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Revista Mexicana de Patología Clínica y Medicina de Laboratorio

ISSN 0185-6014 (Print)
Órgano oficial de difusión de la Federación Mexicana de Patología Clínica, AC y de la Asociación Latinoamericana de Patología Clínica/Medicina de Laboratorio
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2012, Number 1

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Rev Mex Patol Clin Med Lab 2012; 59 (1)

Options to select analytical limits of performance in the clinical laboratory

Porras-Caicedo A, Moreno D, Lugo O, Peña K, Ibarguen J, Amariles A, Díaz M
Full text How to cite this article

Language: Spanish
References: 24
Page: 35-42
PDF size: 122.16 Kb.


Key words:

Analytical quality specifications, analytical quality, analytical limits of performance, metrological requirements, analytical goals.

ABSTRACT

This paper reviews the concept of analytical performance limits highlights the importance of selecting analytical limits of performance and present different options for the clinical laboratories to choose from, is described in more detail the options derived from biological variability in the tri-level model, CLIA, the German Guidelines RiliBAK and state of art in percentiles.


REFERENCES

  1. US Department of Health and Human Services. Medicare, Medicaid and CLIA programs: Regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Final rule. Federal Register 1992; 57: 7002-7186.

  2. Haeckel R, Wosniok W. A new concept to derive permissible limits for analytical imprecision and bias considering diagnostic requirements and technical state-of-the-art. Clin Chem Lab Med 2011; 49: 623–635.

  3. Clinical and Laboratory Standards Institute. Statistical quality control for quantitative measurement procedures: Principles and definitions; approved guideline. 3rd ed (CLSI doc C24–A3). CLSI, Wayne; 2006.

  4. Perry J Riilibak: Quality goals the german way. http://www.westgard.com/rilibak-2.htm (accesado 25 de Julio, 2011)

  5. Kaplan LA. Determination and application of desirable analytical performance goals: The ISO/TC 212 approach. Scand J Clin Lab Invest 1999; 59: 479-482.

  6. Klee GG. Establishment of outcome-related analytical performance goals. Rev Clin Chem 2010; 56: 714-722.

  7. Buño A, Calafell R, Morancho J. Consenso sobre especificaciones mínimas de la calidad analítica. Laboratorio Clínico 2008; 1: 35-39.

  8. International Organization for Standardization. Statistics - vocabulary and symbols. Part 2: Statistical quality control. ISO 3534-2. Geneva; 1993.

  9. Clinical Laboratory Standards Institute CLSI EP21-A. Estimation of total analytical error for clinical laboratory methods. Wayne; 2003. p. 89-140.

  10. Deutsches Ärzteblatt; Jg 105; Heft 7; 15. February (2008); Seite 341 – 355. RiliBAK.

  11. Dybkaer R. Setting quality specifications for the future with newer approaches to defining uncertainty in laboratory medicine. Rev Scand J Clin Lab Invest 1999; 59: 579-584.

  12. Fuentes-Arderiu X. Analytical goals for transferability. Eur J Clin Chem. Clin Biochem 1991; 29: 529-550.

  13. Klee G. Analytic performance Goals bases on direct effect on analytic bias on medical classification decisions. Frontiers Lab Pract Res 1995; 219-226.

  14. Sikaris K. Analytical Quality: What Should we B be aiming for? Clin Biochem 2008; 29 (S5-S10): 156–162.

  15. Fraser C. Biological Variation: From Principles to Practice. AACC Press; 2001.

  16. Wada Y et al. Analytical goals for coagulation test based biological variation. Rev Clin Chem Lab Med 2004; 42: 151-155.

  17. www.seqc.org

  18. www-rhoads.com

  19. Porras CA. Herramientas conceptuales y estadísticas para el mejoramiento continuo de la calidad en medicina del laboratorio. Seminario de grado carrera de Bateriología. Manizales, Colombia; Universidad Católica de Manizales. 2011.

  20. Fuentes-Arderiu X, Miro´-Balague J. State of the art instead of biological variation to set requirements for imprecision. Clin Chem 2000; 46 (10).

  21. Fuentes-Arderiu X. Requisitos metrológicos para los laboratorios clínicos. Take Control 2008; 4 (13). http://qcnet.com/Portals/75/Gaceta%2013.pdf.

  22. ISO 15189:2007 Medical laboratories: Particular requirements for Quality and Competence. 2007.

  23. Krouwer J. Setting performance goals and evaluating total analytical error for diagnostic assays. Clin Chem 2002; 48 (6): 919–927.

  24. Bio-Rad Laboratories Inc. Statistical Profile. UNITY Interlaboratory comparison Report, 2011.




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Rev Mex Patol Clin Med Lab. 2012;59