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

Thermo Fisher Scientific Oy46 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Transplantation Drugs Stability

Interventions

Blood samplingPROCEDURE

Blood sampling from all eligible transplantation patients according to the protocol

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Acceptance criteria for claiming the patient samples storage stability

Stability of cyclosporine A, tacrolimus, everolimus and sirolimus in patient whole blood samples will be tested at +15-25°C up to 4 days, at +2-8°C up to 15 days and at -20±5°C up to 31 days. Relative bias at each time point to T0 baseline is calculated for each patient sample separately. The grand average relative bias across all samples, and the associated 95% confidence interval, must be within -15% and +15%.

Time frame: 5 months