Study Highlights Performance of Abbott's ARCHITECT Tacrolimus Assay, Only Automated Transplant Monitoring Test that Meets International Standards for Low-Level Monitoring WASHINGTON, July 30
WASHINGTON, July 30 /PRNewswire-FirstCall/ -- The ability of blood tests
to precisely measure very low doses of anti-rejection drugs in kidney
transplant patients may make a significant difference in assuring long-term
viability and survival, according to research presented today at the American
Association for Clinical Chemistry (AACC) annual meeting.
The current thinking in transplant medicine favors reducing doses of
tacrolimus and other immune-suppressive drugs as much as possible after
kidney-transplant procedures. "Even though we are succeeding in preventing
organ rejection, we haven't made much progress to improve long-term survival,"
said Sudarshan Hebbar, M.D., senior medical director, Abbott Diagnostics.
"Unfortunately, most kidney transplant patients will go back on dialysis in
eight to ten years, in part because the anti-rejection drugs can be toxic to
the kidneys."
Dr. Hebbar added that kidney-transplant patients have high incidence of
heart attacks and other cardiovascular disorders from long-term effects of
renal disease. Therefore, minimizing drug toxicity over time is considered one
way to help improve long-term graft survival and preserve quality of life for
transplant patients.
To minimize long-term toxicity of transplant medications, physicians
frequently aim to taper down doses of immunosuppressive drugs to as low a
level as possible without risking rejection. "Successful low-dose regimens of
tacrolimus and other anti-rejection medications require highly precise,
ultra-sensitive drug-monitoring assays," said Daniel Levine, Ph.D., director
of the clinical laboratory, Iris and B. Gerald Cantor Clinical Research
Laboratory at The Rogosin Institute in New York City.
Dr. Levine emphasized the importance of using an accurate and precise test
to monitor patients on low-dose treatment regimens. "At low doses, even the
slightest variation in blood-level readings could be devastating to transplant
patients. The consequence for the laboratory is twofold: it must have
accurate, precise testing for immunosuppressive drugs, and tacrolimus tests
that are accurate to 4 ng/mL are no longer adequate," he explained.
Dr. Levine reported results of his studies evaluating the performance of
the Abbott ARCHITECT assay for tacrolimus, the most widely used
immunosuppressant drug. He said the usual dosing range for the medication is
between 2 and 15 ng/mL, with lower doses preferred. "The challenge for the
laboratory, therefore, is to assure with the utmost confidence to the
physician that a tacrolimus blood level of 3 ng/mL is exactly right and not
5," Levine said.
In the trials, the Abbott ARCHITECT tacrolimus assay was accurate and
precise at low levels and showed consistent results. "The functional
sensitivity in our hands was 0.9 ng/mL, exceeding the package insert claim of
2 ng/mL. We are fully confident the ARCHITECT tacrolimus assay meets our
requirement for low-level tacrolimus monitoring," Levine said.
"The ARCHITECT tacrolimus assay is the only automated transplant
monitoring test that meets international standards for low-level monitoring,"
according to Dr. Hebbar.
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.
About the ARCHITECT Family
With its extensive menu of diagnostic tests, user-friendly software and
advanced sample management capabilities, the ARCHITECT family and the
currently marketed flagship analyzer, ARCHITECT(R) ci8200(R), meet the needs
of today's diagnostics laboratory by enhancing workflow and productivity.
ARCHITECT instruments are designed with laboratory-focused features such as
the capability to prioritize emergency tests, the ability to use common
reagents among platforms and sample monitoring. These features not only
minimize training, but also reduce inventory costs and sample contamination
potential, leading to better results for laboratories, physicians and,
ultimately, patients.
About Abbott's Diagnostics Businesses
Abbott is a global leader in in vitro diagnostics and offers a broad range
of innovative instrument systems and tests for hospitals, reference labs,
molecular labs, blood banks, physician offices and clinics. With more than
65,000 institutional customers in more than 100 countries, Abbott's diagnostic
products offer customers automation, convenience, bedside testing, cost
effectiveness and flexibility. Abbott has helped transform the practice of
medical diagnosis from an art to a science through the company's commitment to
improving patient care and lowering costs. Abbott's history is filled with
examples of first-of-a-kind diagnostic products and significant technological
and research advancements.
About Abbott
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The company
employs more than 68,000 people and markets its products in more than 130
countries.
SOURCE Abbott
