MycoTOOL Mycoplasma Real-Time PCR Kit

Rapid and accurate detection of mycoplasma

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.

Sensitivity

Going straight for the answers

Species* 10 CFU/ml 3 CFU/ml
A. laidlawii + +
M. arginini + +
M. fermentans + +
M. hominis + +
M. hyorhinis + +
M. orale + +
M. salivarium + +
M. gallisepticum + +
M. synoviae + +
S. citri + +

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.

Accuracy

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.

Specificity

Minimizing risk of false positive results

Species 10^4 CFU/ml 10^3 CFU/ml
S. bovis - -
L. acidophilus - -
C. sporogenes - -

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
Instrument

1ml 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.