Mycoplasma are common sources of contamination in biopharmaceutical production, cell therapy, and tissue engineering, with contamination rates reported between 15 and 35% according to recent industry data.* The Roche MycoTOOL Real-Time PCR Kit makes mycoplasma testing fast, easy, and reliable, with the broadest range of detection among other commercially available kits. It is also a trusted solution used internally by Roche Pharmaceuticals for testing of several biopharmaceutical products.
Avoid the 28-day culture test and obtain results in <5 hours with an industry-leading kit recognized for high sensitivity, accuracy, and specificity.
*Armstrong SE, Mariano JA, Lundin DJ. The scope of mycoplasma contamination within the biopharmaceutical industry. Biologicals. 2010 Mar;38(2):211-3. https://www.ncbi.nlm.nih.gov/pubmed/20362237
For use in quality control/manufacturing process only.
Going straight for the answers
|Species*||10 CFU/ml||3 CFU/ml|
Positive results for species spiked into CHO reference cell line at 5x10^6 CFU/ml
Source: Roche data on file. *Species listed in EP 2.6.7. M. pneumoniae currently not tested.
Minimizing risk of false negative results
|MycoTOOL detection||Standard detection*|
|149 mollicute species||Limited range|
|One highly accurate test||Two tests|
|Easy interperation with clear "Yes" or "No" result||Difficult interpretation requiring skilled operators|
* Cell culture method
Universal primers in the MycoTOOL kits detect a wide range of species, including Mycoplasma, Spiroplasma, Ureaplasma, and Acholeplasma.
Minimizing risk of false positive results
|Species||10^4 CFU/ml||10^3 CFU/ml|
No cross-reactivity observed at high titers of closely related species
Source: Roche data on file.
Ease of Use
Automated options to maximize efficiency
Workflow with Roche Instruments and Kits
|Options for sample preperation||Real-Time PCR|
|Application||Batch testing, Flexible sample volume||Evaluation, Single sample|
(e.g. unprocessed bulk)
|MagNA Pure 96 Instrument||Manual extraction *||LightCycler® 480 II Instrument ‡|
|Kit||MagNA Pure 96 DNA and Viral NA Kit, Large Volume||MycoTOOL Mycoplasma Detection Prep Kit||MycoTOOL Mycoplasma Real-Time PCR Kit|
Time to results <5 hours including sample preparation
Non-Roche instruments have been tested and perform with comparable sensitivity and specificity on the tested CHO reference cell line.
*For use in quality control/manufacturing process only.
‡ For life science research use only. Not for use in diagnostic procedures.