As of today more than 463 million of people have diabetes worldwide, and around 50 % of people having diabetes are undiagnosed.
Glycated hemoglobin (HbA1c) is a key parameter in the diagnosis of diabetes, HbA1c reflects the average blood glucose over the 3 past months. WHO has concluded, almost one decade ago, that HbA1c can be used as a diagnostic test for diabetes. An HbA1c of 6.5% (48 mmol/mol) is recommended as the cut point for diagnosing diabetes.
The HbA1c test is an indispensable part of routine management of diabetes.
Based on many years of experiences in Capillary electrophoresis technology, Sebia has adapted this technology for HbA1c testing. This innovative technology provides to laboratories and clinicians accurate and meaningful results to ensure a better patient management.
Key Benefits
Excellent separation: The clear-cut and precise separation of the different hemoglobin fractions allows accurate HbA1c measurement thanks to high resolution separation of our capillary instruments.
No interferences: There is no alteration of results in the presence of frequent interferences (labile A1c, carbamylated Hb, Hb F, Hb S, Hb C, Hb D and Hb E) as well as the incidental detection of the common hemoglobin disorders (sickle cell, beta-thalassemia…).
Meaningful results: Using the IFCC reference method calculation formula HbA1c/(HbA1c+HbA0), developed for the worldwide assay standardization, the Sebia methodology ensures accurate and reliable results. Unlike other HbA1c testing methods, Sebia CE technology will not provide any spurious results in presence of sample having homozygous hemoglobin variant or presenting hemoglobin variant interfering with HbA1c calculation.
Adapted to each laboratory: With our broad range of capillary instruments, the laboratory can choose the most suitable platform for its needs, from a benchtop standalone instrument up to the TLA configuration.
Main Characteristics
Test Principle
HbA1c is defined as the hemoglobin A which is irreversibly glycated at one or both N-terminal valines of the beta chain.
The level of glycated hemoglobin corresponds to the “integration” of all the glycemic variations during the previous weeks.
It can be used:
as an index of diabetes control. This quantification allows to evaluate the middle term efficiency of treatments,
as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus
Sample Type
Whole blood samples are used and analysed directly on Capillary instruments.
The Sebia CAPILLARY BLOOD SAMPLE KIT can be used on Capillary instrument and is an interesting alternative to venous blood sampling for HbA1c measurement.
Performances
Hb A1c test
Instrument
Throughput (tests/hour)
CAPILLARYS 3 OCTA
43
CAPILLARYS 3 TERA
63
CAPILLARYS 3 TERA MC3
176
CAPILLARYS 3 TERA TLA
58
MINICAP FLEX-PIERCING
7
* Using Software version 9.30
No interference from common hemoglobin variants, or HbF or carbamylated hemoglobin.
