Ultra-High Performance Liquid Chromatography Tandem Mass Spectrometry for Cyclosporine Analysis in Human Whole Blood and Comparison With an Antibody-Conjugated Magnetic Immunoassay

被引:0
作者
Mei, Shenghui [1 ,2 ]
Wang, Jiaqing [1 ]
Chen, Di [3 ]
Zhu, Leting [1 ]
Zhao, Ming [3 ]
Hu, Xin [3 ]
Yang, Li [1 ,2 ]
Zhao, Zhigang [1 ,2 ]
机构
[1] Capital Med Univ, Beijing Tiantan Hosp, Dept Pharm, 6 Tiantan Xili, Beijing 100050, Peoples R China
[2] Capital Med Univ, Coll Pharmaceut Sci, Dept Clin Pharmacol, Beijing, Peoples R China
[3] Beijing Hosp, Natl Ctr Gerontol, Dept Pharm, Beijing, Peoples R China
关键词
UHPLC-MS/MS; cyclosporine; immunosuppressive drug monitoring; antibody-conjugated magnetic immunoassay; method comparison; SIMULTANEOUS QUANTIFICATION; ORGAN-TRANSPLANTATION; MYCOPHENOLIC-ACID; ROUTINE METHOD; MS/MS METHOD; HPLC-MS/MS; LC-MS; TACROLIMUS; SIROLIMUS; EVEROLIMUS;
D O I
暂无
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
Background: Various immunoassays have been used for cyclosporine A (CsA) analysis in human whole blood; however, they could not fully satisfy the requirements of criteria for accuracy and specificity in CsA measurement. The liquid chromatography tandem mass spectrometry is a gold method for CsA analysis. The aim of the study was to develop and validate an ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS) method for CsA analysis and establish its agreement with an antibody-conjugated magnetic immunoassay (ACMIA) in clinical sample analysis. Methods: An UHPLC-MS/MS method for CsA analysis in human whole blood was developed, validated, and applied in 85 samples, which were also tested by ACMIA. The agreement between UHPLC-MS/MS and ACMIA was evaluated by Bland-Altman plot. Results: The calibration range was 5-2000 ng/mL. The inaccuracy and imprecision were 24.60% to 5.56% and less than 8.57%, respectively. The internal standard-normalized recovery and matrix factor were 100.4%-110.5% and 93.5%-107.6%, respectively. The measurements of ACMIA and UHPLC-MS/MS were strongly correlated (r > 0.98). Evaluated by Bland-Altman plot, the 95% limit of agreement of the ACMIA: UHPLC-MS/MS ratio was 88.7%-165.6%, and the mean bias of the ratio was 21.1%. Conclusions: A rapid, simple, accurate, and reliable UHPLC-MS/MS method for CsA analysis in human whole blood was developed, validated, and applied in 85 samples. On average, 21.1% overestimation was observed in ACMIA compared with that in the UHPLC-MS/MS. Further and larger studies are required to identify whether this degree of variance could be accepted by clinicians.
引用
收藏
页码:69 / 75
页数:7
相关论文
共 47 条
[1]   Cyclosporin: revisions in monitoring guidelines and review of current analytical methods [J].
Andrews, D ;
Cramb, R .
ANNALS OF CLINICAL BIOCHEMISTRY, 2002, 39 :424-435
[2]  
[Anonymous], 2013, Guidance for industry # 213
[3]   Quantification of cyclosporine and tacrolimus in whole blood. Comparison of liquid chromatography-electrospray mass spectrometry with the enzyme multiplied immunoassay technique [J].
Ansermot, Nicolas ;
Fathi, Marc ;
Veuthey, Jean-Luc ;
Desmeules, Jules ;
Rudaz, Serge ;
Hochstrasser, Denis .
CLINICAL BIOCHEMISTRY, 2008, 41 (10-11) :910-913
[4]   Simultaneous quantification of cyclosporine, tacrolimus, sirolimus and everolimus in whole blood by liquid chromatography - electrospray mass spectrometry [J].
Ansermot, Nicolas ;
Fathi, Marc ;
Veuthey, Jean-Luc ;
Desmeules, Jules ;
Rudaz, Serge ;
Hochstrasser, Denis .
CLINICAL BIOCHEMISTRY, 2008, 41 (09) :728-735
[5]   Evaluation of a Novel Commercial Assay for the Determination of Cyclosporine A, Tacrolimus, Sirolimus, and Everolimus by Liquid Chromatography-Tandem Mass Spectrometric Assay [J].
Becker, Susen ;
Thiery, Joachim ;
Ceglarek, Uta .
THERAPEUTIC DRUG MONITORING, 2013, 35 (01) :129-132
[6]   Simultaneous Determination of Protein-Unbound Cyclosporine A and Mycophenolic Acid in Kidney Transplant Patients Using Liquid Chromatography-Tandem Mass Spectrometry [J].
Bittersohl, Heike ;
Herbinger, Juliane ;
Wen, Ming ;
Renders, Lutz ;
Steimer, Werner ;
Luppa, Peter B. .
THERAPEUTIC DRUG MONITORING, 2017, 39 (03) :211-219
[7]  
Bland J M., 2004, How Can I Decide the Sample Size for a Study of Agreement between Two Methods of Measurement?
[8]   COMPARING METHODS OF MEASUREMENT - WHY PLOTTING DIFFERENCE AGAINST STANDARD METHOD IS MISLEADING [J].
BLAND, JM ;
ALTMAN, DG .
LANCET, 1995, 346 (8982) :1085-1087
[9]  
Bland JM, 1999, STAT METHODS MED RES, V8, P135, DOI 10.1177/096228029900800204
[10]   STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT [J].
BLAND, JM ;
ALTMAN, DG .
LANCET, 1986, 1 (8476) :307-310