Quality First! Hotgen Biotech's Glycosylated Hemoglobin (HbA1c) Product Receives IFCC Certification

Recently, Hotgen Biotech's mono-test chemiluminescence immunoassay analyzer MQ60 Smart for HbA1c detection has received certification from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), ensuring the standardization, normalization, and internationalization of its test results. This also signifies that the HbA1c detection results from MQ60 Smart are internationally recognized for their quality and reliability.

Glycosylated Hemoglobin (HbA1c) is currently recognized as the gold standard for assessing long-term blood glucose control in diabetic patients and an important indicator for diabetes screening.

Standardization of HbA1c

The detection methods for HbA1c involve chromatography technology, electrophoresis technology, chemiluminescence technology, immunoassay technology, biochemical (enzymatic) technology, and rapid test technology. Significant differences exist in the results from different detection methods, making it imperative to establish a reference (calibration) system for management and control at the source.

IFCC Standardization Certification

IFCC: The International Federation of Clinical Chemistry and Laboratory Medicine, founded in 1952, is now headquartered in Milan, Italy. It is a global organization in the field of clinical chemistry and laboratory medicine. Currently, IFCC has 119 national and regional members and is one of the most influential organizations in the related field worldwide. IFCC collaborates with other international organizations to develop global standards, improving the accuracy, reliability, and comparability of laboratory testing. The Scientific Division of IFCC, an important department, establishes reference systems, prepares reference materials, or provides traceability procedures for many clinical testing items, including the glycosylated hemoglobin network.

The IFCC's HbA1c detection program has become the global benchmark for glycosylated hemoglobin testing. In 1995, the IFCC established the HbA1c Standardization Working Group to create an international unified standard for HbA1c detection. In 2004, the American Diabetes Association (ADA), the European Association for the Study of Diabetes (EASD), and the International Diabetes Federation (IDF) reached a consensus, designating the IFCC as the global standard for manufacturers' HbA1c detection systems.