Rapid Test Detects Bacterial Strains Contaminating Leukocyte-Reduced Platelets

Immunetics, Inc., (Boston, MA, USA) has received US Food and Drug Administration (FDA; Silver Spring, MD, USA) clearance for its BacTx rapid test for bacterial contamination in platelet units.

The BacTx test detects peptidoglycan, a cell wall component of both Gram-positive and Gram-negative bacteria. A peptidoglycan binding protein initiates a series of enzymatic reactions that convert a substrate to a visible color. In the presence of bacteria, color will develop at a rate proportional to the level of bacterial contamination. The BacTx Reader and software automatically monitor the reaction as color intensity change, providing a kinetic test that rapidly detects bacterial contamination and flags any contaminated platelet units.

The FDA clearance allows use of the BacTx test, which detected all of the bacterial strains tested on leukocyte-reduced whole blood-derived platelet units, a type of platelet preparation, which exhibits relatively high rates of bacterial contamination due to the pooling of units from multiple donors. In the studies reported to the FDA, the BacTx, demonstrated sensitivity, and specificity meeting or exceeding clinical requirements.

“Existing approaches to the detection of bacterial contamination have fallen short, leaving patients at risk. They rely mainly on the culturing of the platelet units, a decades-old method that takes up to several days to yield a result,” Dr. Levin, CEO and scientific director of Immunetics noted. “By contrast, the BacTx test can be run in about 45 minutes, making it suitable to test platelet units shortly before they are transfused into a patient.”

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Immunetics, Inc.
US Food and Drug Administration