Method comparison in the clinical laboratory

Veterinary Clinical Pathology

Volumn 35, Issue 3, 2006, Pages 276-286

  Jensen, Asger Lundorff ^a   Kjelgaard Hansen, Mads ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

Acceptability; Difference plot; Imprecision; Inaccuracy; Reference method

Indexed keywords

CANIS FAMILIARIS;

ANIMAL; ANIMAL DISEASE; COMPARATIVE STUDY; DIAGNOSIS, MEASUREMENT AND ANALYSIS; HUMAN; METHODOLOGY; PATHOLOGY; REFERENCE VALUE; REPRODUCIBILITY; REVIEW; SENSITIVITY AND SPECIFICITY; STANDARD; STATISTICAL MODEL; VETERINARY MEDICINE;

ANIMALS; HUMANS; LABORATORY TECHNIQUES AND PROCEDURES; MODELS, STATISTICAL; PATHOLOGY, CLINICAL; PATHOLOGY, VETERINARY; REFERENCE STANDARDS; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 33750741963     PISSN: 02756382     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1939-165X.2006.tb00131.x     Document Type: Review

References (45)

1. Westgard JO, Hunt MR. Use and interpretation of common statistical tests in method-comparison studies. Clin Chem. 1973;19:49-57.
2. Westgard JO, Carey RN, Wold S. Criteria for judging precision and accuracy in method development and evaluation. Clin Chem. 1974;20:825-833.
3. Westgard JO. A method evaluation decision chart (MEDx chart) for judging method performance. Clin Lab Sci. 1995;8:277-283.
4. Westgard JO. Points of care in using statistics in method comparison studies. Clin Chem. 1998;44:2240-2242.
5. Lumsden JH. Laboratory test method validation. Revue Méd Vét. 2000;151:623-630.
6. Petersen PH, Stockl D, Blaabjerg O, Pedersen B, et al. Graphical interpretation of analytical data from comparison of a field method with a Reference Method by use of difference plots. Clin Chem. 1997;43:2039-2046.
7. Linnet K. Evaluation of regression procedures for methods comparison studies. Clin Chem. 1993;39:424-432.
8. Linnet K. Necessary Sample size for method comparison studies based on regression analysis. Clin Chem. 1999;45:882-894.
9. Linnet K. Limitations of the paired t-test for evaluation of method comparison data. Clin Chem. 1999;45:314-315.
10. Stockl D, Dewitte K, Thienpont LM. Validity of linear regression in method comparison studies: is it limited by the statistical model or the quality of the analytical input data? Clin Chem. 1998;44:2340-2346.
11. Altman DG, Bland JM. Measurement in medicine: the analysis of method comparison studies. Statistician. 1983;32:307-317.
12. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;1:307-310.
13. Passing H, Bablok. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem. 1983;21:709-720.
14. Lin LK. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989;45:255-268.
15. Jones RG, Payne RB. Clinical Investigation and Statistics in Laboratory Medicine. London: ACB Venture Publications; 1997:27-65.
16. Koch DD, Peters T. Selection and evaluation of methods. In: Burtis CA, Ashwood ER, eds. Tietz Fundamentals of Clinical Chemistry. 4th ed. Philadelphia, PA: WB Saunders Co; 1996:170-181.
17. Clinical and Laboratory Standards Institute (formerly NCCLS). Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. 2nd ed. NCCLS document EP9-A2. Wayne, PA: NCCLS; 2002.
18. Westgard JO. Method validation - The comparison of methods experiment. Available at: http://www.westgard.com/lesson23.htm. Accessed August 29, 2005.
19. Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Clin Chem. 2003;49:1-6.
20. Inczedy J, Lengyel T, Ure AM. Compendium of Analytical Nomenclature - The Orange Book. Available at: http://www.iupac.org/publications/ analytical_compendium/. Accessed August 16, 2005.
21. Fuentes-Arderiu X. Glossary of ISO metrological and related terms and definitions relevant to clinical laboratory sciences. Available at: http://www.westgard.com/isoglossary.htm. Accessed August 16, 2005.
