【Objective】 Tacrolimus (TAC) is an immunosuppressant drug that has been used to prevent organ rejection after transplantation and to control autoimmune diseases. TAC has a narrow therapeutic window, requiring therapeutic drug monitoring. Lumipulse Presto iTACT tacrolimus, based on the chemiluminescent enzyme immunoassay method (CLEIA), is a newly developed reagent for the measurement of TAC concentration in whole blood. The iTACT technology automatically pretreats whole blood samples before measuring TAC concentration, which can considerably reduce the laboratory workload. In this study, we evaluated the performance of this new CLEIA-based TAC measurement system.
【Methods】 The performance of Lumipulse Presto iTACT tacrolimus was evaluated in terms of the repeatability, the intermediate precision, the linearity, the limit of quantitation (LoQ), the interferences by bilirubin, chyle, and hematocrit, and the correlation with chemiluminescence immunoassay (CLIA)-based measurement.
【Results】 Lumipulse Presto iTACT tacrolimus showed good analytical performance; the coefficients of variation were 0.6-1.6% for the repeatability and 1.7-2.5% for the intermediate precision. The linearity was observed up to 33.0 ng/mL, whereas the LoQ was 0.24 ng/mL. The regression equation of this CLEIA -based measurement (y) on the CLIA-based one (x) was y＝1.05x＋0.06 (n＝203, r＝0.99).
【Conclusion】 The performance of Lumipulse Presto iTACT tacrolimus was good enough for routine clinical use.
