Good News: Upper's Glycated Hemoglobin Detection System Passes NGSP Certification
Good News: Upper's Glycated Hemoglobin Detection System Passes NGSP Certification
1. Background and Purpose of Certification
Glycated hemoglobin (HbA1c), a product formed by the hemoglobin in red blood cells binding with blood glucose, reliably reflects average blood glucose levels over 2–3 months. As the gold standard for assessing long-term glycemic control in diabetes patients, its standardized detection is crucial for clinical accuracy. The NGSP (National Glycohemoglobin Standardization Program) certification addresses methodological discrepancies among HbA1c tests to ensure global result comparability.
2. Key Developments
- Historical Milestones: The 1993 Diabetes Control and Complications Trial (DCCT) established HbA1c's clinical value, prompting the 1996 launch of NGSP's DCCT-aligned reference system.
- Certification Tiers: NGSP offers three certifications: manufacturer, primary lab, and secondary lab (SRL), with strict accuracy requirements (CV <5%).
3. Upper's Achievement
In January 2025, Upper's Glycated Hemoglobin Detection System achieved NGSP certification, validating its world-class accuracy and alignment with international standards. The system's flagship instruments – OTTOMAN-1000 and Shenbao Platform – are now globally competitive due to:
- Automated technology
- Superior performance with trace samples
- Compliance with NGSP's rigorous criteria
4. Complementary Achievement by Zhongshan Hospital
Fudan University's Zhongshan Hospital Laboratory has been a NGSP-certified Primary Testing Lab since 2010 and became China's first Secondary Reference Lab (SRL) in 2016. This dual progress enables:
- Domestic manufacturers/labs to obtain NGSP certification locally
- Asian test results to meet global benchmarks
5. Future Outlook
Upper's plans to leverage this certification for global market expansion, while continuing to optimize HbA1c detection solutions through:
- Enhanced R&D investment
- Technical collaboration with certified labs like Zhongshan Hospital
- Delivery of standardized diabetes management tools worldwide
Contact:
- Tel: 86-21-50720808
- Email: upper@poct.cn
