Dasgupta Amitava, Khalil Samir A
Department 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
Department 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.
Ann Clin Lab Sci. 2019 Mar;49(2):271-273.
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.
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).
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).
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.
