Microsart® Validation Standard Mycoplasma gallisepticum
Microsart® Validation Standards are quantified CFU preparations, containing 10 CFU per vial, optimized for validating the robustness and sensitivity of NAT-based tests.
- Item No.:
- SMB95-2013
- Availability:
- pcs
*Custom/bulk order quotes are provided within 24 hours of request.
Choose your Microsart® Rapid Mycoplasma Detection
European Pharmacopoeia 2.6.7 Mycoplasmas requires validation of sensitivity and robustness with respect to sample matrix. In addition, the method shall show a performance equal or better to the classical cultivation procedure. As most test and cell culture labs are frighten to cultivate mycoplasma, such comparison is not easy to accomplish.
Microsart® Validation Standards are not infectious and therefore safe in use. They are titrated to 10 CFU/ml, the sensitivity limit for NAT-based methods like PCR to replace the traditional culture method.
The mycoplasma cells used for the manufacture of Microsart® Validation Standard are low passage reference strains cultivated in culture broth described in EP 2.6.7. The cultures are harvested in the early logarithmic phase of the growth to avoid an atypical high ratio of dead mycoplasma particles, titrated immediately in culture broth and plated on Hayflick and Frey medium for quantification based on colony forming units (CFU).
Applications
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ApplicationMycoplasma Detection
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Application AreaRapid testing
Biological Information
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SpeciesMycoplasma gallisepticum
Compliance Information
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Regulatory RequirementsFor EP 2.6.7 compliant validation
Components
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Additional Required Components
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qPCR cycler
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PCR reaction tubes
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Centrifuge for 1.5 mL PCR tubes
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Pipettes
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Extraction kit
- PCR kit
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qPCR cycler
Dimensions
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Filter DiameterN/A
General Specifications
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Culture MediaN/A
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Detection MethodPCR
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Membrane Color | Grid ColorN/A
Materials of Construction
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Filter MaterialN/A
Physicochemical Information
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Pore SizeN/A
Product Information
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BrandMicrosart®
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Pack SizeN/A
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TypeReagents
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What you receive
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3 vials with 10 CFU lyophilized
- 2 vials negative control lyophilized
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3 vials with 10 CFU lyophilized
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.
Mycoplasma contamination sources can vary and be difficult to trace. Common sources include human contamination and contaminated laboratory equipment. The Microsart® ATMP Mycoplasma is your perfect solution for performing Mycoplasma testing of cell-based therapeutics.
Top Features
- Time-to-result within three hours
- Specificity in PCR detection system through TaqMan® probes
- Easy handling and high security
Popular Applications
- Lab research
- Quality control (QC)
- Mycoplasma contamination testing according to EP 2.6.7 in cell-based therapeutics
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.
The Microsart® RESEARCH Mycoplasma real-time PCR kit is optimized for fast and reliable direct screening of cell cultures, cell culture supernatants and media most applicable in research and development and in-process in biopharma.
Reduce your testing time from weeks to 3 hours with the Microsart® AMP Mycoplasma. With the ability to be very flexible in sample volume (up to 18 ml) and sample preparation, the kit is specifically designed for: the control of raw materials, for in-process control, and for lot release testing of finished products.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.
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