Performance of the Dimension TAC assay and comparison of multiple platforms for the measurement of tacrolimus

被引:6
作者
Cho, Eun-Jung [1 ,2 ]
Ko, Dae-Hyun [3 ]
Lee, Woochang [2 ]
Chun, Sail [2 ]
Lee, Hae-Kyung [1 ]
Min, Won-Ki [2 ]
机构
[1] Catholic Univ Korea, Dept Lab Med, Coll Med, Uijeongbu St Marys Hosp, Uijongbu, South Korea
[2] Univ Ulsan, Dept Lab Med, Asan Med Ctr, Coll Med, Seoul, South Korea
[3] Hallym Univ, Dongtan Sacred Heart Hosp, Dept Lab Med, Coll Med, Hwaseong, South Korea
关键词
Dimension TAC assay; immunosuppressive agent; performance evaluation; tacrolimus; transplant; TANDEM MASS-SPECTROMETRY; IMMUNOSUPPRESSIVE DRUGS; LIVER-TRANSPLANTATION; RENAL-TRANSPLANTATION; ORGAN-TRANSPLANTATION; AUTOMATED URINALYSIS; CLINICAL-PRACTICE; IMMUNOASSAY; BLOOD; MICROSCOPY;
D O I
10.1002/jcla.22357
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
Background: Therapeutic monitoring of tacrolimus is essential for reducing organ rejection and adverse effects. The measurement of tacrolimus in whole blood is taken by many automated platforms. We evaluated the analytical performance of the Dimension TAC assay, which is an upgraded reagent from the previous Dimension TACR assay. Methods: The evaluations involved determination of precision, linearity, detection capability, and reagent lot-to-lot variability between three lot numbers. Correlation studies were conducted using the Dimension TACR assay, Architect, Elecsys assay, and MassTrak LC-MS/MS. Results: The total coefficient of variation was below 10%. Acceptable linearity was observed in their respective reportable ranges. The limit of blank, limit of detection, and limit of quantification were 0.29, 0.47, and 0.81 ng/mL, respectively. Correlation analysis indicated that the Dimension TAC assay results were comparable to that of the Dimension TACR assay, Architect, and Elecsys results in liver and heart transplant patients. In kidney transplant patients, the Dimension TAC assay showed the poor correlation with Architect and Elecsys. The results from these assays were slightly higher than that of MassTrak. We found little lot-to-lot reagent variation among the reagents evaluated. Conclusion: The overall analytical performance of the Dimension TAC assay is acceptable for therapeutic monitoring in clinical practice. Our study that compared different platforms may provide some useful information regarding which test method to use.
引用
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页数:8
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