Reference ranges in clinical laboratory;Intervalos de referência no laboratório clínico

Jornal Brasileiro de Patologia e Medicina Laboratorial

Volumn 44, Issue 1, 2008, Pages 11-16

  Ferreira, Carlos Eduardo Dos Santos ^a,b,c,e   Andriolo, Adagmar ^a,d  

^a FEDERAL UNIVERSITY OF SÃO PAULO   (Brazil)

^b INSTITUTO DANTE PAZZANESE DE CARDIOLOGIA   (Brazil)

^c HOSPITAL ISRAELITA ALBERT EINSTEIN   (Brazil)

^d Fleury   (Brazil)

^e Laboratório Clínico   (Brazil)

Author keywords

Clinical laboratory; Normal values; Normality; Reference ranges; Significance range

Indexed keywords

EID: 45349100895     PISSN: 16762444     EISSN: 16784774     Source Type: Journal    
DOI: None     Document Type: Review

References (31)

1. AMERICAN DIABETES ASSOCIATION (ADA). Standards of medical care in diabetes. Diabetes Care, v. 28, suppl. 1, 2005.
2. ANDRIOLO, A.; ROCHA, M. H. Características e interpretaç ão dos resultados dos exames laboratoriais. In: ANDRIOLO, A.; CARRAZA, F. R. Diagnóstico laboratorial em pediatria. 2 ed. São Paulo: Sarvier, 2007. Cap. 1; p. 3-13.
3. BRASIL. Ministério da Saúde. Agência Nacional de Vigilância Sanitária (ANVISA). Dispõe sobre regulamentação técnica para funcionamento de laboratórios clínicos. Resolução da Diretoria Colegiada - RDC no 302, 2005.
4. CLINICAL AND LABORATORY STANDARDS INSTITUTE. How to define and determine reference intervals in the clinical laboratory. Document C 28-A2, 2000.
5. CLINICAL LABORATORY IMPROVEMENT AMENDMENTS of 198 (CLIA), 42 CFR §493.1253(b) (1) (ii) (2003).
6. COLLEGE OF AMERICAN PATHOLOGISTS. Commission on Laboratory Accreditation Inspection Checklist. Laboratory general. Northfield, IL: CAP, 1998.
7. DYBKAER, R.; SOLBERG, H. E. Approved recommendations (1987) on the theory of reference values. Part 6. Presentation of observed values related to reference values. J Clin Chem Clin Biochem, v. 25, p. 657-62, 198 7.
8. FAULKNER, W.; MEITES, S. Geriatric clinical chemistry reference values. Washington, DC: AACC Press, 199 4.
9. FORSMAN, R. W. Why is the laboratory an afterthought for managed care organizations? Clin Chem, v. 42, n. 5, p. 813-6, 1996.
10. FRASER, C. G. Biological variation in clinical chemistry, an update: collated data, 198-1991. Arch Pathol Lab Med, v. 116, p. 916, 1991.
11. FRIEDBERG, R. C. et al. The origin of reference intervals. A College of American Pathologists Q-Probes study of "normal ranges" used in 163 clinical laboratories. Arch Pathol Lab Med, v. 131, n. 3, p. 348-57, 2007.
12. GALLAHER, M. P. et al. The impact of calibration error in medical decision making: final report. Gaithersburg, MD: National Institute of Standards and Technology; 2004.
13. HOWANITZ, P. J. Quality assurance measurements in department of pathology and laboratory medicine. Arch Pathol Lab Med, v. 114, p. 1131-5, 1990.
14. HOWANITZ, P. J.; CEMBROWSKI, G. S. Post analytical quality improvement: a College of American Pathologists Q-Probes study of elevated calcium results in 525 institutions. Arch Pathol Lab Med, v. 124, p. 504-10, 2000.
15. JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS. 1998-99 Comprehensive accreditation manual for pathology and clinical laboratory services. Oakbrook Terrace, IL: JCAHO, 1998.
16. KLEIN, G.; JUNGE, W. Creation of the necessary analytical quality for generating and using reference intervals. Clin Chem Lab Med, v. 42, p. 851-7, 2004.
17. McCLATCHEY, K. D. Clinical laboratory medicine. In: HOLMES, A. C. The interpretation of laboratory tests. 2nd ed. Philadelphia: Lippincott Williams & Wilkins, 2002. Sec. 4; p. 97-122.
18. rd ed. Washington, DC: AACC Press, 1989.
19. PETITCLERC, C.; SOLBERG, H. E. Approved recommendation (198 7) on the theory of reference values. Part 2. Selection of individuals for the production of reference values. J Clin Chem Clin Biochem, v. 25, p. 639-44, 1987.
20. RIDKER, P. M. Clinical application of C-reactive protein for cardiovascular disease detection and prevention. Circulation, v. 107, p. 363-9, 2003.
21. SOCIEDADE BRASILEIRA DE CARDIOLOGIA. III Diretrizes Brasileiras sobre dislipidemias e diretrizes de prevenção da aterosclerose do Departamento de Aterosclerose da Sociedade Brasileira de Cardiologia. Arq Bras Cardiol, v. 77, sup. III, p. 10-1, 2001.
22. SOLBERG, H. E. Approved recommendation (1986) on the theory of reference values. Part 1. The concept of reference values. Clin Chem Acta, v. 167, p. 111-8, 1987.
23. SOLBERG, H. E. Approved recommendations (1987) on the theory of reference values. Part 5. Statistical treatment of collected reference values. Determination of reference limits. J Clin Chem Clin Biochem, v. 25, p. 645-56, 1987.
24. SOLBERG, H. E.; STAMM, D. Approved recommendation on the theory of reference values. Part 4. Control of analytical variation in the production, transfer, and application of reference values. Eur J Clin Chem Clin Biochem, v. 29, p. 531-5, 1991.
25. SOLBERG, H. E; PETITCLERC, C. Approved recommendation (1988 ) on the theory of reference values. Part 3. Preparation of individuals and collection of specimens for the production of reference values. Clin Chem Acta, v. 177, S1-S2, 198.
26. SOLBERG, H. R. Establishment and use of reference values. In: BURTIS, C. A.; ASHWOOD, E. R.; BRUNS, D. E. (editors). Tietz textbook of clinical chemistry and molecular diagnostics. 4th ed. Philadelphia: Elsevier Saunders; 2006. p. 425-48.
27. th ed. Washington, DC: AACC Press, 2003.
28. STEELE, B. W. et al. Total long-term within-laboratory precision of cortisol, ferritin, thyroxine, free thyroxine, and thyroid-stimulating hormone assays based on a College of American Pathologists fresh frozen serum study: do available methods meet medical needs for precision? Arch Pathol Lab Med, v. 129, p. 318-22, 2005.
29. THYGESEN, K. et al. Universal definition of myocardial infarction. European Heart Journal, v. 28, p. 2525-38, 2007.
30. VALENSTEIN, P. Quality management in clinical laboratories: promoting patient safety through risk reduction and continuous improvement. Chicago, Ill: College of American Pathologists, 2005.
31. YUSUF, S. et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. The Lancet, v. 364, n. 9438, 2004.