As of today more than 463 million of people have diabetes worldwide(1), 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(2) 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.
The clear-cut and precise separation of the different hemoglobin fractions allows accurate HbA1c measurement thanks to high resolution separation of our capillary instruments.
There is no alteration of results in the presence of frequent interferences(3) (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…).
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 erronius results in presence of sample having homozygous hemoglobin variant or presenting hemoglobin variant interfering with HbA1c calculation.
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 MC3 configuration.
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:
Whole blood samples are used and analysed directly on Capillary instruments.
Throughput (tests/hour)*
Hb A1c
CAPILLARYS 3 OCTA 43
CAPILLARYS 3 TERA 63
CAPILLARYS 3 TERA MC3 176
MINICAP FLEX-PIERCING 7
* Using Software version 9.30
Each Sebia capillary instrument has a dedicated reagent kit to perform HbA1c analysis.
The power of up to 36 capillaries in one automated high volume workcell.
The compact and affordable automation of Capillary Electrophoresis.
HbA1c is routinely used in the clinical laboratory to diagnose and monitor diabetes mellitus. Many methods have been standardized to provide precise and accurate results for normal patients. For the other common Hb variants, most of the methods are now relatively free of analytical interference.
Educational Webinar with Dr. Cas WEYKAMP
Educational Webinar with David G. Grenache, PhD, D(ABCC)
Chief Scientific Officer, TriCore Reference Laboratories
Educational Webinar Dr. Cornelia L. Harteveld from Leiden University Medical Center
Educational Webinar with Dr. Matthew C. Wagner
The EurA1c trial, organized yearly, investigates the performance of HbA1c assays across countries and manufacturers.
This article reminds the reader of the importance of detecting the Hb variants when measuring HbA1c for the labs and clinicians to better interpret the results and to ensure optimal management of the diabetic patient.
Hemoglobin C, D Punjab, E or S trait can interfere with hemoglobin A1c (HbA1c) results depending on the method of analysis used. Therefore, it is important to know the limitations of the method used for HbA1c determination.
(1) IDF DIABETES ATLAS – 9th edition 2019
(2) Use of Glycated Haemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus – https://www.who.int/diabetes/publications/report-hba1c_2011.pdf
(3) Factors that interfere with HbA1c test results – http://www.ngsp.org/factors.asp
This section contains information intended for wide distribution and may therefore contain product details or information that is not available or valid in your country.
Please contact your local Sebia representative. Information intended for healthcare professionals.
Carefully read the instructions in the reagent package inserts and instrument manuals.