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Clinical Chemistry, Vol 42, 279-285, Copyright © 1996 by American Association for Clinical Chemistry
PJ Taylor, A Jones, GA Balderson, SV Lynch, RL Norris and SM Pond
Department of Clinical Pharmacology, Princess Alexandra Hospital, Brisbane, Australia.
The capacity of liquid chromatography-tandem mass spectrometry (LC-MS2) to detect and define individual components in a complex mixture has been utilized to develop a quantitative assay of the potent immunosuppressant drug, tacrolimus. Trough blood concentrations were measured in 175 samples obtained over several weeks after liver transplantation from seven patients. The assay was linear over the range of 0.2 to 100 micrograms/L. Imprecision was <8%, and accuracy was 99-101%. The turnaround time for a batch of 20 samples was 2.5 h. No interference from any of the other drugs being administered to the patients was evident. An ELISA also performed on the same samples overestimated the concentrations substantially, as indicated by a plot of the difference between the results for the two methods vs their mean. The favorable characteristics of the LC-MS2 assay, especially its sensitivity and specificity, will facilitate detailed pharmacokinetic studies of tacrolimus, particularly under circumstances in which metabolism is perturbed by either hepatic dysfunction or drug interactions.
The following articles in journals at HighWire Press have cited this article:
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  B. G. Keevil, D. P. Tierney, D. P. Cooper, and M. R. Morris Rapid Liquid Chromatography-Tandem Mass Spectrometry Method for Routine Analysis of Cyclosporin A Over an Extended Concentration Range Clin. Chem., January 1, 2002; 48(1): 69 - 76. [Abstract] [Full Text] [PDF]
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G. D. MacFarlane, D. G. Scheller, D. L. Ersfeld, L. M. Shaw, R. Venkatarmanan, L. Sarkozi, R. Mullins, and B. R. Fox Analytical Validation of the PRO-Trac II ELISA for the Determination of Tacrolimus (FK506) in Whole Blood Clin. Chem., September 1, 1999; 45(9): 1449 - 1458. [Abstract] [Full Text] [PDF]
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V. W. Armstrong, E. Schuetz, Q. Zhang, S. Groothuisen, C. Scholz, M. Shipkova, H. Aboleneen, and M. Oellerich Modified pentamer formation assay for measurement of tacrolimus and its active metabolites: comparison with liquid chromatography–tandem mass spectrometry and microparticle enzyme-linked immunoassay (MEIA-II) Clin. Chem., December 1, 1998; 44(12): 2516 - 2523. [Abstract] [Full Text] [PDF]
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J. L. Cogill, P. J. Taylor, I. S. Westley, R. G. Morris, S. V. Lynch, and A. G. Johnson Evaluation of the tacrolimus II microparticle enzyme immunoassay (MEIA II) in liver and renal transplant recipients Clin. Chem., September 1, 1998; 44(9): 1942 - 1946. [Abstract] [Full Text] [PDF]
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C. Vidal, G. I. Kirchner, G. Wunsch, and K.-F. Sewing Automated simultaneous quantification of the immunosuppressants 40-O-(2-hydroxyethyl)rapamycin and cyclosporine in blood with electrospray-mass spectrometric detection Clin. Chem., June 1, 1998; 44(6): 1275 - 1282. [Abstract] [Full Text] [PDF]
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P. J. Taylor, N. S. Hogan, S. V. Lynch, A. G. Johnson, and S. M. Pond Improved Therapeutic Drug Monitoring of Tacrolimus (FK506) by Tandem Mass Spectrometry Clin. Chem., November 1, 1997; 43(11): 2189 - 2190. [Full Text]
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P. E. Hickman, J. M. Potter, and A. J. Pesce Clinical chemistry and post-liver-transplant monitoring Clin. Chem., August 1, 1997; 43(8): 1546 - 1554. [Abstract] [Full Text] [PDF]
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