MycoTOOL PCR Mycoplasma Detection Kit by Roche Applied Science - a member of the Roche Group

Mycoplasmas are frequent causes of contamination in biopharmaceutical production, cell therapy and tissue engineering. Traditional detection methods, use growth on culture media to detect contaminating organisms. These culture-based methods are time-consuming, requiring as much as 28 days to complete, laborious and difficult to interpret. Rapid methods, like the new MycoTOOL Test for detecting Mycoplasma contamination, can help improve efficiency, quality and safety in the manufacturing of pharmaceutical and biological products.

MycoTOOL PCR Mycoplasma Detection Kit is accepted for release testing of biopharmaceutical products by FDA, EMA and authorities in several other countries for fast, easy, and reliable Mycoplasma testing.

MycoTOOL PCR Mycoplasma Detection Kit Features:

• Save time. Replace traditional 28 days culture testing with the rapid MycoTOOL PCR Test.
• Speed up your validation. Rely on published Roche validation data (see Literature).
• Detect traces of Mycoplasmas. The sensitivity is 1 CFU/ml.
• Minimize the risk of false negatives and false positives. The matrix lysis control eliminates risk of undetected intracellular Mycoplasma. The diluted GAPDH and positive control identify potential PCR inhibition. False positives are prevented by nucleic acid free reagents, tested according to Roche's current ultrasensitive Quality Control procedures. Uracil-DNA Glycosylase pretreatment is performed to prevent contamination by PCR carryover.
• Detect the broad panel of Mollicute species. A universal primer design covers a whole range of Mycoplasmas.
• Achieve process security. Rely on test results using a consistent kit quality and established change control procedures.