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Multi-center evaluation of a commercial Kit for tacrolimus determination by LC/MS/MS.

OBJECTIVES: A multi-center evaluation (3 sites) of the LC/MS/MS MassTrak 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 31.7ng/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 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. CONCLUSIONS: This evaluation indicates that the Kit is suitable for the monitoring of tacrolimus in kidney and liver transplant recipients.[1]

References

  1. Multi-center evaluation of a commercial Kit for tacrolimus determination by LC/MS/MS. Napoli, K.L., Hammett-Stabler, C., Taylor, P.J., Lowe, W., Franklin, M.E., Morris, M.R., Cooper, D.P. Clin. Biochem. (2010) [Pubmed]
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