BacTx Rapid Assay System
Universal bacterial detection for apheresis and whole blood-derived platelets
Bacterial contamination of platelets represents a significant risk to the highly vulnerable patients that require transfusions. The most important question is, "Are your platelets free of bacterial contamination?" No testing system can answer this question as quickly and accurately as the BacTx® Rapid Assay.
BacTx is the only platelet contamination test that combines universal bacterial detection with simple, easy workflow integration. Now FDA-cleared for apheresis and whole blood-derived platelets, the assay gives hospitals and blood banks a practical tool for assuring platelet safety.
The BacTx assay is a rapid, qualitative, colorimetric, quality-control test for the detection of aerobic and anaerobic, Gram-positive and Gram-negative bacteria in:
- Leukocyte-reduced apheresis platelet units (LRAP) (Apheresis Platelets Leukocytes Reduced) as a quality-control test following testing with a growth-based bacterial detection device cleared by the FDA for quality-control testing of leukocyte-reduced apheresis platelets and;
- Pools of up to six units of leukocyte-reduced whole blood-derived platelets (Platelets, Leukocytes Reduced) that are pooled within 4 hours of transfusion.
The assay meets AABB sensitivity recommendations for all clinically relevant bacterial strains, and is highly specific since it detects the components of cell walls that exist in all forms of bacteria. BacTx incorporates a binding protein that only reacts with bacterial peptidoglycan to start an enzymatic reaction. The reaction will develop a red color that is automatically measured and reported by the BacTx Analyzer. The assay can be run in about 45 minutes, making it suitable to test platelet units shortly before they are transfused.
Current Testing Methods Are Insufficient
Today's bacterial detection assays do not meet the industry's needs to ensure patient safety.
- The current testing protocol - testing 24 hours after collection - does not represent the state of the platelets transfused on day 3, 4, or 5 (several days after sampling).
- Sampling 24 hours after collection has been proven ineffective - since slow-growing bacteria may not be measureable until 3 to 4 days after collection.
- Culture testing requires a multi-day waiting period, reducing the time available for transfusion of platelet units.
Only BacTx offers the speed and accuracy that enable bacterial contamination testing for greater patient safety.
- Rapid results (<1 hour) allows testing at point-of-release, to reduce the risk of transfusing bacterially contaminated platelets**
- Sensitive detection thresholds are 103-104 CFU/mL for all clinically relevant strains
- Universal detection detects aerobic, anaerobic, gram-positive and gram-negative strains; patented detection method targets peptidoglycan – a component of all bacterial cells
The BacTx Rapid Assay System delivers proven technology for bacterial detection in platelets with a workflow-integrated lab instrument that generates fast, accurate results. Only BacTx:
- Reduces patient risk of receiving contaminated platelets
- Meets the demands of a fast-paced transfusion service
- Reduces the number of platelets discarded due to aging
…to increase patient safety.
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