Mycoplasma DNA Detection Kit

Mycoplasma are the smallest and simplest prokaryotic organisms known, ranging in size from 0.1 to 0.8 μm, and they can proliferate on artificial media. Animal cells, commonly used in laboratories and the production of biological products, are susceptible to Mycoplasma contamination during cell culture. Pharmacopoeias and regulatory authorities in various countries have clearly defined guidelines for the detection of Mycoplasma in the production of biological products.

Traditional Mycoplasma detection methods require culturing for at least 28 days to obtain results, making the process time-consuming. According to the European Pharmacopoeia (EP) guidelines, if the sensitivity of Nucleic Acid Testing (NAT) methods is equivalent to that of classical culture methods, and they demonstrate good robustness and specificity, NAT can be used as an alternative method for Mycoplasma detection. The qPCR kit offers a very fast and user-friendly solution for Mycoplasma control, suitable for use in laboratories or production lines.

 * This kit is fully validated according to relevant regulations and guidelines. Performance validation report is available upon request.

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