Abbott’s ARCHITECT Aids Long-Term Transplant Success

A new study published in the journal Clinical Chemistry has reported that Abbott’s ARCHITECT® Tacrolimus assay is an accurate and consistent way of monitoring medication for patients taking tacrolimus, an immunosuppressive medication, after receiving solid organ transplantation.

Tacrolimus is often used in transplant patients to prevent organ rejection. In order for the organ to survive, the patients medication level must be monitored accurately and precisely to ensure that it is sufficient to prevent organ rejection, and to help the organ remain functional.

Methods used to monitor tacrolimus concentration in the blood are not standardized and this can lead to varying results for patients. Underestimating tacrolimus levels could result in prescribing unnecessarily high doses of medication that could be toxic to the transplanted organ over time. Overestimating levels could lead to insufficient dosing, poor immunosuppression and subsequent organ rejection.

The ARCHITECT Tacrolimus assay is used for the quantitative determination of tacrolimus in human whole blood, as an aid in managing liver and kidney transplant patients receiving tacrolimus therapy. It is the only automated transplant monitoring test that meets published international guidelines for low-level monitoring. It is accurate and precise at low levels and shows consistent results between laboratories.

"Kidney-transplant patients have a high incidence of cardiovascular complications which may be exacerbated by the long-term effects of taking calcineurin inhibitors," said Gregory Maine, Ph.D., co-author and associate research fellow, Diagnostics, Abbott. "The ARCHITECT Tacrolimus assay addresses an unmet clinical need for consistent site-to-site patient results by providing uniform instrumentation, test kits, calibrators and controls across the world."

The global tacrolimus proficiency study compared the performance of the Abbott ARCHITECT Tacrolimus assay with a candidate reference method exact-matching isotope-dilution mass spectrometry (EM-IDMS), laboratory developed LC-MS (liquid chromatography tandem mass spectrometry) assays and another commercially available immunoassay. Panels of whole blood samples containing patient specimens and spiked samples with tacrolimus concentrations ranging from 0-30 microgram/L were tested at 22 laboratories in 14 countries.

The study showed tacrolimus values were not comparable between laboratories and across methods, but the ARCHITECT assay was close to the target values and comparable from lab to lab. Today, the ARCHITECT Tacrolimus assay is used by 10 of the 19 U.S. hospitals recently named as the nation's top organ transplant centers by HealthGrades, the leading independent health care ratings company.