Assay Monitors Immunosuppressant Drug Everolimus Level in Blood

A new assay monitors blood levels of everolimus, an immunosuppressant drug that helps prevent rejection in kidney transplant patients.

The QMS everolimus assay is a homogeneous, particle-enhanced turbidimetric immunoassay in which everolimus in the sample competes with everolimus-coated microparticles for antibody-binding sites of the everolimus antibody reagent. In the absence of competing drug in the sample, the everolimus-coated microparticle reagent is agglutinated rapidly in the presence of anti-everolimus antibody reagent. The rate of absorption change is measured photometrically.

The QMS Everolimus reagent kit completes Thermo Fisher Scientific's (Palm Springs, CA, USA) array of immunosuppressant immunoassays that includes cyclosporine, tacrolimus, and mycophenolic acid. It was the first to receive US Food and Drug Administration (FDA; Silver Spring, MD, USA) clearance for monitoring the appropriate blood levels of everolimus.

The ready-to-use liquid QMS Everolimus assay is used as part of therapeutic drug monitoring, an integral part in organ transplant-recipient treatment programs. The QMS Everolimus assay is used on automated clinical chemistry analyzers for quantitative determination of everolimus in human whole blood, the active ingredient in the immunosuppressant drug Zortress.

QMS Everolimus calibrator and control sets are also available for use with the QMS Everolimus Assay. The calibrator kit contains six different calibrators to complete a full six-point calibration, as part of the test procedure; and the QMS Everolimus control set contains three levels.

Thermo Fisher Scientific launched the products during the Clinical Lab Expo at AACC 2011, which took place from July 26–28, 2011 at the Georgia World Congress Center, Atlanta (USA).

Transplant physicians working with clinical laboratories must carefully manage dosages of immunosuppressant drugs to avoid organ rejection or toxicity issues caused by excessive levels of a drug or a potentially lethal combination.

Related Links:
Thermo Fisher Scientific
US Food and Drug Administration