Accuracy and precision of the axis-shield afinion hemoglobin A1c measurement device

Journal of Diabetes Science and Technology

Volumn 6, Issue 2, 2012, Pages 380-386

  Wood, Jamie R ^a,b   Kaminski, Brett M ^b   Kollman, Craig ^b   Beck, Roy W ^b   Hall, Callyn A ^b   Yun, Jason P ^a   Cengiz, Eda ^c   Haller, Michael J ^d   Hassan, Krishna ^e   Klingensmith, Georgeanna J ^f   Tamborlane, William V ^c  

^a CHILDREN S HOSPITAL LOS ANGELES   (United States)

^b JAEB CENTER FOR HEALTH RESEARCH   (United States)

^c YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF FLORIDA   (United States)

^e BAYLOR COLLEGE OF MEDICINE   (United States)

^f UNIVERSITY OF COLORADO DENVER   (United States)

Author keywords

Accuracy; Diabetes mellitus; Glycated hemoglobin; HbA1c; Point of care testing; Precision

Indexed keywords

HEMOGLOBIN A1C; BIOLOGICAL MARKER; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN;

ADOLESCENT; ARTICLE; AXIS SHIELD AFINION HEMOGLOBIN A1C MEASUREMENT DEVICE; BLOOD ANALYSIS EQUIPMENT; CAPILLARY BLOOD; CONTROLLED STUDY; DIABETES MELLITUS; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IMMUNOASSAY ANALYZER; MAJOR CLINICAL STUDY; MALE; MEASUREMENT ACCURACY; POINT OF CARE TESTING; BLOOD; CHILD; CLINICAL TRIAL; COMPARATIVE STUDY; EQUIPMENT DESIGN; HOSPITAL INFORMATION SYSTEM; IMMUNOASSAY; INSTRUMENTATION; MATERIALS TESTING; MULTICENTER STUDY; OBSERVER VARIATION; PREDICTIVE VALUE; REPRODUCIBILITY; STANDARD; UNITED STATES;

ADOLESCENT; BIOLOGICAL MARKERS; CHILD; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DIABETES MELLITUS; EQUIPMENT DESIGN; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; IMMUNOASSAY; MALE; MATERIALS TESTING; OBSERVER VARIATION; POINT-OF-CARE SYSTEMS; PREDICTIVE VALUE OF TESTS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; UNITED STATES;

EID: 84865127683     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/193229681200600224     Document Type: Article

References (11)

1. 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. (Pubitemid 36929265)
2. Petersen JR, Finley JB, Okorodudu AO, Mohammad AA, Grady JJ, Bajaj M. Effect of point-of-care on maintenance of glycemic control as measured by A1C. Diabetes Care. 2007;30(3):713-15. (Pubitemid 46354358)
3. Tamborlane WV, Kollman C, Stefes MW, Ruedy KJ, Dongyuan X, Beck RW, Chase P, Fox LA, Wilson DM, Tsalikian E; Diabetes Research in Children Network (DirecNet) Study Group. Comparison of fingerstick hemoglobin A1c levels assayed by DCA 2000 with the DCCT/EDIC central laboratory assay: results of a Diabetes Research in Children Network (DirecNet) Study. Pediatr Diabetes. 2005;6(1):13-16. (Pubitemid 40514886)
4. Pediatric Diabetes Consortium. The Pediatric Diabetes Consortium: improving care of children with type 1 diabetes through collaborative research. Diabetes Technol Ther. 2010;12(9):685-8.
5. Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999;8(2):135-60. (Pubitemid 29425900)
6. Lenters-Westra E, Slingerland RJ. Six of eight hemoglobin A1c point-of-care instruments do not meet the general accepted analytical performance criteria. Clin Chem. 2010;56(1):44-52.
7. 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.
8. Guerci B for the DCA Study Group. Multicentre evaluation of the DCA 2000 system for measuring glycated haemoglobin. Diabetes Metab. 1997;23(3):195-201.
9. 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.
10. Petersen JR, Omoruyi FO, Mohammad AA, Shea TJ, Okorodudu AO, Ju H. Hemoglobin A1c: assessment of three POC analyzers relative to a central laboratory method. Clin Chim Acta. 2010;411(23-24):2062-6.
11. Sanchez-Mora C, Rodriguez-Oliva MS, Fernandez-Riejos P, Mateo J, Polo-Padillo J, Goberna R, Sánchez-Margalet V. Evaluation of two HbA1c point-of-care analyzers. Clin Chem Lab Med. 2011;49(4):653-7. Diseases