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 optional prior enrichment step using the Vivaspin® 20 or 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.