Technical Note: Experience of Implementing Tacrolimus Immunoassay on the Alinity i Analyzer in an Academic Medical Center: Small Percentage of Specimens Were Sent to Reference Laboratory for LC-MS/MS Analysis.
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Abstract
Objective: Liquid chromatography combined with tandem mass spectrometry (LC-MS/MS) is considered the gold standard for analysis of tacrolimus as this method is free from metabolite interferences. Due to complexity of analysis and initial high cost, many hospital laboratories use immunoassays for routine monitoring of tacrolimus. In 2023, we implemented a Federal Food and Drug Administration (FDA) approved Chemiluminescent microparticle immunoassay (CMIA) of tacrolimus on the Alinity i analyzer with an option for physicians to request LC-MS/MS analysis if they were not satisfied with the immunoassay result.
Methods: CMIA tacrolimus was performed on the Alinity i analyzer, and the result was reported within four hours. After evaluating a particular tacrolimus result, if a physician requested LC-MS/MS analysis, the same whole blood specimen was sent to the reference laboratory. Then, we compared LC-MS/MS value with initial immunoassay result.
Results: In a 12-month period, 25,897 tacrolimus tests were ordered by physicians. Only 388 specimens (1.49%) were sent to the reference laboratory for LC-MS/MS analysis. The overall correlation between LC-MS/MS value (x-axis) and immunoassay result was excellent (y=1.045x+0.652, r=0.96, n=388). Out of 388 specimens, only 70 specimens were considered discordant due to more than 20% bias between the LC-MS/MS and immunoassay values. When these specimens were compared, the regression equation was 1.277x+0.412, r=0.95.
Conclusions: The CMIA assay on the Alinity i analyzer is suitable for routine therapeutic drug monitoring of tacrolimus with high physician satisfaction.
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