Analytical performances in screening of hemoglobinopathies based on HbA1c SEBIA capillary electrophoresis assay

Analytical performances in screening of hemoglobinopathies based on HbA1c SEBIA capillary electrophoresis assay

 

The precise separation of Hb variants is a big advantage of HbA1c assay using SEBIA Capillarys/Minicap Flex Piercing instruments.

An accurate and reliable estimation of the presence of Hb variants during Hb A1c measurement could be very interesting in some clinical situations:

  • The screening of hemoglobinopathies during a visit to the doctor for diabetes diagnosis
  • For an HbA2 increase that support a β thalassemic syndrome. As it is already known, β thalassemia could altered the Hb A1c results by the decrease of red blood cells life span (80-90 days) that lead to an underestimation of it.
  • For patients with HbS who need to be transfused urgently. The possible use of the Minicap/Capillarys HbA1c kit would avoid the change the kit if it is not the right one installed

A retrospective study carried out in France on 3,233 patient samples received for diabetes screening and monitoring demonstrates a prevalence of 3.74% of hemoglobin disorders detected during HbA1c SEBIA capillary electrophoresis assay. Patient samples detected with Hb variant and β thalassemia trait during the HbA1c capillary electrophoresis assay were analyzed by SEBIA Hemoglobin(e) Capillarys assay technique. The presence of abnormalities was confirmed in all samples indicating a 100% sensitivity of SEBIA Capillarys HbA1c kit in detection and screening of hemoglobinopathies.

The same analytical performances have been shown by a working group from Lyon, France. A negative bias of 0.6% for HbA2 compared to the reference SEBIA Hemoglobin(e) kit  has been reported. Moreover, the study demonstrated that SEBIA HbA1c Capillarys kit is able to detect a β thalassemia by using a cut off of 2.8% as well as other hemoglobinopathies (e.g.HbA/S).

 

References

  1. Baidjibai N, Van de Loo M. – Prevalence of hemoglobin disorders based on HbA1c capillary electrophoresis assay: experience from a laboratory in France – poster presented at IFCC 2015.
  2. Jolly P, et al. Comparison of the “Hemoglobin(e)” and “HbA1c” kits for HbA2 and HbS quantification on the Capillarys 2 Flex Piercing (SEBIA)- poster presented at IFCC 2015.