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

Clin Chim Acta. 2010 Jun 3;411(11-12):806-11. doi: 10.1016/j.cca.2010.02.062. Epub 2010 Feb 24.

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.

Publication types

  • Comparative Study
  • Controlled Clinical Trial
  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Binding, Competitive
  • Cyclosporine / blood*
  • Cyclosporine / isolation & purification
  • Drug Monitoring / methods
  • Drug Monitoring / standards*
  • Female
  • Fluorescence Polarization Immunoassay / methods
  • Fluorescence Polarization Immunoassay / standards
  • Humans
  • Immunosuppressive Agents / blood
  • Immunosuppressive Agents / isolation & purification
  • Male
  • Middle Aged
  • Reference Values
  • Transplantation / standards
  • Young Adult

Substances

  • Immunosuppressive Agents
  • Cyclosporine