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Mycoplasma 10CFU™ Sensitivity Standards
10CFU™ Sensitivity Standards for validation of detection limit and robustness for individual sample material according to EP 2.6.7 with inactivated mycoplasma particles
Minerva Biolabs
| Catalogue No. | Description | Pack Size | Price | Qty |
|
|---|---|---|---|---|---|
| 102-0002 | Mycoplasma set | all listed species | £1,289.00 | Quantity | Add to Order |
| 102-1003 | Mycoplasma arginini | 3 ampoulles 10CFU each | £239.00 | Quantity | Add to Order |
| 102-1103 | Mycoplasma salivarium | 3 ampoulles 10CFU each | £239.00 | Quantity | Add to Order |
| 102-2003 | Mycoplasma orale | 3 ampoulles 10CFU each | £239.00 | Quantity | Add to Order |
| 102-3003 | Mycoplasma gallisepticum | 3 ampoulles 10CFU each | £239.00 | Quantity | Add to Order |
| 102-4003 | Mycoplasma pneumoniae | 3 ampoulles 10CFU each | £239.00 | Quantity | Add to Order |
| 102-5003 | Mycoplasma synoviae | 3 ampoulles 10CFU each | £239.00 | Quantity | Add to Order |
| 102-6003 | Mycoplasma fermentans | 3 ampoulles 10CFU each | £239.00 | Quantity | Add to Order |
| 102-7003 | Mycoplasma hyorhinis | 3 ampoulles 10CFU each | £239.00 | Quantity | Add to Order |
| 102-8003 | Acholeplasma laidlawii | 3 ampoulles 10CFU each | £239.00 | Quantity | Add to Order |
| 102-9003 | Spiroplasma citri | 3 ampoulles 10CFU each | £239.00 | Quantity | Add to Order |
Related products
Mycoplasma 10CFU™ Sensitivity Standards
10CFU™ Sensitivity Standards for validation of detection limit and robustness for individual sample material according to EP 2.6.7 with inactivated mycoplasma particles
Minerva Biolabs
10CFU™ Sensitivity Standards
European Pharmacopoeia 2.6.7 Mycoplasmas requires a sensitivity of 10 CFU/ml sample volume for NAT-based methods like PCR to replace the traditional culture method. This feature of the test method must be shown by the performing lab as part of the robustness testing in presence of the sample matrix. As most cell culture labs and production facilities cannot accept vital mycoplasma in their facility or do not have access to a microbiology lab able to cultivate mycoplasma, these preparations allow safe and reliable validation of the procedure.The mycoplasma have been cultivated in culture broth described in EP 2.6.7, titrated immediately in culture broth and plated for quantification in colony forming units (CFU/ml). Each dilution series has been performed in multiple by different operators for highest precision. The mycoplasma broth was harvested in the early logarithmic phase of the growth to avoid an atypical high ratio of dead mycoplasma particles and correspondingly a high GU*:CFU ratio. All strains have been obtained from the National Collection of Type Cultures (NCTC), UK, and cultivated in low passages.
Kit Components
3 vials with 10 CFU of the corresponding mycoplasma species, 2 negative control vials
For the mycoplasma set:2 vials with 10 CFU of each mycoplasma species listed in the EP 2.6.7 (18 vials in total), 2 negative controls
Result evaluation
Use of a suitable Mycoplasma PCR kit, e.g. Intego® Mycoplasma
Required Consumables
None
Required lab devices
Regular lab equipment (centrifuge, pipettes, etc.)
Shelf Life and Storage
Kit components are maintainable at2 to8 °C for at least 12 months.
Fig. 10 CFU have been resuspended in cell culture medium, 200 µl DNA extracted with the MB DNA Extraction and mycoplasmal DNA amplified with Intego® Mycoplasma. PCR was performed on a Corbett RotorGene®6000.
If you cannot find the answer to your problem below then please contact us or telephone 01954 210 200
Mycoplasma 10CFU™ Sensitivity Standards
10CFU™ Sensitivity Standards for validation of detection limit and robustness for individual sample material according to EP 2.6.7 with inactivated mycoplasma particles
Minerva Biolabs
Click here for protocols
If you cannot find the answer to your problem below then please contact us or telephone 01954 210 200
Mycoplasma 10CFU™ Sensitivity Standards
10CFU™ Sensitivity Standards for validation of detection limit and robustness for individual sample material according to EP 2.6.7 with inactivated mycoplasma particles
Minerva Biolabs
For validating robustness and sensitivity of NAT-based mycoplasma test methods in presence of the sample matrix.
Each vial contains 10 CFU of inactivated mycoplasma. By adding the sample matrix of interest a sample according to EP 2.6.7 is prepared which has to be tested positive by the method applied. Obviously, the inactivated sample material is not suitable for the culture method anymore. As a result of proficiency tests on NAT-methods for mycoplasma detection it became obvious that in means of highest sensitivity DNA extraction is indispensible. The extract can directly be used for PCR.
If you cannot find the answer to your problem below then please contact us or telephone 01954 210 200
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