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  • Title: Is the affinity column-mediated immunoassay method suitable as an alternative to the microparticle enzyme immunoassay method as a blood tacrolimus assay?
    Author: Ju MK, Chang HK, Kim HJ, Huh KH, Ahn HJ, Kim MS, Kim SI, Kim YS.
    Journal: Transplant Proc; 2008 Dec; 40(10):3673-8. PubMed ID: 19100463.
    Abstract:
    BACKGROUND: Tacrolimus is a potent immunosuppressive drug used in organ transplantation. Because of its substantial toxic effects, narrow therapeutic index, and interindividual pharmacokinetic variability, therapeutic drug monitoring of whole-blood tacrolimus concentrations has been recommended. We investigated the comparability of the results of 2 immunoassay systems, affinity column-mediated immunoassay (ACMIA) and microparticle enzyme immunoassay (MEIA), comparing differences in the tacrolimus concentrations measured by the 2 methods in relation to the hematologic and biochemical values of hepatic and renal functions. METHODS: A total of 154 samples from kidney or liver transplant recipients were subjected to Dimension RxL HM with a tacrolimus Flex reagent cartilage for the ACMIA method and IMx tacrolimus II for the MEIA method. RESULTS: Tacrolimus concentrations measured by the ACMIA method (n = 154) closely correlated with those measured by the MEIA method (r = 0.84). The Bland-Altman plot using concentration differences between the 2 methods and the average of the 2 methods showed no specific trends. The tacrolimus levels determined by both the MEIA method and the ACMIA method were not influenced by hematocrit levels, but the difference between the 2 methods (ACMIA - MEIA) tended to be larger in low hematocrit samples (P < .001). CONCLUSION: The ACMIA method used for a tacrolimus assay is precise and has advantages, including the lack of a required pretreatment procedure. Furthermore, it is only slightly influenced by the hematologic or biochemical status of the samples.
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