Hemoglobin A1c point-of-care assays; a new world with a lot of consequences!

Journal of Diabetes Science and Technology

Volumn 3, Issue 3, 2009, Pages 418-423

  Lenters Westra, Erna ^a,b   Slingerland, Robbert J ^a,b  

^a ISALA HOSPITAL   (Netherlands)

^b European Reference Laboratory for Glycohemoglobin   (Netherlands)

Author keywords

HbA1c; Point of care; Regulation

Indexed keywords

GLYCOSYLATED HEMOGLOBIN;

ARTICLE; CAPILLARY; CLINICAL PROTOCOL; COMPARATIVE STUDY; EVALUATION; GLUCOSE BLOOD LEVEL; HOSPITAL INFORMATION SYSTEM; HUMAN; QUALITY CONTROL; REPRODUCIBILITY; STANDARD; VEIN;

BLOOD GLUCOSE; CAPILLARIES; CLINICAL PROTOCOLS; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; POINT-OF-CARE SYSTEMS; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; VEINS;

EID: 77955883454     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/193229680900300303     Document Type: Conference Paper

References (17)

1. Cagliero E, Levina EV, Nathan DM. Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients. Diabetes Care. 1999;22(11):1785-9.
2. Ferenczi A, Reddy K, Lorber DL. Effect of immediate haemoglobin A1c results on treatment decisions in office practice. Endocr Pract. 2001;7(2):85-8.
3. Miller CD, Barnes CS, Phillips LS, Ziemer DC, Gallina DL, Cook CB, Maryman SD, El-Kebbi IM. Rapid A1c availability improves clinical decision-making in an urban primary care clinic. Diabetes Care. 2003;26(4):1158-63.
4. Greaves RF, Northfield JA, Cameron F J. Haemoglobin A1c: evaluation of three point of care analysers for use in a paediatric diabetes clinic. Ann Clin Biochem. 2005;42(Pt 2):124-129.
5. Hawkins RC. Comparison of four point-of-care HbA1c analytical systems against central laboratory analysis. Singapore Med J. 2003;44(1):8-11.
6. Clinical and Laboratory Standards Institute. Preliminary evaluation of clinical chemistry methods; approved guideline. CLSI Document EP10-A (1998). CLSI, Wayne, PA.
7. Clinical and Laboratory Standards Institute. Evaluation of precision performance of clinical chemistry devices; approved guideline. NCCLS Document EP5-A (1992). CLSI, Wayne, PA.
8. Clinical and Laboratory Standards Institute. Method comparison and bias estimation using patient samples; approved guideline. CLSI Document EP9-A (1995). CLSI, Wayne, PA.
9. Rhoads DG. EP Evaluator Release 8. DG Rhoads Associates Inc. Available from: www.dgrhoads.com.
10. Guercci B, Durain D, Leblanc H, Rouland JC, Passa P, Godeau T, Charbonnel B, Mathieu Daude JC, Boniface H, Monnier L, Dauchy F, Slama G, Drouin P. Multicentre evaluation of the DCA 2000 system for measuring glycated hemoglobin. Diabetes Metab. 1997;23(3):195-201.
11. Fonfrède M, Grimaldi A. Evaluation of the DCA 2000 system for glycated haemoglobin measurement. Diabetes Metab. 1998;24(1):66-7.
12. Arsie MP, Marchioro L, Lapolla A, Giacchetto GF, Bordin MR, Rizzotti P, Fedele D. Evaluation of diagnostic reliability of DCA 2000 for rapid and simple monitoring of HbA1c. Acta Diabetol. 2000;37(1):1-7.
13. Szymezak J, Leroy N, Lavalard E, Gillery P. Evaluation of the DCA Vantage analyzer for HbA1c assay. Clin Chem Lab Med. 2008;46(8):1195-8.
14. Little RR. Glycated haemoglobin standardization - National Glycohemoglobin Standardization Program (NGSP) perspective. Clin Chem Lab Med. 2003;41(9):1191-9.
15. Holmes EW, Erşahin C, Augustine GJ, Charnogursky GA, Gryzbac M, Murrell JV, McKenna KM, Nabhan F, Kahn SE. Analytic bias among certified methods for the measurement of hemoglobin a1c, a cause for concern? Am J Clin Pathol. 2008;129(4):540-7.
16. College of American Pathologists. Glycohemoglobin Survey 2008, set GH2-B. Northfield, IL: CAP; 2008.
17. CLIA requirements for waived tests. Available from: http://www.cms.hhs. gov/CLIA/01-overview.