MycoSEQ Mycoplasma Detection System
The Applied Biosystems MycoSEQ Mycoplasma Detection System is an integrated, real-time PCR (qPCR) solution for rapid mycoplasma testing. Comprised of functionally confirmed sample-to-answer protocols, commercially available kits for sample preparation and qPCR, and instruments with analytical software to help enable regulatory compliance, the MycoSEQ Mycoplasma Detection System workflow provides a flexible approach to meet a variety of mycoplasma testing applications.
- Method accepted by regulatory agencies for mycoplasma detection in a cGMP environment.
- Requires no live mycoplasma for testing or process validation.
- Total workflow solution, from sample prep to analysis with SAE compatible software.
- Detection of all recommended species listed in European, US, and Japanese Pharmacopeias.
- Supported throughout the validation process by our regulatory and field application specialists.
MycoSEQ Mycoplasma Detection Assays
Core to the MycoSEQ System are the real-time PCR assay kits. MycoSEQ mycoplasma detection assays deliver high sensitivity that meet or exceed regulatory guidance for mycoplasma detection while delivering same-day actionable results to enable early detection of mycoplasma contamination.
- Proven—Regulatory-accepted method for mycoplasma detection, with Drug Master File (DMF)*, filed with the United States Food and Drug Administration (FDA) and Health Canada
- Sensitive—Meets or exceeds the recommended regulatory guidance of 10 CFU/mL or 10 genome copies (GC)/mL for a wide variety of mycoplasma species, including those commonly known to contaminate bioprocessing cultures
- Specific—Validated in numerous independent studies* to specifically detect a wide variety of Mycoplasma, Acholeplasma, and Spiroplasma species with no known cross-reactivity with closely related bacterial species
- Fast—qPCR-based workflow delivers actionable results in less than 5 hours, enabling quick detection
of in-process, raw materials, or harvest contamination—helping expedite the release of
your product - Accurate—Discriminatory positive control allows discrimination between true mycoplasma and accidental contamination of test sample with positive control
*MycoSEQ Detection Assay
Learn more about MycoSEQ Assay options and performance ›
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