Advanced search
1 file | 261.05 KB Add to list

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 Decavele (UGent) , NIELS FAVOREEL (UGent) , FIEN VANDER HEYDEN (UGent) and Alain Verstraete (UGent)
Author
Organization
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 (TM)) 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 x LC-MS/MS (mg/L)-0.50 and Cobas 6000 (mg/L) = 0.98 x 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
liquid chromatography-tandem mass spectrometry, inosine monophosphate dehydrogenase, enzyme assay, liver transplantation, mycophenolic acid, TANDEM MASS-SPECTROMETRY, INOSINE MONOPHOSPHATE DEHYDROGENASE, GLUCURONIDE METABOLITES, ACYL GLUCURONIDE, HUMAN PLASMA, QUANTIFICATION, EMIT, RECIPIENTS, HPLC, IMMUNOASSAY

Downloads

  • Decavele 2011 CCLM 49 7 1159.pdf
    • full text
    • |
    • open access
    • |
    • PDF
    • |
    • 261.05 KB

Citation

Please use this url to cite or link to this publication:

MLA
Decavele, An-Sofie, NIELS FAVOREEL, FIEN VANDER HEYDEN, et al. “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.” CLINICAL CHEMISTRY AND LABORATORY MEDICINE 49.7 (2011): 1159–1165. Print.
APA
Decavele, A.-S., FAVOREEL, N., VANDER HEYDEN, F., & Verstraete, A. (2011). 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. CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 49(7), 1159–1165.
Chicago author-date
Decavele, An-Sofie, NIELS FAVOREEL, FIEN VANDER HEYDEN, and Alain Verstraete. 2011. “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.” Clinical Chemistry and Laboratory Medicine 49 (7): 1159–1165.
Chicago author-date (all authors)
Decavele, An-Sofie, NIELS FAVOREEL, FIEN VANDER HEYDEN, and Alain Verstraete. 2011. “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.” Clinical Chemistry and Laboratory Medicine 49 (7): 1159–1165.
Vancouver
1.
Decavele A-S, FAVOREEL N, VANDER HEYDEN F, Verstraete A. 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. CLINICAL CHEMISTRY AND LABORATORY MEDICINE. 2011;49(7):1159–65.
IEEE
[1]
A.-S. Decavele, N. FAVOREEL, F. VANDER HEYDEN, and A. Verstraete, “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,” CLINICAL CHEMISTRY AND LABORATORY MEDICINE, vol. 49, no. 7, pp. 1159–1165, 2011.
@article{2045313,
  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 (TM)) 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 x LC-MS/MS (mg/L)-0.50 and Cobas 6000 (mg/L) = 0.98 x 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.}},
  author       = {{Decavele, An-Sofie and FAVOREEL, NIELS and VANDER HEYDEN, FIEN and Verstraete, Alain}},
  issn         = {{1434-6621}},
  journal      = {{CLINICAL CHEMISTRY AND LABORATORY MEDICINE}},
  keywords     = {{liquid chromatography-tandem mass spectrometry,inosine monophosphate dehydrogenase,enzyme assay,liver transplantation,mycophenolic acid,TANDEM MASS-SPECTROMETRY,INOSINE MONOPHOSPHATE DEHYDROGENASE,GLUCURONIDE METABOLITES,ACYL GLUCURONIDE,HUMAN PLASMA,QUANTIFICATION,EMIT,RECIPIENTS,HPLC,IMMUNOASSAY}},
  language     = {{eng}},
  number       = {{7}},
  pages        = {{1159--1165}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1515/CCLM.2011.194}},
  volume       = {{49}},
  year         = {{2011}},
}

Altmetric
View in Altmetric
Web of Science
Times cited: