Immunetics has received FDA clearance for its BacTx rapid test for bacteria in apheresis platelets. The BacTx system is a colorimetric assay that can detect aerobic, anaerobic, gram-negative, and gram-positive bacteria in a single test.
The BacTx assay uses a patented, specific, universal bacterial detection reagent that has been shown to detect wild and cultured bacterial strains. BacTx is intended for use as a point-of-issue test performed at the transfusion site on the day of issue.
The BacTx assay can be used for QC testing of leukocyte-reduced apheresis platelets within 24 hours of transfusion, after testing with an FDA-cleared growth-based bacterial detection device, and for pools of up to six units of leukocyte-reduced, whole-blood–derived platelets that are pooled within four hours of transfusion.