TY - JOUR
T1 - Comparison of fingerstick hemoglobin A1c levels assayed by DCA 2000 with the DCCT/EDIC central laboratory assay
T2 - Results of a Diabetes Research in Children Network (DirecNet) Study
AU - Chase, H. Peter
AU - Fiallo-Scharer, Rosanna
AU - Fisher, Jennifer H.
AU - Tallant, Barbara
AU - Tsalikian, Eva
AU - Tansey, Michael J.
AU - Larson, Linda F.
AU - Coffey, Julie
AU - Wysocki, Tim
AU - Mauras, Nelly
AU - Fox, Larry A.
AU - Bird, Keisha
AU - Lofton, Kelly L.
AU - Buckingham, Bruce A.
AU - Wilson, Darrell M.
AU - Block, Jennifer M.
AU - Clinton, Paula
AU - Weinzimer, Stuart A.
AU - Tamborlane, William V.
AU - Doyle, Elizabeth A.
AU - Sikes, Kristin
AU - Beck, Roy W.
AU - Ruedy, Katrina J.
AU - Kollman, Craig
AU - Xing, Dongyuan
AU - Silvester, Cynthia R.
AU - Becker, Dorothy M.
AU - Cox, Christopher
AU - Ryan, Christopher M.
AU - White, Neil H.
AU - White, Perrin C.
AU - Steffes, Michael W.
AU - Bucksa, Jean M.
AU - Nowicki, Maren L.
AU - Van Hale, Carol A.
AU - Grave, Gilman D.
AU - Linder, Barbara
AU - Winer, Karen K.
PY - 2005/3
Y1 - 2005/3
N2 - Background: The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) high-performance liquid chromatography (HPLC) method for measuring hemoglobin A1c (HbA1c) serves as a reference standard against which other assays are compared. The DCA 2000® + Analyzer (Bayer Inc., Tarrytown, NY, USA), which uses an immunoassay, is a very popular device for measuring HbA1c levels in pediatric diabetes practices. Objective: To determine how HbA1c values measured with the DCA 2000 in a multisite, pediatric diabetes clinic setting compare with corresponding HbA1c values measured in the DCCT/EDIC laboratory. Design/Methods: To examine this question, the Diabetes Research in Children Network (DirecNet) used the DCA 2000 in five clinical centers to measure baseline HbA1c levels in 200 youth with type 1 diabetes mellitus (T1DM) (aged 12.5 ± 2.8 yr) who were participating in an outpatient clinical trial. At the same visit, an additional blood sample was obtained, refrigerated, and shipped to the DCCT/EDIC central laboratory for determination of HbA1c values. Results: The central laboratory HbA1c value averaged 8.0 ± 0.9% (mean ± SD), with a median (25th and 75th quartiles) of 7.8% (7.3 and 8.5%, respectively). The DCA 2000 HbA1c values were strongly correlated (r = 0.94, p < 0.001), but significantly higher than DCCT/EDIC central laboratory values with a mean difference of +0.2% (95% confidence interval +0.14 to 0.23%, p < 0.001). There was some variation in the differences between DCA 2000 and central laboratory values at the five clinical centers (p < 0.001) with mean differences ranging between 0.0 and 0.3%, but differences between the two methods did not vary significantly by age or gender. Conclusion: Measurements of HbA1c by the DCA 2000 compare favorably with the DCCT/EDIC central laboratory method, albeit with slightly higher values.
AB - Background: The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) high-performance liquid chromatography (HPLC) method for measuring hemoglobin A1c (HbA1c) serves as a reference standard against which other assays are compared. The DCA 2000® + Analyzer (Bayer Inc., Tarrytown, NY, USA), which uses an immunoassay, is a very popular device for measuring HbA1c levels in pediatric diabetes practices. Objective: To determine how HbA1c values measured with the DCA 2000 in a multisite, pediatric diabetes clinic setting compare with corresponding HbA1c values measured in the DCCT/EDIC laboratory. Design/Methods: To examine this question, the Diabetes Research in Children Network (DirecNet) used the DCA 2000 in five clinical centers to measure baseline HbA1c levels in 200 youth with type 1 diabetes mellitus (T1DM) (aged 12.5 ± 2.8 yr) who were participating in an outpatient clinical trial. At the same visit, an additional blood sample was obtained, refrigerated, and shipped to the DCCT/EDIC central laboratory for determination of HbA1c values. Results: The central laboratory HbA1c value averaged 8.0 ± 0.9% (mean ± SD), with a median (25th and 75th quartiles) of 7.8% (7.3 and 8.5%, respectively). The DCA 2000 HbA1c values were strongly correlated (r = 0.94, p < 0.001), but significantly higher than DCCT/EDIC central laboratory values with a mean difference of +0.2% (95% confidence interval +0.14 to 0.23%, p < 0.001). There was some variation in the differences between DCA 2000 and central laboratory values at the five clinical centers (p < 0.001) with mean differences ranging between 0.0 and 0.3%, but differences between the two methods did not vary significantly by age or gender. Conclusion: Measurements of HbA1c by the DCA 2000 compare favorably with the DCCT/EDIC central laboratory method, albeit with slightly higher values.
KW - Assay
KW - Child
KW - Diabetes mellitus
KW - HbA1c
KW - Type 1
UR - http://www.scopus.com/inward/record.url?scp=20244372561&partnerID=8YFLogxK
U2 - 10.1111/j.1399-543X.2005.00088.x
DO - 10.1111/j.1399-543X.2005.00088.x
M3 - Article
C2 - 15787896
AN - SCOPUS:20244372561
SN - 1399-543X
VL - 6
SP - 13
EP - 16
JO - Pediatric Diabetes
JF - Pediatric Diabetes
IS - 1
ER -