Hemoglobinopathies, multiple myeloma (MM), and diabetes are major diseases. Diagnosis and monitoring of these diseases require technologies that can separate and quantitate complex molecules of Hb variants, protein, and immunoglobulins and HbA1c. Precise and accurate quantitation of these molecules is important. Many instruments in clinical laboratories used for this quantitation are based on old technologies of the last century.
Capillary electrophoresis is the latest and most advanced technology and is being used globally. This technology offers full automation, complete walkaway, and high throughput, which are of prime importance for most of the clinical laboratories. In this technology, complex molecules are separated according to their electric charge in a silica capillary and quantified directly at a specific wavelength of 415 nm.
Detection of structural hemoglobin (Hb) variants and thalassemia diagnosis have become increasingly important in clinical laboratories. Early detection of variants such as HbS has important therapeutic consequences early in life and may lead to the appropriate application of preventive actions. Quantitative estimation of HbA2 is challenging because its level is low and only slightly increases in beta-thalassemia carriers, thus requiring a high degree of precision.
Till recent years, separation of Hb fractions was performed using age old technologies. Capillary electrophoresis is now widely accepted for the separation of Hb fractions and presumptive Hb variant identifications. In this technology, Hbs are separated and quantified with precision and accuracy. Presumptive identification of an Hb variant is made by comparing its migration position against specific migration zones of known Hb variants found in a library.
Most Hb variants are separated using this technology without any interference. Direct detection provides accurate relative quantification of individual Hb fractions, particularly HbA2 Hb for beta-thalassemia diagnostics. In addition, the high resolution of this technology allows the identification of the Hb S from Hb D and Hb E from Hb C. The HbA2 quantification can also be performed when Hb E is present.
Capillary electrophoresis is the only advanced technique that provides a complete solution for monitoring MM. This technique has improved the quality of electrophoresis when compared to traditional methods used in clinical laboratories. Precise and accurate quantification of HbA1c is a primary requirement of diagnosis and management of diabetes. Capillary electrophoresis provides a robust and accurate technique for the quantification of HbA1c. Its high resolution allows the detection of hemoglobinopathies and thalassemia in parallel, giving useful information to the laboratories for the correct interpretation of the HbA1c values.
HbA1c quantitation by capillary electrophoresis is not affected due to interference from maximum concentration of labile HbA1c, carbamylated Hb, HbF, bilirubin, and triglycerides. It is also not affected by varying Hb concentrations. In addition, no significant bias is observed with the HbA1c results in the presence of vitamin C.
Capillary electrophoresis technology identifies the most common Hb variants and measures HbA1c without any clinically significant interference from Hb variants which may result in inconsistent results depending on the methodology used for measurement of HbA1c; results may be falsely elevated or lower. HbA1c quantified by capillary electrophoresis has traceability for IFCC and NGSP. It is also CE certified and US FDA approved.
Capillary electrophoresis technology is being adopted by many clinical laboratories globally and is on a strong growth trajectory and offers more clinical value, efficiency, and throughput to clinical laboratories of all sizes.