Why the study?
Is there a discrepancy in HbA1c measurements between local laboratories and a central reference laboratory?
Is there a discrepancy in HbA1c measurements between local laboratories and a central reference laboratory?
Significant negative bias in local HbA1c measurements compared to a central reference laboratory highlights the need for method standardization to avoid clinical mismanagement.
Discrepant HbA1c readings may compromise diabetes management; leaves open questions on laboratory standardization.
As participants in a general practice intervention study, 66 patients had their HbA1c measured both at a local and at a selected central reference laboratory. A discrepancy in the results was observed, as 97% of the results measured locally were lower than the centrally determined results. Bias (as calculated from mean value of measured HbA1c) between local laboratories and the central laboratory was measured to -1.47% HbA1c. A bias of this magnitude gave "problems" both to the general practitioners, patients and laboratories. To reduce the "problems" a bias of 0.5% HbA1c is estimated to be acceptable. But, to avoid these "problems" totally, a bias of 0.25% HbA1c is estimated to be the highest allowed bias. For HbA1c, a control system for both control of method standardisation and for specificity is described.
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Jensen et al. (1993) studied this question.
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