MSACL 2019 EU Abstract

Performance of the Cascadion SM Immunosuppressants Panel on the Cascadion SM Clinical Analyzer

Mari Kiviluoma (1), Marta Kozak (2), Pekka Östman (1), Sirkku Jäntti (1), Tore Gulbrandsen (1), Mia Halme (1), Laura Heiskanen (1)
(1) Thermo Fisher Scientific, Ratastie 2 A, 01650 Vantaa, Finland; (2) Thermo Fisher Scientific, 46500 Kato Rd., Fremont, CA 94538, USA

Warning: Undefined variable $headshot in /var/www/html/view_abstract/view_abstract_in_program.php on line 704

Mari Kiviluoma (Presenter) Thermo Fisher Scientific Oy

Relevant Financial Disclosures (within past 24 months) Salary Thermo Fisher Scientific Conflict mitigation NOT REQUIRED.

INTRODUCTION
Sustained immunosuppressive therapy is an essential component for long-term outcome after allografic organ and tissue transplantation. As therapeutic indices of all immunosuppressant drugs (ISDs) are narrow and all substances are subject to significant transversal and longitudinal fluctuations in pharmacokinetics, therapeutic drug monitoring (TDM) is mandatory. Today the quantification of ISDs using LC-MS/MS is the widely-accepted reference method in clinical TDM.

OBJECTIVES
The ISD assay* for Thermo Scientific™ Cascadion™ SM Clinical Analyzer** for the quantification of tacrolimus, sirolimus, everolimus and cyclosporin in whole blood is described in technical detail and data on the analytical performance are presented.

RESULTS
Lower limit of quantification (LLoQ) for Tacrolimus, Sirolimus and Everolimus is 1.0 ng/mL and upper limit of quantification (ULoQ) 30 ng/mL. For Cyclosporine A LLoQ is 10 ng/mL and ULoQ is 800 ng/mL. Linearity (R) of the method for Tacrolimus is 0.999, Sirolimus 0.997, Everolimus 0.999 and Cyclosporine A 1.000. Tacrolimus repeatability varies between 2.8% and 3.4%, Sirolimus between 2.8% and 6.6%, Everolimus between 5.0% and 6.0%, and Cyclosporine between 1.4% and 2.3%. Accuracy of Tacrolimus varies between –9.5% and -5.4%, Sirolimus between -9.3% and -3.2%, Everolimus between 1.7% and 3.5%, and Cyclosporine between -17.7% and -7.7%.

CONCLUSION
The ISD assay for CascadionTM Clinical analyzer provides analytical results from whole blood patient samples without off-line sample pretreatment fulfilling all guideline specifications and proficiency testing requirements.

* ISD assay for Cascadion SM Clinical Analyzer is in development. Product is not IVD/CE marked or 510(k) cleared, and is not available for sale.
** Cascadion SM Clinical Analyzer is IVD/CE marked but not 510(k)-cleared and not yet available for sale in the U.S. Availability of product in each country depends on local regulatory marketing authorization status.