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一种用于定量检测由DEMECAL微量血浆分离装置制备的指尖刺血血浆样本中25-羟基维生素D的液相色谱/串联质谱法:迈向维生素D状态的邮寄评估。

An LC/MS/MS method for quantifying 25-hydroxyvitamin D in finger-prick plasma sample prepared by DEMECAL micro plasma separation device: toward mail-in assessment of vitamin D status.

作者信息

Maeda Kodai, Sakamoto Kyoka, Ito Eiko, Sugimoto Shinya, Tajima Shingo, Sasahara Takahisa, Kawamura Shunji, Yaegashi Kazuo, Higashi Tatsuya

机构信息

Faculty of Pharmaceutical Sciences, Tokyo University of Science, 6-3-1 Niijuku, Katsushika-ku, Tokyo, 125-8585, Japan.

Leisure, Inc., 2-33-8 Nihombashi Ningyocho, Chuo-ku, Tokyo, 103-0013, Japan.

出版信息

Anal Bioanal Chem. 2025 Jun 10. doi: 10.1007/s00216-025-05939-4.

Abstract

A mail-in assessment of vitamin D status will make it possible for the subjects to early detect any vitamin D insufficiency/deficiency at their homes, thus leading to a better management of their health. In this study, a liquid chromatography/electrospray ionization-tandem mass spectrometry (LC/ESI-MS/MS) method was developed and validated for quantifying 25-hydroxyvitamin D [25(OH)D], which is the established marker of the vitamin D status, in the finger-prick blood plasma sample prepared by the DEMECAL device. By using the DEMECAL device, the subjects can collect their finger-prick blood at their homes and immediately separate the plasma from the blood by themselves. The DEMECAL-based procedure had advantages over the venipuncture- and dried blood spot-based procedures because it is less invasive and a medical professional-free blood collection, and no need to be concerned with the heterogeneity of the analyte distribution in the sample. The developed LC/ESI-MS/MS method enabled the precise and accurate quantification of 25(OH)D and provided the lower limit of quantification of 0.10 ng/mL in the diluted plasma sample due to the derivatization with 4-(4-dimethylaminophenyl)-1,2,4-triazoline-3,5-dione. 25(OH)D was stable in the plasma sample prepared by the DEMECAL device at room temperature (23-27 °C) for 7 days (simulated condition in the mail) and at 4 °C for 30 days (simulated condition during storage at a laboratory). The measured 25(OH)D concentrations by the DEMECAL-based procedure well agreed with those by the conventional venipuncture-based procedure. These results demonstrated that the derivatization-LC/ESI-MS/MS combined with the DEMECAL-based sample preparation is a promising procedure for the mail-in assessment of the vitamin D status.

摘要

通过邮寄方式评估维生素D状态将使受试者能够在家中早期检测出任何维生素D不足/缺乏情况,从而更好地管理自身健康。在本研究中,开发并验证了一种液相色谱/电喷雾电离串联质谱(LC/ESI-MS/MS)方法,用于定量测定通过DEMECAL设备制备的指尖采血血浆样本中的25-羟基维生素D [25(OH)D],25(OH)D是维生素D状态的既定标志物。使用DEMECAL设备,受试者可以在家中采集指尖血,并立即自行从血液中分离出血浆。基于DEMECAL的操作方法比基于静脉穿刺和干血斑的操作方法具有优势,因为它侵入性较小,无需医疗专业人员即可采血,并且无需担心样本中分析物分布的异质性。所开发的LC/ESI-MS/MS方法能够精确、准确地定量测定25(OH)D,并且由于使用4-(4-二甲基氨基苯基)-1,2,4-三唑啉-3,5-二酮进行衍生化,在稀释血浆样本中的定量下限为0.10 ng/mL。25(OH)D在通过DEMECAL设备制备的血浆样本中,于室温(23-27°C)下可稳定保存7天(模拟邮寄条件),在4°C下可稳定保存30天(模拟实验室储存条件)。通过基于DEMECAL的操作方法测得的25(OH)D浓度与基于传统静脉穿刺的操作方法测得的结果高度一致。这些结果表明,衍生化-LC/ESI-MS/MS结合基于DEMECAL的样本制备方法是一种有前景的通过邮寄方式评估维生素D状态的方法。

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