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人类血清样本中抗药抗体的稳定性

Helene Solberg¹, Christina Bartholdy¹, Lone Hummelshøj Landsy¹

¹Novo Nordisk A/S, Global Discovery & Development Sciences, Novo Nordisk Park, Måløv DK-2760, Denmark.

Journal of immunological methods

|January 11, 2024

概括

抗药抗体 (ADA) 稳定性对于可靠的分析至关重要. 这项研究发现,血清中的抗胰岛素抗体在-20°C和短期储存下多年保持稳定,简化了实验室处理.

科学领域:

免疫学免疫学免疫学
分析化学分析化学
生物化学生物化学

背景情况:

对抗药物抗体 (ADA) 分析的可靠性对于治疗药物监测和临床试验结果至关重要.
在各种存储条件下评估ADAs的稳定性对于确保随着时间的推移得到一致和准确的结果至关重要.

研究的目的:

评估血清样本中抗胰岛素抗体 (ADA) 的短期和长期稳定性.
为了确定不同储存温度和持续时间对ADA测量可靠性的影响.

主要方法:

血清样本在22°C和4°C进行短期存储,并在-20°C进行长期存储.
在不同的时间点进行了ADAS的测量.
应用了相关性分析和所产生的样本再分析标准来评估稳定性.

主要成果:

反胰岛素抗体在22°C下72小时后表现出稳定性.
在4°C下2周后,稳定性得到维持.
最重要的是,在-20°C下储存时,ADA保持稳定长达6.3年.

结论:

血清抗药抗体,特别是抗胰岛素抗体,在-20°C下长时间表现出显著的稳定性.
这些发现表明,当样品在标准实验室条件下储存时,特别是在-20°C时,可能不需要对ADA进行常规稳定性调查.

关键词:

抗药物抗体抗药物抗体免疫性免疫性免疫性血清的血清是什么意思稳定的稳定性稳定的稳定性

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