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Reference Standards

Mycoplasma Reference Standards

We offer Culture and DNA Reference Standards of more than 20 mycoplasma type strains and 10 mycoplasma reference field strains.

Among them are those mycoplasma reference strains is the first ever developed reference standard for “non-cultivable” Mycoplasma hyorhinis cultivar-α strains.

 

Culture Reference Standards

Mycoplasma testing by NAT-based assays is regulated in the European Pharmacopoeia EP 9th Ed. Chapter 2.6.7. as well as in the Japanese Pharmacopoeia JP 17th Ed. According to the stringent requirements of those regulatory authorities, quantified low-GC/CFU mycoplasma reference standards are essential. They are required for determination of the sensitivity of the PCR assay compared to the conventional culture methods and for evaluation of the entire detection procedure. Only when using quantified low-GC/CFU mycoplasma reference standards approval from the regulatory authorities for mycoplasma testing of the product for which the PCR method is intended to be used, can be obtained.

Mycoplasma Biosafety’s flash-frozen mid-log phase mycoplasma culture reference standards (mbsCRS) have very high quality standards and are accepted by the EMA and the FDA for generic and product-specific validation of NAT-based mycoplasma detection assays.

Each mycoplasma reference standard lot

  • is confirmed to represent a low-passage of the corresponding mycoplasma reference strain
  • has been authenticated based on the mycoplasma species (and strain) level
  • is quantified/calibrated based on colony forming units (CFU)
  • is evaluated for genome copy (GC) numbers
  • is confirmed to have a low GC/CFU ratio
  • is confirmed to have a high viability after thawing
  • has a shelf life of at least 2 years which can be prolonged based on stability test results

 

All culture reference standards are available individually for each mycoplasma strain. Our staff can advise you on the choice of the mycoplasma strain. Please contact us: office@mycoplasma.cc  for more information.

Custom-made mycoplasma reference standards of mycoplasma strains not included in our reference standard portfolio of 30 strains can be prepared on request.

 

Aliquot Sizes & CFU Concentrations

We offer our CFU-calibrated mycoplasma culture reference standards in the following CFU concentrations of total mycoplasma cells, ready-to-use without any further dilution requirements:

  • 1.000 CFU/100 µL
  • 100 CFU/100 µL
  • 10 CFU/100 µL

For each lot of reference standard preparation, CFU values corresponding to total cells and to viable cells after thawing as well as the GC/CFU ratio are provided in certificates of analysis.

Our mycoplasma culture reference standards come in 250 µL volumes.

If you have special requirements regarding volume, titer or viability, please contact us: office@mycoplasma.cc.  We will make sure to satisfy your specific needs.

 

mbsCRS Panels according to EP 9th Ed. Chapter 2.6.7 & JP 17th Ed.

For customers who wish to conduct NAT validation studies at their in-house facility we have the complete set of type strains of the 9 mycoplasma species  listed in EP 9th Ed. Chapter 2.6.7. (mbsCRS-EP9) available as culture reference standard package, and - if an enrichment step is included in the assay format -  the reference strain Mycoplasma hyorhinis DBS 1050 for highly fastidious "non-cultivable" cell culture-adapted cultivar-α strains is included in this EP reference standard panel (mbsCRS-EP10). These 10 strains as well as the 5 EDQM reference strains and in-house reference field strains are recommended as test strains in the guideline for mycoplasma NAT validation described in EP 2.6.7.

The 7 mycoplasma type strains required according to JP 17th Ed. as test organisms for validation of PCR assays, are offered as JP reference standard panel (mbsCRS-JP7).

 

Mycoplasma
Type/Reference Strain
Product Code Optional CFU Titer/100 µL
mbsCRS-EP9 mbsCRS-EP10 mbsCRS-JP7
A. laidlawii PG8T 1.000 CFU
100 CFU
10 CFU
M. arginini G230T
M. fermentans PG18T
M. hyorhinis BTS7T
M. orale CH19299T
M. pneumoniae FHT
M. gallisepticum PG31T  
M. synoviae WVU 1853T  
S. citri R8-A2T  
M. hyorhinis DBS 1050    
M. salivarium PG20T    


DNA Reference Standards

Mycoplasma DNA reference standards (mbsDNA) are offered by Mycoplasma Biosafety for application in qualitative and real-time NAT-based mycoplasma detection assays.

A comprehensive portfolio of DNA reference standards of mycoplasma type and reference field strains - including all strains referenced in the EP 2.6.7. Guidance for NAT-based assays - are available with the following specifications provided in lot-specific certificates of analysis:

  • Genomic DNA derived from low-passage mycoplasma culture reference standard preparations
  • Precisely calibrated based on the number of genome copies (GC): 100 GC/µL
  • All DNA reference standards are provided in 100 µL aliquots.
  • Conveniently ready-to-use without further dilution.

 

Our mycoplasma DNA reference standards are suitable for the following applications:

  • for highest-accuracy spike inoculation of cell culture and product matrix samples
  • for method- and product-specific validation of qualitative and real time NAT-based test systems
  • as positive controls for routine mycoplasma testing by NAT-based assays

 

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