Performance evaluation of the new ADVIA Centaur system cyclosporine assay (single-step extraction).

Academic Article

Abstract

  • BACKGROUND: Cyclosporine (CsA) monitoring is essential for transplant success. We report a performance study of the recently released, fully automated Siemens ADVIA Centaur CsA assay. METHODS: Whole blood samples from 248 transplant patients were prepared using a new 1-step extraction method. Performance evaluations vs. HPLC-tandem MS (LC-MS/MS), Abbott TDx and AxSYM assays were conducted according to CLSI EP5-A2 and EP9-A2 guidelines. RESULTS: The correlation coefficient for LC-MS/MS and ADVIA Centaur was > or = 0.97 at each site, and for each transplant type. Regression analysis yielded y=0.94x+19 for all sites: 95% CI=0.91-0.96 (slope) and 10-28 (intercept). Absolute and relative bias was minimal for C0 and C2 sampling. Centaur vs. Abbott TDx and AxSYM assays: y = 0.72x+6, r = 0.98, 95% CI = 0.70-0.73 (slope), 3-9 (intercept); and y = 0.69x+18, r = 0.97, 95% CI = 0.67-0.71 (slope), 8-27(intercept). Within run CVs were 4.5%-7.1%, total CVs were 5.3%-7.7%. CONCLUSIONS: The ADVIA Centaur assay compared favorably with LC-MS/MS and Abbott assays, displaying good correlation for all transplant types and methods.
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    Keywords

  • Adolescent, Adult, Aged, Aged, 80 and over, Binding, Competitive, Cyclosporine, Drug Monitoring, Female, Fluorescence Polarization Immunoassay, Humans, Immunosuppressive Agents, Male, Middle Aged, Reference Values, Transplantation, Young Adult
  • Digital Object Identifier (doi)

    Authorlist

  • Soldin SJ; Hardy RW; Wians FH; Balko JA; Mendu DR; Chaffin CH; Streit F; Barbarakis M; Martel J; Canfield W
  • Start Page

  • 806
  • End Page

  • 811
  • Volume

  • 411
  • Issue

  • 11-12