Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples

Cascadion™ SM Immunosuppressants Panel, Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples

This is a prospective, observational evaluation study to assess the stability of the analytes tacrolimus, cyclosporine A, everolimus and sirolimus measured with Cascadion™ SM Immunosuppressants Panel. Study is pre-market evaluation for the regions where Cascadion™ SM Immunosuppressants Panel is not on the market yet and post-market evaluation where it is.

To assess the stability of tacrolimus, cyclosporine A, everolimus and sirolimus in patient whole blood samples after they are collected, processed and subjected to various storage conditions or freeze-thaw cycles that represent common sample handling conditions in the commercial clinical laboratory setting.

Study subjects will undergo one venous sample collection where 30 mL of blood is drawn.

Inclusion Criteria:

1. Age ≥18 years

2. Ability to sign informed consent form

3. At least one of the following

   1. Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A
   2. Kidney or liver transplant patient using everolimus
   3. Kidney transplant patient using sirolimus

Exclusion Criteria:

1. Inability to provide informed consent
2. Pregnancy or breastfeeding
3. Likely to believe that the sample collection procedure will pose an unusually high risk for subject's physical or mental health or their comfort