Mycoplasma Detection: Why Waste Time Waiting for Results?

Mycoplasmas are unfortunately common contaminants of cell cultures in the biopharmaceutical industry. Without causing any visible changes in the culture, they can reach high numbers, with no effect on viability and may thus go undetected. The detection of mycoplasma DNA with conventional methods is labor-intensive, time-consuming and can take up to four weeks to produce a result. Now, real-time PCR kits offer a fast and easy-to-use solution for early detection at all stages of your process, whether you are screening in the lab or testing in your production line.

Microsart® AMP Mycoplasma Kit

Rapid methods for the detection of mycoplasma contamination are essential for improving monitoring of the production process of biologicals. The Microsart® AMP Mycoplasma is the first member of a qPCR product line of kits for mycoplasma detection. The Microsart® AMP Mycoplasma can be easily implemented because no specific hardware is needed. The kit can be used with any type of real-time PCR cycler that is able to detect the fluorescence dyes FAM and ROX. The total testing procedure takes only 3 hours. The Microsart® AMP Mycoplasma is effectively validated according to chapter EP 2.6.7 in combination with EP 2.6.21 for sensitivity, specificity and robustness. Carefully selected primer/probe combinations are highly specific for a region within the 16S rRNA gene for more than 110 Mycoplasma species. Due to the prior enrichment step using the Vivaspin® 20 and Vivaspin® 6 the starting volume for the DNA extraction is flexible. You have the option to analyze a testing volume from 200 µl up to 18 ml which ensures highest sensitivity. The kit contains all essential components in a function tested ready-to-use master mix, including the polymerase.

  • Minimizes testing time from weeks down to hours.
  • Microsart AMP Mycoplasma is validated according to EP 2.6.7
  • Convenient and simple use
  • For use with all common qPCR cyclers able to detect FAM ™- and ROX™-labeled probes
  • The product fulfills all the different demands in regard to sensitivity and security.

Microsart® ATMP Mycoplasma Kit

A fast detection of Mycoplasma contamination in Advanced Therapy Medicinal Products (ATMP) is very important due to the short shelf life of this type of product. With the use of the Microsart® ATMP Mycoplasma the testing time can be reduced from weeks to just 3 hours. Additionally, the utilization of a TagMan® probe adds high specificity to the PCR system and minimizes the result interpretation. The Microsart® ATMP Mycoplasma has been effectively validated according EP 2.6.7 in combination with EP 2.6.21 with respect to the detection limit for all listed Mycoplasma species, specificity and robustness for autologous cell transplants (e.g. chondrocytes).

The Microsart® ATMP Mycoplasma kit can be easily implemented because no specific hardware is needed.

The kit can be used with any type of real-time PCR cycler able to detect the fluorescence dyes FAM and ROX. The kit contains all essential components in a function tested ready-to-use master mix including the polymerase.

  • Fast results within 3 hours
  • Easy to use
  • Validated according EP 2.6.7 for ATMP`s

Microsart® RESEARCH

Microsart® RESEARCH Mycoplasma enables a fast and reliable detection of Mycoplasma DNA in cell culture supernatants most applicable in research and development.
The Microsart® RESEARCH Mycoplasma real-time PCR kit is especially designed for fast and reliable Mycoplasma contamination control in cell culture supernatants most applicable in research and development, e.g. biotech and biopharmaceutical research and development, university and governmental research groups. 2 µl sample material can be added directly to the PCR reaction tube without the need for any sample preparation. Nevertheless standard DNA isolation procedures can be done obligatory prior to the DNA amplification. The DNA can be amplified with the help of any qPCR cycler that is able to detect the dyes FAM ™and ROX™ and the evaluation can be performed with the standard cycler software. The use of TaqMan® probes adds specificity to the PCR detection system. Due to the high specificity no melting curve analysis is needed after the amplification steps.TaqMan® is a registered trademark of Roche Molecular system Inc.

  • Fast results within less than 3 hours
  • Easy to use
  • Reliable screening with a small sample volume
  • Cost saving