Schütz E, Svinarov D, Shipkova M, Niedmann P D, Armstrong V W, Wieland E, Oellerich M
Abteilung Klinische Chemie, Georg-August-Universität Göttingen, Germany.
Clin Chem. 1998 Oct;44(10):2158-64.
Assays with different specificity are used for cyclosporin monitoring in clinical transplantation. A recent survey of 35 centers showed that 86% used immunoassays for cyclosporin A (CsA). In consensus documents the following performance criteria were recommended: (a) imprecision < or = 10% at 50 microg/L and < or = 5% at 300 microg/L; and (b) comparison with the reference method (HPLC) should yield a slope of 0.9-1.1, an intercept of -15 to 15 microg/L, and S(y/x) < or = 15 microg/L. The newly developed CsA assays for the AxSYM (Abbott) and the CEDIA (Boehringer Mannheim) as well as the Emit assay (Behring Diagnostica) were evaluated. Results from samples of heart, kidney, and liver recipients (100 specimens each) were compared with a validated HPLC-ultraviolet detection method. Between-series imprecision (CV) with commercial controls was 5.8% and 1.7% for AxSYM (70 and 300 microg/L), 11% and 5.5% for CEDIA (90 and 200 microg/L), and 8.1% and 4.5% for Emit (63 and 172 microg/L). In the presence of 300 microg/L parent CsA, cross-reactivities were (for AxSYM, CEDIA, and Emit, respectively) 7%, 4%, and none for AM1 (1 mg/L) and 12.6%, 25%, and 6% for AM9 (0.5 mg/L). Comparison with HPLC showed in heart and kidney recipients an average overestimation with the Emit and the CEDIA of approximately 22%, with overestimation in the AxSYM of 32%. In liver recipients, the most challenging patient group, the CEDIA and the AxSYM showed a mean overestimation of 43% and 47%, respectively, and the Emit differed by 31% compared with HPLC. None of the immunoassays fully satisfied the performance criteria recommended in the consensus documents. In terms of specificity, Emit ranks before CEDIA, which ranks before AxSYM. Regarding imprecision, the ranking is AxSYM < Emit < CEDIA. These limitations must be considered when using these assays for therapeutic drug monitoring of CsA in clinical transplantation.
在临床移植中，使用具有不同特异性的检测方法来监测环孢素。最近对35个中心的一项调查显示，86%的中心使用免疫分析法检测环孢素A（CsA）。在共识文件中，推荐了以下性能标准：（a）在50μg/L时不精密度≤10%，在300μg/L时不精密度≤5%；（b）与参考方法（HPLC）比较时，斜率应为0.9 - 1.1，截距为-15至15μg/L，且S(y/x)≤15μg/L。对新开发的用于AxSYM（雅培公司）、CEDIA（宝灵曼公司）的CsA检测方法以及Emit检测方法（贝林诊断公司）进行了评估。将心脏、肾脏和肝脏移植受者的样本（各100份）检测结果与经过验证的HPLC - 紫外检测方法进行比较。AxSYM（70和300μg/L）商业对照品的批间不精密度（CV）分别为5.8%和1.7%，CEDIA（90和200μg/L）为11%和5.5%，Emit（63和172μg/L）为8.1%和4.
