Background

Recently, the State Council Information Office held a press conference on the theme of “High-Quality Fulfillment of the 14th Five-Year Plan,” highlighting achievements in healthcare during the period. It was clarified that free health checkups for the elderly will now include digital chest X-ray examinations and HbA1c testing.

Policy Benefits: HbA1c Testing Receives Strong Attention

In June this year, the National Health Commission, the Ministry of Finance, and two other departments jointly issued the Notice on Implementing Basic Public Health Services in 2025, which for the first time included HbA1c testing alongside chest digital X-ray (DR) as mandatory items in health checkups for people over 65 years old.

Including HbA1c testing in elderly health checkups marks a shift in China’s diabetes prevention and control strategy from “blood glucose management” to “long-term glycemic monitoring.” This reflects an increased emphasis on early diabetes risk screening. The policy signifies that diabetes screening will, for the first time, be truly popularized nationwide at the grassroots level.

Golden Standard Value: Why HbA1c Testing is Irreplaceable

Diabetes poses a severe threat to global health. Early screening, precise diagnosis, and long-term glycemic control are critical in preventing complications. HbA1c, the irreversible binding product of glucose and hemoglobin in red blood cells, accurately reflects an individual’s average blood glucose over the past 2–3 months. It has been recognized by the World Health Organization (WHO), the American Diabetes Association (ADA), and both the Chinese Guideline for Type 2 Diabetes Prevention and Treatment and the China Diabetes Prevention and Treatment Guideline (2024 edition) as a diagnostic standard for diabetes. It plays an irreplaceable role in blood glucose management.

01 IFCC and NGSP Dual Traceability

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the National Glycohemoglobin Standardization Program (NGSP) are the highest international authorities for HbA1c test standardization, ensuring traceability and accuracy worldwide.

The IFCC defines HbA1c as hemoglobin A with glycation at the N-terminal valine of the β-chain. Moreover, in the IFCC reference method, the definition extends to the first six amino acids starting from the N-terminal valine of the β-chain. Only glycated hemoglobin that strictly matches this hexapeptide sequence qualifies as true HbA1c.

This means it is incorrect to define HbA1c simply as hemoglobin with a glycated β-chain N-terminal valine. Accordingly, the IFCC reference materials for HbA1c testing consist of HbA0 (non-glycated β-chain) and HbA1c (glycated β-chain N-terminal valine product). Any other forms are excluded.

In conventional latex-based HbA1c assays, the denominator includes all types of hemoglobin in the sample, rather than only the glycated and non-glycated β-chain defined by IFCC. This leads to underestimation of results.

Hzymes’ dual-channel enzymatic HbA1c assay accounts for both non-glycated HbA β-chain and glycated HbA1c (glycated N-terminal valine of HbA β-chain), ensuring traceability to the IFCC reference system while remaining largely unaffected by hemoglobin variants.

02 High Accuracy — Comparable to International Reference Methods, Meeting Clinical Needs

Method comparison: Hzymes dual-channel enzymatic HbA1c assay shows excellent correlation with both HPLC and latex methods, with correlation coefficient r > 0.99.

Comparison with imported brands: Hzymes HbA1c assay also demonstrates high correlation with international products, with correlation coefficient r > 0.99.

03 Enhanced Stability — 30-Day Open-Vial Shelf Life, 18-Month Long-Term Storage

Hzymes HbA1c reagent remains stable for over 30 days after opening at 2°C–8°C and offers up to 18 months of shelf life, supporting both domestic and international customer requirements.

04 Strong Anti-Interference Performance

The reagent ensures resistance against interference from lipids, bilirubin, vitamin C, glucose, and uric acid, while reducing the impact of modified hemoglobins on test results.

05 Patent Protection & Safe Animal-Derived Calibrator/Controls

Most current products use human whole blood–derived HbA1c calibrators and controls, which pose biosafety risks. Furthermore, obtaining blood samples with specific low or high HbA1c concentrations is difficult due to rarity and variability.

Hzymes innovatively adopts animal-derived blood to produce HbA1c calibrators and controls. This approach is safer, cost-effective, and suitable for large-scale production, addressing biosafety and import/export regulation risks while ensuring consistent supply.

Leading Technology: Hzymes’ Comprehensive HbA1c Solutions

Leveraging its biochemical and fine-chemical platforms, Hzymes develops complete solutions from enzyme raw materials to chromogenic substrates, creating both critical core materials and accurate detection reagents. It is the first domestic provider to offer both single-channel and dual-channel enzymatic HbA1c testing solutions, enabling analysis from multiple perspectives. This ensures accurate results while meeting the diverse needs of different laboratories.

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