Ann Lab Med 2018; 38(2): 85-94
Multi-center Performance Evaluations of Tacrolimus and Cyclosporine Electrochemiluminescence Immunoassays in the Asia-Pacific Region
Xuzhen Qin, M.D.1,*, Jianzhong Rui, Ph.D.2,*, Yong Xia, Ph.D.3, Hong Mu, M.S.c.4, Sang Hoon Song, M.D.5, Raja Elina Raja Aziddin, Ph.D.6, Gabrielle Miles, M.S.c.7, Yuli Sun, M.D.8, and Sail Chun, M.D.9
Peking Union Medical College Hospital1, Beijing, China; Department of Pharmacology2, Jinling Hospital, Medical School of Nanjing University, Nanjing, China; The Third Affiliated Hospital of Guangzhou Medical University3, Guangzhou, China; Tianjin First Center Hospital4, Tianjin, China; Department of Laboratory Medicine5, Seoul National University College of Medicine, Seoul, Korea; Department of Pathology6, Hospital Kuala Lumpur Drug and Research Laboratory, Kuala Lumpur, Malaysia; Roche Diagnostics7, Indianapolis, USA; Roche Diagnostics8, Penzberg, Germany; Department of Laboratory Medicine9, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Corresponding author: Sail Chun
Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic 43-gil, Songpa-gu, Seoul 05505, Korea
Tel: +82-2-3010-4513
Fax: +82-2-478-0884
*These authors contributed equally to this work.
Received: February 6, 2017; Revised: June 23, 2017; Accepted: September 29, 2017; Published online: March 1, 2018.
© Korean Society for Laboratory Medicine. All rights reserved.

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Background: The immunosuppressant drugs (ISDs), tacrolimus and cyclosporine, are vital for solid organ transplant patients to prevent rejection. However, toxicity is a concern, and absorption is highly variable across patients; therefore, ISD levels need to be precisely monitored. In the Asia-Pacific (APAC) region, tacrolimus and cyclosporine concentrations are typically measured using immunoassays. The objective of this study was to assess the analytical performance of Roche Elecsystacrolimus and cyclosporinee electrochemiluminescence immunoassays (ECLIAs).
Methods: This evaluation was performed in seven centers across China, South Korea, and Malaysia. Imprecision (repeatability and reproducibility), assay accuracy, and lot-to-lot reagent variability were tested. The Elecsys ECLIAs were compared with commercially available immunoassays (Architect, Dimension, and Viva-E systems) using whole blood samples from patients with various transplant types (kidney, liver, heart, and bone marrow).
Results: Coefficients of variation for repeatability and reproducibility were ≤5.4% and ≤12.4%, respectively, for the tacrolimus ECLIA, and ≤5.1% and ≤7.3%, respectively, for the cyclosporine ECLIA. Method comparisons of the tacrolimus ECLIA with Architect, Dimension, and Viva-E systems yielded slope values of 1.01, 1.14, and 0.897, respectively. The cyclosporine ECLIA showed even closer agreements with the Architect, Dimension, and Viva-E systems (slope values of 1.04, 1.04, and 1.09, respectively). No major differences were observed among the different transplant types.
Conclusions: The tacrolimus and cyclosporine ECLIAs demonstrated excellent precision and close agreement with other immunoassays tested. These results show that both assays are suitable for ISD monitoring in an APAC population across a range of different transplant types.
Keywords: Cyclosporine, Tacrolimus, Immunosuppressant drugs, Immunoassay, Therapeutic drug monitoring, Asia-Pacific

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