Microsart® Validation Standard Acholeplasma laidlawii

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.: 
SMB95-2018
Availability: 

*Custom/bulk order quotes are provided within 24 hours of request.

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

  • Application
    Mycoplasma Detection  
  • Application Area
    Rapid testing  

Biological Information

  • Species
    Acholeplasma laidlawii  

Compliance Information

  • Regulatory Requirements
    For EP 2.6.7 compliant validation  

Components

  • Additional Required Components
    • qPCR cycler  
    • PCR reaction tubes  
    • Centrifuge for 1.5 mL PCR tubes  
    • Pipettes  
    • Extraction kit  
    • PCR kit  

Dimensions

  • Filter Diameter
    N/A  

General Specifications

  • Culture Media
    N/A  
  • Detection Method
    PCR  
  • Membrane Color | Grid Color
    N/A  

Materials of Construction

  • Filter Material
    N/A  

Physicochemical Information

  • Pore Size
    N/A  

Product Information

  • Brand
    Microsart®  
  • Pack Size
    N/A  
  • Type
    Reagents  
  • What you receive
    • 3 vials with 10 CFU lyophilized  
    • 2 vials negative control lyophilized  
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