Performance characteristics of a no-pretreatment, random access sirolimus assay for the Dimension® RxL clinical chemistry system

Mark A. Cervinski, Show Hong Duh, Karl G. Hock, Jeffery Gray, Tie Q. Wei, Daniel C. Kilgore, Robert H. Christenson, Mitchell G. Scott

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

Abstract

Objectives: Current therapeutic drug monitoring methods for sirolimus require a manual pre-treatment step and batch analysis. We describe and validate a no-pretreatment, random access sirolimus assay for the Dimension® RxL clinical chemistry system from Siemens Healthcare Diagnostics Inc. Design and methods: Whole blood samples from renal transplant patients prescribed sirolimus were analyzed by the LC-MS/MS reference method, Abbott IMx and Dimension RxL methods in accordance with CLSI recommendations. Results: The Dimension sirolimus assay had a functional sensitivity of 2.0 ng/mL and repeatability and within-laboratory imprecision less than 12.6% at 3 ng/mL and less than 5% at 11-12 ng/mL. Least squares linear regression demonstrated the following relationships: RxL = 1.20(LC-MS/MS) - 0.70, r = 0.95 and RxL = 1.33(IMx) - 0.75, r = 0.96. Conclusions: The Dimension sirolimus assay correlates well with the LC-MS/MS reference and IMx immunoassay methods and has the advantage of random access analysis without a manual pre-treatment step.

Original languageEnglish
Pages (from-to)1123-1127
Number of pages5
JournalClinical Biochemistry
Volume42
Issue number10-11
DOIs
StatePublished - Jul 2009

Keywords

  • Dimension RxL
  • Random access
  • Sirolimus

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