Waters’ MassTrak Immunosuppressants XE kit is now CE-marked in accordance with the IVD Directive 98/79/EC. The kit is used for the quantitative measurement of the immunosuppressive drugs. While Tacrolimus (FK506;Prograf) is for liver and kidney transplant patients,  Everolimus (Certican) is prescribed for adult kidney and cardiac transplant patients from human whole blood samples as an aid in the management of immunosuppressant drug therapy.

Waters LC/MS/MS system consists of the MassTrak Immunosuppressants XE Kit and method. The Waters Acquity UPLC UltraPerformance Liquid Chromatography system coupled to an Acquity TQD tandem quadrupole mass spectrometer, offers enhanced sensitivity and specificity, and measures target compounds at low ng/mL levels (0.5 ng/mL).

“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.

With 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. Waters' 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.

According to a report released by Kalorama Information, approximately 70,000 organ transplant surgeries are performed worldwide each year with most patients requiring lifelong immunosuppressant therapy to prevent rejection. Today, tacrolimus, in combination with mycophenolate mofetil (MMF) is the standard of care for organ transplantation.

Immunosuppressant drugs help to prevent organ rejection by suppressing the immune system of patients with donor kidneys, livers, hearts, and other organs. Treating transplant patients requires skill on the part of the surgeons and the transplant team and compliance on the part of the patient. Transplant recipients must take these drugs for life and are closely monitored for side-effects and toxicity. Every transplant patient is unique and many factors influence the rate at which these drugs are absorbed, metabolized, utilized, and eliminated. Other influencing factors are the patient’s age, genetic background, general state of health and other drugs they may be taking.

Monitoring immunosuppressant drug concentrations is crucial for successful patient outcomes. If the concentration level of the immunosuppressant is too low, the patient is at risk of organ rejection. If the level in the bloodstream is too high, then toxicity can occur. Other conditions such as pregnancies, temporary illnesses, emotional and physical stressors, accidents, and surgeries all play a role in how patient levels of the immunosuppressants are managed over time. As such, regular monitoring of patients becomes vital to their health and well-being over time. Regular monitoring also assures patient compliance.

With advances in analytical techniques, LC/MS/MS is now a well-established technology for immunosuppressant drug monitoring. Since 1990, internationally-convened consensus groups have called for the use of analytical procedures for Therapeutic Drug Monitoring (TDM) that are specific for the active parent compound.

The Waters MassTrak Immunosuppressants XE Solution is specific for the parent drugs tacrolimus and everolimus and measures concentrations of the parent drugs independent of the level of known metabolites in patient samples. Other benefits include increased sensitivity and precision at the low end of the dosing range, and the potential to lower consumable and operating costs relative to established immunoassay methods.