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Mycoplasma Rapid Detection Kit (qPCR)

For research use only.

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  • Product Details
    To expedite in-process and lot-release testing, the Mycoplasma rapid detection kit, based on Nucleic Acid Amplification Technology (NAT), has been developed and validated to meet the requirements outlined in European Pharmacopeia Chapter 2.6. 7.

    Combined with ACRO's mycoplasma DNA Sample Preparation kit, this kit sensitively and reliably detects mycoplasma contamination in biological products, meeting or exceeding the regulatory guidance of 10 CFU/mL. The assay eliminates the need for time-consuming culture-based methods, simplifying the mycoplasma testing process and yielding results in 2-2.5 hours with high efficiency.

  • Features
    1. Broad Coverage: Covers over 250 Mollicutes (Mycoplasma, Acholeplasma and Spiroplasma) species, including all mycoplasma species listed in Pharmacopoeias (EP, USP, JP)

    2. Strong Specificity: Developed with multiple primers and probes targeting mycoplasma species' 16s rRNA, with no cross-reactivity with closely related non-mycoplasma strains

    3. High Sensitivity: Fully compliant with or superior to regulatory guidance of 10 CFU/mL

    4. Convenient Operation: Designed for single-well testing, with the kit containing essential components for easy use

    5. Comparable Results: Detection results from the kit are comparable to those from culture-based methods

    6. High-quality: This Kit is manufactured in GMP-like facility and alignment with the ISO 13485 standard

  • Application

    The kit is used for detection of mycoplasma contamination in cells and bioproduct media.

    For use in quality control/manufacturing process only.

    It is for research use only.

  • Technical Specifications
     DNA Technical Specifications
Typical Data

Please refer to DS document for the assay protocol.


24 tests were conducted on each of the 10 Mycoplasma Standards (10 CFU/mL), and all test results were positive, meeting or exceeding the recommended regulatory guidance of 10 CFU/mL.



  1. Coverage of assay

  3. Cross reactivity to cell lines/unrelated-species

  4. Detection was conducted on two cell lines and four unrelated species (Streptococcus pneumoniae, Lactobacillus acidophilus, Staphylococcus epidermidis, and Bacillus sp.) at 300 pg/reaction, and all test results were negative.


Robustness and Ruggedness

The robustness and ruggedness of the assay have been verified, and the assay is suitable for the following conditions. All test results were negative, indicating that these conditions do not interfere with the detection of mycoplasma.

Materials Provided
OPA-S101-01PC Powder1 tube
OPA-S101-02Purple-capped empty tube1 tube
OPA-S101-03DNA Dilution Buffer1.5 mL×2
OPA-S101-04Internal Control DNA300 μL
OPA-S101-052×qPCR Master Mix400 μL
OPA-S101-06Myco Primer&Probe Mix100 μL
OPA-S101-07Dnase/Rnase-Free Water1.0 mL
  • Background
    During the production of biological products (cell isolation, modification, and proliferation), contamination by mycoplasma poses potential risks to patients. Therefore, it is crucial to ensure that the final products are free from mycoplasma contamination during release testing. Traditionally, assessing whether biological products have been contaminated relied on conventional microbiological culture procedures using liquid media and agar media (culture method or indicator cell culture method). However, with the advancement of Biopharmaceuticals and Advanced Therapy Medicinal Products (ATMPs), culture-based methods no longer meet the rapid release requirements.
  • Clinical and Translational Updates

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ETA of in-stock products: 2 business days

Price(USD) : $648.00

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