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.
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