22. Bellamy JEC, Olexson DW. Evaluating laboratory procedures. In: Quality Assurance Handbook for Veterinary Laboratories. Ames, IA: Iowa State University Press; 2000:61-77.
23. Montori VM, Guyatt GH. What is evidence-based medicine and why should it be practiced? Respir Care. 2001;46:1201-1214.
24. Kenny D, Fraser CG, Petersen PH, Kallner A. Consensus agreement. Scand J Clin Lab Invest. 1999;59:585.
25. Wess G, Reusch C. Assessment of five portable blood glucose meters for use in cats. Am J Vet Res. 2000;61:1587-1592.
26. Wess G, Reusch C. Evaluation of five portable blood glucose meters for use in dogs. J Am Vet Med Assoc. 2000;216:203-209.
27. Ricos C, Alvarez V, Cava F, et al. Biological variation database & desirable quality specifications: the 2001 update. Available at: http://www.westgard.com/guest21.htm. Accessed August 29, 2005.
28. Fraser CG. Desirable performance standards for clinical chemistry tests. Adv Clin Chem. 1983;23:299-339.
29. Fraser CG. The application of theoretical goals based on biological variation data in proficiency testing. Arch Pathol Lab Med. 1988;112:404-415.
30. Fraser CG, Harris EK. Generation and application of data on biological variation in clinical chemistry. CRC Crit Rev Clin Lab Sci. 1989;29:409-430.
31. Fraser CG, Petersen PH, Ricos C, Haeckel R. Proposed quality specifications for the imprecision and inaccuracy of analytical systems for clinical chemistry. Eur J Clin Chem Clin Biochem. 1992;30:311-317.
32. Petersen PH, Ricos C, Stockl D, et al. Proposed guidelines for the internal quality control of analytical results in the medical laboratory. Eur J Clin Chem Clin Biochem. 1996;34:983-999.
33. Payne RB. Method comparison: evaluation of least squares, Deming and Passing/Bablok regression procedures using computer simulation. Ann Clin Biochem. 1997;34:319-320.
34. Lin's concordance. Available at: http://www.niwa.co.nz/services/ statistical/concordance. Accessed August 16, 2005.
35. Jensen AL, Bantz M. Comparing laboratory tests using the difference plot method. Vet Clin Pathol 1993;22:46-48.
36. Bland JM, Altman DG. Comparing methods of measurements: why plotting difference against standard method is misleading. Lancet. 1995;346:1085-1087.
37. Jensen AL, Iversen L, Hoier R. Evaluation of analytical performance assisted by total error criteria of a commercial enzyme immunometric assay for canine serum thyrotropin. Vet Clin Pathol. 1999;28:53-56.
38. Westgard JO. Six Sigma Quality Design and Control. Madison, WI: Westgard QC Inc; 2001.
39. Jensen AL, Iversen L, Petersen TK. Study on biological variability of haematological components in dogs. Comp Haemat Internat. 1998;8:202-204.
40. Jensen AL, Aaes H. Critical differences of clinical chemical parameters in blood from dogs. Res Vet Sci. 1993;54:10-14.
41. Jensen AL, Aaes H, Iversen L, Petersen TK. The long-term biological variability of fasting plasma glucose and serum fructosamine in healthy Beagle dogs. Vet Res Commun. 1999;23:73-80.
42. Jensen AL, Pedersen HD, Koch J, Aaes H, Flagstad A. Applicability of the critical difference. Zentralbl Veterinarmed A. 1993;40:624-630.
43. Jensen AL, Hoier R. Evaluation of thyroid function in dogs by hormone analysis: effects of data on biological variation. Vet Clin Pathol. 1996;25:130-134.
44. Iversen L, Jensen AL, Hoier R, Aaes H. Biological variation of canine serum thyrotropin (TSH) concentration. Vet Clin Pathol. 1999;28:16-19.
45. Kjelgaard-Hansen M, Mikkelsen LM, Kristensen AT, Jensen AL. Study on biological variability of five acute-phase reactants in dogs. Comp Clin Path. 2003;12:69-74.