Measurement standardization and analytical goals for glycated hemoglobin;Standardizzazione della misura e traguardi analitici per l'emoglobina glicata

Biochimica Clinica

Volumn 37, Issue 2, 2013, Pages 100-107

  Braga, Federica ^a   Panteghini, Mauro ^a  

^a UNIVERSITY OF MILAN   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN A1C; HEMOGLOBIN BETA CHAIN; HEXAPEPTIDE; VALINE;

CLINICAL LABORATORY; DIABETES MELLITUS; GLUCOSE BLOOD LEVEL; REVIEW;

EID: 84877764278     PISSN: 03930564     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (44)

1. Mosca A. La determinazione dell'emoglobina glicata nel sangue umano: Attualità e prospettive. Biochim Clin 2008;32:27-35.
2. American Diabetes Association. Standards of medical care in diabetes-2012. Diabetes Care 2012;35(suppl 1):S11-63.
3. American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care 2010;33(suppl 1):S62-9.
4. Panteghini M. Un nuovo referto per l'emoglobina glicata: il futuro è qui. Biochim Clin 2010;34:93-5.
5. Panteghini M. Application of traceability concepts to analytical quality control may reconcile total error with uncertainty of measurement. Clin Chem Lab Med 2010;48:7-10.
6. Panteghini M. Implementation of standardization in clinical practice: not always an easy task. Clin Chem Lab Med 2012;50:1237-41.
7. Infusino I, Panteghini M. Stima dell'incertezza di una misurazione: la riferibilità metrologica ci salverà? Biochim Clin 2010;34:245-6.
8. Weykamp C, John WG, Mosca A, et al. The IFCC reference measurement system for HbA1c: A 6-year progress report. Clin Chem 2008;54:240-8.
9. Little RR, Rohlfing CL, Sacks DB. Status of hemoglobin A1c measurement and goals for improvement: from chaos to order for improving diabetes care. Clin Chem 2011;57:205-14.
10. Jeppsson J, Kobold U, Barr J, et al. Approved IFCC reference method for the measurement of HbA1c in human blood. Clin Chem Lab Med 2002;40:78-89.
11. Nordin G, Dybkaer R. Recommendation for term and measurement unit for "HbA1c". Clin Chem Lab Med 2007;45:1081-2.
12. Panteghini M, John WG. Implementation of haemoglobin A1c results traceable to the IFCC reference system: the way forward. Clin Chem Lab Med 2007;45:942-4.
13. Hoelzel W, Weykamp C, Jeppsson J, et al. IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan, and Sweden: A method-comparison study. Clin Chem 2004;50:166-74.
14. Geistanger A, Arends S, Berding C, et al. Statistical methods for monitoring the relationship between the IFCC reference measurement procedure for hemoglobin A1c and the designated comparison methods in the United States, Japan, and Sweden. Clin Chem 2008;54:1379-85.
15. Roche Diagnostics GmbH, Centralized diagnostics operations, Quality operations Penzberg. Traceability and uncertainty. Cobas Integra C.f.a.s. HbA1c. March 2008.
16. Braga F, Dolci A, Scapellato L, et al. Utilizzo di un pool di sangue fresco congelato per la valutazione intralaboratorio dell'imprecisione della determinazione dell'emoglobina glicata. Biochim Clin 2010;34:203-6.
17. Braga F, Dolci A, Mosca A, et al. Variabilità biologica dell'emoglobina glicata: un'analisi sistematica della letteratura. Biochim Clin 2009;33:297-302.
18. Panteghini M. Traceability as a unique tool to improve standardization in laboratory medicine. Clin Biochem 2009;42:236-40.
19. Mosca A, Branca MT, Carta M, et al. Raccomandazioni per l'implementazione della standardizzazione internazionale della misura dell'emoglobina glicata in Italia. Documento prodotto dal Gruppo di Lavoro GLAD (Gruppo di Lavoro A1c Delegati). Biochim Clin 2009;33:258-61.
20. Kallner A, McQueen M, Heuck C. The Stockholm Consensus Conference on quality specifications in laboratory medicine, 25-26 April 1999. Scand J Clin Lab Invest 1999;59:475-585.
21. Klee GG. Definizione dei traguardi di prestazione analitica sulla base dell'"outcome" clinico. Biochim Clin 2011;35:254-61.
22. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-86.
23. Clinical and Laboratory Standards Institute (CLSI). Verification of comparability of patient results within one health care system; Proposed guideline, C54-P. Wayne, PA: CLSI, 2007.
24. Fraser CG, Hyltoft Petersen P, Libeer JC, et al. Proposals for setting generally applicable quality goals solely based on biology. Ann Clin Biochem 1997;34:8-12.
