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品质为先!热景生物糖化血红蛋白(HbA1c)产品获IFCC认证
2025-02-21

近日,热景生物单人份化学发光免疫分析仪MQ60 Smart 检测HbA1c获得国际临床化学与实验室医学联合会(IFCC)的认证,确保了其检测结果的标准化、规范化和国际化水平。同时意味着MQ60 Smart 检测HbA1c的检测结果具有国际认可的质量和可靠性。


糖化血红蛋白(HbA1c)是目前公认的用于评估糖尿病患者长期血糖控制情况的金标准及糖尿病筛查的重要指标。


糖化血红蛋白(HbA1c)标准化

HbA1c的检测方法涉及层析技术、电泳技术、化学发光技术、免疫技术、生化(酶学)技术、快速检测技术。不同检测方法的结果存在明显差异, 建立参考(参比)系统, 从源头上进行管理和控制势在必行。


IFCC标准化认证

IFCC:国际临床化学和检验医学联合会,成立于1952年,现总部位于意大利的米兰,是一个全球性的临床化学和实验医学组织。目前IFCC已发展了119个国家和地区会员,是全球相关领域最具有影响力组织之一。IFCC通过与其他国际组织合作制定全球标准,提升实验室检测的准确性、可靠性和可比性。IFCC其重要部门——科学部为许多临床检验项目建立参考系统或制备参考物质或提供一些项目的溯源程序,糖化血红蛋白网络就是其一。


IFCC的HbA1c检测程序,成为全球糖化检测的基准。1995年,IFCC确定了HbA1c标准化工作组,以建立HbA1c检测的国际统一标准。2004年,ADA、欧洲糖尿病研究学会、国际糖尿病学会3大国际组织达成共识,确定IFCC作为厂商标准HbA1c检测系统的全球标准。


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.
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