血液血红蛋白A1c检测材料的可交换性和不确定性
Clinical laboratory
|March 12, 2024
概括
血红蛋白A1C (HbA1C) 测试的血液材料 (BM) 被评估为可交换性. 该研究发现,BMs可以成功地升级,用于质量控制或能力测试材料,可根据制备和HbA1C水平进行交换.
科学领域:
- 临床化学 临床化学
- 实验室医学 实验室医学
- 生物材料科学 生物材料科学
背景情况:
- 血红蛋白A1C (HbA1C) 对于评估长期血糖控制至关重要.
- 基于血液矩阵的标准化材料对于精确的HbA1C测量质量控制至关重要.
- 这项研究的重点是用于HbA1C测试的血液材料 (BMs) 的可换性.
研究的目的:
- 为了研究各种血液材料 (BMs) 的可交换性,进行血红蛋白A1C (HbA1C) 测试.
- 升级BMs用于作为能力测试 (PT) 材料.
- 为HbA1C分析建立可靠的参考材料.
主要方法:
- 在来自不同来源 (捐赠者,体外糖化,商业) 的体质样本中测量HbA1C水平,并与新鲜的体质样本和临床样本进行比较.
- 两种NGSP认证的方法 (度检测和酶性免疫检测) 用于HbA1C的确定.
- 根据CLSI EP14-Ed4指南进行了交换性评估.
主要成果:
- 可交换的BMs显示了与参考方法相比0%9%的平均配对差异;非可交换的BMs显示3%11%.
- 低HbA1C (6.0%) 的新鲜BM显示出比HbA1C较高的人更大的通用性.
- 升级的PT材料实现了1%和0.4%的特定BM的相对不确定性.
结论:
- 制备过程显著影响BMs中的血红蛋白的可变性.
- 在BM中较高的HbA1C含量通常与类似地准备时较低的通用性相关.
- 血液材料是可行的,可以有效地作为质量控制或PT材料用于HbA1C测试.
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