SEBIA Capillarys HbA1c on capillary blood samples
SEBIA Capillarys HbA1c assay on capillary blood samples
Hb A1c testing on capillary blood samples has some advantages over venous blood samples: saves extra visits to the practitioner office and enhances the patient comfort, in particular in case of diabetic children and the elderly.
HbA1c assay on capillary blood samples can be performed through point-of-care testing or home sampling. Many studies have revealed the poor analytical performances of point-of-care instruments. Home sampling could be an important part of the patient management if the instrument that is used for the capillary blood samples is based on the same technology as for venous samples. Thus, the results are well correlated and the glycemic control is improved.
SEBIA France has launched the first kit designed for HbA1c assay on capillary blood samples using capillary electrophoresis. The Capillarys A1c/ CE kit is now available on Capillarys 2 Flex Piercing system and under development on Capillarys 3 Tera. SEBIA capillary collection kit contains capillary tubes, transport tubes with hemolyzing solution and clamps to grab the capillary tubes.
HbA1c test using capillary blood. SEBIA innovative method for capillary blood collection.
Analytical performances of SEBIA HbA1c assay on capillary blood samples
Analytical performances of HbA1c testing on capillary blood samples using Capillarys 2 Flex Piercing have been recently evaluated by comparison with Tosoh G8 (Tosoh Corporation Tokyo Japan) system. A large spectrum of samples has been tested containing low, elevated and highly elevated HbA1c values. HbA1c values were tested For SEBIA Capillarys 2 Flex Piercing, a comparative study between the HbA1c results on capillary and venous blood samples as well as the evaluation of stability in different conditions for the capillary samples has been also performed.
The study demonstrated
- Total imprecision less than 2.5% (IFCC units) for both instruments
- Bias ≤ 1mmol/mol for Capillarys 2 Flex Piercing SEBIA France compared to 4 mmol/mol or less for Tosoh G8 (Tosoh Corporation Tokyo Japan)
- Linearity over a broad clinical range (29- 152 mmol/mol HbA1c) for both analyzers
- No interferences of labile HbA1c (28 mmol/L glucose), carbamylated Hb (1 mmol/L KCNO), Hb variants (HbS, Hb C, Hb D, HbE), bilirubin (280 μmol/L), and lipemia (triglycerides 26 mmol/L) have been reported for SEBIA Capillarys 2 Flex Piercing system. For Tosoh G8 system, carbamylated Hb and some Hb variants (Hb D, HbE) altered the HbA1c results.
Additionally, for Capillarys 2 Flex Piercing system, a good correlation of HbA1c results on capillary and venous blood samples, as well as a similarity of electrophoretic profiles in the two types of samples has been demonstrated. Moreover, the storage of capillary blood samples at room temperature for at least 5 days before being assayed does not alter the HbA1c results using SEBIA Capillarys 2Flex Piercing.
It can be concluded that, the measurement of HbA1c using capillary blood samples on SEBIA Capillarys 2 Flex Piercing is an inexpensive alternative for venous blood samples when preanalytical factors such as mailing time and temperature are well controlled. HbA1c capillary blood analysis could contribute to a reduction of health care costs without reducing quality of HbA1c results. Regarding the long term precision, the HbA1c methodology using capillary blood samples is robust, providing high accurate results, in a good agreement with those obtained on venous blood samples.
- Heylen O et al.- Evaluation of the Sebia CAPILLARYS 2 Flex Piercing for the measurements of Hb A1c on venous and capillary blood sample. Am J Clin Pathol 2014; 141 (6): 867-77.