Multi-center evaluation of a commercial Kit for tacrolimus determination by LC/MS/MS.
OBJECTIVE
A multi-center evaluation (3 sites) of the LC/MS/MS MassTrak tacrolimus Immunosuppressants Kit (Kit) was undertaken.


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.
Napoli
Kimberly L
KL
Division of Immunology and Organ Transplantation, University of Texas Medical School at Houston, Houston, TX, USA.
Hammett-Stabler
Catherine
C
Taylor
Paul J
PJ
Lowe
Webb
W
Franklin
Michael E
ME
Morris
Michael R
MR
Cooper
Donald P
DP
D000328:Adult; D002851:Chromatography, High Pressure Liquid; D006801:Humans; D016030:Kidney Transplantation; D016014:Linear Models; D016031:Liver Transplantation; D015337:Multicenter Studies as Topic; D017410:Practice Guidelines as Topic; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D016559:Tacrolimus / Q000097:blood*; D053719:Tandem Mass Spectrometry
D011933:Reagent Kits, Diagnostic; D016559:Tacrolimus