一种用于西罗莫司常规测定的免疫分析方法（雅培IMX分析仪）的评估：与液相色谱 - 质谱法的比较。
Evaluation of an immunoassay (Abbott-IMX Analyzer) allowing routine determination of sirolimus: comparison with LC-MS method.
作者信息
Bargnoux A S, Bonardet A, Chong G, Garrigue V, Deleuze S, Dupuy A M, Mourad G, Cristol J P
机构信息
Department of Biochemistry, Transplantation and Peritoneal Dialysis, University Hôpital Lapeyronie, University of Montpellier Medical School, 191 avenue du doyen Gaston Giraud, 34295 Montpellier 05, France.
出版信息
Transplant Proc. 2006 Sep;38(7):2352-3. doi: 10.1016/j.transproceed.2006.06.127.
BACKGROUND
The use of the immunosuppressive agent sirolimus is increasing in renal transplantation but its monitoring often requires high-performance liquid chromatography (HPLC) with ultra-violet (UV) or tandem mass spectrometric (MS-MS) detection. The aim of this study was to compare a new microparticle enzyme immunoassay (MEIA, Microparticle Enzyme Immunoassay) on IMx Abbott Analyser with a liquid chromatography-mass spectometry (LC-MS) method.
METHOD
The accuracy of immunoassay analytical performance including within run and between run imprecision and linearity was tested. For comparison studies, sirolimus level was then determined with the two methods on 98 samples from 52 transplant patients.
RESULTS
Total intra-assay and inter-assay variation coefficients were below 10% at the three levels tested, and the coefficient of linearity was r = 0.99. The values obtained were highly correlated with the LC-MS method (MEIA = 1.02LC-MS + 0.91; r(2) = 0.87). As a result, the immunoassay showed good performance, and clinical sample measurements were not affected by the method. The MEIA may be a useful alternative for routine monitoring of sirolimus.
背景
免疫抑制剂西罗莫司在肾移植中的应用日益增加，但其监测通常需要采用配备紫外（UV）或串联质谱（MS-MS）检测的高效液相色谱（HPLC）法。本研究的目的是比较雅培IMx分析仪上的新型微粒酶免疫测定法（MEIA，微粒酶免疫测定法）与液相色谱-质谱法（LC-MS）。
方法
对免疫测定分析性能的准确性进行了测试，包括批内和批间不精密度以及线性。为进行比较研究，随后采用这两种方法对52例移植患者的98份样本测定西罗莫司水平。
结果
在三个测试水平下，总批内和批间变异系数均低于10%，线性系数为r = 0.99。所得值与LC-MS法高度相关（MEIA = 1.02LC-MS + 0.91；r² = 0.87）。因此，免疫测定表现出良好的性能，临床样本测量不受该方法影响。MEIA可能是西罗莫司常规监测的一种有用替代方法。
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