Method and system of producing a cartridge for performing nucleic acid amplification tests, and cartridge produced therewith
A nucleic acid contamination-free cartridge system addresses sterility testing challenges by integrating all components and reagents in a cleanroom, ensuring accurate and reliable detection of microbial nucleic acids, reducing manual handling and enhancing test reliability.
Patent Information
- Application Number
- PCT/EP2025/078374
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-10-02
- Filing Date
- 2025-10-02
- Publication Date
- 2026-04-09
AI Technical Summary
Current sterility testing methods for biological samples face challenges such as nucleic acid contamination, manual handling risks, and inadequate sample processing, leading to false positives and negatives, particularly in complex samples with low microbial counts or uneven contamination.
A nucleic acid contamination-free cartridge system is produced in a cleanroom environment, integrating all components and reagents to minimize human intervention, ensuring thorough lysis, homogenization, and accurate detection of microbial nucleic acids without interference from host DNA, using microfluidic channels and controllable valves for automated processing.
The system significantly reduces contamination risks, enhances accuracy and reliability of sterility testing, and improves patient safety by providing consistent and reproducible results, even in complex biological samples.