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Microsart® Validation Standard Mycoplasma arginini
European Pharmacopoeia 2.6.7 Mycoplasmas requires validation of sensitivity and robustness with respect to sample matrix. In addition,...
Vendor:
Sartorius
SKU:
SMB95-2011
Availability:
In Stock
Product Type:
Kits & Assays
- $480.06 USD
- $480.06 USD
- Unit price
- per
Subtotal:
$480.06
Estimated Delivery
Oct 06 - Oct 13
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Products Specifications
xApplications
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ApplicationMycoplasma Detection
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Application AreaRapid testing
Biological Information
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SpeciesMycoplasma arginini
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
-
3 vials with 10 CFU lyophilized
- 2 vials negative control lyophilized
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3 vials with 10 CFU lyophilized
Overview
xEuropean 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).
Accessories
x
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Microsart® Calibration Reagent Mycoplasma fermentans
Microsart® Calibration Reagents provide isolated genomic DNA of a specific Mycoplasma species. Titrated genomic DNA can serve for creating standard curves by using dilutions of the material as samp...
$480.06
Product Part
x
Document
x-
Catalog
Products for Microbiological Control
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Presentation
Microsart® Mycoplasma Kits Portfolio
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Presentation
Microsart® PCR Portfolio Overview
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User Manual
Microsart® Validation Standard 10 CFU - Instructions for Use 09-2024
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