Abbott’s Architect tacrolimus assay meets international standards

Research presented at the annual meeting of the American Association for Clinical Chemistry (AACC) has suggested having blood tests which can precisely measure low doses of anti-rejection drugs in patients who have had kidney transplants may help assure long-term viability and survival.

Abbott’s Architect tacrolimus assay is used to measure tracrolimus in human whole blood in order to assist in managing kidney and liver transplant patients receiving tacrolimus therapy.

Daniel Levine, director of the Iris and B Gerald Cantor Clinical Research Laboratory at the Rogosin Institute in New York, said effective low-dose regimens of tacrolimus require ultra-sensitive drug-monitoring assays.

Reporting the results of his studies, which looked at the performance of Abbott’s Architect assay for tacrolimus, Dr Levine said the assay was accurate and precise at low levels.

He stated the functional sensitivity was 0.9 ng/mL, which exceeded the package insert claim of two ng/mL.

Sudarshan Hebbar, senior medical director at Abbott Diagnostics said: “The Architect tacrolimus assay is the only automated monitoring test that meets international standards for low-level monitoring.”

Earlier this week, Abbott announced it will submit registration applications for a tablet formulation of its HIV drug Norvir (ritonavir) and request priority review by EU and US authorities before the end of the year.