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首页> 外文期刊>Clinical Biochemistry >Comparison of cyclosporine concentrations in renal transplant recipients using ACMIA and mFPIA methods.
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Comparison of cyclosporine concentrations in renal transplant recipients using ACMIA and mFPIA methods.

机译：使用ACMIA和mFPIA方法比较肾移植受者中环孢素的浓度。

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OBJECTIVE:: This study investigated the performance and data comparability of a new, relatively specific immunoassay method, affinity column mediated immunoassay (ACMIA) run on the Dimension Xpand-HM, and the established less specific monoclonal fluorescence polarization immunoassay (mFPIA) method on the TDx analyzer (mFPIA/TDx) in determining cyclosporine (CsA) concentrations. METHODS:: Accuracy and within and between-run precision were tested. Then we measured CsA concentrations of 216 samples obtained from 51 patients and divided the 113 samples from 21 patients with renal transplants into two groups based on sampling time. RESULTS:: Accuracy relative to the four weighed-in concentrations ranged from 99% to 104% and from 106% to 117% for ACMIA and mFPIA/TDx, respectively. The mean within-run precision (CV%) for the ACMIA and mFPIA/TDx methods was 4.31% and 2.57%, respectively. The mean recovery for ACMIA and mFPIA/TDx in the between-run study was 104.50% and 111.12%, respectively. The mFPIA/ACMIA ratio (the ratio of the concentration measured by mFPIA/TDx to that measured by ACMIA) of C2-3 (concentrations measured 2-3 h after oral administration) was 118.85%, which was significantly smaller than that (139.12%) of C8-12 (those measured more than 8 h after the administration) at each mean concentration. CONCLUSIONS:: These results indicate that ACMIA is more accurate than mFPIA/TDx, and the difference in the mFPIA/ACMIA ratio between C2-3 and C8-12 was due to the difference in the relative cross-reactivity with CsA metabolites. Although mFPIA/TDx had an apparent calibration error, both methods had a clinically acceptable within and between-run precision.
机译：目的：本研究调查了一种新的，相对特异性的免疫测定方法的性能和数据可比性，亲和柱介导的免疫测定（ACMIA）在Dimension Xpand-HM上运行，而建立的特异性较低的单克隆荧光偏振免疫测定（mFPIA）方法在TDx分析仪（mFPIA / TDx）用于测定环孢霉素（CsA）浓度。方法：检验了准确性，批内和批间精度。然后，我们测量了51例患者的216份样品的CsA浓度，并根据采样时间将21例肾移植的113例样品分为两组。结果：ACMIA和mFPIA / TDx相对于四个称量浓度的准确度分别为99％至104％和106％至117％。 ACMIA和mFPIA / TDx方法的平均批内精密度（CV％）分别为4.31％和2.57％。运行间研究中ACMIA和mFPIA / TDx的平均回收率分别为104.50％和111.12％。 C2-3的mFPIA / ACMIA比（通过mFPIA / TDx测量的浓度与通过ACMIA测量的浓度之比）（口服后2-3小时测量的浓度）为118.85％，明显小于（139.12％ C8-12（在给药后超过8小时测量的）的平均浓度。结论：这些结果表明ACMIA比mFPIA / TDx更准确，并且C2-3和C8-12之间的mFPIA / ACMIA比值的差异是由于与CsA代谢物的相对交叉反应性的差异。尽管mFPIA / TDx具有明显的校准误差，但两种方法在运行内和运行间精度之间均具有临床可接受的水平。

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