Roche MycoTool PCR Mycoplasma Detection Kit

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The MycoTool PCR Mycoplasma Detection Kit from Roche can be used to obtain results in hours by using PCR instead of culture-based testing.

Mycoplasma is a known cause of contamination in biopharmaceutical production, cell therapy and tissue engineering. Traditional detection methods, required by pharmacopoeias and drug-regulating agencies, use growth on culture media to detect contaminating organisms. This traditional method is difficult to interpret and time-consuming, requiring as much as 28 days to complete.

Rapid product-release testing using the MycoTool PCR test is approved by the European Medicines Agency for several pharmaceutical products. The limit of detection is <1 CFU/mL for all validated species.

Purified reagents avoid false positives and carryover contamination. The assay is accurate and sensitive with protein-rich media, high cell densities and cell-free matrices. Positive and negative controls are provided.

Universal primer designs enable the detection of over 90 Mollicute species, including Spiroplasma and Acholeplasma.