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.
100CFU™ Sensitivity Standards are intended as complementary products to the 10CFU™ Sensitivity Standards to validate the robustness and sensitivity of NAT-based mycoplasma tests.
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.
Application of a PCR-based mycoplasma test, e.g. Venor®GeM qEP Mycoplasma Detection kit (Cat. No. 11-9025 / 11-9100 / 11-9250)
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
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.
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