Qiagen’s TB blood test gains CE-marking under new EU IVDR framework

Qiagen announced the certification of QuantiFERON-TB Gold Plus – a tuberculosis blood test – under the European Union’s 2017/746 In Vitro Diagnostic Medical Devices Regulation which is replacing the 98/79/EC In Vitro Diagnostic Directive. QFT-Plus is QIAGEN’s trusted test, endorsed by the WHO, that aids in indirect detection of the bacteria that causes tuberculosis. 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. The updated set of rules, which became effective May 26, 2022, is now imposing higher and broader requirements on IVD manufacturers to receive CE-marking for their products. It also includes stronger oversight by independent EU-designated organizations, referred to as Notified Bodies. QuantiFERON-TB Gold Plus is classified as a Class C device under IVDR. With its more stringent mandates, the European regulatory framework comes closer to the FDA IVD regulations in the US and aims to ensure higher quality of health services for patients.