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

H. Peter Chase, Rosanna Fiallo-Scharer, Jennifer H. Fisher, Barbara Tallant, Eva Tsalikian, Michael J. Tansey, Linda F. Larson, Julie Coffey, Tim Wysocki, Nelly Mauras, Larry A. Fox, Keisha Bird, Kelly L. Lofton, Bruce A. Buckingham, Darrell M. Wilson, Jennifer M. Block, Paula Clinton, Stuart A. Weinzimer, William V. Tamborlane, Elizabeth A. Doyle & 18 others Kristin Sikes, Roy W. Beck, Katrina J. Ruedy, Craig Kollman, Dongyuan Xing, Cynthia R. Silvester, Dorothy M. Becker, Christopher Cox, Christopher M. Ryan, Neil H. White, Perrin C. White, Michael W. Steffes, Jean M. Bucksa, Maren L. Nowicki, Carol A. Van Hale, Gilman D. Grave, Barbara Linder, Karen K. Winer

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)13-16
Number of pages4
JournalPediatric Diabetes
Volume6
Issue number1
DOIs
StatePublished - Mar 1 2005

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Diabetes Complications
Hemoglobins
Epidemiology
Research
Pediatrics
Type 1 Diabetes Mellitus
Immunoassay
Outpatients
High Pressure Liquid Chromatography
Clinical Trials
Confidence Intervals
Equipment and Supplies

Keywords

  • Assay
  • Child
  • Diabetes mellitus
  • HbA1c
  • Type 1

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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. / Chase, H. Peter; Fiallo-Scharer, Rosanna; Fisher, Jennifer H.; Tallant, Barbara; Tsalikian, Eva; Tansey, Michael J.; Larson, Linda F.; Coffey, Julie; Wysocki, Tim; Mauras, Nelly; Fox, Larry A.; Bird, Keisha; Lofton, Kelly L.; Buckingham, Bruce A.; Wilson, Darrell M.; Block, Jennifer M.; Clinton, Paula; Weinzimer, Stuart A.; Tamborlane, William V.; Doyle, Elizabeth A.; Sikes, Kristin; Beck, Roy W.; Ruedy, Katrina J.; Kollman, Craig; Xing, Dongyuan; Silvester, Cynthia R.; Becker, Dorothy M.; Cox, Christopher; Ryan, Christopher M.; White, Neil H.; White, Perrin C.; Steffes, Michael W.; Bucksa, Jean M.; Nowicki, Maren L.; Van Hale, Carol A.; Grave, Gilman D.; Linder, Barbara; Winer, Karen K.

In: Pediatric Diabetes, Vol. 6, No. 1, 01.03.2005, p. 13-16.

Research output: Contribution to journalArticle

Chase, HP, Fiallo-Scharer, R, Fisher, JH, Tallant, B, Tsalikian, E, Tansey, MJ, Larson, LF, Coffey, J, Wysocki, T, Mauras, N, Fox, LA, Bird, K, Lofton, KL, Buckingham, BA, Wilson, DM, Block, JM, Clinton, P, Weinzimer, SA, Tamborlane, WV, Doyle, EA, Sikes, K, Beck, RW, Ruedy, KJ, Kollman, C, Xing, D, Silvester, CR, Becker, DM, Cox, C, Ryan, CM, White, NH, White, PC, Steffes, MW, Bucksa, JM, Nowicki, ML, Van Hale, CA, Grave, GD, Linder, B & Winer, KK 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, vol. 6, no. 1, pp. 13-16. https://doi.org/10.1111/j.1399-543X.2005.00088.x
Chase, H. Peter ; Fiallo-Scharer, Rosanna ; Fisher, Jennifer H. ; Tallant, Barbara ; Tsalikian, Eva ; Tansey, Michael J. ; Larson, Linda F. ; Coffey, Julie ; Wysocki, Tim ; Mauras, Nelly ; Fox, Larry A. ; Bird, Keisha ; Lofton, Kelly L. ; Buckingham, Bruce A. ; Wilson, Darrell M. ; Block, Jennifer M. ; Clinton, Paula ; Weinzimer, Stuart A. ; Tamborlane, William V. ; Doyle, Elizabeth A. ; Sikes, Kristin ; Beck, Roy W. ; Ruedy, Katrina J. ; Kollman, Craig ; Xing, Dongyuan ; Silvester, Cynthia R. ; Becker, Dorothy M. ; Cox, Christopher ; Ryan, Christopher M. ; White, Neil H. ; White, Perrin C. ; Steffes, Michael W. ; Bucksa, Jean M. ; Nowicki, Maren L. ; Van Hale, Carol A. ; Grave, Gilman D. ; Linder, Barbara ; Winer, Karen K. / 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. In: Pediatric Diabetes. 2005 ; Vol. 6, No. 1. pp. 13-16.
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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{\circledR} + 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.",
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author = "Chase, {H. Peter} and Rosanna Fiallo-Scharer and Fisher, {Jennifer H.} and Barbara Tallant and Eva Tsalikian and Tansey, {Michael J.} and Larson, {Linda F.} and Julie Coffey and Tim Wysocki and Nelly Mauras and Fox, {Larry A.} and Keisha Bird and Lofton, {Kelly L.} and Buckingham, {Bruce A.} and Wilson, {Darrell M.} and Block, {Jennifer M.} and Paula Clinton and Weinzimer, {Stuart A.} and Tamborlane, {William V.} and Doyle, {Elizabeth A.} and Kristin Sikes and Beck, {Roy W.} and Ruedy, {Katrina J.} and Craig Kollman and Dongyuan Xing and Silvester, {Cynthia R.} and Becker, {Dorothy M.} and Christopher Cox and Ryan, {Christopher M.} and White, {Neil H.} and White, {Perrin C.} and Steffes, {Michael W.} and Bucksa, {Jean M.} and Nowicki, {Maren L.} and {Van Hale}, {Carol A.} and Grave, {Gilman D.} and Barbara Linder and Winer, {Karen K.}",
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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 - 2005/3/1

Y1 - 2005/3/1

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.

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

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