Glycated hemoglobin (HbA1c) is a key indicator of a patient’s average blood glucose level over the past 2 to 3 months and is widely used in the screening and diagnosis of diabetes, as well as in evaluating the effectiveness of blood glucose control. However, due to variations in testing methods and results across laboratories, the comparability of HbA1c test results has long limited its clinical application.

To address this issue, the United States launched the National Glycated Hemoglobin Standardization Program (NGSP) in 1996. Its core objective is to uniformly standardize HbA1c test results worldwide to the reference levels established by the Diabetes Control and Complications Trial (DCCT) and the UK Prospective Diabetes Study (UKPDS), thereby ensuring that HbA1c results reported by clinical laboratories are comparable to those from these landmark clinical trials. 

NGSP manufacturer certification is a critical type of certification within this system. Manufacturers must conduct sample comparisons between their testing systems and NGSP Secondary Reference Laboratories (SRLs) and pass precision and accuracy assessments before they can obtain a “Certificate of Traceability.” Guidelines issued by the Diabetes Branch of the Chinese Medical Association also explicitly state that when HbA1c is used for diabetes diagnosis, testing should be performed in laboratories that are NGSP-certified and standardized according to the DCCT method

The DIAGREAT Bio D10 Time-Resolved Immunofluorescence Analyzer utilizes time-resolved immunofluorescence technology and is paired with glycated hemoglobin (HbA1c) test kits, making it suitable for the quantitative determination of HbA1c concentrations in human whole blood samples in clinical laboratories. This platform features ease of operation and rapid testing, meeting the needs of medical institutions at all levels for routine HbA1c testing. The recent NGSP certification serves as authoritative validation of the accuracy and stability of DIAGREAT Bio’s glycated hemoglobin testing system.

The recent NGSP certification serves as authoritative validation of the accuracy and stability of the DIAGREAT HbA1c testing system. The standardization and accuracy of HbA1c testing directly impact the scientific rigor of diabetes diagnosis and treatment decisions. DIAGREAT has always placed product quality at the core of its corporate development and continues to invest in research and development as well as quality system construction. The attainment of this NGSP certification marks a significant milestone in DIAGREAT’s internationalization process within the HbA1c testing field and serves as a strong endorsement of the company’s quality management system. Moving forward, DIAGREAT will continue to uphold a rigorous and pragmatic approach, constantly optimizing testing technologies and product performance to provide clinical laboratories with accurate, stable, and traceable in vitro diagnostic products. This commitment will support the advancement of diabetes prevention and treatment efforts and contribute to the health of patients everywhere.