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品質(zhì)為先！熱景生物糖化血紅蛋白（HbA1c）產(chǎn)品獲IFCC認(rèn)證

2025-02-21

近日，熱景生物單人份化學(xué)發(fā)光免疫分析儀MQ60 Smart 檢測HbA1c獲得國際臨床化學(xué)與實驗室醫(yī)學(xué)聯(lián)合會（IFCC）的認(rèn)證，確保了其檢測結(jié)果的標(biāo)準(zhǔn)化、規(guī)范化和國際化水平。同時意味著MQ60 Smart 檢測HbA1c的檢測結(jié)果具有國際認(rèn)可的質(zhì)量和可靠性。

糖化血紅蛋白(HbA1c)是目前公認(rèn)的用于評估糖尿病患者長期血糖控制情況的金標(biāo)準(zhǔn)及糖尿病篩查的重要指標(biāo)。

糖化血紅蛋白(HbA1c)標(biāo)準(zhǔn)化

HbA1c的檢測方法涉及層析技術(shù)、電泳技術(shù)、化學(xué)發(fā)光技術(shù)、免疫技術(shù)、生化(酶學(xué))技術(shù)、快速檢測技術(shù)。不同檢測方法的結(jié)果存在明顯差異, 建立參考(參比)系統(tǒng), 從源頭上進行管理和控制勢在必行。

IFCC標(biāo)準(zhǔn)化認(rèn)證

IFCC：國際臨床化學(xué)和檢驗醫(yī)學(xué)聯(lián)合會，成立于1952年，現(xiàn)總部位于意大利的米蘭，是一個全球性的臨床化學(xué)和實驗醫(yī)學(xué)組織。目前IFCC已發(fā)展了119個國家和地區(qū)會員，是全球相關(guān)領(lǐng)域最具有影響力組織之一。IFCC通過與其他國際組織合作制定全球標(biāo)準(zhǔn)，提升實驗室檢測的準(zhǔn)確性、可靠性和可比性。IFCC其重要部門——科學(xué)部為許多臨床檢驗項目建立參考系統(tǒng)或制備參考物質(zhì)或提供一些項目的溯源程序，糖化血紅蛋白網(wǎng)絡(luò)就是其一。

IFCC的HbA1c檢測程序，成為全球糖化檢測的基準(zhǔn)。1995年，IFCC確定了HbA1c標(biāo)準(zhǔn)化工作組，以建立HbA1c檢測的國際統(tǒng)一標(biāo)準(zhǔn)。2004年，ADA、歐洲糖尿病研究學(xué)會、國際糖尿病學(xué)會3大國際組織達成共識，確定IFCC作為廠商標(biāo)準(zhǔn)HbA1c檢測系統(tǒng)的全球標(biāo)準(zhǔn)。

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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