Diabetes and Hemoglobin
Variants
Accurate HbA1c measurement depends fundamentally on appropriate analytical methodology.
HbA1c is the core indicator for diabetes diagnosis and long-term glycemic
management.
However, in the presence of hemoglobin variants or hemoglobinopathies, inappropriate testing methods may lead to result deviations and affect clinical judgment.
Clinical Impact of Hemoglobin
Variants in HbA1c Measurement
Hemoglobinopathies are widely present globally, especially common among populations in Africa, the Middle East, Southeast Asia and the Mediterranean region.Certain hemoglobin variants may cause falsely elevated or decreased HbA1c, masking the true glycemic control level and increasing the risk of misdiagnosis and treatment decision errors.
Analytical methodology directly determines the reliability and
clinical validity of reported results
Not all HbA1c testing methods are equally reliable in the presence of hemoglobin variants.Methods based on separation principles (such as HPLC and capillary electrophoresis) can accurately determine HbA1c while identifying abnormal hemoglobin components, providing higher credibility data support for clinical practice.
A single analytical run provides extended diagnostic insight
Advanced HbA1c analytical systems can, in a single test, deliver HbA1c results compliant with NGSP and IFCC standards, as well as indication and identification of hemoglobin variants, while supporting diabetes management and hemoglobinopathy risk assessment, providing a testing solution for multi-ethnic populations.
As diabetes testing continues to expand in multi-ethnic regions worldwide, HbA1c methodologies capable of identifying hemoglobin variants have become essential configurations for laboratories rather than optional additions.
| Comparison Dimension | HPLC (High Performance Liquid Chromatography) | Immunoassay |
| Testing Principle | Based on separation and quantitative analysis of hemoglobin components | Based on antigen-antibody specific reaction |
| HbA1c Accuracy | High, minimally affected by hemoglobin variants | Easily interfered by certain hemoglobin variants |
| Hemoglobin Variants Identification Capability | Can directly separate and indicate abnormal peaks | Usually unable to identify variants |
| Traceability of Abnormal Results | High, results can be interpreted through chromatograms | Low, only outputs a single numerical result |
| Applicability to Multi-ethnic Populations | Suitable for regions with high prevalence of hemoglobin variants | There is a potential risk of detection bias |
| Clinical Information Value | Support diabetes monitoring and preliminary screening of hemoglobinopathies | Limited to HbA1c numerical reporting |
| Laboratory Confidence | High (transparent methodology, interpretable results) | Moderate |
Why HPLC Remains the Reference Method for HbA1c Analysis
In populations with high prevalence of hemoglobin variants, reporting only one HbA1c value can no longer meet clinical needs.The HPLC method provides “visual evidence” for results through true separation of hemoglobin components, significantly enhancing testing credibility and clinical safety.
Minimally influenced by common hemoglobin variants
Our method is based on physical separation of hemoglobin components, directly distinguishing HbA0, HbF, HbA1c and abnormal hemoglobin peaks. Whether variants exist is visible at a glance, rather than suspected afterwards.
Each test corresponds to a clear separation chromatogram. Abnormal peaks can be automatically indicated or manually reviewed, supporting laboratories in interpreting and tracing results, providing doctors not only with “results”, but with a basis for judgment.
Our HbA1c solution is not only used for diabetes management, but also helps laboratories identify potential hemoglobin abnormalities at an early stage, suggesting the possibility of further examination to physicians, enhancing the professional image of laboratories in the local market, and serving as an HbA1c solution for the global market.
Our system architecture is designed with the assumption that hemoglobin variants are clinically present, ensuring analytical robustness under real-world conditions.
