Ko Dae-Hyun, Cho Eun-Jung, Lee Woochang, Chun Sail, Min Won-Ki
a Department of Laboratory Medicine , Hallym University College of Medicine , Hwaseong , Korea.
b Department of Laboratory Medicine , University of Ulsan College of Medicine and Asan Medical Center , Seoul , Korea.
Scand J Clin Lab Invest. 2018 Oct;78(6):431-438. doi: 10.1080/00365513.2018.1472801. Epub 2018 Oct 1.
Therapeutic drug monitoring of tacrolimus and cyclosporine is crucial to the success of organ transplantation. We evaluated the analytical performances and accuracy of two commercially available tacrolimus and cyclosporine assays (Roche ISD and Siemens) in comparison with liquid chromatography-tandem mass spectrometry (LC-MS/MS). A total of 342 leftover whole blood samples requested for tacrolimus or cyclosporine assays were stored at -20 °C until analysis. Repeatability and between-run imprecision were evaluated using quality control materials provided by the manufacturer. Ring trial samples were used for the assessment of recovery. The results of the Roche ISD assay were compared with those of Siemens tacrolimus and cyclosporine assays and LC-MS/MS. Repeatability and between-run imprecision were 2.1-5.3% and 2.6-7.5%, respectively. Recovery of Roche ISD was 85.7 - 90.6% for cyclosporine and 96.2-98.5% for tacrolimus. The two immunoassays showed slight positive biases relative to LC-MS/MS for cyclosporine. For tacrolimus, Roche ISD produced virtually identical results to those of LC-MS/MS, whereas Siemens showed proportional differences, especially in patients receiving kidney transplantation. The analytical performances of Roche ISD were generally acceptable, especially regarding accuracy. Clinical laboratory staff should be aware of the strengths and weaknesses of commercial immunoassays in order to ensure accurate results.
他克莫司和环孢素的治疗药物监测对器官移植的成功至关重要。我们评估了两种市售的他克莫司和环孢素检测方法（罗氏ISD和西门子）相对于液相色谱-串联质谱法（LC-MS/MS）的分析性能和准确性。总共342份因他克莫司或环孢素检测而留存的全血样本在-20°C下保存直至分析。使用制造商提供的质量控制材料评估重复性和批间不精密度。采用环形试验样本评估回收率。将罗氏ISD检测结果与西门子他克莫司和环孢素检测结果以及LC-MS/MS结果进行比较。重复性和批间不精密度分别为2.1-5.3%和2.6-7.5%。环孢素的罗氏ISD回收率为85.7%-90.6%，他克莫司为96.2-98.5%。两种免疫测定法相对于环孢素的LC-MS/MS显示出轻微的正偏差。对于他克莫司，罗氏ISD产生的结果与LC-MS/MS几乎相同，而西门子则显示出比例差异，尤其是在接受肾移植的患者中。罗氏ISD的分析性能总体上是可接受的，尤其是在准确性方面。临床实验室工作人员应了解商业免疫测定法的优缺点，以确保结果准确。
