Skip to content Skip to navigation menu

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:  $310.00

Availability (ex works):  For more information please log in

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

宣传手册:微生物质量控制产品精简目录
zh 2,4 MB
宣传手册:微生物限度检测产品
zh 5,1 MB

Catalog

Products for Microbiological Control
en 12,0 MB

User Manual

Microsart® Validation Standard
en 666,0 kB

Applications

  • Application
    Mycoplasma Detection

Biological Information

  • Species
    Mycoplasma orale

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

Product Information

  • Pack Size
    3
  • Primary Product Type
    Kits & Assays
  • What you receive
    • 3 vials with 10 CFU lyophilized
    • 2 vials negative control lyophilized

Specifications

  • Detection Method
    PCR
Microsart® AMP Mycoplasma
Microsart® AMP Mycoplasma
Item no.:   SMB95-1002

$2,575.00

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® ATMP Mycoplasma
Microsart® ATMP Mycoplasma
Item no.:   SMB95-1004

$2,110.00

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® RESEARCH Mycoplasma
Microsart® RESEARCH Mycoplasma
Item no.:   SMB95-1006

$1,215.00

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 Reagent Mycoplasma arginini

$355.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® Calibration Reagent Mycoplasma orale

$355.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® Calibration Reagent Mycoplasma gallisepticum

$355.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® Calibration Reagent Mycoplasma pneumoniae

$355.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® Calibration Reagent Mycoplasma synoviae

$355.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® Calibration Reagent Mycoplasma fermentans

$355.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® Calibration Reagent Mycoplasma hyorhinis

$355.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® Calibration Reagent Acholeplasma laidlawii

$355.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® Calibration Reagent Spiroplasma citri

$355.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.