title: Performance evaluation of the new ADVIA Centaur system cyclosporine assay (single-step extraction).
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.
authors.affiliation: Georgetown University, Washington, DC, USA.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Soldin
authors.forename: Robert W
authors.initials: RW
authors.lastname: Hardy
authors.forename: Frank H
authors.initials: FH
authors.lastname: Wians
authors.forename: Jody A
authors.initials: JA
authors.lastname: Balko
authors.forename: Damodara R
authors.initials: DR
authors.lastname: Mendu
authors.forename: Carolyn H
authors.initials: CH
authors.lastname: Chaffin
authors.forename: Frank
authors.initials: F
authors.lastname: Streit
authors.forename: Minas
authors.initials: M
authors.lastname: Barbarakis
authors.forename: Julie
authors.initials: J
authors.lastname: Martel
authors.forename: William
authors.initials: W
authors.lastname: Canfield
authors.forename: H Roma
authors.initials: HR
authors.lastname: Levy
authors.forename: Michael
authors.initials: M
authors.lastname: Oellerich
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001667:Binding, Competitive; D016572:Cyclosporine / Q000097:blood* / Q000302:isolation & purification; D016903:Drug Monitoring / Q000379:methods / Q000592:standards*; D005260:Female; D016231:Fluorescence Polarization Immunoassay / Q000379:methods / Q000592:standards; D006801:Humans; D007166:Immunosuppressive Agents / Q000097:blood / Q000302:isolation & purification; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D014180:Transplantation / Q000592:standards; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine