71
Views
35
CrossRef citations to date
0
Altmetric
Research Article

Evaluation of systematic and random factors in measurements of fasting plasma glucose as the basis for analytical quality specifications in the diagnosis of diabetes. 3. Impact of the new WHO and ADA recommendations on diagnosis of diabetes mellitus

Pages 191-204 | Published online: 08 Jul 2009

REFERENCES

  • Definition, diagnosis and classification of diabetes mellitus and its complications. Report of a WHO consultation. Part 1: Diagnosis and classifi-cation of diabetes mellitus. WHO: Geneva; 1999.
  • The report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care 1997; 20: 1183–97.
  • ISO/TC 212/WG3 ISO/WD 15196. Draft.
  • Stahl M, Brandslund I, Iversen S, Filtenborg JA. Quality assessment of blood glucose testing in general practitioners' offices improves quality. Clin Chem 1997;43:1926–31.
  • Stahl M, Jorgensen LGM, Hyltoft Petersen P, Brandslund I, de Fine Olivarius N, Borch-Johnsen K. Optimization of preanalytical conditions and analysis of plasma glucose. 1. Impact of the new WHO and ADA recommendation on diagnosis of diabetes mellitus. Scand J Clin Lab Invest 2001; 61: 169–180.
  • JOrgensen LGM, Stahl M, Brandslund I, Hyltoft Petersen P, Borch-Johnsen K, de Fine Olivarius N. The plasma glucose reference interval in a low-risk population. 2. Impact of the new WHO and ADA recommendation on diagnosis of diabetes mellitus. Scand J Clin Lab Invest 2001; 61: 181–190.
  • Cotlove E, Harris EK, Williams GZ. Biological and analytical components of variation in long-term studies of serum constituents in normal sub-jects. III. Physiological and medical implications. Clin Chem 1970; 16: 1028–32.
  • Fraser CG, Hyltoft Petersen P, Ricos C, Haeckel R. Proposed quality specifications for the impre-cision and inaccuracy of analytical systems for clinical chemistry. Eur Clin Chem Clin Biochem 1992; 30: 311–7.
  • Stöckl D, Baadenhuijsen H, Fraser CG, Libeer J-C, Hyltoft Petersen P, Ricós C. Desirable routine analytical goals for quantities assayed in serum. Discussion paper from the members of the external quality assessment (EQA) working group A on analytical goals in laboratory medicine. Eur J Clin Chem Clin Biochem 1995; 33: 157–69.
  • Medical need for quality specifications in clinical laboratories. In: de Verdier C-H, Groth T, Hyltoft Petersen P, editors. Report of a NORDKEM Project 1989–1993. Upsala J Med Sci 1993; 98: 187–491.
  • Hyltoft Petersen P, Fraser CG, Kallner A, Kenny D, editors. Strategies to set global analytical quality specifications in laboratory medicine. Scand J Clin Lab Invest 1999; 59: 475–585.
  • Horder M, editor. Assessing quality requirements in clinical chemistry. Report by a project group initiated by the Nordic Clinical Chemistry Project (NORDKEM ). The Nordic Clinical Chemistry Project (NORDKEM ). Helsinki, Finland; 1980. p. 1–144.
  • Groth T, Ljunghall S, de Verdier C-H. Optimum screening for patients with hyperparathyroidism with use of serum calcium observations. A decision-theoretical analysis. Scand J Clin Lab Invest 1983; 43: 699–707.
  • von Eyben FE, Hyltoft Petersen P, Blaabjerg 0, Lindegaard Madsen E. Analytical quality specifi-cations for serum lactate dehydrogenase isoenzyme 1 based on clinical goals. Clin Chem Lab Med 1999; 37: 553–61.
  • Klee G. A conceptual model for establishing toler-ance limits for analytical bias and imprecision based on variations in population test distributions. Clin Chem Acta 1997; 260: 175–88.
  • Thue G, Sandberg S, Fugelli P. Clinical assessment of haemoglobin values by general practitioners related to analytical and b iological variation. Scand J Clin Lab Invest 1991;51: 453–9.
  • Hyltoft Petersen P. Quality specifications based on analysis of effects of performance on clinical decision-making. In: Hyltoft Petersen P, Fraser CG, Kallner A, Kenny D, editors. Strategies to set global analytical quality specifications in labora-tory medicine. Scand J Clin Lab Invest 1999; 59: 517–21.
  • Fraser CG, Hyltoft Petersen P, Libeer J-C, Ric& C. Proposals for setting generally applicable quality goals solely based on biology. Ann Clin Biochem 1997; 34: 8–12.
  • Harris EK. Effects of intra- and inter-individual variation on the appropriate use of normal ranges. Clin Chem 1974; 20: 1535–42.
  • Sebastian-Gambaro MA, Liron-Hermandez FJ, Fuentes-Arderiu X. Intra- and inter-individual bio-logical variability data bank. Eur J Clin Chem Clin Biochem 1997; 35: 845–52.
  • Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, Minchinela J, Perich C, Simon M. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest 1999; 59: 491–500.
  • Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, Minchinela J, Perich C, Simon M (Analytical Quality Commission of the Spanish Society of Clinical Chemistry and Molecular Pathology (SEQC).). Biological vari-ation database. hap J/www.westgard.co m/gu est 17.htm
  • Cummings ST, Fraser CG. Variability of capillary plasma glucose in healthy individuals in repeated 75g oral glucose tolerance tests. Ann Clin Biochem 1988; 25: 634–7.
  • Dahler-Eriksen BS, Flensted Lassen J, Hyltoft Petersen P, Dalsgaard Lund E, Lauritzen T, Brandslund I. Evaluation of a near-patient test for C-reactive protein used in daily routine in primary healthcare by use of difference plots. Clin Chem 1997; 43: 2065–75.
  • Hyltoft Petersen P, Horder M. Clinical test evalu-ation. Unimodal and bimodal approaches. Scand J Clin Lab Invest 1992; 52 Suppl 208: 51–7.
  • Hyltoft Petersen P, Horder M. Ways of assessing quality goals for diagnostic tests in clinical situ-ations. Arch Pathol Lab Med 1988; 112: 435–43.
  • Hyltoft Petersen P, Horder M. Influence of analyt-ical quality on test results. Scand J Clin Lab Invest 1992; 52 Suppl 208: 65–87.
  • Parvin CA. Quality-control (QC) performance measures and the QC-planning process. Clin Chem 1997;43: 602–7.
  • Fraser CG, Hyltoft Petersen P. Analytical perform-ance characteristics should be judged against objec-tive quality specifications. Clin Chem 1999; 45: 321–3.
  • Kenny D, Fraser CG, Hyltoft Petersen P, Kallner A. Consensus agreement. In: Hyltoft Petersen P, Fraser CG, Kallner A, Kenny D, editors. Strategies to set global analytical quality specifications in laboratory medicine. Scand J Clin Lab Invest 1999; 59: 585.
  • Westgard JO, Hyltoft Petersen P, Wiebe DA. Laboratory process specifications for assuring quality in the US national cholesterol education program. Clin Chem 1991;37: 656–61.
  • Dinneen SF, Maldonado D, Leibson CL, Klee GG, Li H, Melton LJ, Rizza RA. Effect of chang-ing diagnostic criteria on the risk of developing diabetes. Diabetes Care 1998; 21: 1408–13.
  • Wiener K, Roberts NB. Diagnostic criteria for diabetes mellitus. Clin Chem 1998; 44: 2222–3.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.