Waters Corporation MassTrak Immunosuppressant Kit to monitor the tacrolimus levels in kidney and liver transplant patients has been cleared by US Food and Drug Administration (FDA).
The kit comprises a complete validated solution for transplant centres to perform tacrolimus therapeutic drug monitoring. The kit, is specifically designed to quantify the immunosuppressant tacrolimus in kidney and liver transplant patients by LC/MS/MS.
The MassTrak kit combines quality controls, calibrators, an internal standard and HPLC column together with methodology that assures rapid, reliable, consistent and reproducible tacrolimus measurements. The kit introduction is a continuing demonstration of Waters commitment to solve a variety of challenges in the clinical laboratory.
"At Waters, we understand and recognize that for customers to realize the benefits of LC/MS/MS based assays, we needed to provide validated robust methodologies with FDA cleared kits," said Michael Yelle, senior director of clinical operations of the Waters division. The kit can help make a difference in the clinical laboratory by providing turnkey methods that have demonstrated reliability, reproducibility, accuracy and precision backed by the Waters clinical service team, he added.
For transplant patients, Therapeutic Drug Monitoring (TDM) is required to manage immunosuppressant therapy by determining the optimum dose for the individual patient. LC/MS/MS is widely used today for these measurements but there have been no FDA cleared methodologies with appropriate calibrators and controls to enable labs to routinely generate high quality reproducible data. This kit will enable broader adoption of LC/MS/MS by clinical labs by ensuring the that labs can confidently perform the assays and generate reliable data.
The MassTrack Immunosuppressant Kit is currently available in Europe, and will be available in the US later this year. Waters also has a variety of products currently under development that will continue to help make a difference in the clinical laboratory.