- Comprehensive Control Plasmas
- Optional Control Scheme
- Stability and Storage
- CE Marked, IVD
PathTROLâ„¢ Tryptase Controls consist of lyophilized Human plasma controls containing native Human Î±-Tryptase and Î²-Tryptase, comparable to patient plasma.
They are free from preservatives or stabilizers, ensuring accurate representation of clinical samples.
By purchasing PathTROLâ„¢ Control Material, you gain access to the optional PathQASâ„¢ Allergy/Tryptase Internal Quality Control Scheme. This peer-to-peer monthly QC scheme provides comparisons with user-group consensus values, local inter-laboratory comparisons, and independent third-party controls, recommended for ISO 15189 compliance.
The lyophilized PathTROLâ„¢ Tryptase control plasma is stable until the expiry date when stored at 2-8Â°C. After reconstitution, the control plasma can be stored at 2-8Â°C for up to 5 days or, for longer-term storage, aliquot the plasma to 125Î¼l and freeze at -20Â°C.
PathTROLâ„¢ Tryptase Controls carry the CE mark and are classified as in vitro diagnostic (IVD) products, meeting the highest regulatory standards for diagnostic use.
PathTROLâ„¢ Tryptase Positive Controls: Ensuring Quality in Tryptase Testing
PathTROLâ„¢ Tryptase Positive Controls are lyophilized third-party control plasmas designed for the continuous long-term quality control of Tryptase tests in clinical and research laboratories. These controls contain Human Tryptase at two levels, providing a reliable solution to monitor the performance and accuracy of Tryptase assays.
Ensure the accuracy and reliability of your Tryptase testing with PathTROLâ„¢ Tryptase Positive Controls, combined with the PathQASâ„¢ Allergy/Tryptase Internal Quality Control Scheme for enhanced quality assurance and ISO 15189 compliance. Here are some key features of the PathQASâ„¢ Allergy Internal Quality Control Scheme:
- Complimentary Access: The PathQASâ„¢ Allergy/Tryptase Internal Quality Control Scheme is available free of charge to customers who purchase PathTROLâ„¢ Control Material. We are committed to supporting your laboratory's quality control efforts.
- Monthly Submission: Participating laboratories are encouraged to submit monthly data, allowing for regular assessment and monitoring of performance. This frequency enables timely identification of any potential issues and promotes continuous improvement.
- Within and Between Lab Comparison: The PathQASâ„¢ Allergy/Tryptase Internal Quality Control Scheme provides valuable insights by facilitating comparisons both within your laboratory and with other participating labs. This comparative analysis helps identify trends, assess performance, and benchmark against industry standards.
- Aids UKAS/ISO 15189 Compliance: By participating in the PathQASâ„¢ Allergy/Tryptase Internal Quality Control Scheme, your laboratory demonstrates a commitment to meeting UKAS/ISO 15189 requirements and ensuring the accuracy and reliability of your tryptase testing procedures.