A fully automated blood-screening assay called the PRISM Chagas test, developed by Abbott, has received biologic license application (BLA) approval from the US Food and Drug Administration (FDA).
The PRISM Chagas test, an in-vitro chemiluminescent immunoassay, can detect antibodies to Trypansoma cruzi (T. cruzi), a parasite only found in the Americas and most commonly acquired through contact with the blood-sucking triatomine or “kissing bug”.
The Chagas assay screens individual human donors for T. cruzi antibodies. It 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.
Abbott PRISM systems can examine more than 1,200 donations in an eight-hour laboratory shift.
The system is currently used by more than 30 countries to screen the majority of the blood supply in the US and around the world.
The system is not used on cord blood specimens for the laboratory diagnosis of Chagas infection and has not been authorised for use with plasmapheresis specimens, amniotic fluid, cerebrospinal fluid, pleural fluid or pooled specimens.