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Drug Monitoring and Toxicology |
1
Abteilung Klinische Chemie, Georg-August-Universität Göttingen, D-37075 Göttingen, Germany.
2
Department of Clinical Laboratory, Medical University of
Sofia, 1341, Bulgaria.
a Address correspondence to this author at: Abteilung Klinische Chemie, Zentrum Innere Medizin, Georg-August-Universität, Robert Koch Strasse 40, D-37075 Göttingen, Germany. Fax 49-551-398551; e-mail eschuetz{at}med.uni-goettingen.de.
Assays with different specificity are used for cyclosporin monitoring in
clinical transplantation. A recent survey of 35 centers showed that
86% used immunoassays for cyclosporin A (CsA). In consensus documents
the following performance criteria were recommended: (a)
imprecision 
10% at 50 µg/L and 5% at 300 µg/L; and
(b) comparison with the reference method (HPLC) should
yield a slope of 0.9–1.1, an intercept of -15 to 15 µg/L, and
Sy
x 15 µg/L. The newly developed CsA assays
for the AxSYM (Abbott) and the CEDIATM (Boehringer
Mannheim) as well as the EmitTM assay (Behring Diagnostica)
were evaluated. Results from samples of heart, kidney, and liver
recipients (100 specimens each) were compared with a validated
HPLC-ultraviolet detection method. Between-series imprecision (CV) with
commercial controls was 5.8% and 1.7% for AxSYM (70 and 300 µg/L),
11% and 5.5% for CEDIA (90 and 200 µg/L), and 8.1% and 4.5% for
Emit (63 and 172 µg/L). In the presence of 300 µg/L parent CsA,
cross-reactivities were (for AxSYM, CEDIA, and Emit, respectively) 7%,
4%, and none for AM1 (1 mg/L) and 12.6%, 25%, and 6% for AM9 (0.5
mg/L). Comparison with HPLC showed in heart and kidney recipients an
average overestimation with the Emit and the CEDIA of ~22%, with
overestimation in the AxSYM of 32%. In liver recipients, the most
challenging patient group, the CEDIA and the AxSYM showed a mean
overestimation of 43% and 47%, respectively, and the Emit differed by
31% compared with HPLC. None of the immunoassays fully satisfied the
performance criteria recommended in the consensus documents. In terms
of specificity, Emit ranks before CEDIA, which ranks before AxSYM.
Regarding imprecision, the ranking is AxSYM < Emit < CEDIA.
These limitations must be considered when using these assays for
therapeutic drug monitoring of CsA in clinical transplantation.
The following articles in journals at HighWire Press have cited this article:
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  R. G Morris Immunosuppressant Drug Monitoring: Is the Laboratory Meeting Clinical Expectations? Ann. Pharmacother., January 1, 2005; 39(1): 119 - 127. [Abstract] [Full Text] [PDF]
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 J. M. Juenke, P. I. Brown, F. M. Urry, and G. A. McMillin Specimen Dilution for C2 Monitoring with the Abbott TDxFLx Cyclosporine Monoclonal Whole Blood Assay Clin. Chem., August 1, 2004; 50(8): 1430 - 1433. [Full Text] [PDF]
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A. R. Terrell, T. M. Daly, K. G. Hock, D. C. Kilgore, T. Q. Wei, S. Hernandez, D. Weibe, L. Fields, L. M. Shaw, and M. G. Scott Evaluation of a No-Pretreatment Cyclosporin A Assay on the Dade Behring Dimension RxL Clinical Chemistry Analyzer Clin. Chem., July 1, 2002; 48(7): 1059 - 1065. [Abstract] [Full Text] [PDF]
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F. Streit, V. W. Armstrong, and M. Oellerich Rapid Liquid Chromatography-Tandem Mass Spectrometry Routine Method for Simultaneous Determination of Sirolimus, Everolimus, Tacrolimus, and Cyclosporin A in Whole Blood Clin. Chem., June 1, 2002; 48(6): 955 - 958. [Full Text] [PDF]
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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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N. von Ahsen, M. Richter, C. Grupp, B. Ringe, M. Oellerich, and V. W. Armstrong No Influence of the MDR-1 C3435T Polymorphism or a CYP3A4 Promoter Polymorphism (CYP3A4-V Allele) on Dose-adjusted Cyclosporin A Trough Concentrations or Rejection Incidence in Stable Renal Transplant Recipients Clin. Chem., June 1, 2001; 47(6): 1048 - 1052. [Abstract] [Full Text] [PDF]
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D. W. Holt, A. Johnston, B. D. Kahan, R. G. Morris, M. Oellerich, and L. M. Shaw New Approaches to Cyclosporine Monitoring Raise Further Concerns about Analytical Techniques Clin. Chem., June 1, 2000; 46(6): 872 - 874. [Full Text] [PDF]
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