How Improved Selectivity in Immunosuppressant Analysis Can Help Organ Transplant Patients

According to the organ procurement and transplantation network, there are currently more than 106,000 people on the waiting list for an organ. On average, patients can wait six to 10 years for an organ match. During this period, one’s physical condition and psychological well-being can continue to deteriorate. When the call comes in with the discovery of a matching organ – relief, joy, and hope ensue.

However, at the very onset of the preparation for transplant, the medical team must warn the patients of the high possibility of graft rejection. In fact, according to a University of California San Francisco Department of Surgery study, “rejection is an expected side effect of transplantation and up to 30% of people who receive a kidney transplant will experience some degree of rejection.” The immunosuppressant drugs that are administered must be tightly controlled to ensure quality of life while minimizing this risk of rejection.

The Vital Role of the Diagnostic Laboratory

The laboratory has a great responsibility in providing accurate and timely test results to patients. Using Waters systems (sets and kits), labs can specifically measure the levels of one (or more) of the anti-rejection immunosuppressant drugs. Maintaining these drugs within the patient’s therapeutic window helps to ensure the recipients immune system doesn’t reject the organ and greatly minimizes the risk of toxic side-effects associated with drug levels that are too high.

In the early 2000’s, many improvements to immunosuppressant test reagents came to the market. Biopharmaceutical companies worked to create diagnostics with better accuracy, greater sensitivity, and minimal sample preparation; however, they commonly still struggled with an issue of cross reactivity. Studies such as Standardization of LC-MS for Therapeutic Drug Monitoring of Tacrolimus, showed that accuracy could be hindered by metabolites of immunosuppressant medications, antibodies against these medications and heterophilic antibodies.

To reduce these unwanted results, many diagnostic laboratories turned to the standard liquid chromatography-mass spectrometry (LC-MS/MS) due to its powerful specificity. LC-MS/MS process enables the medical teams to obtain more accurate results within these narrow therapeutic windows allowing physicians to adjust the patient’s medication in hopes to reduce the risk of graft rejection.

Standardizing the Standard

As LC-MS/MS grows in its utilization globally there is still a need for standardization of the methods.

The Waters MassTrak Immunosuppressant Calibrator, Control, and Internal Standard Sets, soon available, are developed to help laboratories utilize LC-MS/MS with confidence in their assay results providing them with:

• Compliance to ISO 15189 with metrological traceability
• Lot to lot consistency with certified reagents
• Prolonged shelf-life with lyophilized reagents
• Time saved to prepare in-house developed calibrators and controls

In the end, the most important consideration in immunosuppressant drug monitoring is about improving the quality of life for transplant patients. With our new sets, Waters continues to empower new scientific breakthroughs to help solve problems that matter.

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Additional Resources:

Waters IVD Diagnostics Regulation

Expand Your Clinical Capabilities – Infographic

Blog: Uncovering the Why of Breast Cancer with LC-MS Solutions

References:

Standardization of LC-MS for Therapeutic Drug Monitoring of Tacrolimus Thomas M. Annesley, Denise A. McKeown, David W. Holt,2 Christopher Mussell, Elodie Champarnaud, Leonie Harter, Lisa Calton and Donald S. Mason5