Abbott received Biologic License Application (BLA) approval from the FDA for the ABBOTT PRISM Chagas test.
The test is a fully automated blood screening assay that can detect antibodies to Trypansoma cruzi (T. cruzi), a parasite found only in the Americas and most commonly acquired through contact with the blood-sucking triatomine or "kissing bug."
According to the Centers for Disease Control and Prevention, an estimated eight to 11 million people are infected worldwide with Chagas disease and an additional 108.6 million people are considered to be at risk. If left undiagnosed and untreated, Chagas disease can result in death.
In 2007, national screening of the blood supply for the disease was instituted. The FDA reports that in the last three years more than 1,000 donors with Chagas disease were identified.
This latest approval for the ABBOTT PRISM analyzer marks the completion of Abbott’s full menu of blood screening tests, which includes assays for hepatitis, HIV and other retroviruses. Most recently, the ABBOTT PRISM HIV O Plus test was added to the analyzer’s menu of available assays. ABBOTT PRISM systems can screen 160 blood donations per hour, making it possible to test more than 1,200 donations in an eight-hour laboratory shift. Speed and efficiency are important to labs, given that the Department of Health and Human Services reports that more than 16 million units of blood are collected in the United States each year. Used by more than 30 countries, the ABBOTT PRISM system is used to screen the majority of the blood supply in the United States and around the world.
"The approval of the ABBOTT PRISM Chagas test marks the availability of an important automated tool to ensure the continued safety of our blood supply, and it also offers our customers the ability to conduct all their serology testing on one system to increase the productivity and efficiency of their labs," said John Coulter, divisional vice president, U.S. commercial operations, Abbott Diagnostics.
The ABBOTT PRISM Chagas assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components and other living donors, for the presence of antibodies to T. cruzi. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (non–heart-beating) donors. It is not intended for use on cord blood specimens or for the laboratory diagnosis of Chagas infection. This assay has not been validated for use with plasmapheresis specimens, amniotic fluid, cerebrospinal fluid, pleural fluid or pooled specimens. This product contains human sourced and/or potentially infectious components.