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Abbott Prism Chagas Blood Test Receives BLA Approval

Abbott's Prism Chagas test has received biologic license application (BLA) approval from the FDA. The Abbott Prism Chagas assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to Trypanosoma cruzi (T cruzi), the causative agent of Chagas disease in human serum and plasma specimens.

Abbott said that the latest approval for the Prism analyzer marks the completion of its full menu of blood screening tests, which includes assays for hepatitis, HIV and other retroviruses. Recently, the Abbott Prism HIV O Plus test was added to the analyzer’s menu of available assays.

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 acquired through contact with the blood-sucking triatomine or ‘kissing bug.’

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.

The assay has not been validated for use with plasmapheresis specimens, amniotic fluid, cerebrospinal fluid, pleural fluid or pooled specimens. The product contains human sourced and/or potentially infectious components.

Abbott said that the 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.

John Coulter, divisional vice president of US commercial operations at Abbott Diagnostics, said: “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.”