Evaluation of 2 Immunoassays for Monitoring Low Blood Levels of Tacrolimus
Evaluation of 2 Immunoassays for Monitoring Low Blood Levels of Tacrolimus
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DOI：
10.1097/ftd.0b013e318196dfed
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发表时间：
2009-04-01
影响因子：
2.5
通讯作者：
Levine, Daniel M.
中科院分区：
文献类型：
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作者：
Amann, Shawn;Parker, Thomas S.;Levine, Daniel M.
本研究的目的是评价2种新的他克莫司免疫测定法（Dade Dimension Xpand和Abbott ARCHITECT）用于治疗药物监测的分析性能，作为我们实验室当前方法Abbott IMx他克莫司测定法的可能替代品。我们研究所的主治医师希望尽量减少肾移植受者的钙调磷酸酶抑制剂治疗，以延长移植物存活率并改善患者的生活质量。全血中他克莫司的拟定未来目标谷水平在2-4 ng/mL范围内，这需要定量限（LOQ）低于该范围的测定，理想情况下约为1 ng/mL（他克莫司优化委员会的欧洲共识建议）。Dade和ARCHITECT检测的方法比较分析显示与IMx检测具有良好的相关性。相关系数分别为0.94和0.96。两种试验报告的他克莫司浓度平均低于IMx，斜率分别为0.83（Dade）和0.93（ARCHITECT）。检测的两种Dade仪器的LOQ均>4 ng/mL，而ARCHITECT i2000和i1000仪器的LOQ分别为0.8和0.5 ng/mL（95%置信上限）。观察到两种Dade仪器报告的值随时间推移发生变化，而IMx和ARCHITECT仪器上的值稳定。Abbott ARCHITECT他克莫司检测试剂盒是一种符合新LOQ建议的灵敏度和精密度检测试剂盒。1 ng/mL，用于监测全血中的他克莫司。
The objective of this study was to evaluate the analytical performance of 2 new tacrolimus immunoassays (Dade Dimension Xpand and Abbott ARCHITECT) for therapeutic drug monitoring as possible replacements for the current method in our laboratory, the Abbott IMx tacrolimus assay. Attending physicians at Our institute desire to minimize calcineurin inhibitor therapy in kidney allograft recipients to prolong graft survival and improve the quality of life of their patients. Proposed future target trough levels of tacrolimus in whole blood are in the range of 2-4 ng/mL, which requires an assay with a limit of quantification (LOQ) below this range, ideally around I ng/mL (European Consensus Recommendation from the Committee on Tacrolimus Optimization). Method comparison analysis of the Dade and ARCHITECT assays showed good correlation to the IMx assay. with correlation coefficients of 0.94 and 0.96, respectively. Both assays reported tacrolimus concentrations lower on average than IMx as demonstrated by slopes of 0.83 (Dade) and 0.93 (ARCHITECT). LOQ for both Dade instruments tested was >4 ng/mL, whereas the LOQ for the ARCHITECT i2000 and i1000 instruments was 0.8 and 0.5 ng/mL, respectively (upper 95% confidence limit). Values reported from both Dade instruments were observed to shift over time, whereas the values on the IMx and ARCHITECT instruments were stable. The Abbott ARCHITECT Tacrolimus assay is a sensitive and precise assay that meets the new LOQ recommendation. 1 ng/mL, for monitoring tacrolimus in whole blood.