Sebia has achieved the CE mark for its HbA1c capillary electrophoresis technique to be used for the diagnosis of diabetes. Sebia’s capillary electrophoresis, until recently only used for monitoring patients, can now be used in laboratories equipped with Sebia’s devices (Capillarys 3 TERA, Capillarys 2 Flex Piercing, Minicap Flex Piercing), in all countries where the CE marking is required, for the diagnosis of diabetes.
Sebia’s technique uses quantitative measurement of HbA1c. The World Health Organization (WHO) recently recommended the use of HbA1c for diabetes diagnosis. An HbA1c value of 48 mmol/mol in IFCC/ SI units (6.5% NGSP units) or higher can be used as a cut-off for the diagnosis of diabetes. The technique can also help to identify patients who may be at risk of developing diabetes (pre-diabetes).
As it does not require fasting, an HbA1c sample can be collected on the patient’s first visit to the clinic. When using traditional diabetes testing, such as the fasting plasma glucose method (FPG), patients are expected to fast overnight, usually for eight to 12 hours. The accuracy of the FPG testing relies on patient compliance; this presents a major barrier to follow-up and receiving a diagnosis from the clinician. Furthermore, when the FPG samples are collected, the glucose concentrations decrease over the following two hours, even when a preservative is used, whereas the HbA1c samples are stable; there is no change in concentration from the time of collection to analysis.