Performance evaluation of the new ADVIA Centaur system cyclosporine assay (single-step extraction).
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.
Soldin
Steven J
SJ
Georgetown University, Washington, DC, USA.
Hardy
Robert W
RW
Wians
Frank H
FH
Balko
Jody A
JA
Mendu
Damodara R
DR
Chaffin
Carolyn H
CH
Streit
Frank
F
Barbarakis
Minas
M
Martel
Julie
J
Canfield
William
W
Levy
H Roma
HR
Oellerich
Michael
M
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
D007166:Immunosuppressive Agents; D016572:Cyclosporine