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Clinical Chemistry 44: 1942-1946, 1998;
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(Clinical Chemistry. 1998;44:1942-1946.)
© 1998 American Association for Clinical Chemistry, Inc.

Drug Monitoring and Toxicology

Evaluation of the tacrolimus II microparticle enzyme immunoassay (MEIA II) in liver and renal transplant recipients

Jan L. Cogill1, Paul J. Taylor1,a, Ian S. Westley2, Raymond G. Morris2, Stephen V. Lynch3, and Anthony G. Johnson1

1 The University of Queensland Department of Medicine, Princess Alexandra Hospital, Brisbane, Queensland, Australia 4102.

2 Department of Clinical Pharmacology, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia 5011.

3 The University of Queensland Department of Surgery, Princess Alexandra Hospital, Brisbane, Queensland, Australia 4102.
a Address correspondence to this author at: Centre for Clinical and Experimental Therapeutics, First Floor, Lions Clinical Research Building, Princess Alexandra Hospital, Ipswich Road, Brisbane, QLD, Australia 4102. Fax 61 7 3240 5031; e-mail Ptaylor{at}gpo.pa.uq.edu.au.

We evaluated the MEIA II with blood samples with added tacrolimus (3.0, 5.0, 11.0, and 22.0 µg/L). The assay had acceptable recoveries (99–103%) and intraday imprecision (<16.0%) across the range of concentrations studied, except for the recoveries at 3.0 µg/L (86.3%) and 5.0 µg/L (80.7%). Comparison of liver (n = 116) and renal (n = 113) patient samples measured by MEIA II against HPLC-tandem mass spectrometry (HPLC-MS/MS) found a mean overestimation of 15.6%. From these comparison data it can be calculated that at values of 5 and 20 µg/L in liver or renal transplant patient samples, measured by HPLC-MS/MS, MEIA II will have the corresponding range estimates of 3.6–7.9 µg/L and 20.9–25.4 µg/L, respectively. No clinically significant difference in results, in terms of overestimation or correlation, was observed between the two transplant groups studied. The MEIA II is an improvement on the previous MEIA I and is suitable for the therapeutic drug monitoring of tacrolimus where HPLC-MS/MS is unavailable.


Key Words: TDM, therapeutic drug monitoring • MEIA, microparticle enzyme immunoassay • MS, mass spectrometry • MS/MS, tandem mass spectrometry.




The following articles in journals at HighWire Press have cited this article:


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N. W. Brown, C. E. Gonde, J. E. Adams, and J. M. Tredger
Low Hematocrit and Serum Albumin Concentrations Underlie the Overestimation of Tacrolimus Concentrations by Microparticle Enzyme Immunoassay versus Liquid Chromatography-Tandem Mass Spectrometry
Clin. Chem., March 1, 2005; 51(3): 586 - 592.
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R. G Morris
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Ann. Pharmacother., January 1, 2005; 39(1): 119 - 127.
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P. Salm, P. J. Taylor, and P. I. Pillans
Analytical Performance of Microparticle Enzyme Immunoassay and HPLC-Tandem Mass Spectrometry in the Determination of Sirolimus in Whole Blood
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Z. T. Cao, M. W. Linder, A. W. Jevans, G. Brown, and R. Valdes Jr
Comparison of Tacrolimus Concentrations Measured by the IMx Tacrolimus II vs the PRO-TRAC II FK506 ELISA Assays
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