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Evaluation of a No-Pretreatment Cyclosporin A Assay on the Dade Behring Dimension RxL Clinical Chemistry Analyzer

¹ Division of Laboratory Medicine, Washington University School of Medicine, 660 S. Euclid Ave., St. Louis, MO 63110-1093.

² Dade Behring, Inc., Glasgow Business Community, PO Box 6101, Newark, DE 19714.

³ Departments of Pathology and Laboratory Medicine, University of Wisconsin Hospital, 600 Highland Ave., Madison, WI 53792.

⁴ Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania, 3400 Spruce St., Philadelphia, PA.

^aAuthor for correspondence. Fax 314-362-1461; e-mail mscott{at}pathbox.wustl.edu.

Background: Monitoring whole-blood concentrations of cyclosporin A (CsA) is common practice in the management of solid organ and bone marrow transplant recipients. In a multicenter study we evaluated a new, direct (no pretreatment) CsA assay on the Dade Behring Dimension RxL^TM system and compared results with those from the Abbott TDx CsA immunoassay and a HPLC method.

Methods: Whole-blood samples from heart (n = 111; 35 patients), liver (n = 201; 44 patients), kidney (n = 279; 65 patients), and miscellaneous organ (n = 77; 12 lung, 12 bone marrow, 5 kidney/pancreas, and 1 pancreas patient) recipients were obtained from patient populations of the participating institutions. Routine clinical monitoring of CsA was performed using either the TDx method or HPLC.

Results: The minimum detectable concentration of CsA averaged 9.4 µg/L, and the lower limit of quantification was 30 µg/L. The method was linear from 30 to 500 µg/L. Cross-reactivity with seven different CsA metabolites ranged from 0.0% to 5.7% for the Dimension RxL assay compared with 0.4–15.9% for the TDx assay. Total imprecision (CV) averaged 6.2%, and within-run imprecision averaged 4.9%. Passing–Bablok linear regression analyses of all samples from two sites yielded the following: RxL = 0.81 x TDx - 16.8; and RxL = 1.12 x HPLC - 1.7.

Conclusions: The Dade Behring CsA assay for the random-access Dimension platform offers adequate performance characteristics for routine clinical use, does not require a manual pretreatment step, and demonstrates less cross-reactivity with CsA metabolites than another commonly used immunoassay.

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