目的 评估肝、肾移植患者全血西罗莫司药物浓度在罗氏cobas e411检测平台上的分析性能。方法 选取2022-01至2022-10来解放军总医院第三医学中心就诊的100例器官移植患者作为研究对象,其中实施肝移植者和肾移植者分别为47例和53例。在罗氏 cobas e411检测平台上评价西罗莫司的分析性能,包括批内精密度、批间精密度和正确度。同时,利用临床肝、肾移植者全血标本,评价西罗莫司在罗氏cobas e411和雅培ARCHITECT i1000sr平台上的可比性,并做相关性分析。结果 三水平质控物的批内精密度分别为1.45%、1.25%和1.09%,批间精密度分别为4.18%、2.08%和2.36%,均低于厂家声称的精密度要求。正确度样本浓度水平从5 ng/ml至30 ng/ml均处于允许范围之内。100例器官移植者西罗莫司血药浓度在罗氏cobas e411和雅培ARCHITECT i1000sr两分析系统上的结果呈显著正相关,相关系数(R2)为0.9072。随后,分别在肝移植和肾移植患者中,两分析系统间西罗莫司结果也呈正相关,R2分别为0.9322和0.83。结论 西罗莫司在罗氏cobas e411检测平台上具有优秀的分析性能,在面向肝或肾移植患者的临床样本检测时,西罗莫司在罗氏和雅培两个主流检测平台间均表现出了良好的可比性。
Abstract
Objective To evaluate the performance of whole blood Sirolimus concentration analysis on Roche Cobas E411 detection platform in liver and kidney transplant patients. Methods A total of 100 patients with organ transplantation who came to the Third Medical Center of Chinese PLA General Hospital from January 2022 to October 2022 were selected as research objects. Among them, 47 patients underwent liver transplantation and 53 patients underwent kidney transplantation. The analytical performance of Sirolimus was evaluated on Roche cobas e411, including in-batch precision, inter-batch precision and accuracy. Meanwhile, the comparability of sirolimus on the Roche cobas e411 and Abbott architect i1000sr platforms was evaluated by using the whole blood samples of clinical liver and kidney transplanters, and correlation analysis was performed. Results The intra-lot precision of the three levels of quality control materials were 1.45%, 1.25% and 1.09%, and the inter-lot precision were 4.18%, 2.08% and 2.36%, respectively, which were lower than the precision requirements claimed by the manufacturer. Accuracy sample concentration levels from 5 ng/ml to 30 ng/ml were within the permissible range. There was a significant positive correlation between sirolimus concentration in 100 transplant subjects by Roche cobas e411 and Abbott architect i1000sr, and the correlation coefficient (R2) was 0.9072. Subsequently, sirolimus results were also positively correlated between the two analysis systems in liver and kidney transplant patients, with R2 of 0.9322 and 0.83, respectively. Conclusions Sirolimus is characterized by excellent analytical performance on cobas e411 chemiluminescence analysis platform, and good comparability of Sirolimus between Roche and Abbott in the detection of clinical samples for liver and kidney transplantation patients, which lays a foundation for the early analysis of Sirolimus in the mutual recognition of results between laboratories.
关键词
西罗莫司 /
雷帕霉素 /
化学发光分析平台 /
分析性能评价
Key words
Sirolimus /
Rapamycin /
chemiluminescence analysis platform /
analytical performance evaluation
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