Journal article
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(1), pp.13-16
03/2005
DOI: 10.1111/j.1399-543X.2005.00088.x
PMID: 15787896
Abstract
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.
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.
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.
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.
Measurements of HbA1c by the DCA 2000 compare favorably with the DCCT/EDIC central laboratory method, albeit with slightly higher values.
Details
- Title: Subtitle
- 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
- Creators
- William V Tamborlane - Jaeb Center for Health Research, Tampa, FL 33647, USA. direcnet@jaeb.orgCraig KollmanMichael W SteffesKatrina J RuedyXing DongyuanRoy W BeckPeter ChaseLarry A FoxDarrell M WilsonEva TsalikianDiabetes Research in Children Network (DirecNet) Study Group
- Resource Type
- Journal article
- Publication Details
- Pediatric diabetes, Vol.6(1), pp.13-16
- DOI
- 10.1111/j.1399-543X.2005.00088.x
- PMID
- 15787896
- ISSN
- 1399-543X
- eISSN
- 1399-5448
- Grant note
- HD041918-01 / NICHD NIH HHS HD041919-01 / NICHD NIH HHS HD041908-01 / NICHD NIH HHS HD041906-01 / NICHD NIH HHS HD041890 / NICHD NIH HHS HD041915-01 / NICHD NIH HHS
- Language
- English
- Date published
- 03/2005
- Academic Unit
- Stead Family Department of Pediatrics; Fraternal Order of Eagles Diabetes Research Center
- Record Identifier
- 9984093502402771
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