Mycoplasma Real-time qPCR Detection Kit

MycAwayTM Mycoplasma qPCR Detection Kit (probe method) is a product based on NAT (nucleic acid amplification techniques) for rapid qualitative detection of potential mycoplasma contamination in production materials, cell banks, virus seeds, virus or cell harvest fluids, and therapeutic cells. The kit is based on the principle of fluorescent probe qPCR and uses two fluorescent probes, FAM and VIC, to detect target sequences and internal references respectively, covering 169 mycoplasma DNA sequences.
MycAwayTM Mycoplasma qPCR Detection Kit (probe method) has been fully verified for its specificity, detection limit and durability according to EP 2.6.7, etc., and covers the mycoplasma strain types required for verification in USP, JP, WHO, ChP, etc. The performance of the kit meets the requirements of Chinese and foreign regulations, helping biopharmaceutical customers to successfully obtain the acceptance of clinical trial applications for drug development projects by domestic and foreign drug regulatory authorities.

Features:
· Easy to operate: The total time for sample preparation and detection is less than 3h, without the 28-day waiting time required by the culture method.
· High sensitivity: the detection limit reaches 10CFU/mL, which can replace the direct culture method
· Strong specificity: multiple related species, common cell lines and sample matrices have been verified, and there is no cross-reaction
· High safety: the positive control (PC) in the kit is non-infectious, completely eliminating the risk of contamination
· Strong anti-interference: the introduction of internal quality control (IC) can eliminate factors such as sample interference and abnormal reaction preparation, effectively avoiding false negatives

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