Immunetics Inc, Boston, 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 combines high sensitivity with simple, easy workflow integration. It uses s a patented, highly specific, universal bacterial detection reagent that has been shown to detect wild and cultured bacterial strains. It is intended for use as a point-of-issue test performed at the transfusion site on the day of issue.
The assay can be used for quality control testing of:
- Leukocyte-reduced apheresis platelets (LRAP) within 24 hours of transfusion, following testing with an FDA-cleared growth-based bacterial detection device.
- Pools of up to six units of leukocyte-reduced whole-blood derived platelets that are pooled within
[Source: Immunetics]
