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Performance Evaluation of the ARCHITECT i2000 for the Determination of Whole Blood Cyclosporin A and Tacrolimus
J Lab Med Qual Assur 2019;41:117-119
Published online June 30, 2019
© 2019 Korean Association of External Quality Assessment Service.

Misun Lim and Yong-Wha Lee

Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
Correspondence to: Yong-Wha Lee, Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, 170 Jomaruro, Wonmi-gu, Bucheon 14584, Korea, Tel: +82-32-621-5943 Fax: +82-32-621-5944 E-mail: lywmd@daum.net
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
 Abstract
Maintaining immunosuppressant concentrations within the therapeutic range in organ recipients requires regular monitoring. The blood concentrations of immunosuppressants are routinely measured using one of several automated immunoassays, such as chemiluminescence immunoassays (CLIAs) and liquid chromatography-tandem mass spectrometry (LC-TMS). The ARCHITECT i2000 immunoassay analyzer (Abbott Diagnostics, USA) was developed as an automated CLIA analyzer for the measurement of cyclosporin A and tacrolimus in whole blood. Here, the precision and linearity of the ARCHITECT i2000 analyzer for the detection of cyclosporin A and tacrolimus in whole blood were evaluated according to Clinical and Laboratory Standards Institute guidelines and were compared with those of an LC-TMS detection method. The total coefficient of variation for the two drugs was less than 10%, and they showed linearity values of 0.97 or more, which was within the manufacturer셲 range. The measurements of both immunosuppressants by the ARCHITECT i2000 were closely correlated with measurements determined by LC-TMS. However, most measurements were lower with LC-TMS than with the ARCHITECT i2000. Measurement of cyclosporin A and tacrolimus in whole blood using the ARCHITECT i2000 showed very satisfactory performance in terms of precision and linearity as well as good correlation with the comparative method.