Microsart® Validation Standard Mycoplasma orale
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.: SMB95-2012
Price: $330.00
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Choose your Microsart® Mycoplasma Validation and Sensitivity Standards
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).
Brochure
Catalog
User Manual
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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
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Detection MethodPCR
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SpeciesMycoplasma orale
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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
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ApplicationMycoplasma Detection
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Pack Size3
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Regulatory RequirementsFor EP 2.6.7 compliant validation
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.
The Microsart® ATMP Mycoplasma detection kit is especially designed for an easy and fast detection of mycoplasma in cell-based therapeutics like autologous chondrocyte transplants (ATMPs –advanced therapy medical products). Due to the short shelf life of these therapeutics, a fast result is needed. The PCR-technology makes it possible to reduce the time-to-result to only 3 hours.
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.
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.
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.