25. Fraser CG, Harris EK. Generation and application of data on biological variation in clinical chemistry. Crit Rev Clin Lab Sci 1989;27:409-37.
26. Goodall I, Colman PG, Schneider HG, et al. Desirable performance standards for HbA1c analysis -precision, accuracy and standardisation. Consensus statement of the Australasian Association of Clinical Biochemists (AACB), the Australian Diabetes Society (ADS), the Royal College of Pathologists of Australasia (RCPA), Endocrine Society of Australia (ESA), and the Australian Diabetes Educators Association (ADEA). Clin Chem Lab Med 2007;45:1083-97.
27. Carobene A, Franzini C, Ceriotti F. Traguardi analitici per VEQ: due programmi a confronto. Biochim Clin 2010;34:607-11.
28. Ponzo P, Dolci A, Scapellato L, et al. Valutazione della commutabilità per il sistema analitico Cobas Integra dei materiali di controllo utilizzati nella VEQ per l'emoglobina glicata. Biochim Clin 2008;32:44-7.
29. Mosca A. Considerazioni sull'implementazione a livello nazionale delle raccomandazioni per la standardizzazione della misura dell'emoglobina glicata. Biochim Clin 2011;35:36-41.
30. Weykamp CW, Mosca A, Gillery P, et al. The analytical goals for hemoglobin A1c measurement in IFCC units and National Glycohemoglobin Standardization Program units are different. Clin Chem 2011;57:1204-6.
31. Trapé J, Aliart M, Brunet M, et al. Reference change value for HbA1c in patients with type 2 diabetes mellitus. Clin Chem Lab Med 2000;38:1283-7.
32. Braga F, Dolci A, Montagnana M, et al. Revaluation of biological variation of glycated hemoglobin (HbA1c) using an accurately designed protocol and an assay traceable to the IFCC reference system. Clin Chim Acta 2011;412:1412-6.
33. Braga F, Dolci A, Mosca A, et al. Biological variability of glycated hemoglobin. Chim Clin Acta 2010;411:1606-10.
34. Franzini C. Need for a more correct estimate of biological variation values. Biochim Clin 2011;35:382-5.
35. Braga F, Panteghini M. Biological variability of C-reactive protein: is the available information reliable? Clin Chim Acta 2012;413:1179-83.
36. Panteghini M. Traceability in Laboratory Medicine: Copernican revolution or activity for a restricted professional club? 4th International Scientific Meeting "Rethinking quality control in the traceability era". November 30, 2010, Milano, Italy. Available at: http://users.unimi.it/cirme/public/ UploadAttach/Panteghini2010.pdf
37. Infusino I, Braga F, Paleari R, et al. Il "Joint Committee for Traceability in Laboratory Medicine" (JCTLM): una cooperazione internazionale per promuovere la standardizzazione dei risultati in Medicina di Laboratorio. Biochim Clin 2011;35:377-81.
38. Carobene A, Ceriotti F, Infusino I, et al. Valutazione dell'impatto del processo di standardizzazione sulla qualità della misura della creatininemia nei laboratori italiani. Biochim Clin 2012;37:414-24.
39. Infusino I, Panteghini M. Accuratezza nella misura e impiego clinico dell'esame di laboratorio: l'esempio dell'albumina sierica. Biochim Clin 2013;37:48-52.
40. Finke A, Kobold U, Hoelzel W, et al. Preparation of a candidate primary reference material for the international standardisation of HbA1c determinations. Clin Chem Lab Med 1998;36:299-308.
41. ISO 15194:2009. In vitro diagnostic medical devices -Measurement of quantities in samples of biological origin -Requirements for certified reference materials and content of supporting documentation. 2nd ed. Geneva, Switzerland: ISO, 2009.
42. Kaiser P, Akerboom T, Molnar P, et al. Modified HPLC electrospray ionization/mass spectrometry method for HbA1c based on IFCC reference measurement procedure. Clin Chem 2008;54:1018-22.
43. Kaiser P, Akerboom T, Ohlendorf R, et al. Liquid chromatography-isotope dilution-mass spectrometry as a new basis for the reference measurement procedure for hemoglobin A1c determination. Clin Chem 2010;56:750-4.
44. Bunk D. Requirements of a reference measurement procedure and how they relate to a certified reference material for cTnI that is fit for purpose. 5th International Scientific Meeting "Standardization of cardiac troponin I: the ongoing international efforts". November 30, 2011, Milano, Italy. Available at: http://users.unimi.it/barb/public/UploadAttach/2011Bunk.pdf.