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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
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An-Sofie C. Decavele
Published/Copyright:
June 13, 2011
Abstract
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
Received: 2010-11-10
Accepted: 2011-2-27
Published Online: 2011-06-13
Published in Print: 2011-07-01
©2011 by Walter de Gruyter Berlin Boston
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Keywords for this article
enzyme assay;
inosine monophosphate dehydrogenase;
liquid chromatography-tandem mass spectrometry;
liver transplantation;
mycophenolic acid
Articles in the same Issue
- Editorial
- Method comparison: where do we draw the line?
- Review
- Current role of liquid chromatography coupled to mass spectrometry in clinical toxicology screening methods
- Minireview
- Molecular diagnostics for pharmacogenomic testing of fluoropyrimidine based-therapy: costs, methods and applications
- Opinion Paper
- Preanalytical quality improvement: from dream to reality
- Point
- Towards more complete specifications for acceptable analytical performance – a plea for error grid analysis
- Counterpoint
- Closing the brain-to-brain loop in laboratory testing
- General Clinical Chemistry and Laboratory Medicine
- Harmonization of growth hormone measurements with different immunoassays by data adjustment
- Comparison of the results from two different External Quality Assessment Schemes supports the utility of robust quality specifications
- High-throughput LC-MS/MS method for monitoring sirolimus and everolimus in the routine clinical laboratory
- 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
- Diagnostic efficiency of truncated area under the curve from 0 to 2 h (AUC0–2) of mycophenolic acid in kidney transplant recipients receiving mycophenolate mofetil and concomitant tacrolimus
- Good performance of an immunoassay based method for nevirapine measurements in human breast milk
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- Interchangeability of blood gas, electrolyte and metabolite results measured with point-of-care, blood gas and core laboratory analyzers
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- Direct chromogenic substrate immuno-capture activity assay for testing of factor VII-activating protease
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- Monoclonal gammopathy missed by capillary zone electrophoresis
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- Letter to the Editor Reply: Statistical methods for assessment of added usefulness of new biomarkers
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