首页|基于国产液相色谱串联质谱检测系统对血清中25-羟基维生素D含量检测的验证

基于国产液相色谱串联质谱检测系统对血清中25-羟基维生素D含量检测的验证

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目的:基于国产高效液相色谱串联质谱检测系统HAK6000,建立了准确测量血清中25-羟基维生素D的液相色谱-串联质谱法.方法:通过对样本中的25-羟基维生素D2[25(OH)D2]、25-羟基维生素D3[25(OH)D3]进行沉淀蛋白、萃取、氮吹浓缩等步骤获取目标物及其内标的提取液,采用HAK6000直接对其中的目标物进行检测.另外,使用HAK6000、AB 4500MD两台不同厂家的串联质谱设备测定26例血清样本,进行相关性分析.结果:采用HAK6000对样本中的目标物25(OH)D2、25(OH)D3进行检测,分别在1.25~40ng/mL和5~160ng/mL范围内的线性相关系数R>0.9990,两者的检出限分别为0.4ng/mL、1.6ng/mL,定量限分别为1.25ng/mL、5.0ng/mL,质控品精密度优于5.0%.HAK6000、AB 4500MD串联质谱设备测定血清样本,2组数据的相关系数R≥0.99,这表明2台仪器所测结果一致.结论:HAK6000可以达到准确定量检测血清25-羟基维生素D的水平,能够满足临床诊断需求.HAK6000将为临床质谱分析提供一种更具性价比的选择,助力国产质谱仪发展.
Determination of 25(OH)D in Serum Based on High Performance Liquid Chromatography Tandem Mass Spectrometry Detection System HAK6000
Objective:To establish a high performance liquid chromatography-tandem mass spectrometry(LC-MS/MS)method for accurate measurement of 25-hydroxyvitamin D in serum based on domestic high performance liquid chromatography-tandem mass spectrometry system HAK6000.Methods:By precipitation,extraction,nitrogen blow concentration and other steps of 25-hydroxyvitamin D2[25(OH)D2]and 25-hydroxyvitamin D3[25(OH)D3]in the sample to obtain the extraction solution of the target substance and its internal standard,HAK6000 was used to directly detect the target substance.In addition,26 serum samples were measured by HAK6000 and AB 4500MD tandem mass spectrometry devices of different manufacturers,and the correlation was analyzed.Results:HAK6000 was used to detect 25(OH)D2 and 25(OH)D3 in the samples.The linear correlation coefficient R>0.9990 in the range of 1.25-40ng/mL and 5-160ng/mL,respectively,and the detection limit of the two was 0.4ng/mL and 1.6ng/mL,respectively.The limits of quantification were 1.25ng/mL and 5.0ng/mL,respectively.The precision of quality control was better than 5.0%.HAK6000 and AB 4500MD tandem mass spectrometry were used to measure serum samples,and the correlation coefficient R≥0.99,which indicated that the results measured by the two instruments were consistent.Conclusion:HAK6000 can accurately and quantitatively detect serum 25-hydroxyvitamin D level,which can meet the needs of clinical diagnosis.HAK6000 will provide a more cost-effective choice for clinical mass spectrometry and help the development of domestic mass spectrometry.

liquid chromatography-tandem mass spectrometry(LC-MS/MS)high performance liquid chromatography tandem mass spectrometry detection system25-hydroxyvitamin D

姜瑞凤、刘传兴、宋文君、张曼玉、杲立博、牛天渭

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青岛惠安康生物工程有限公司(山东 青岛 266114)

液相色谱-串联质谱(LC-MS/MS) 高效液相色谱串联质谱检测系统 25-羟基维生素D

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(5)
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