Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/22803
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Type: Journal article
Title: CEDIA (R) mycophenolic acid assay compared with HPLC-UV in specimens from transplant recipients
Author: Westley, I.
Ray, J.
Morris, R.
Citation: Therapeutic Drug Monitoring, 2006; 28(5):632-636
Publisher: Lippincott Williams & Wilkins
Issue Date: 2006
ISSN: 0163-4356
1536-3694
Statement of
Responsibility: 
Westley, Ian S ; Ray, John E ; Morris, Raymond G
Abstract: Routine monitoring of mycophenolic acid (MPA) has been accepted as an essential tool in the management of this therapy in transplant recipients. The availability of simple, sensitive assays that measure MPA in plasma permits individualization of dosing regimens according to pharmacokinetic principles. We report the results of an evaluation of the CEDIA Mycophenolic Acid Immunoassay (Microgenics Corporation, Fremont, California) for the measurement of plasma MPA concentrations in a range of transplant indications and compare its performance and specificity to an established HPLC/UV method. Precision and accuracy were determined both within and between runs using the quality control materials provided with the CEDIA MPA assay, which produced within run (n = 21) coefficients of variation (CV%) and biases of less than 5%. The between run analyses, performed over consecutive days following daily calibration of the assay, showed CVs and biases of less than 7%. Routine patient samples (n = 298) from 142 patients of varying transplant type were analyzed using the CEDIA MPA kit and HPLC/UV methods. Regression analysis of the patient samples gave an equation of CEDIA = 1.18 HPLC/UV + 0.45 (r = 0.83). According to the manufacturer's product information, there is 192% cross reactivity with the active mycophenolate acyl glucuronide. The data presented suggest that the CEDIA MPA immunoassay, run on the Hitachi 911 analyzer, over-estimates plasma MPA concentrations with a magnitude that is influenced by transplant type. Hence, users must interpret the immunoassay results with caution and not assume that the metabolite fraction is constant in recipients of the same organ type or in different organ transplant populations.
Keywords: mycophenolic acid; therapeutic drug monitoring; immunoassay
RMID: 0020061502
DOI: 10.1097/01.ftd.0000243963.53322.8d
Appears in Collections:Pharmacology publications

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