The results obtained by Sebia demonstrated that the new method for the measurement of HbA1c brings a significant performance improvement. This is due, the company says, to a direct analysis of HbA1c, the absence of interferences and distortion of results, an improved reproducibility and linearity, and traceability from the primary tube to the end result.
The tests formed part of the Biologie- Prospective-Réalité initiative in France, which was formed by biologists working in the private sector in one region of France to become part of a national network of laboratories. Sebia is one of the network’s suppliers and asked the organisation to test the new method against those currently used for dosing HbA1c assays (the HPLC reference method).
The trial took place over 28 days, during which the HbA1c assays dosed at the MEDIBIO technical platform in Melun were tested in parallel on the Capillarys 2 Flex Piercing automated instrument, applying the same analytical conditions. The trial involved over 5,000 HbA1c assays, so the system handled more than 200 Hb1Ac a day. The trial was also designed to demonstrate the reliability and sturdiness of the equipment.
The results showed that the speed was comparable with the HPLC method, the software was easy to use and limited technical training was required. One advantage of the Capillarys 2 Flex Piercing method is its ability to distinguish between different types of hemoglobin. As a result, it may be possible to use this dosing method in diabetics who suffer from hemoglobinopathy.
