Jiachang Biological - biotechnology services and research and development as one of the high-tech enterprises
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The bacterial, fungal, and mycoplasma Q-PCR test kits developed by Canvest Bio have undergone thorough validation (including comparability validation with pharmacopoeia methods). These kits can complete rapid release testing for cell therapy products within 6 hours, meeting the release testing requirements for certain applications, especially for fresh cell-based products.
Mycoplasma qPCR Test Kit (Probe Method)
[Kit Introduction]
This test kit uses the fluorescence probe qPCR method for the qualitative detection of mycoplasma contamination in cell banks, virus seed banks, cell and gene therapy products, and other biological products (intermediate and final products).
The kit has been validated in strict accordance with EP 2.6.7 and JP XVII mycoplasma detection guidelines and requirements. The primers and probes used can detect over 132 species of mycoplasma, with high specificity, and will not cross-react with bacteria, fungi, human and animal cells, or common viruses. The nucleic acid detection limit is 1-5 genome copies/reaction, with high sensitivity. Mycoplasma sensitivity is below 10 CFU/ml, with strong durability, resistance to matrix interference, and can withstand repeated freeze-thaw cycles, demonstrating comparability with pharmacopoeia methods.
It is recommended to use in conjunction with the QIAamp® MinElute® Virus Spin Kit (QIAGEN, Cat#57704) for mycoplasma extraction and purification.
Catalog Number: Cat# JCMY50
