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Updated: Jan 25, 2026

Electrochemiluminescence Assays for Human Islet Autoantibodies
Published on: March 23, 2018
Technical Note: Analytical Performance Evaluation of Electrochemiluminescence Cyclosporine Assay on Cobas e411
Amitava Dasgupta1, Samir A Khalil2
1Department of Pathology and Laboratory Medicine, University of Texas McGovern Medical School at Houston and Laboratory Services, Memorial-Hermann Hospital at Texas Medical Center, Houston, TX, USA Amitava.Dasgupta@uth.tmc.edu.
Background:
Roche Diagnostics has developed electrochemiluminescence cyclosporine assay for application on multiple platforms including Cobas e 411 analyzer. This assay is not yet approved by the FDA for clinical application. We evaluated analytic performance of this new assay.
Methods:
Within run, between run and linearity of this new assay were evaluated. In addition, cyclosporine values in 100 specimens obtained by using this new method were compared with values obtained by using the CMIA assay (Abbott Laboratories).
Results:
New electrochemiluminescence cyclosporine assay showed excellent precision and accuracy. Comparing cyclosporine values obtained by using the CMIA tacrolimus assay (x-axis) with corresponding values obtained by using the Cobas tacrolimus assay (y-axis), the following regression equation was observed: y=0.9446x-2.018 (n=100, r=0.99).
Conclusion:
The new electrochemiluminescence cyclosporine assay is comparable to the FDA approved CMIA tacrolimus assay. Therefore, when this assay is approved by the FDA, it can be used for therapeutic drug monitoring of cyclosporine.
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