Mycoplasma QA Program for Nucleic Acid Detection Techniques

Minerva Biolabs GmbH and Mycoplasma Experience Ltd. are organizing the first collaborative study of molecular biological mycoplasma detection for cell culture materials and biologicals. This study was strong demanded by customer requests and was requested by the IRPCM Group 'Cell Culture' of the International Organisation of Mycoplasmology (IOM).

The aim of the collaborative study is an initial survey on the quality of mycoplasma testing and long term to establish an external quality assurance programme and thus improving the reliability of NAT-based mycoplasma testing. The study will allow each individual laboratory an assessment of the accuracy and sensitivity of the tests carried out in international comparison. The collaborative study is planned in future on a semi-annual basis.
An identical set of samples will be shipped to all participants and independently analyzed under individual conditions. The results are evaluated statistically. All participants receive the evaluation for information about the correctness of the analysis as well as an individual certificate of success, if 4 of 5 samples were analyzed properly. The evaluation is anonymous. The data might be published in respect of relevance and interest at conferences or in print media but not for commercial use.

The mycoplasmas in the sample set will be titrated by Mycoplasma Experience Ltd. applying the culture method (CFU/ml), and by Minerva Biolabs using a qPCR method (GU/ml). The samples set may contain different sample matrices, concentrations and species.