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Microsart® Mycoplasma Validation and Sensitivity Standards

Microsart® Validation Standards are quantified CFU preparations, containing 10 CFU per vial, optimized for validating the robustness and sensitivity of NAT-based tests.

   

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Products (24)

Microsart® Mycoplasma Orale Validation Standard 100CFU
Brand
Microsart®
Species
Mycoplasma orale
Detection Method
PCR
Microsart® Mycoplasma Pneumoniae Validation Standard 100CFU
Brand
Microsart®
Species
Mycoplasma pneumoniae
Detection Method
PCR
Microsart® Validation Standard Candida glabrata
Brand
Microsart®
Species
Candida glabrata
Detection Method
PCR
Microsart® Validation Standard Staphylococcus aureus
Brand
Microsart®
Species
Staphylococcus aureus
Detection Method
PCR
Microsart® Validation Standard Candida albicans
Brand
Microsart®
Species
Candida albicans
Detection Method
PCR
Microsart® Validation Standard Mycoplasma pneumoniae
Brand
Microsart®
Species
Mycoplasma pneumoniae
Detection Method
PCR
Microsart® Validation Standard Kocuria rhizophila
Brand
Microsart®
Species
Kocuria rhizophila
Detection Method
PCR
Microsart® Validation Standard Aspergillus fumigatus
Brand
Microsart®
Species
Aspergillus fumigatus
Detection Method
PCR
Microsart® Validation Standard Candida tropicalis
Brand
Microsart®
Species
Candida tropicalis
Detection Method
PCR
Microsart® Validation Standard Candida krusei
Brand
Microsart®
Species
Candida krusei
Detection Method
PCR
Microsart® Validation Standard Mycoplasma synoviae
Brand
Microsart®
Species
Mycoplasma synoviae
Detection Method
PCR
Microsart® Validation Standard Clostridium sporogenes
Brand
Microsart®
Species
Clostridium sporogenes
Detection Method
PCR
Microsart® Validation Standard Spiroplasma citri
Brand
Microsart®
Species
Spiroplasma citri
Detection Method
PCR
Microsart® Validation Standard Penicillium chrysogenum
Brand
Microsart®
Species
Penicillium chrysogenum
Detection Method
PCR
Microsart® Validation Standard Bacillus subtilis
Brand
Microsart®
Species
Bacillus subtilis
Detection Method
PCR
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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).

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Products for Microbiological Control
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