Mycoplasma contamination detection assays for lot-release testing

Rapidly detect Mycoplasma with confidence

Applied Biosystems MycoSEQ Mycoplasma Detection Kits offer a fully integrated solution for real-time PCR–based Mycoplasma detection. Used throughout the bioproduction workflow, MycoSEQ kits are an alternative to costly, time-consuming culture-based tests, delivering accurate and actionable results in about five hours. Backed by technical and regulatory experts and a successful track-record of regulatory acceptance, MycoSEQ Detection Kits can help simplify mycoplasma detection for both in-process and lot-release testing.

MycoSEQ Detection Assay Kits offer a variety of solutions to meet sample and workflow requirements:

  • Chemistry options include probe-based or dye-based qPCR assays to ensure optimum performance, regardless of sample matrices
  • Kits available with and without sample preparation supporting both manual and automated extraction


Featured solution: MycoSEQ Plus Mycoplasma Detection Kit

The Applied Biosystems MycoSEQ Plus Mycoplasma Detection Kit is a probe-based quantitative PCR (qPCR) assay kit featuring gold-standard TaqMan chemistry. Developed specifically for the detection of Mycoplasma in cell therapy and complex bioproduction samples, TaqMan-based assays deliver performance that meets or exceeds the regulatory requirements of 10 CFU/mL, the high level of performance needed to support product lot release testing, including the ability to meet regulatory guidance for assay sensitivity and specificity.

  • Multiplexed assay enables simultaneous screening of over 200 species of Mycoplasma, with no demonstrated cross-reactivity to closely related bacterial species
  • Demonstrated to meet or exceed LOD less than/equal to 10 GC/mL for all mycoplasma species listed in Pharmacopoeia (USP, EP, JP), as well as representative hemoplasma, mesoplasma and ureaplasma.
  • Unique discriminatory positive control that can differentiate a control-based contamination event from a true positive sample call
  • Flexible and scalable throughput supports fluctuating testing needs and enables reduced cost per rxn by batch testing multiple samples
  • Limits risk to production facilities as it does not require live Mycoplasma for testing or process validation.
  • Internal positive control confirms PCR reaction consistency across all samples
Components of the MycoSEQ Plus Mycoplasma contamination detection for lot-release testing

MycoSEQ Mycoplasma Detection Kit

Components of the MycoSEQ Mycoplasma contamination detection assay for lot-release testing

The tried and true Applied Biosystems MycoSEQ Mycoplasma Detection Kit set the standard for rapid Mycoplasma testing and has been validated in more than 44 therapeutics across a variety of modalities. This dye-based assay design utilizes a proprietary bioinformatics pipeline to detect >90 Mycoplasma species with high specificity and no cross-reactivity with closely related bacterial species. Its sensitivity has been demonstrated by internal and external validation methods to detect 10 CFU/mL, or the genomic equivalent of 10 10 cfu/mL, or the genomic equivalent of 10 GC/mL, as recommended by regulatory guidance

Download the MycoSEQ Mycoplasma Detection Kit product bulletin ›

Compare MycoSEQ Assays


MycoSEQ Plus Kit

MycoSEQ Kit

Sample type

Bioproduction media, cells

Bioproduction media, cells

Therapeutic type

Cell therapies, gene therapies, viral vector based therapies, biosimilars

Cell therapies, gene therapies, viral vector based therapies, biosimilars

Detection chemistry

TaqMan (probe based)

SYBR (dye based)

Number of reactions per kit



Hours per workflow

≤ 5 hours

≤ 5 hours

Discriminatory positive control



Internal positive control



Performance capable of meeting lot release requirements



Number of species



The sample sets the stage

Efficient sample preparation and DNA extraction are the basis for a high-sensitivity assay. Our Applied Biosystems PrepSEQ nucleic acid extraction kits utilize magnetic bead-based technology to provide quantitative recovery of nucleic acids from a variety of complex sample matrices. Our MycoSEQ system is optimized with sample preparation protocols for use with either automated or manual workflows.

PrepSEQ kits are available separately or can be bundled with either MycoSEQ or MycoSEQ Plus kits for a complete workflow and added savings.  

Learn more about PrepSEQ and our sample prep solutions ›

Ordering information

Sample preparation

MycoSEQ Assay kits

Bioprocessing resources

Access a targeted collection of scientific application notes, case studies, posters, white papers and more for bioprocessing:

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