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Multisite Analytical Evaluation of the Abbott ARCHITECT Cyclosporine Assay

Wallemacq, Pierre PhD*; Maine, Gregory T PhD; Berg, Keith BS; Rosiere, Thomas PhD; Marquet, Pierre MD; Aimo, Giuseppe MD§; Mengozzi, Giulio MD§; Young, Julianna BS; Wonigeit, Kurt MD; Kretschmer, Robert BS#; Wermuth, Bendicht PhD#; Schmid, Rainer W PhD**

doi: 10.1097/FTD.0b013e3181d46386
Original Article
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The objective of this study was to evaluate the analytical performance of the Abbott ARCHITECT Cyclosporine (CsA) immunoassay in 7 clinical laboratories in comparison to liquid chromatography/tandem mass spectrometry (LC/MS/MS), Abbott TDx, Cobas Integra 800, and the Dade Dimension Xpand immunoassay. The ARCHITECT assay uses a whole blood specimen, a pretreatment step with organic reagents to precipitate proteins and extract the drug, followed by a 2-step automated immunoassay with magnetic microparticles coated with anti-CsA antibody and an acridinium-CsA tracer. Imprecision testing at the 7 evaluation sites gave a range of total % coefficient of variations of 7.5%-12.2% at 87.5 ng/mL, 6.6%-14.3% at 411 ng/mL, and 5.2%-10.7% at 916 ng/mL. The lower limit of quantification ranged from 12 to 20 ng/mL. Purified CsA metabolites AM1, AM1c, AM4N, AM9, and AM19 were tested in whole blood by the ARCHITECT assay and showed minimal cross-reactivity at all 7 sites. In particular, AM1 and AM9 cross-reactivity in the ARCHITECT assay, ranged from −2.5% to 0.2% and −0.8% to 2.2%, respectively, and was significantly lower than for the TDx assay, in which the values were 3.2% and 16.1%, respectively. Comparable testing of metabolites in the Dade Dimension Xpand assay at 2 evaluation sites showed cross-reactivity to AM4N (6.4% and 6.8%) and AM9 (2.6% and 3.6%) and testing on the Roche Integra 800 showed cross-reactivity to AM1c (2.4%), AM9 (10.7%), and AM19 (2.8%). Cyclosporine International Proficiency Testing Scheme samples, consisting of both pooled specimens from patients receiving CsA therapy as well as whole-blood specimens supplemented with CsA, were tested by the ARCHITECT assay at 6 sites and showed an average bias of −24 to −58 ng/mL versus LC/MSMS CsA and −2 to −37 ng/mL versus AxSYM CsA. Studies were performed with the ARCHITECT CsA assay on patient specimens with the following results: ARCHITECT CsA assay versus LC/MSMS, average bias of 31 ng/mL; ARCHITECT versus the Dade Dimension assay (4 sites), average biases of −7 to −228 ng/mL; ARCHITECT versus AxSYM and TDx, average biases of −4 and −53 ng/mL, respectively. Spearman correlation coefficients were ≥0.89. The ARCHITECT CsA assay has significantly reduced CsA metabolite interference relative to other immunoassays and is a convenient and sensitive semiautomated method to measure CsA in whole blood.

From the *Université Catholique de Louvain, Cliniques Universitaires St. Luc, Brussels, Belgium; †Abbott Diagnostics, Abbott Park, IL; ‡CHU Limoges, Limoges, France; §Molinette Hospital, Torino, Italy; ¶Fujirebio Diagnostics, Malvern, PA; Medizinische Hochschule Hannover, Hannover, Germany; #Institut für Klinische Chemie, Inselspital, Universität Bern, Bern, Switzerland; and **Medizinische Universität Wien, Vienna, Austria.

Received for publication October 14, 2009; accepted Januray 15, 2010.

Supported by Abbott Diagnostics.

Correspondence: Pierre Wallemacq, PhD, Laboratory of Analytical Biochemistry, Cliniques Universitaires St. Luc, 10 Hippocrate Ave, B-1200 Brussels, Belgium (e-mail: pierre.wallemacq@uclouvain.be).

© 2010 Lippincott Williams & Wilkins, Inc.