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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 Mar; 6(1):13-6.PD

Abstract

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.

Authors+Show Affiliations

Jaeb Center for Health Research, Tampa, FL 33647, USA. direcnet@jaeb.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

15787896

Citation

Tamborlane, William V., et al. "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." Pediatric Diabetes, vol. 6, no. 1, 2005, pp. 13-6.
Tamborlane WV, Kollman C, Steffes MW, et al. 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):13-6.
Tamborlane, W. V., Kollman, C., Steffes, M. W., Ruedy, K. J., Dongyuan, X., Beck, R. W., Chase, P., Fox, L. A., Wilson, D. M., & Tsalikian, E. (2005). 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. Pediatric Diabetes, 6(1), 13-6.
Tamborlane WV, et al. 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):13-6. PubMed PMID: 15787896.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Tamborlane,William V, AU - Kollman,Craig, AU - Steffes,Michael W, AU - Ruedy,Katrina J, AU - Dongyuan,Xing, AU - Beck,Roy W, AU - Chase,Peter, AU - Fox,Larry A, AU - Wilson,Darrell M, AU - Tsalikian,Eva, AU - ,, PY - 2005/3/25/pubmed PY - 2005/7/6/medline PY - 2005/3/25/entrez SP - 13 EP - 6 JF - Pediatric diabetes JO - Pediatr Diabetes VL - 6 IS - 1 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. SN - 1399-543X UR - https://www.unboundmedicine.com/medline/citation/15787896/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_ L2 - https://doi.org/10.1111/j.1399-543X.2005.00088.x DB - PRIME DP - Unbound Medicine ER -