Evaluation of a no-pretreatment cyclosporin a assay on the Dade Behring Dimension RxL clinical chemistry analyzer

Andrea R. Terrell, Thomas M. Daly, Karl G. Hock, Daniel C. Kilgore, Tie Q. Wei, Sharon Hernandez, Don Weibe, Leona Fields, Leslie M. Shaw, Mitchell G. Scott

Research output: Contribution to journalArticlepeer-review

30 Scopus citations

Abstract

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™ 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 × TDx - 16.8; and RxL = 1.12 × 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.

Original languageEnglish
Pages (from-to)1059-1065
Number of pages7
JournalClinical chemistry
Volume48
Issue number7
DOIs
StatePublished - 2002

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