1. Multi-center evaluation of a commercial Kit for tacrolimus determination by LC/MS/MS
- Author
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Paul J. Taylor, Kimberly L. Napoli, Donald P. Cooper, Michael E. Franklin, Webb Lowe, Michael Morris, and Catherine A. Hammett-Stabler
- Subjects
Adult ,medicine.medical_treatment ,Clinical Biochemistry ,Commercial kit ,Liver transplantation ,Sensitivity and Specificity ,Tacrolimus ,Tandem Mass Spectrometry ,Lc ms ms ,medicine ,Humans ,Multicenter Studies as Topic ,Chromatography, High Pressure Liquid ,Kidney transplantation ,Chromatography ,medicine.diagnostic_test ,Chemistry ,General Medicine ,medicine.disease ,Kidney Transplantation ,Liver Transplantation ,surgical procedures, operative ,Therapeutic drug monitoring ,Practice Guidelines as Topic ,Linear Models ,Reagent Kits, Diagnostic - Abstract
A multi-center evaluation (3 sites) of the LC/MS/MS MassTrak tacrolimus Immunosuppressants Kit (Kit) was undertaken.Ten aspects of the analytical performance of the Kit were investigated based on FDA and CLSI guidelines.The linear analytical range of the procedure was between 0.68 and 31.7ng/mL. Within-run and total imprecision were6% and8% (n=240), respectively. Recoveries of tacrolimus added to clinical samples that contained between 5 and 10ng/mL of tacrolimus before addition were 99, 102 and 105% at 5.0, 10 and 20ng/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 15ng/mL.This evaluation indicates that the Kit is suitable for the monitoring of tacrolimus in kidney and liver transplant recipients.
- Published
- 2010