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One in five laboratories using various hemoglobin A1c methods do not meet the criteria for optimal diabetes care

Erna Lenters-Westra1, Cas Weykamp, Roger K Schindhelm

  • 1Department of Clinical Chemistry, Isala Klinieken, Zwolle, The Netherlands. w.b.lenters@isala.nl

Diabetes Technology & Therapeutics
|March 2, 2011
PubMed

Insights

The reference change value (RCV) for hemoglobin A1c (HbA1c) assays is critical for tracking health status. While most lab methods perform well, some struggle to differentiate small HbA1c changes, impacting treatment decisions.

Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Diagnostic Assays

Background:

  • Assessing the reference change value (RCV) for hemoglobin A1c (HbA1c) laboratory assays is crucial.
  • RCV signifies critical differences in consecutive HbA1c measurements, indicating significant health status changes.

Purpose of the Study:

  • To evaluate the RCV of current hemoglobin A1c (HbA1c) laboratory assays.
  • To determine if laboratory performance meets clinical requirements for distinguishing HbA1c variations.

Main Methods:

  • Examined individual laboratory coefficients of variation (CVs) using lyophilized samples.
  • Calculated RCV per laboratory (n=220) and per assay method.
  • Compared laboratory results against an allowable total error (TEa) of 6%.

Main Results:

  • Most laboratories (99% and 98%) reported HbA1c values within the 6% TEa limit at specific concentrations.
  • The analytical CV for HbA1c methods in 78% of labs was below 2.4%.
  • Mean RCV varied by method, with Tosoh showing the lowest at 3.3 mmol/mol (0.33%-DCCT).

Conclusions:

  • The analytical performance of most HbA1c laboratory methods meets clinical requirements.
  • However, 21.8% of laboratories cannot reliably distinguish between a 53 mmol/mol (7.0%-DCCT) and 59 mmol/mol (7.5%-DCCT) HbA1c result.
  • Differences of 5 mmol/mol (0.5%-DCCT) in HbA1c can influence treatment decisions.
Abstract

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