Sterility testing is a critical step in the release of cell therapy products, as microbial contamination could prove fatal for recipients. Traditional methods take up to 14 days, which is impractical for autologous cell therapies required by critically ill patients. Our digital PCR (dPCR) technology offers a revolutionary solution by reducing testing time to just a few hours while improving precision and sensitivity.
- Rapid Testing: Digital PCR reduces sterility testing time from 14 days to hours, crucial for timely treatment of critically ill patients.
- Precision and Sensitivity: Utilizes individual reactions to isolate DNA targets, minimizing background noise and enhancing detection accuracy.
- Background Signal Management: Effectively differentiates between background and real positive signals, reducing false positives.
- Cyclus® dPCR Tool Box: Includes primers, TaqMan® probes and controls for bacteria and fungi detection, optimized for various dPCR systems.
- Highest Sensitivity: Detects microbial contamination at concentrations as low as 10 CFU/mL, with potential for even lower detection.
- System Compatibility: Compatible with Qiagen and Bio Rad systems, ensuring widespread adoption.
- Robust Performance: Demonstrated consistent sensitivity across different digital PCR technologies, confirming its reliability.
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