 2001. Available from: www.
fda.gov/downloads/Drugs/Guidance- Com-
plianceRegulatoryInformation/Guidances/
UCM070107.pdf.
19. EU. Directive 98/79/EC of the European
Parliament and of the Council of 27 October
1998 on in vitro diagnostic medical devices,
http:// eur-lex.europa.eu/LexUriServ/LexU-
riServ. do?uri=CELEX:31998L0079:EN:NOT.
Eur-Lex,
LexUri-Serv.do?uri=CELEX:31998L0079:EN:
NOT;1998.
20. CLSI. EP9-A2 Method Comparison and Bias
Estimation using Patient Samples Clinical and
Laboratory Standards Institute; 2010.
21. Stankovic AK, Romeo P. The role of in vitro
diagnostic companies in reducing laboratory
error. Clin Chem Lab Med 2007;45:781-8.
22. Passing H, BablockW. Comparison of several
regression procedures for method comparison
studies and determination of sample sizes.
Application of linear regression procedures
for method comparison studies in clinical
chemistry. Part II. J Clin ChemClin Biochem
1984;22:431-45.
23. Deming WE. Statistical adjustment of data.
John Wiley & Sons, Inc. 1943.
24. Bland JM, Altman DG. Statistical methods for
assessing agreement between two methods of
clinical measurement. Lancet 1986;I:307-10.
25. Altman DG, Bland JM. Measurement in
medicine: the analysis of method comparison
studies. Statistician 1983;32:307-17.
26. Aronsson T, Groth T. Nested control proce-
dures for internal analytical quality control.
Theoretical design and practical evaluation.
Scand J Clin Lab Invest 1984;44:51-64.
27. Kallner A. Laboratory statistics : handbook of
formulas and terms. First edition. ed. Amster-
dam: Elsevier; 2014. xiv, 139 pages p.
28. Bland J, Altman DG. Measuring agreement
in method comparison studies. Statistical
methods in medical research. 1999;8:135-60.
29. Altman DG, Bland JM. Comparing met-
hods of Measurement. Applied Statistics.
1987;36:224-5.
30. Altman DG, Bland JM. Commentary on
quantifying agreement between two methods
of measurement. Clin Chem 2002;48(5):801-2.
31. (ISO) IOfS. In vitro diagnostic medical devi-
ces—measurement of quantities in biological
samples—metrological traceability of values
assigned to calibrators and control materials.
Geneva, Switzerland: International Organiza-
tion for Standardization (ISO); 2003.
32. Bossuyt PM, Reitsma JB, Linnet K, Moons
KG. Beyond diagnostic accuracy: the clini-
cal utility of diagnostic tests. Clin Chem
2012;58:1636-43.
33. Bossuyt PM, Cohen JF, Gatsonis CA, Korevaar
DA, group S. STARD 2015: updated reporting
guidelines for all diagnostic accuracy studies.
Ann Transl Med 2016;4:85.
34. Moons KG, de Groot JA, Linnet K, Reitsma JB,
Bossuyt PM. Quantifying the added value of
a diagnostic test or marker. Clin Chemistry.
2012;58:1408-17.
35. Galen RS, Gambino SR. Beyond normality:
The predictive value and efficiency of medical
diagnoses. John Wiley and Sons. 1975.
36. Pepe MS. The statistical evaluation of medical
tests for classification and prediction. Oxford:
Oxford University Press; 2003. xvi, 302 p. p.
37. Zhou X-h, Obuchowski NA, McClish DK.
Statistical methods in diagnostic medicine.
New York: Wiley-Interscience; 2002. xv, 437
p. p.
