Multisite Analytical Evaluation of the Abbott ARCHITECT Cyclosporine Assay

Autor: K. Berg, Bendicht Wermuth, G.T. Maine, Pierre Marquet, Guilio Mengozzi, Thomas Rosiere, Pierre Wallemacq, Giuseppe Aimo, Kurt Wonigeit, Robert Kretschmer, Rainer W. Schmid, J. Young
Přispěvatelé: Cliniques Universitaires Saint-Luc [Bruxelles], Abbott Diagnostics, Service de Pharmacologie, toxicologie et pharmacovigilance [CHU Limoges], CHU Limoges, Molinette Hospital, Fujirebio Diagnostics, Medizinische Hochschule Hannover (MHH), Department of Chemistry and Biochemistry [Bern], University of Bern, Medizinische Universität Wien = Medical University of Vienna, Marquet, Pierre
Jazyk: angličtina
Rok vydání: 2010
Předmět:
Zdroj: Therapeutic Drug Monitoring
Therapeutic Drug Monitoring, Lippincott, Williams & Wilkins, 2010, 32 (2), pp.145-51. ⟨10.1097/FTD.0b013e3181d46386⟩
ISSN: 0163-4356
DOI: 10.1097/FTD.0b013e3181d46386⟩
Popis: International audience; 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.
Databáze: OpenAIRE
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