[Diagnosis and evaluation of metabolic control in diabetes mellitus].
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Biomedical subjects
Publications and source records attributed to M Lytken Larsen.
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Without a consensus on either a reference method or a single glycated haemoglobin standard, the individual laboratory has to establish and secure its own assay method. Prior to selection of a method for glycated haemoglobin we used an assessment model and defined our clinical goals. Based on clinical goals it was possible to set up goals of analytical quality and evaluate available literature concerning the performance characteristics of different assay methods. We wanted a method that measured HbAlc, without measuring the labile intermediate pre-HbAlc, and that provided separate detection of haemoglobin variants. Low imprecision was required to secure the measured, non-diabetic reference interval, and to minimize random analytical error. We found the isoelectric focusing method the only one able to meet our goals, and a method evaluation was carried out. Clinical goals of analytical quality should always be defined before method selection and implementation. Using this model, we were able to establish a precise isoelectric focusing method that fulfilled our clinical goals by measuring HbAlc with a total coefficient of variation of 2.1% and a non-diabetic reference interval from 5.2% to 6.8% HbAlc.
Measurement of glycated haemoglobin has been shown to be a useful index of long-term blood glucose control in diabetes mellitus. The utility for routine care has to some extent been diminished by the practical problem of not having the actual results at the time of the clinic visit. We therefore found it of interest to test a new system for capillary blood collection, storage and transportation, which makes it possible to perform capillary blood collection at home, and then forward the blood sample for the laboratory assay of glycated haemoglobin. In the out-patient clinic 32 insulin-dependent diabetics performed capillary blood sampling by this new system. Simultaneously a venous blood collection was carried out by a technician, and all samples were analysed in the laboratory by isoelectric focusing. The results from the two ways of sampling showed perfect correlation (r = 0.98), and comparable stability. This new system may solve one of the practical problems of the utility of glycated haemoglobin in routine diabetes care.