Clinical application of an optimized reference measurement procedure for serum digoxin using bracketing calibration method by ID-LC-MS/MS

被引:0
作者
Yan, Qiaofang [1 ,2 ]
Huang, Fei [1 ,2 ]
Wang, Chuyang [1 ,2 ]
Zhan, Min [1 ]
Zhang, Qiaoxuan [1 ]
Huang, Di [1 ]
Yan, Jun [1 ]
Lin, Haibiao [1 ]
Huang, Xianzhang [1 ]
Han, Liqiao [1 ]
机构
[1] Guangzhou Univ Chinese Med, Guangdong Prov Hosp Chinese Med, Dept Lab Med, Affiliated Hosp 2, Guangzhou 510120, Peoples R China
[2] Guangzhou Univ Chinese Med, Clin Med Coll 2, Guangzhou 510405, Peoples R China
关键词
Digoxin; Standardization; Reference measurement procedure; ID-LC-MS/MS; Trueness Verification Plan; Clinical laboratory; INTOXICATION; INTERFERENCE; CANRENONE;
D O I
10.1007/s00216-024-05587-0
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
Digoxin, a cardiac glycoside, is widely used in the treatment of cardiovascular diseases. Due to its narrow therapeutic range, precise monitoring of its blood concentration is essential. A reference measurement procedure (RMP) is pivotal for ensuring result accuracy and comparability. The RMP for serum digoxin by ID-LC-MS/MS was optimized with sample pre-treatment and detection processes, and the bracketing calibration method was used, which facilitates more accurate measurement, especially for extreme concentrations. The performance of this optimized RMP was thoroughly evaluated. The limit of detection (LoD) was 0.05 ng/mL (0.06 nmol/L) and the lowest limit of quantification (LLoQ) was 0.10 ng/mL (0.13 nmol/L). The intra- and inter-assay imprecisions were 2.24%, 2.51%, 1.40% and 1.72%, 1.65%, 0.97% at 0.5, 2.0, 5.0 ng/mL, respectively. Recoveries were 99.63 to 101.42% and the linear response ranged from 0.1 to 10.0 ng/mL. The relative bias was 0.41% and 2.00% of our results compared with the median of all participating reference laboratories for IFCC-RELA (External Quality Assessment Scheme for Reference Laboratories in Laboratory Medicine) 2023A and 2023B. The uncertainty, calibration and measurement capability (CMC) of this method were also evaluated. The optimized RMP was applied in the Trueness Verification Plan of Southern China, which indicates significant differences among clinical systems, highlighting the need for standardization efforts. In addition, two commonly used clinical systems which employed immunoassay methods were compared with this optimized RMP, and 26 individual serum samples were analyzed. The good correlations indicate the feasibility of standardization for serum digoxin. The optimized RMP serves as an accurate reference baseline for routine methods, aiming to enhance the accuracy and precision of measurements in clinical laboratories.
引用
收藏
页码:6909 / 6918
页数:10
相关论文
共 28 条
[1]  
[Anonymous], Database of higher-order reference materials, measurement methods/procedures and services
[2]  
[Anonymous], 2008, GUID EXPR UNC MEAS
[3]  
[Anonymous], 2017, REFERENCE MAT GUIDAN
[4]  
[Anonymous], 2018, 15195 ISO
[5]  
[Anonymous], 2009, ISO 15193
[6]  
[Anonymous], 2023, CNAS GL025
[7]  
[Anonymous], 2009, 15194 ISO
[8]   Isotope-Dilution Liquid Chromatography-Tandem Mass Spectrometry Candidate Reference Method for Total Testosterone in Human Serum [J].
Botelho, Julianne Cook ;
Shacklady, Christopher ;
Cooper, Hans C. ;
Tai, Susan S. -C. ;
Van Uytfanghe, Katleen ;
Thienpont, Linda M. ;
Vesper, Hubert W. .
CLINICAL CHEMISTRY, 2013, 59 (02) :372-380
[9]  
Clinical Laboratory Standards Institute (CLSI), 2003, CLSI DOCUMENT EP06
[10]  
CLSI, 2014, EP05A3 CLSI