QIAGEN's tuberculosis blood test QuantiFERON-TB Gold Plus gains CE-marking under new EU IVDR framework

Author's Avatar
Feb 14, 2023

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the certification of QuantiFERON-TB Gold Plus (QFT-Plus) – the world’s leading tuberculosis (TB) blood test – under the European Union’s 2017/746 In Vitro Diagnostic Medical Devices Regulation (IVDR) which is replacing the 98/79/EC In Vitro Diagnostic Directive (IVDD). QFT-Plus is QIAGEN’s trusted test, endorsed by the WHO, that aids in indirect detection of the bacteria that causes tuberculosis (TB). The IVDR certification of QFT-Plus follows the QIAGEN ipsogen JAK2 RGQ PCR Kit as well as the NeuMoDx Systems and reagents, which gained IVDR CE-marking in late 2022.