XE kit gets CE mark

August 8, 2011

The MassTrak immunosuppressants XE kit from Waters has obtained its CE mark in accordance with the IVD Directive 98/79/EC.

The MassTrak immunosuppressants XE kit from Waters has obtained its CE mark in accordance with the IVD Directive 98/79/EC. When used with the company’s LC–MS–MS system, the kit provides quantitative measurement of the immunosuppressive drugs tacrolimus in liver and kidney transplant patients and everolimus in adult kidney and cardiac transplant patients from human whole blood samples.

"LC–MS plays an increasingly important role in many clinical laboratories today. Waters is committed to advancing technology-based diagnostic solutions in the clinical laboratory that impact the quality of results in many areas including immunosuppressant drug monitoring", said Mark Bruns, senior director, Clinical Business Operations, Waters Division.

The company reports that with the instrumentation and kit, clinical laboratories in the European Economic Area and Switzerland will no longer have to spend time and money to develop and validate in house LC–MS–MS methods for tacrolimus or everolimus, or source calibrators, QCs and internal standards.

The company’s clinical specialists will support the system and methodology. The instrumentation and kit is currently only available for sale in the European Economic Area and Switzerland.

For more information on the products visit www.waters.com