CEDIA® mycophenolic acid assay compared with HPLC-UV in specimens from transplant recipients

Therapeutic Drug Monitoring

Volumn 28, Issue 5, 2006, Pages 632-636

  Westley, Ian S ^a   Ray, John E ^b   Morris, Raymond G ^a,c  

^a QUEEN ELIZABETH HOSPITAL   (Australia)

^b ST VINCENT S HOSPITAL   (Australia)

^c UNIVERSITY OF ADELAIDE   (Australia)

Author keywords

Immunoassay; Mycophenolic acid; Therapeutic drug monitoring

Indexed keywords

DRUG METABOLITE; MYCOPHENOLATE ACYLGLUCURONIDE; MYCOPHENOLIC ACID; UNCLASSIFIED DRUG;

ACCURACY; ANALYTICAL EQUIPMENT; ANALYZER; ARTICLE; CALIBRATION; CONTROLLED STUDY; CROSS REACTION; DRUG BLOOD LEVEL; DRUG MONITORING; GRAFT REJECTION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IMMUNOASSAY; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; ORGAN TRANSPLANTATION; PRIORITY JOURNAL; QUALITY CONTROL; REGRESSION ANALYSIS; SENSITIVITY AND SPECIFICITY; ULTRAVIOLET SPECTROSCOPY; BLOOD; COMPARATIVE STUDY; METHODOLOGY;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG MONITORING; HUMANS; IMMUNOASSAY; MYCOPHENOLIC ACID; ORGAN TRANSPLANTATION;

EID: 33749854274     PISSN: 01634356     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.ftd.0000243963.53322.8d     Document Type: Article

References (21)

1. Cox VC, Ensom MH. Mycophenolate mofetil for solid organ transplantation: does the evidence support the need for clinical pharmacokinetic monitoring? Ther Drug Monit. 2003;25:137-157.
2. Shaw LM, Korecka M, Brayman L. Pharmacokinetic-pharmacodynamic relationship for mycophenolic acid in renal transplant patients. Graft. 1999;5:196-199.
3. Hale MD, Nicholls AJ, Bullingham RE, et al. The pharmacokinetic- pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther. 1998;64:672-683.
4. Pillans PI, Rigby RJ, Kubler P, et al. A retrospective analysis of mycophenolic acid and cyclosporin concentrations with acute rejection in renal transplant recipients. Clin Biochem. 2001;34:77-81.
5. Takahashi K, Ochiai T, Uchida K, et al. Pilot study of mycophenolate mofetil (RS-61443) in prevention of acute rejection following renal transplantation in Japanese patients. Transplant Proc. 1995;27:1421-1424.
6. Holt DW. Monitoring mycophenolic acid. Ann Clin Biochem. 2002;39:173-183.
7. Mourad M, Wallemacq P, Konig J, et al. Therapeutic monitoring of mycophenolate mofetil in organ transplant recipients. Clin Pharmacokinet. 2002;41:319-327.
8. Westley IS, Sallustio BC, Morris RG. Validation of a high-performance liquid chromatography method for the measurement of mycophenolic acid and its glucuronide metabolites in plasma. Clin Biochem. 2005;38:824-829.
9. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;1:307-10.
10. Hollis S. Analysis of method comparison studies. Ann Clin Biochem. 1996;33:1-4.
11. Shah VP, Midha KK, Dighe S, et al. Analytical methods validation: Bioavailability, bioequivalence, and pharmacokinetic studies. J Pharma Sci. 1992;81:309-312.
12. Beal JL, Jones CE, Taylor PJ, et al. Evaluation of an Immunoassay (EMIT) for mycophenolic acid in plasma from renal transplant recipients compared with a high-performance liquid chromatography assay. Ther Drug Monit. 1998;20:685-690.
13. Schutz E, Shipkova M, Armstrong VW, et al. Therapeutic drug monitoring of mycophenolic acid: comparison of HPLC and immunoassay reveals new MPA metabolites. Transplant Proc. 1998;30:1185-1187.
14. Microgenics Corporation. CEDIA Mycophenolic acid assay product information 2005.
15. Shipkova M, Armstrong VW, Weber L, et al. Pharmacokinetics and protein adduct formation of the pharmacologically active acyl glucuronide metabolite of mycophenolic acid in pediatric renal transplant recipients. Ther Drug Monit. 2002;24:390-399.
16. Shipkova M, Wieland E, Schutz E, et al. The acyl glucuronide metabolite of mycophenolic acid inhibits the proliferation of human mononuclear leukocytes. Transplant Proc. 2001;33:1080-1081.
17. Vogeser M, Zachoval R, Spohrer U, et al. Potential lack of specificity using electrospray tandem-mass spectrometry for the analysis of mycophenolic acid in serum. Ther Drug Monit. 2001;23:722-724.
18. Weber L, Shipkova M, Armstrong VW, et al. Comparison of the EMIT immunoassay with HPLC for therapeutic drug monitoring of mycophenolic acid in pediatric renal-transplant recipients on mycophenolate mofetil therapy. Clin Chem. 2002;48:517-525.
19. Shipkova M, Schutz E, Armstrong VW, et al. Determination of the acyl glucuronide metabolite of mycophenolic acid in human plasma. Clin Chem. 2000;46:365-372.
20. Kahan BD, Keown P, Levy GA, et al. Therapeutic drug monitoring of immunosuppressant drugs in clinical practice. Clin Ther. 2002;24:330-350.
21. van Gelder T, Le Meur Y, Shaw LM, et al. Therapeutic drug monitoring of mycophenolate mofetil in transplantation. Ther Drug Monit. 2006;28:145-154.