Journal
CLINICAL BIOCHEMISTRY
Volume 43, Issue 10-11, Pages 910-920Publisher
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.clinbiochem.2010.03.016
Keywords
HPLC; Tandem mass spectrometry; Tacrolimus; Therapeutic drug monitoring; Harmonization
Categories
Funding
- Waters Corporation, Milford, MA, USA
Ask authors/readers for more resources
Objectives: A multi-center evaluation (3 sites) of the LC/MS/MS MassTrak (TM) tacrolimus Immunosuppressants Kit (Kit) was undertaken. Design and methods: Ten aspects of the analytical performance of the Kit were investigated based on FDA and CLSI guidelines. Results: The linear analytical range of the procedure was between 0.68 and 31.7 ng/mL. Within-run and total imprecision were <6% and <8% (n=240), respectively. Recoveries of tacrolimus added to clinical samples that contained between 5 and 10 ng/mL of tacrolimus before addition were 99, 102 and 105% at 5.0, 10 and 20 ng/mL, respectively. Comparison of in-house and Kit procedures in samples from liver (n=50-58) or kidney (n=50 or 51) transplant recipients yielded method mean biases between -2.0 and +10.7% at 5 and 15 ng/mL. Conclusions: This evaluation indicates that the Kit is suitable for the monitoring of tacrolimus in kidney and liver transplant recipients. (c) 2010 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available