A model for an uncertainty budget for preanalytical variables in clinical chemistry analyses

Clinical Chemistry

Volumn 53, Issue 7, 2007, Pages 1343-1348

  Rynning, Marit ^a   Wentzel Larsen, Tore ^a   Bolann, Bjørn J ^a,b  

^a HAUKELAND UNIVERSITY HOSPITAL   (Norway)

^b UNIVERSITY OF BERGEN   (Norway)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL ERROR; ARTICLE; BLOOD CLOTTING TIME; BLOOD SAMPLING; CLINICAL ARTICLE; CLINICAL CHEMISTRY; CLINICAL LABORATORY; CLINICAL PRACTICE; HUMAN; LABORATORY TEST; MEASUREMENT; MODEL; PROBABILITY; STATISTICAL ANALYSIS;

BLOOD GLUCOSE; BLOOD SPECIMEN COLLECTION; CALCIUM; CLINICAL CHEMISTRY TESTS; CREATININE; HUMANS; MAGNESIUM; MODELS, STATISTICAL; UNCERTAINTY;

EID: 34347381718     PISSN: 00099147     EISSN: None     Source Type: Journal    
DOI: 10.1373/clinchem.2007.086371     Document Type: Article

References (20)

1. Guder WG, Narayanan S, Wisser H, Zawta B. Samples: from the patient to the laboratory. The Impact of Preanalytical Variables on the Quality of Laboratory Results, 3rd ed. Weinheim, Germany: Wiley-VCH Verlag GmbH & Co. KgaA, 2003:106pp.
2. Lippi G, Guidi GC, Mattiuzzi C, Plebani M. Preanalytical variability: the dark side of the moon in laboratory testing. Clin Chem Lab Med 2006;44:358-65.
3. Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med 2006;44:750-9.
4. Brix R, Hansen SH, Barwick V, Tjornelund J. Method optimisation with the use of uncertainty budgets. Analyst 2002;127:140-3.
5. International Organization for Standardization. Guide to the Expression of Uncertainty in Measurement: Corrected and Reprinted. Geneva, Switzerland: International Organization for Standardization, 1995:101pp.
6. Eurachem/CITAC. Quantifying Uncertainty in Analytical Measurement, 2nd ed. London: Eurachem, 2000:120pp.
7. EA-4/16, EA guidelines on the expression of uncertainty in quantitative testing. http://www.european-accreditation.org/nl/doc/EA-4-16.pdf (accessed November 2006).
8. NIST. Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results. Gaithersburg, MD: NIST, 1994:20pp.
9. ISO Standards. Medical Laboratories: Particular Requirements for Quality and Competence (ISO 15189:2003). Geneva, Switzerland: ISO Standards, 2003:39pp.
10. Clinical and Laboratory Standards Institute. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture. Approved Standard H03-A5, 5th ed. Wayne, PA: NCCLS, 2003:52pp.
11. Bland JM, Altman GG. Measuring agreement in method comparison studies. Stat Methods Med Res 1999;8:135-60.
12. Ross SM. Introduction to Probability Models, 6th ed. San Diego: Academic Press, 1997:669pp.
13. Linnet K, Boyd JC. Selection and analytical evaluation of methods: with statistical techniques. In: Burtis CA, Bruns DE, Tietz NW, Ashwood ER, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Philadelphia: Elsevier Saunders, 2006:353-407.
14. Clinical and Laboratory Standards Institute. Procedures for the handling and processing of blood specimens. Approved Guideline H18-A3, 3rd ed. Wayne, PA: NCCLS, 2004;39pp.
15. Laessig RH, Hassemer DJ, Paskey TA, Schwartz TH. Effects of 0.1 and 1.0 per cent erythrocytes and hemolysis on serum chemistry values. Am J Clin Pathol 1976;66:639-44.
16. Hill BM, Laessig RH, Koch DD, Hassemer DJ. Comparison of plastic vs glass evacuated serum-separator (SST) blood-drawing tubes for common clinical-chemistry determinations. Clin Chem 1992;38:1474-8.
17. Fuentes-Arderiu X, Acebes-Frieyro G, Gavaso-Navarro L, Castineiras-Lacambra MJ. Pre-metrological (pre-analytical) variation of some biochemical quantities. Clin Chem Lab Med 1999;37:987-9.
18. Linko S, Ornemark U, Kessel R, Taylor PDP. Evaluation of uncertainty of measurement in routine clinical chemistry: applications to determination of the substance concentration of calcium and glucose in serum. Clin Chem Lab Med 2002;40:391-8.
19. Kallner A, Waldenstrom J. Does the uncertainty of commonly performed glucose measurements allow identification of individuals at high risk for diabetes? Clin Chem Lab Med 1999;37:907-12.
20. Krouwer JS. Critique of the guide to the expression of uncertainty in measurement method of estimating and reporting uncertainty in diagnostic assays. Clin Chem 2003;49:1818-21.