10CFU™ Sensitivity Standards

10CFU™ Sensitivity Standards

Description

The European Pharmacopoeia Chapter 2.6.7 (EP 2.6.7) and the Japanese Pharmacopoeia Chapter G3 (JP G3) describe nucleic acid amplification technology (NAT)-based tests for mycoplasma such as PCR. Both require to show the detection of 10 Colony Forming Units per ml of sample volume (CFU/ml), if said tests are proposed as alternative methods to traditional culture assays. Such sensitivity must be demonstrated as part of the robustness testing for each specific sample matrix of interest. However, since most cell culture labs and production facilities do not have access to a microbiology lab, culturing or handling viable mycoplasma colonies to use as reference tools for sensitivity testing is inadmissible.

Recommended Use

10CFU™ Sensitivity Standards are intended for validating the robustness and sensitivity of NAT-based mycoplasma tests.

Required Consumables

Sterile 1.5 ml reaction tubes, filter tips, appropriate DNA extraction kit

Required Lab Devices

Microcentrifuge, pipetting equipment

Shelf Life and Storage

The date of expiry is given on each package. The unopened kit should be stored at +2 to +8 °C.