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Related Experiment Videos

Different DCCT-aligned HbA1c methods and the GMS contract.

P J Twomey1, D R Pledger

  • 1Department of Clinical Biochemistry, The Ipswich Hospital, Ipswich, Suffolk, UK. ptwomey@nhs.net

International Journal of Clinical Practice
|January 18, 2008
PubMed
Summary
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Two HbA1c analysers showed statistically significant differences in classifying glycaemic control, potentially impacting diabetes management and payments under the GMS contract. Healthcare professionals must understand these method limitations.

Area of Science:

  • Clinical Chemistry
  • Diabetes Mellitus Diagnostics
  • Analytical Method Comparison

Background:

  • The UK's primary care contract (since 2003) introduced clinical targets for comparing analytical methods.
  • Previous comparisons focused on statistical and clinical grounds.

Purpose of the Study:

  • To compare two DCCT-aligned HbA1c analysers (Variant II and Tosoh G7).
  • To assess if method differences affect glycaemic control classification.

Main Methods:

  • 161 patient specimens were analyzed using Variant II and Tosoh G7 HbA1c analysers.
  • Results were compared against the DM6 GMS target.

Main Results:

  • Significant differences in glycaemic control classification were observed between the two analysers (p<0.00083).

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  • 12 patients (7.5%) were classified differently, with 60.2% and 67.7% below the 7.4% HbA1c threshold respectively.

    • Conclusions:

    • While current GMS contract payments were unaffected, changes in thresholds could impact reimbursement.
    • Limitations of DCCT alignment for HbA1c methods require awareness among policymakers and healthcare professionals.