Get QC Results for Advanced Therapy Medicinal Products (ATMPs) Before Treatment with the Microsart® ATMP Bacteria Kit
Detect bacterial contamination within 3 hours using the proven real-time PCR method in our Microsart® ATMP Bacteria Kit. To assure patient safety and reduce the need for prophylactic medication with antibiotics, make certain you only release bacteria-free cell therapy products for use.
Microsart® ATMP Bacteria Kit: A pioneering test no one else can offer.
Rapid bacteria detection in only 3 hours with Microsart® ATMP Bacteria Kit
ATMPs are tested using qPCR detecting a broad range of gram-positive and gram-negative bacterial contaminants.
Avoid lengthy 14-day cultivation protocols and save time. TaqMan® probes ensure the highest level of qPCR specificity. No need to perform uncertain melting curve analysis.
Validation standards for required bacterial species in Microsart® Bacteria Kits are lyophilized to render them non-infectious. We provide step-by-step, matrix-specific validation guidance from Sartorius qPCR experts. Avoid the risk of cross-contamination with individually packaged, sample-specific vials.
Microsart® Bacteria Kits were developed in close cooperation with authorities, and are validated according to EP 5.1.6 and USP <1223> for sensitivity, specificity, and robustness.
The ready-to-use master mix has the DNA for internal control already included. Avoid false-negative results and minimize the number of reactions you need to run.
Microsart® Bacteria Kits can be used with any qPCR cycler able to detect the fluorescent dyes FAM® and ROX®. Our clear, color-coded reagents guide the user through the short and simple protocol. Lyophilized reagents ensure consistent quality without the need for freezer storage.
Two kits are available:
- For testing cell-based therapeutics (ATMPs) such as autologous chondrocyte transplants or CAR-T cells: Microsart® ATMP Bacteria Kit
- For detection of Bacteria DNA in cell culture supernatants in research and development labs: Microsart® RESEARCH Bacteria Kit
Coming soon: Microsart® ATMP Fungi