Mycoplasma Crystal Digital PCR® Assay

Cell and Gene Therapy

Assay-specific Crystal Flex Probes and primers for the detection of Mycoplasma species, its Positive Control, and an Extraction Control.

For Research Use Only. Not for use in diagnostic procedures.

Wet-lab tested
Product Details

The Mycoplasma Crystal Digital PCR® Assay is a 10X assay designed to detect and quantify mycoplasma species using the Ruby Chip. Mycoplasmas are frequent contaminants of cell cultures and bioprocessing fluids, often compromising product integrity and downstream applications.

The assay aligns with regulatory requirements, including the United States Pharmacopeia Chapter 63 (USP 63), the European Pharmacopoeia Chapter 2.6.7 (EP 2.6.7), and the Japanese Pharmacopoeia Chapter G3 (JP G3), which mandates the detection of 10 specific mycoplasma species. Six key species, namely M. orale, M. hyorhinis, M. fermentans, M. salivarum and A. laidlawii account for more than 95% of mycoplasma contaminants in cell culture. This assay has been validated on the previously described species and the additional ones recommended by the pharmacopeia: M. arginini, M. pneumoniae, S. citri, M. synoviae, M. gallisepticum.

To support assay performance and sample processing quality, the assay includes a spiked-in extraction control to be added to the samples before extraction. This control allows users to determine the extraction yield of the chosen method.

This assay is available in 200 and 1000 reaction formats.

Features & Benefits

Ready-to-use assay reagents to detect multiple targets in a single reaction

Detection of Mycoplasma species recommended by the United States, European, and Japanese Pharmacopoeia in a single assay

Internal extraction control to determine extraction yield

Crystal Flex Probe detection chemistry for flexible assay configuration

Same set of Crystal Universal Reporters to detect any target in different assays

Targets

Mcoplasma species, including:

M. orale

M. hyorhinis

M. fermentans

M. salivarum

A. laidlawii

M. arginini

M. pneumoniae

S. citri

M. synoviae

M. gallisepticum

Assays & kits

Ready-to-use assays & kits

Explore our catalogue of assays and kits and take a leap into the world of multiplexing. Crystal Digital PCR® assays and kits allow for the detection of multiple targets of interests within one single Ruby Chip chamber.

Custom assay design services

Rapid high-plex assay customization

Stilla offers the fastest assay design service in the market for multiplexed digital PCR assays. Stilla exploits its proprietary Crystal Flex Probe PCR chemistry to offer customized assays in record time, at competitive prices.