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Cell culture contamination control

Cell culture contamination control: Misc 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

Catalogue No.DescriptionPack SizePriceQty
102-0002Mycoplasma setall listed species £1,161.70 Quantity Add to Order
102-1003Mycoplasma arginini3 ampoulles 10CFU each £215.80 Quantity Add to Order
102-2003Mycoplasma orale3 ampoulles 10CFU each £215.80 Quantity Add to Order
102-3003Mycoplasma gallisepticum3 ampoulles 10CFU each £215.80 Quantity Add to Order
102-4003Mycoplasma pneumoniae3 ampoulles 10CFU each £215.80 Quantity Add to Order
102-5003Mycoplasma synoviae3 ampoulles 10CFU each £215.80 Quantity Add to Order
102-6003Mycoplasma fermentans3 ampoulles 10CFU each £215.80 Quantity Add to Order
102-7003Mycoplasma hyorhinis3 ampoulles 10CFU each £215.80 Quantity Add to Order
102-8003Acholeplasma laidlawii3 ampoulles 10CFU each £215.80 Quantity Add to Order
102-9003Spiroplasma citri3 ampoulles 10CFU each £215.80 Quantity Add to Order

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 Standards10CFU box

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 at 2 to 8 °C for at least 12 months.

10CFU graph

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