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Cell culture contamination control

Cell culture contamination control: Misc Products

Mycoplasma 100CFU™ Sensitivity Standards

Mycoplasma 100CFU™ Sensitivity Standards are designed as complementary products to the 10CFU™ Sensitivity Standards (Cat. No. 102-XX03) to perform the validation of nucleic acid amplification technology (NAT)-based tests for mycoplasma detection.

Minerva Biolabs

Catalogue No.DescriptionPack SizePriceQty
103-1003Mycoplasma arginini 100CFU Sensitivity Standard3 vials of 100 CFU £395.35 Quantity Add to Order
103-1103Mycoplasma salivarium 100CFU Sensitivity Standard3 vials of 100 CFU £395.35 Quantity Add to Order
103-2003Mycoplasma orale 100CFU Sensitivity Standard3 vials of 100 CFU £395.35 Quantity Add to Order
103-3003Mycoplasma gallisepticum 100CFU Sensitivity Standard3 vials of 100 CFU £395.35 Quantity Add to Order
103-4003Mycoplasma pneumoniae 100CFU Sensitivity Standard3 vials of 100 CFU £395.35 Quantity Add to Order
103-5003Mycoplasma synoviae 100CFU Sensitivity Standard3 vials of 100 CFU £395.35 Quantity Add to Order
103-6003Mycoplasma fermentans 100CFU Sensitivity Standard3 vials of 100 CFU £395.35 Quantity Add to Order
103-7003Mycoplasma hyorhinis 100CFU Sensitivity Standard3 vials of 100 CFU £395.35 Quantity Add to Order
103-8003Acholeplasma laidlawii 100CFU Sensitivity Standard3 vials of 100 CFU £395.35 Quantity Add to Order

Mycoplasma 100CFU™ Sensitivity Standards

Mycoplasma 100CFU™ Sensitivity Standards are designed as complementary products to the 10CFU™ Sensitivity Standards (Cat. No. 102-XX03) to perform the validation of nucleic acid amplification technology (NAT)-based tests for mycoplasma detection.

Minerva Biolabs

100CFU™ Sensitivity Standards are designed as complementary products to the 10CFU™ Sensitivity Standards (Cat. No. 102-XX03) to perform the validation of nucleic acid amplification technology (NAT)-based tests for mycoplasma detection.

The European Pharmacopoeia Chapter 2.6.7 (EP 2.6.7) and the Japanese Pharmacopoeia (JP G3, 17th Edition) require NAT-based tests (e.g. PCR) to detect 10 Colony Forming Units per ml of sample volume (CFU/ml). The testing facility must perform an in-house method validation for the selected sample matrix (matrix validation). This process aims at verifying the test’s compliance in terms of sensitivity and robustness and generally requires one or more mycoplasma spikes. However, for most cell culture and production facilities culturing or handling viable mycoplasma as reference tools is inadmissible.

Our 100CFU™ Sensitivity Standards contain irreversibly inactivated mycoplasma in an amount corresponding to 100 CFU and provide an additional test concentration to the 10CFU™ Sensitivity Standards for the validation of PCR-based detection tests. Including this supplementary concentration in the matrix validation procedure significantly improves the confidence of the tested method.

The Certificate of Analysis provides the specific genome units (GU) to CFU ratio for each lot.

 

Recommended Use:

100CFU™ Sensitivity Standards are intended as complementary products to the 10CFU™ Sensitivity Standards to validate the robustness and sensitivity of NAT-based mycoplasma tests.

Contains 3 vials containing 100 CFU of the particular mycoplasma as well as 2 vials negative control. The components are lyophilized.

Note: Due to its characteristic low output titers, Spiroplasma citri is not available.

Result Evaluation

Application of a PCR-based mycoplasma test, e.g. Venor®GeM qEP Mycoplasma Detection kit (Cat. No. 11-9025 / 11-9100 / 11-9250) Required Consumables Sterile 1.5 ml reaction tubes and filter tips Appropriate DNA extraction kit (e.g. Venor®GeM Sample Preparation Kit, Cat. No. 56-1050) 10CFU™ Sensitivity Standards available for all EP-/JP-listed mycoplasma species (Cat. No. 102-XX03) Required Lab Devices Microcentrifuge Pipetting equipment Shelf Life and Storage The date of expiry of the unopened product is given on the package label. The components must be stored until use at 2 to 8 °C. The product is shipped at ambient temperature.

If you cannot find the answer to your problem below then please contact us or telephone 01954 210 200

Mycoplasma 100CFU™ Sensitivity Standards

Mycoplasma 100CFU™ Sensitivity Standards are designed as complementary products to the 10CFU™ Sensitivity Standards (Cat. No. 102-XX03) to perform the validation of nucleic acid amplification technology (NAT)-based tests for mycoplasma detection.

Minerva Biolabs

Dowload pdf from supplier's website here

If you cannot find the answer to your problem below then please contact us or telephone 01954 210 200

Mycoplasma 100CFU™ Sensitivity Standards

Mycoplasma 100CFU™ Sensitivity Standards are designed as complementary products to the 10CFU™ Sensitivity Standards (Cat. No. 102-XX03) to perform the validation of nucleic acid amplification technology (NAT)-based tests for mycoplasma detection.

Minerva Biolabs

Recommended Use:

100CFU™ Sensitivity Standards are intended as complementary products to the 10CFU™ Sensitivity Standards to validate the robustness and sensitivity of NAT-based mycoplasma tests.

If you cannot find the answer to your problem below then please contact us or telephone 01954 210 200