Certification of Reference Materials for Detection of the Human Prothrombin Gene G20210A Sequence Variant

There is a need for reference materials in the field of genetic testing for verification of tests results obtained in patients and probands. New types of certified reference materials (CRMs) for genetic testing of the human prothrombin gene G20210A mutation are available. Homogeneity, stability and fitness for the purpose of the plasmids could be demonstrated and no evidence was found that they would not work with other methods as long as these are targeting the whole or parts of the prothrombin gene fragment inserted into the plasmids. The described CRMs support the efforts of the international community in development, validation and harmonisation of tests for molecular genetic testingJRC.D.2-Reference material