推出新的歐洲參考材料ERM®-AD500/IFCC：用於校準HbA1c測量的創新準則

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ERM-DA500/IFCC是一套含有不同HbA1c水平的血紅蛋白的6個小瓶，用於HbA1c與HbA0和HbA1c總和的物質量分數的認證。這種材料根據ISO Guide 34:2009標準生產，並依據ISO Guide 35:2006認證。該材料旨在用於IFCC參考測量程序的校準或方法性能評估，且已通過歐洲參考材料聯盟合作夥伴的同行評估，被認可為歐洲參考材料（ERM®）。

認證報告：整個血液中分離出的血紅蛋白中HbA1c的物質量分數與HbA0和HbA1c總和的認證

CERTIFICATION REPORT Certification of the amount-of-substance fraction of HbA1c versus the sum of HbA0 and HbA1c in haemoglobin isolated from whole blood: ERM®-AD500/IFCC
2016Scientific methods, data and information

Abstract

This report describes the production of ERM-DA500/IFCC, which is a set of 6 ampoules containing haemoglobin with different levels of HbA1c, certified for the amount-of-substance fraction of HbA1c versus the sum of HbA0 and HbA1c. HbA1c is defined as the stable adduct from glucose and the N-terminal amino group of the β-chain of haemoglobin A0 that is beta-N-(1-deoxyfructos-1-yl) haemoglobin.
This material was produced following ISO Guide 34:2009 [ ] and is certified in accordance with ISO Guide 35:2006
The ampoules contain buffered solutions of haemoglobin with different amount of substance concentrations of HbA1c and HbA0. The base materials (solutions of purified HbA1c and HbA0) were prepared from whole blood obtained from diabetic volunteers and provided by Roche Diagnostic GmbH, Department for Biochemical Materials, Penzberg, Germany. Mixtures of these base materials were filled into the ampoules, with each ampoule containing approximately 1 mg haemoglobin in 30 microliter solution, sealed under an atmosphere of argon.
Between-unit homogeneity was quantified and stability during dispatch and storage were assessed in accordance with ISO Guide 35:2006.
The certified value was obtained from the gravimetric preparation of mixtures, taking into account the purity of the base materials. The values were confirmed with two datasets obtained using the reference measurement procedure for HbA1c [ , , ].
Uncertainties of the certified values were calculated in accordance with the Guide to the Expression of Uncertainty in Measurement (GUM) and include uncertainties related to possible inhomogeneity, instability and characterisation.
The material is intended for the calibration of the IFCC reference measurement procedure or for the assessment of method performance. As with any reference material, it can be used for establishing control charts or validation studies.
The CRM was accepted as European Reference Material (ERM®) after peer evaluation by the partners of the European Reference Materials consortium.

摘要

本報告描述了ERM-DA500/IFCC的生產，這是一套包含6個安瓿的產品，其中包含了不同水平的HbA1c血紅蛋白，其對HbA1c的物質量分數與HbA0和HbA1c總和的認證。HbA1c被定義為葡萄糖與血紅蛋白A0β鏈N端氨基群的穩定加成物，即β-N-(1-脫氧果糖基)-1-血紅蛋白。
該材料按照ISO指南34:2009 [ ] 的規定生產，並根據ISO指南35:2006進行認證。
安瓿中含有不同物質量濃度的HbA1c和HbA0的血紅蛋白緩衝溶液。基礎材料（純化的HbA1c和HbA0溶液）是從糖尿病志願者提供的全血中製備而成，由德國彭茨貝格羅氏診斷有限公司生化材料部提供。這些基礎材料的混合物被灌裝進安瓿中，每個安瓿大約含有1毫克血紅蛋白在30微升溶液中，並在氬氣氛圍下密封。
單位間均勻性進行了量化，並根據ISO指南35:2006評估了在運送和儲存期間的穩定性。
認證值是根據混合物的重量法製備獲得的，考慮到了基礎材料的純度。這些值通過使用HbA1c參考測量程序 [ , , ] 獲得的兩組數據確認。
認證值的不確定性是根據測量不確定性表達指南（GUM）計算的，包括與可能的不均勻性、不穩定性和特性化相關的不確定性。
該材料旨在用於校準IFCC參考測量程序或評估方法性能。與任何參考材料一樣，它可以用於建立控制圖或驗證研究。
在歐洲參考材料聯盟合作夥伴的同行評估後，該CRM被接受為歐洲參考材料（ERM®）。