engleski

Verification of method for tacrolimus in whole blood on automatic analyser abbott architect i1000sr

Tacrolimus is an immunosuppressive drug shown to be effective for treatement of organ rejection following transplantation. Current studies recomend whole blood rather than plasma as more appropriate sample to describe the pharmacokinetic characteristics of tacrolimus. Because of its nephrotoxicity, tacrolimus concentration should be determined to prevent severe side effects. The aim of this study was to verify method (CMIA – carbonylmetalloimmunoassay) for tacrolimus determination in whole blood on automatic analyser Abbott Architect i1000sr. Verification was preformed according to CLSI protocol EP 15-A2. Using two levels of comercial control samples (Architect TP multichem WBT), tacrolimus concentration was measured three times a day during five days (N = 15 for each level). Following parameters have been determined: precision (CVp) and trueness (BIAS). Precision was interpreted according to external QC provider’s permited values. For determining trueness, declared manufacurer values for control samples were interpreted. Obtained values of CVp for precision were 3, 73% (level 1 ; target value 6.41 μg/L) and 2, 55% (level 3 ; target value 24.5 μg/L), and mean CV is 3, 14%. Values for trueness (BIAS) were 18, 25 (level 1) and 18, 06 (level 3) with mean value of 18, 16. The coefficient of variation for the precision obtained in the verification of method for the tacrolimus meets the criteria of the providers of external quality control (for toxicology- drug monitoring 10-20%). This means that the measurement reproducibility is satisfactory, and thus the method is acceptable for the longitudinal monitoring of patients. The results for trueness show difference between target values of the commercial control, but are not clinically significant because it proves that the immunochemical methods on different devices can not be compared. Method for determination of tacrolimus in whole blood on analyzer Abbott Architect i1000sr should be implemented in routine work.

verification ; tacrolimus ; precision ; trueness

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