色谱2026，Vol.44Issue(3)：267-275,9.DOI:10.3724/SP.J.1123.2025.04002
3种液相色谱-串联质谱法检测脂溶性维生素的性能确认和一致性评价
Performance validation and consistency assessment of three liquid chromatography-tandem mass spectrometry methods for detecting fat-soluble vitamins
摘要
Abstract
Accurate quantification of fat-soluble vitamin A(VA),vitamin D(25(OH)D),vitamin E(VE),vitamin K(VK)is essential for health assessment and disease diagnosis.Liquid chromatography-tandem mass spectrometry(LC-MS/MS)plays a crucial role in the measurement of these vitamins due to its high specificity and sensitivity.However,the comparability and con-cordance of the detection results among different LC-MS/MS methods are still suboptimal.In this study,the analytical performance including linearity,limit of detection,limit of quantitation,precision,accuracy and carryover was evaluated according to CLSI C62 and the Suggestions on Clinical Application of Liquid Chromatography-Mass Spectrometry.Aliquots of 40 patient samples were collected from August to October 2022 from the Second Xiangya Hospital,Central South University.These fat-soluble vitamins were measured using three LC-MS/MS methods.Passing-Bablok regression,Bland-Altman plots and concordance correlation coefficient(CCC)were performed to compare the differences among three methods.The consistency of the results before and after recalibration with a unified calibrator was evaluated.The results showed that the total CVs for the three mass spectrometry kits were 2.7%-10.1%,and the recoveries for all kits ranged from 88.8%to 109.2%,indicating that their detection performance met the requirements for clinical application.Concordance correlation analysis showed that two of the three methods had substantial agreement in vitamin D testing(CCC:0.938),while the CCCs for other methods ranged from 0.322 to 0.853.After reca-libration with a unified calibrator,except for vitamin K,the CCCs for the results of the three methods ranged from 0.918 to 0.983.In conclusion,the performance validation results of three LC-MS/MS methods for fat-soluble vitamins meet clinical requirements.The consistency among the three methods was poor,but using a unified calibrator significantly improved the consistency of these methods.The study provides recommendations for the standardization of clinical fat-soluble vitamin testing,thereby contributing to improved accuracy and consistency of results.This study will provide more reliable evidence for clinical diagnosis and treatment.关键词
脂溶性维生素/液相色谱-串联质谱/一致性/校准Key words
fat-soluble vitamins/liquid chromatography-tandem mass spectrometry(LC-MS/MS)/consistency/calibration分类
化学化工引用本文复制引用
李炳杵,李冰慧,陈芷阳,李子阳,尹美玲,吕星,项忠元,龙琪琛,胡敏..3种液相色谱-串联质谱法检测脂溶性维生素的性能确认和一致性评价[J].色谱,2026,44(3):267-275,9.基金项目
国家自然科学基金(82302586) （82302586）
湖南省自然科学基金(2023JJ40812) （2023JJ40812）
中南大学湘雅二医院新进员工科研启航计划.National Natural Science Foundation of China(No.82302586) （No.82302586）
Natural Science Foundation of Hunan Province(No.2023JJ40812) （No.2023JJ40812）
the Voyage Project of the Second Xiangya Hospital of Central South University. （）
