10CFU Sensitivity Standard: Mycoplasma orale

Mycoplasma tests according to the European Pharmacopoeia (EP) Chapter 2.6.7 require a sensitivity of 10 colony forming units (CFU) per ml sample volume for NAT-based methods such as PCR in order to replace traditional culture methods. This sensitivity must be accomplished as part of the robustness testing for any particular sample matrix. Using vital mycoplasma is not acceptable for the majority of cell culture laboratories due to safety regulations. Our 10CFU™ sensitivity standards contain non-vital material and allow safe and reliable validation. The mycoplasma were grown in culture medium as described in EP 2.6.7, subsequently titrated and plated on Hayflick and Frey medium for CFU determination. The mycoplasma were harvested in the early logarithmic growth phase to ensure a high ratio of vital to non-vital mycoplasma and thus a low ratio of GU* to CFU. All strains were obtained from the National Collection of Type Cultures (NCTC), UK, and cultivated in low passages. Scope of Application 10CFU™ Sensitivity Standards are intended for validating the robustness and sensitivity of NAT-based mycoplasma tests. Kit Components Unit package: 3 vials containing 10 cfu of the particular mycoplasma as well as 3 vials negative control Set package: 2 vials of each EP 2.6.7-listed mycoplasma containing 10 cfu (18 vials in total) as well as 2 vials negative control The components are lyophilized. Evaluation Application of a PCR-based mycoplasma test, e.g. Venor®GeM qEP Mycoplasma Detection kit Required Consumables Sterile 1.5 ml reaction tubes, filter tips, appropriate DNA extraction kit Required lab devices Microcentrifuge, micropipettes Shelf Life and Storage The date of expiry is given on each package. The unopened kit should be stored at +2 to +8°C.

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