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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter

IMPACT FACTOR 2017: 3.556

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

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Volume 49, Issue 7


Performance of the Roche Total Mycophenolic Acid® assay on the Cobas Integra 400®, Cobas 6000® and comparison to LC-MS/MS in liver transplant patients

An-Sofie C. Decavele / Niels Favoreel / Fien Vander Heyden / Alain G. Verstraete
Published Online: 2011-06-13 | DOI: https://doi.org/10.1515/CCLM.2011.194


Background: Mycophenolic acid (MPA) is an immunosuppressant for which therapeutic drug monitoring (TDM) is performed for optimal prophylaxis and avoidance of toxicity in transplant patients. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is ideally suited for TDM of MPA. There have been several method comparisons of the Roche Total MPA assay, but none have been performed with respect to liver transplant patients.

Methods: We validated the Roche Total MPA assay on the Cobas Integra 400 and Cobas 6000 and compared it to a validated LC-MS/MS (API 2000™) method. Fifty-five EDTA plasma samples from liver transplant patients were measured with the Roche assay on these platforms and compared to the LC-MS/MS results.

Results: Validation of the LC-MS/MS, Cobas Integra 400 and 6000 was performed with good results. The LC-MS/MS/Integra 400/Cobas 6000 were linear up to 30, 15 and 17 mg/L, respectively. Imprecision was <10% for LC-MS/MS and <7% for the Roche assay on both platforms. The samples showed good agreement with LC-MS/MS. Passing-Bablok regression analysis showed Cobas Integra (mg/L)=1.02×LC-MS/MS (mg/L)–0.50 and Cobas 6000 (mg/L)=0.98×LC-MS/MS–0.47.

Conclusions: The Roche Total Mycophenolic Acid-assay is suitable for measuring total MPA in plasma from liver transplant patients and is a good alternative for LC-MS/MS.

Keywords: enzyme assay; inosine monophosphate dehydrogenase; liquid chromatography-tandem mass spectrometry; liver transplantation; mycophenolic acid

About the article

Corresponding author: Prof. Alain Verstraete, Laboratory of Toxicology, Ghent University Hospital, Department of Laboratory Medicine, Ghent University, Department of Clinical Chemistry, De Pintelaan 185, 9000 Ghent, Belgium Phone: +32 9 332 34 07, Fax: +32 9 332 49 85

Received: 2010-11-10

Accepted: 2011-02-27

Published Online: 2011-06-13

Published in Print: 2011-07-01

Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 49, Issue 7, Pages 1159–1165, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2011.194.

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